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a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "27/10/2010", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Allergy Therapeutics (UK) Ltd; Tel. +44(0)1903 844 700; E-mail: infoservices@allergytherapeutics.com", "first_published_date": "25/11/2010", "last_updated_date": "25/03/2026", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000807-pip01-09" }, { "decision_number": "P/220/2010", "pip_number": "EMEA-000812-PIP01-09", "active_substance": "12 grass pollen extract, cultivated rye pollen extract and birch/alder/hazel pollen extract", "invented_name": "", "therapeutic_area": "Pneumology-allergology", "pharmaceutical_forms": "Suspension for injection", "condition_indication": "Treatment of allergic rhinitis / rhino-conjunctivitis", "routes_of_administration": "Subcutaneous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "29/10/2010", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Allergy Therapeutics (UK) Ltd; Tel. +44(0)1903 844 700; E-mail: infoservices@allergytherapeutics.com", "first_published_date": "25/11/2010", "last_updated_date": "25/03/2026", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000812-pip01-09" }, { "decision_number": "P/28/2010", "pip_number": "P/28/2010", "active_substance": "dalcetrapib", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Lipoprotein deficiency", "routes_of_administration": "Oral use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "05/03/2010", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Roche Registration Limited; info.paediatrics@roche.com; Switzerland; Phone: +41 616879411; Fax: +41 616879233", "first_published_date": "19/04/2010", "last_updated_date": "25/03/2026", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/p-28-2010" }, { "decision_number": "P/0322/2020", "pip_number": "EMEA-002101-PIP02-18-M01", "active_substance": "iodine (131-I) murine IgG1 monoclonal antibody against B7-H3 (131I-omburtamab)", "invented_name": "", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Solution for infusion", "condition_indication": "Treatment of neuroblastoma", "routes_of_administration": "Intracerebral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "10/08/2020", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Y-mAbs Therapeutics A/S; E-mail: jow@ymabs.com; Tel. +45 70261414", "first_published_date": "02/04/2020", "last_updated_date": "25/03/2026", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002101-pip02-18-m01" }, { "decision_number": "P/0095/2020", "pip_number": "EMEA-001964-PIP02-19", "active_substance": "cannabidiol", "invented_name": "Epidyolex", "therapeutic_area": "Neurology", "pharmaceutical_forms": "Oral solution", "condition_indication": "Treatment of Rett syndrome", "routes_of_administration": "Oral use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "18/03/2020", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Jazz Pharmaceuticals Ireland Limited; E-mail: medinfo-int@jazzpharma.comTel: +353 1 968 1631", "first_published_date": "17/06/2021", "last_updated_date": "25/03/2026", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001964-pip02-19" }, { "decision_number": "P/0234/2022", "pip_number": "EMEA-001964-PIP03-21", "active_substance": "cannabidiol", "invented_name": "", "therapeutic_area": "Neurology", "pharmaceutical_forms": "Oral solution", "condition_indication": "Epilepsy with myoclonic atonic seizures", "routes_of_administration": "Oral use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "08/07/2022", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Jazz Pharmaceuticals Ireland Limited; E-mail: medinfo-int@jazzpharma.comTel: +353 1 968 1631", "first_published_date": "19/06/2023", "last_updated_date": "25/03/2026", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001964-pip03-21" }, { "decision_number": "P/0396/2017", "pip_number": "EMEA-002142-PIP01-17", "active_substance": "trazodone (hydrochloride)", "invented_name": "Trittico and associated names", "therapeutic_area": "Neurology", "pharmaceutical_forms": "Age appropriate oral liquid dosage formulation", "condition_indication": "Treatment of insomnia", "routes_of_administration": "Oral use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "19/12/2017", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F - S.p.A; Tel. +39 0691045249; E-mail: m.gatto@angelini.it", "first_published_date": "05/03/2018", "last_updated_date": "25/03/2026", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002142-pip01-17" }, { "decision_number": "P/34/2011", "pip_number": "EMEA-000977-PIP01-10", "active_substance": "house dust mites allergen extract from Dermatophagoides pteronyssinus and Dermatophagoides farinae (50/50)", "invented_name": "", "therapeutic_area": "Pneumology-allergology", "pharmaceutical_forms": "Oral solution", "condition_indication": "Treatment of allergic rhinitis / rhino-conjunctivitis", "routes_of_administration": "Sublingual use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "28/01/2011", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Stallergenes S.A.; pip.germany@stallergenes.fr; France; Phone: +33 155592100; Fax: +33 155592002", "first_published_date": "24/02/2011", "last_updated_date": "25/03/2026", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000977-pip01-10" }, { "decision_number": "P/0153/2024", "pip_number": "EMEA-003277-PIP02-23", "active_substance": "live attenuated respiratory syncytial virus (RSV)", "invented_name": "", "therapeutic_area": "Infections and infestations", "pharmaceutical_forms": "Nasal spray (solution)", "condition_indication": "Prevention of respiratory syncytial virus disease", "routes_of_administration": "Nasal use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "06/05/2024", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Sanofi Winthrop IndustrieE-mail: contact-us@sanofi.comTel: +33 1 69 74 56 95", "first_published_date": "10/06/2025", "last_updated_date": "25/03/2026", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003277-pip02-23" }, { "decision_number": "EMA/PE/0000232315", "pip_number": "EMA/PE/0000232315", "active_substance": "spesolimab", "invented_name": "Spevigo", "therapeutic_area": "Congenital, familial and genetic disorders", "pharmaceutical_forms": "Solution for infusion;Solution for injection", "condition_indication": "Treatment of Netherton syndrome", "routes_of_administration": "Intravenous use;Subcutaneous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "19/03/2025", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Boehringer Ingelheim International GmbH E-mail: COMMSPaediatrics@boehringer-ingelheim.comTel. +49 (0)6132 77 8271", "first_published_date": "15/07/2024", "last_updated_date": "20/03/2026", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/ema-pe-0000232315" }, { "decision_number": "P/0217/2015", "pip_number": "EMEA-001272-PIP02-13-M01", "active_substance": "azacitidine", "invented_name": "Vidaza", "therapeutic_area": "Haematology-Hemostaseology", "pharmaceutical_forms": "Powder for suspension for injection;Powder for solution for infusion", "condition_indication": "Treatment of acute myeloid leukaemia;Treatment of myelodysplastic syndrome (including juvenile myelomonocytic leukaemia)", "routes_of_administration": "Subcutaneous use;Intravenous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "02/10/2015", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Celgene Europe LimitedTel.  +41 327298500E-mail: medinfo.intl@celgene.com", "first_published_date": "20/03/2014", "last_updated_date": "16/03/2026", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001272-pip02-13-m01" }, { "decision_number": "P/0073/2024", "pip_number": "EMEA-002741-PIP01-20-M02", "active_substance": "fordadistrogene movaparvovec", "invented_name": "", "therapeutic_area": "Congenital, familial and genetic disorders", "pharmaceutical_forms": "Concentrate for solution for infusion", "condition_indication": "Treatment of Duchenne muscular dystrophy", "routes_of_administration": "Intravenous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "08/03/2024", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Pfizer Europe MA EEIGE-mail: medical.information@pfizer.com Tel. +44 1304646607", "first_published_date": "22/09/2021", "last_updated_date": "16/03/2026", "pip_url": 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"https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/ema-pe-0000226246" }, { "decision_number": "EMA/PE/0000226217", "pip_number": "EMA/PE/0000226217", "active_substance": "bictegravir;emtricitabine;tenofovir alafenamide", "invented_name": "Biktarvy", "therapeutic_area": "Infectious diseases", "pharmaceutical_forms": "Age appropriate oral formulation;Film-coated tablet", "condition_indication": "Treatment of human immunodeficiency virus (HIV-1) infection", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "28/01/2025", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Gilead Sciences International Ltd. ; Tel. +44 (0)1223 897 300 ; E-mail: regulatory.pip@gilead.com", "first_published_date": "02/02/2016", "last_updated_date": "12/03/2026", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/ema-pe-0000226217" }, { "decision_number": "EMA/PE/0000225746", "pip_number": "EMA/PE/0000225746", "active_substance": "atogepant", "invented_name": "Aquipta", "therapeutic_area": "Surgical and medical procedures", "pharmaceutical_forms": "Tablet;Age appropriate oral solid dosage form", "condition_indication": "Prevention of migraine headaches", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "02/01/2025", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "AbbVie LtdE-mail: paediatricteam@abbvie.comTel. +44(0) 1628925033", "first_published_date": "09/06/2020", "last_updated_date": "12/03/2026", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/ema-pe-0000225746" }, { "decision_number": "EMA/PE/0000226088", 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"pharmaceutical_forms": "Solution for injection", "condition_indication": "Treatment of Sjögren's syndrome", "routes_of_administration": "Intravenous use;Subcutaneous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "03/01/2025", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Argenx  E-mail: regulatory@argenx.com  Tel.  +32 93103400", "first_published_date": "12/03/2026", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/ema-pe-0000225023" }, { "decision_number": "EMA/PE/0000225073", "pip_number": "EMA/PE/0000225073", "active_substance": "recombinant parathyroid hormone", "invented_name": "Natpar", "therapeutic_area": "Endocrine disorders", "pharmaceutical_forms": "Powder and solvent for solution for injection", "condition_indication": "Angina pectoris;Treatment of hypoparathyroidism", "routes_of_administration": "Subcutaneous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "28/01/2025", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Takeda Pharmaceuticals International AG Ireland Branch; E-mail: medinfoemea@takeda.com; Tel. +80066838470", "first_published_date": "12/03/2026", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/ema-pe-0000225073" }, { "decision_number": "EMA/PE/0000225073", "pip_number": "EMA/PE/0000225241", "active_substance": "calcium chloride dihydrate;magnesium chloride hexahydrate;sodium chloride;sodium lactate;xylitol;d-glucose;levocarnitine", "invented_name": "", "therapeutic_area": "Renal and urinary disorders", "pharmaceutical_forms": "Solution for peritoneal dialysis", "condition_indication": "Acute 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seizures associated with Tuberous Sclerosis Complex (TSC)", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "03/01/2025", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Jazz Pharmaceuticals Ireland Limited; E-mail: michael.chiarella@jazzpharma.com; Tel. +1 6092436211", "first_published_date": "24/07/2017", "last_updated_date": "12/03/2026", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/ema-pe-0000224912" }, { "decision_number": "EMA/PE/0000224955", "pip_number": "EMA/PE/0000224955", "active_substance": "ribitol", "invented_name": "", "therapeutic_area": "Congenital, familial and genetic disorders", "pharmaceutical_forms": "Powder for oral use;Age appropriate oral dosage formulation", "condition_indication": "Treatment of limb-girdle muscular dystrophy", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "03/01/2025", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "BridgeBio Europe B.V.; E-mail: info@mlbiosolutions.comTel: (704) 285-8153", "first_published_date": "10/01/2023", "last_updated_date": "12/03/2026", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/ema-pe-0000224955" }, { "decision_number": "EMA/PE/0000224768", "pip_number": "EMA/PE/0000224768", "active_substance": "vosoritide", "invented_name": "Voxzogo", "therapeutic_area": "Congenital, familial and genetic disorders", "pharmaceutical_forms": "Powder and solvent for solution for injection", "condition_indication": "Treatment of hypochondroplasia", "routes_of_administration": "Subcutaneous use", "decision_type": "PM: decision on the application for modification of an 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"pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003639-pip01-24" }, { "decision_number": "P/0001/2025", "pip_number": "EMEA-003636-PIP01-24", "active_substance": "respiratory syncytial virus, prefusion F protein, virus-like particle / human metapneumovirus, prefusion F protein, virus-like particle (IVX-A12)", "invented_name": "", "therapeutic_area": "Infections and infestations", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Prevention of lower respiratory tract disease caused by human metapneumovirus;Prevention of lower respiratory tract disease caused by respiratory syncytial virus", "routes_of_administration": "Intramuscular use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "28/01/2025", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "AstraZeneca ABE-mail: paediatrics@astrazeneca.com", "first_published_date": "11/03/2026", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003636-pip01-24" }, { "decision_number": "P/0003/2025", "pip_number": "EMEA-003635-PIP01-24", "active_substance": "heterologous intestinal microbiota from healthy donors (MBK-01)", "invented_name": "", "therapeutic_area": "Infections and infestations", "pharmaceutical_forms": "Gastro-resistant capsule (hard)", "condition_indication": "Treatment of Clostridioides difficile infection (CDI)", "routes_of_administration": "Oral use;Gastric use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "29/01/2025", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Mikrobiomik Healthcare Company S.L.Email: hello@mikrobiomik.net Tel.: 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"last_updated_date": "11/03/2026", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001161-pip02-11-m03" }, { "decision_number": "EMA/PE/0000224110", "pip_number": "EMA/PE/0000224110", "active_substance": "esketamine hydrochloride", "invented_name": "Spravato", "therapeutic_area": "Psychiatry", "pharmaceutical_forms": "Nasal spray (solution)", "condition_indication": "Treatment of major depressive disorder", "routes_of_administration": "Intranasal use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "28/01/2025", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Janssen-Cilag International NV; Tel. +32 1460 2111; E-mail: contact@janssen-emea.com", "first_published_date": "17/03/2017", "last_updated_date": "11/03/2026", "pip_url": 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"EMEA-003604-PIP01-24", "active_substance": "luliconazole", "invented_name": "", "therapeutic_area": "Skin and subcutaneous tissue disorders", "pharmaceutical_forms": "Cutaneous solution", "condition_indication": "Treatment of onychomycosis", "routes_of_administration": "Cutaneous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "27/01/2025", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Sato Pharmaceutical Co. Ltd.Email: t.hirano@sato-seiyaku.co.jp Tel.:  + 81 354127056", "first_published_date": "11/03/2026", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003604-pip01-24" }, { "decision_number": "P/0400/2024", "pip_number": "EMEA-003161-PIP02-24", "active_substance": "golcadomide hydrochloride", "invented_name": "", "therapeutic_area": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)", "pharmaceutical_forms": "Capsule, hard", "condition_indication": "Treatment of mature B cell neoplasms", "routes_of_administration": "Oral use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "03/01/2025", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Bristol-Myers Squibb Pharma EEIG E-mail: medical.information@bms.com Tel. +44 (0)1423 533610", "first_published_date": "11/03/2026", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003161-pip02-24" }, { "decision_number": "EMEA-003533-PIP01-23", "pip_number": "EMEA-003533-PIP01-23", "active_substance": "livmoniplimab", "invented_name": "", "therapeutic_area": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)", "pharmaceutical_forms": "Solution for infusion", "condition_indication": "Treatment of all conditions included in the category of malignant neoplasms except melanoma, central nervous neoplasms, haematopoietic and lymphoid tissues neoplasms", "routes_of_administration": "Intravenous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "28/01/2025", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Abbvie Deutschland GmbH & Co. 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"first_published_date": "11/03/2026", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002476-pip03-24" }, { "decision_number": "EMA/PE/0000223656", "pip_number": "EMA/PE/0000223656", "active_substance": "givinostat", "invented_name": "", "therapeutic_area": "Blood and lymphatic system disorders", "pharmaceutical_forms": "Capsule, hard", "condition_indication": "Treatment of polycythaemia vera", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "03/01/2025", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Italfarmaco S.p.A. E-mail: ITFPIP@italfarmacogroup.comTel. +39 0264432500", "first_published_date": "19/08/2021", "last_updated_date": "11/03/2026", "pip_url": 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acromegaly and pituitary gigantism", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "28/01/2025", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Crinetics Pharmaceuticals Inc; E-mail: clinicaltrials@crinetics.com; Tel. +1 8338279714", "first_published_date": "10/03/2026", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/ema-pe-0000223523" }, { "decision_number": "EMA/PE/0000223677", "pip_number": "EMA/PE/0000223677", "active_substance": "coramitug", "invented_name": "", "therapeutic_area": "Immune system disorders", "pharmaceutical_forms": "Powder for solution for infusion", "condition_indication": "Adjunctive treatment in haematopoietic cell transplantation;Treatment of transthyretin amyloidosis (ATTR)", "routes_of_administration": 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"pharmaceutical_forms": "Film-coated tablet;Tablet for oral suspension;Powder for oral suspension", "condition_indication": "Treatment of malignant neoplasms of the haematopoietic and lymphoid tissue;Treatment of solid malignant tumours", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "03/01/2025", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Abbvie Deutschland GmbH & Co. KGE-mail: paediatricteam@abbvie.com Tel: +44 1628925033", "first_published_date": "28/09/2017", "last_updated_date": "06/03/2026", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/ema-pe-0000182075" }, { "decision_number": "EMA/PE/0000181243", "pip_number": "EMA/PE/0000181243", "active_substance": "glutamatergic neurotransmission enhancer BI 1569912", "invented_name": "", "therapeutic_area": "Psychiatric disorders", "pharmaceutical_forms": "Tablet", "condition_indication": "Treatment of major depressive disorder", "routes_of_administration": "Oral use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "03/01/2025", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Boehringer Ingelheim International GmbH E-mail: COMMSPaediatrics@boehringer-ingelheim.comTel. +49 (0)6132 77 8271", "first_published_date": "06/03/2026", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/ema-pe-0000181243" }, { "decision_number": "EMA/PE/0000181174", "pip_number": "EMA/PE/0000181174", "active_substance": "Dasiglucagon", "invented_name": "Zegalogue", "therapeutic_area": "Endocrine disorders", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Treatment of hypoglycaemia", "routes_of_administration": "Subcutaneous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "03/01/2025", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Zealand Pharma A/S; E-mail: info@zealandpharma.com; Tel: + 45 50603821", "first_published_date": "27/11/2018", "last_updated_date": "06/03/2026", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/ema-pe-0000181174" }, { "decision_number": "EMA/PE/0000181050", "pip_number": "EMA/PE/0000181050", "active_substance": "lonigutamab", "invented_name": "", "therapeutic_area": "Eye disorders", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Treatment of thyroid eye disease", "routes_of_administration": "Subcutaneous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "28/01/2025", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Acelyrin Inc.E-mail: info@acelyrin.com Tel.:  +1 8054564393", "first_published_date": "06/03/2026", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/ema-pe-0000181050" }, { "decision_number": "EMA/PE/0000225681", "pip_number": "EMA/PE/0000225681", "active_substance": "recombinant human ectonucleotide pyrophosphatase/phosphodiesterase 1 fused to the Fc fragment of IgG1", "invented_name": "", "therapeutic_area": "Musculoskeletal and connective tissue disorders", "pharmaceutical_forms": "Powder for solution for injection", "condition_indication": "Treatment of ectonucleotide pyrophosphatase/phosphodiesterase 1 (ENPP1) deficiency", "routes_of_administration": "Subcutaneous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "03/01/2025", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Inozyme Pharma IrelandE-mail: info@inozyme.com Tel.:  +1 8573304340", "first_published_date": "19/07/2024", "last_updated_date": "05/03/2026", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/ema-pe-0000225681" }, { "decision_number": "EMA/PE/0000225592", "pip_number": "EMA/PE/0000225592", "active_substance": "ulixacaltamide (hydrochloride)", "invented_name": "", "therapeutic_area": "Nervous system disorders", "pharmaceutical_forms": "Tablet", "condition_indication": "Treatment of essential tremor", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "03/01/2025", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Transcrip Ireland LimitedTel: +353 18851710E-mail: regulatory@transcrip-group.com", "first_published_date": "05/03/2026", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/ema-pe-0000225592" }, { "decision_number": "EMA/PE/0000225245", "pip_number": "EMA/PE/0000225245", "active_substance": "nedosiran", "invented_name": "", "therapeutic_area": "Congenital, familial and genetic disorders;Uro-nephrology", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Treatment of primary hyperoxaluria", "routes_of_administration": "Subcutaneous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "03/01/2025", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Novo Nordisk A/S; E-mail: paediatrics@novonordisk.com ; Tel.: +45 44444848", "first_published_date": "03/04/2020", "last_updated_date": "05/03/2026", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/ema-pe-0000225245" }, { "decision_number": "EMA/PE/0000223498", "pip_number": "EMA/PE/0000223498", "active_substance": "Infigratinib", "invented_name": "", "therapeutic_area": "Congenital, familial and genetic disorders", "pharmaceutical_forms": "Tablet", "condition_indication": "Treatment of achondroplasia", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "03/01/2025", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "QED Therapeutics Inc.; E-mail: info@qedtx.com; Tel: +1 65202314088", "first_published_date": "08/09/2022", "last_updated_date": "05/03/2026", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/ema-pe-0000223498" }, { "decision_number": "EMA/PE/0000223490", "pip_number": "EMA/PE/0000223490", "active_substance": "Eptinezumab", "invented_name": "Vyepti", "therapeutic_area": "Surgical and medical procedures;Neurology", "pharmaceutical_forms": "Concentrate for solution for infusion", "condition_indication": "Prevention of migraine headaches", "routes_of_administration": "Intravenous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "28/01/2025", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "H. Lundbeck A/S E-mail: commres2738@lundbeck.com Tel: +45 36301311", "first_published_date": "23/03/2020", "last_updated_date": "05/03/2026", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/ema-pe-0000223490" }, { "decision_number": "EMA/PE/0000223351", "pip_number": "EMA/PE/0000223351", "active_substance": "Cipaglucosidase alfa", "invented_name": "Pombiliti", "therapeutic_area": "Congenital, familial and genetic disorders", "pharmaceutical_forms": "Powder for concentrate for solution for infusion", "condition_indication": "Treatment of glycogen storage disease Type II (Pompe's disease)", "routes_of_administration": "Intravenous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "03/01/2025", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Amicus Therapeutics Europe Limited; E-mail: IR@amicusrx.com; Tel: +1 6096623809", "first_published_date": "17/09/2021", "last_updated_date": "05/03/2026", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/ema-pe-0000223351" }, { "decision_number": "EMA/PE/0000223288", "pip_number": "EMA/PE/0000223288", "active_substance": "evenamide", "invented_name": "", "therapeutic_area": "Nervous system disorders", "pharmaceutical_forms": "Capsule, hard", "condition_indication": "Treatment of schizophrenia", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "03/01/2025", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Newron Pharmaceuticals S.p.A. E-mail: ravi@anand.chTel: +39026103461", "first_published_date": "07/03/2023", "last_updated_date": "05/03/2026", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/ema-pe-0000223288" }, { "decision_number": "EMA/PE/0000222938", "pip_number": "EMA/PE/0000222938", "active_substance": "Neisseria meningitidis group A polysaccharide conjugated to tetanus toxoid carrier protein (MenABCWY);Neisseria meningitidis group C polysaccharide conjugated to tetanus toxoid carrier protein;Neisseria meningitidis group W-135 polysaccharide conjugated to tetanus toxoid carrier protein;Neisseria meningitidis group Y polysaccharide conjugated to tetanus toxoid carrier protein;recombinant Neisseria meningitidis serogroup B protein 1;recombinant Neisseria meningitidis serogroup B protein 2;recombinant Neisseria meningitidis serogroup B protein 3;Neisseria meningitidis serogroup B Protein-based active substance (MenPenta vaccine)", "invented_name": "", "therapeutic_area": "Vaccines", "pharmaceutical_forms": "Suspension for injection", "condition_indication": "Prevention of meningococcal disease (serogroups A, B, C, W and Y)", "routes_of_administration": "Intramuscular use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "28/01/2025", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Sanofi Winthrop IndustrieE-mail: contact-us@sanofi.comTel: +33 1 69 74 56 95", "first_published_date": "20/11/2024", "last_updated_date": "05/03/2026", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/ema-pe-0000222938" }, { "decision_number": "P/0545/2022", "pip_number": "EMEA-003219-PIP01-22", "active_substance": "inclacumab", "invented_name": "", "therapeutic_area": "Haematology-Hemostaseology", "pharmaceutical_forms": "Concentrate for solution for infusion", "condition_indication": "Treatment of sickle cell disease", "routes_of_administration": "Intravenous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "30/12/2022", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Pfizer Europe MA EEIG; Tel. +44 (0)1304 646 607; E-mail: pip_enquiries@pfizer.com", "first_published_date": "10/11/2023", "last_updated_date": "05/03/2026", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003219-pip01-22" }, { "decision_number": "EMA/PE/0000230484", "pip_number": "EMA/PE/0000230484", "active_substance": "alprazolam", "invented_name": "", "therapeutic_area": "Nervous system disorders", "pharmaceutical_forms": "Inhalation powder", "condition_indication": "Treatment of epileptic seizures", "routes_of_administration": "Inhalation use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "28/01/2025", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "UCB Pharma SAE-mail: UCBCares.IE@ucb.com Tel.: +353 14632371", "first_published_date": "13/06/2023", "last_updated_date": "04/03/2026", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/ema-pe-0000230484" }, { "decision_number": "EMA/PE/0000227908", "pip_number": "EMA/PE/0000227908", "active_substance": "nerandomilast", "invented_name": "", "therapeutic_area": "Respiratory, thoracic and mediastinal disorders", "pharmaceutical_forms": "Age appropriate oral solid dosage form;Film-coated tablet", "condition_indication": "Treatment of fibrosing Interstitial Lung Diseases (ILD)", "routes_of_administration": "Gastric use;Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "28/01/2025", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Boehringer Ingelheim International GmbH E-mail: COMMSPaediatrics@boehringer-ingelheim.comTel. +49 (0)6132 77 8271", "first_published_date": "20/02/2023", "last_updated_date": "04/03/2026", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/ema-pe-0000227908" }, { "decision_number": "EMA/PE/0000227558", "pip_number": "EMA/PE/0000227558", "active_substance": "danicopan", "invented_name": "Voydeya", "therapeutic_area": "Renal and urinary disorders", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Treatment of paroxysmal nocturnal haemoglobinuria", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "28/01/2025", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Alexion EuropeEmail: regulatory-eu-lcm@alexion.com Tel.:  +353 871138827", "first_published_date": "22/07/2021", "last_updated_date": "04/03/2026", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/ema-pe-0000227558" }, { "decision_number": "EMA/PE/0000227526", "pip_number": "EMA/PE/0000227526", "active_substance": "ceftobiprole medocaril (sodium)", "invented_name": "Zeftera (previously Zevtera); Zevtera and associated names", "therapeutic_area": "Infections and infestations", "pharmaceutical_forms": "Powder for concentrate for solution for infusion", "condition_indication": "Treatment of pneumonia", "routes_of_administration": "Intravenous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "28/01/2025", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Basilea Pharmaceutica Deutschland GmbH Email: information.medical@basilea.com Tel. +41 616061111", "first_published_date": "17/10/2012", "last_updated_date": "04/03/2026", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/ema-pe-0000227526" }, { "decision_number": "EMA/PE/0000227462", "pip_number": "EMA/PE/0000227462", "active_substance": "deucrictibant monohydrate", "invented_name": "", "therapeutic_area": "Congenital, familial and genetic disorders", "pharmaceutical_forms": "Age appropriate oral solid dosage form;Capsule, soft;Prolonged-release tablet", "condition_indication": "Treatment of hereditary angioedema", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "28/01/2025", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Pharvaris Netherlands BVE-mail: info@pharvaris.comTel:  +31 (0)7120336410", "first_published_date": "21/05/2024", "last_updated_date": "04/03/2026", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/ema-pe-0000227462" }, { "decision_number": "EMA/PE/0000227425", "pip_number": "EMA/PE/0000227425", "active_substance": "efgartigimod alfa", "invented_name": "Vyvgart", "therapeutic_area": "Blood and lymphatic system disorders", "pharmaceutical_forms": "Concentrate for solution for infusion", "condition_indication": "Treatment of immune thrombocytopenia", "routes_of_administration": "Intravenous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "28/01/2025", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Argenx BVE-mail: regulatory@argenx.comTel: +32 93103400", "first_published_date": "13/04/2023", "last_updated_date": "04/03/2026", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/ema-pe-0000227425" }, { "decision_number": "EMA/PE/0000227394", "pip_number": "EMA/PE/0000227394", "active_substance": "tezacaftor;ivacaftor", "invented_name": "Symkevi", "therapeutic_area": "Congenital, familial and genetic disorders", "pharmaceutical_forms": "Film-coated tablet;Age appropriate oral solid dosage form", "condition_indication": "Treatment of cystic fibrosis", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "28/01/2025", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Vertex Pharmaceuticals (Ireland) LimitedE-mail: vertexmedicalinfo@vrtx.comTel: +353 17617299", "first_published_date": "26/07/2017", "last_updated_date": "04/03/2026", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/ema-pe-0000227394" }, { "decision_number": "EMA/PE/0000226957", "pip_number": "EMA/PE/0000226957", "active_substance": "efgartigimod alfa", "invented_name": "Vyvgart", "therapeutic_area": "Nervous system disorders", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Treatment of myasthenia gravis", "routes_of_administration": "Subcutaneous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "28/01/2025", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Argenx BVE-mail: regulatory@argenx.comTel: +32 93103400", "first_published_date": "10/01/2023", "last_updated_date": "04/03/2026", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/ema-pe-0000226957" }, { "decision_number": "EMA/PE/0000228283", "pip_number": "EMA/PE/0000228283", "active_substance": "balstilimab", "invented_name": "", "therapeutic_area": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)", "pharmaceutical_forms": "Solution for infusion", "condition_indication": "Treatment of all conditions included in the category of malignant neoplasms (except melanoma, SMARCB1 (INI1) tumours, hypermutated tumours, nervous system, haematopoietic and lymphoid tissue)", "routes_of_administration": "Intravenous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "28/02/2025", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Agenus Inc.E-mail: med.info@agenusbio.com Tel.:  +1 7816744400", "first_published_date": "03/03/2026", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/ema-pe-0000228283" }, { "decision_number": "EMA/PE/0000226753", "pip_number": "EMA/PE/0000226753", "active_substance": "mRNA encoding Influenza A, H1N1 strain, hemagglutinin glycoprotein;mRNA encoding Influenza A, H3N2 strain, hemagglutinin glycoprotein;mRNA encoding Influenza B/Victoria, hemagglutinin glycoprotein", "invented_name": "", "therapeutic_area": "Infections and infestations", "pharmaceutical_forms": "Dispersion for injection", "condition_indication": "Prevention of influenza", "routes_of_administration": "Intramuscular use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "03/01/2025", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Moderna Biotech Spain S.L.E-mail: EMEAMedInfo@modernatx.comTel: +34 900031015", "first_published_date": "03/03/2026", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/ema-pe-0000226753" }, { "decision_number": "EMA/PE/0000226657", "pip_number": "EMA/PE/0000226657", "active_substance": "abelacimab", "invented_name": "", "therapeutic_area": "Vascular disorders", "pharmaceutical_forms": "Concentrate for solution for injection;Concentrate for solution for infusion", "condition_indication": "Prevention of thromboembolic events;Treatment of thromboembolic events", "routes_of_administration": "Intravenous use;Subcutaneous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "28/01/2025", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Novartis Europharm LimitedE-mail: paediatric.enquiries@novartis.comTel. +41 613241111", "first_published_date": "14/09/2022", "last_updated_date": "25/02/2026", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/ema-pe-0000226657" }, { "decision_number": "EMA/PE/0000226303", "pip_number": "EMA/PE/0000226303", "active_substance": "naldemedine tosilate", "invented_name": "Rizmoic", "therapeutic_area": "Gastrointestinal disorders", "pharmaceutical_forms": "Tablet;Powder for oral suspension", "condition_indication": "Treatment of opioid-induced constipation (OIC)", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "28/01/2025", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Shionogi Limited; E-mail: shionogiclintrials-admin@shionogi.co.jp; Tel. +44 (0)20 3534 200", "first_published_date": "10/01/2017", "last_updated_date": "25/02/2026", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/ema-pe-0000226303" }, { "decision_number": "P/0122/2024", "pip_number": "EMEA-003395-PIP02-23", "active_substance": "iodine (131I) apamistamab", "invented_name": "", "therapeutic_area": "Surgical and medical procedures", "pharmaceutical_forms": "Solution for infusion", "condition_indication": "Treatment in allogenic stem cell transplantation", "routes_of_administration": "Intravenous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "11/04/2024", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Immedica Pharma AB; E-mail: info@immedica.comTel. +46 (0)853339500", "first_published_date": "10/06/2025", "last_updated_date": "25/02/2026", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003395-pip02-23" }, { "decision_number": "P/0318/2021", "pip_number": "EMEA-001238-PIP02-20", "active_substance": "vatiquinone", "invented_name": "", "therapeutic_area": "Neurology", "pharmaceutical_forms": "Oral solution", "condition_indication": "Treatment of mitochondrial disease", "routes_of_administration": "Oral use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "11/08/2021", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "PTC Therapeutics International Limited; Tel. +353 19068700; E-mail: medinfo@ptcbio.com", "first_published_date": "08/09/2022", "last_updated_date": "25/02/2026", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001238-pip02-20" }, { "decision_number": "P/0002/2025", "pip_number": "EMEA-003618-PIP01-24", "active_substance": "2-isopropyl-3H-naphtho[1,2-d]imidazole-4,5-dione", "invented_name": "", "therapeutic_area": "Congenital, familial and genetic disorders", "pharmaceutical_forms": "Film-coated tablet;Age appropriate oral liquid dosage formulation", "condition_indication": "Treatment of primary mitochondrial disorders", "routes_of_administration": "Oral use;Gastric use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) 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"https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003402-pip01-23" }, { "decision_number": "EMA/PE/0000232896", "pip_number": "EMA/PE/0000232896", "active_substance": "antisense oligonucleotide against patatin like phospholipase domain containing protein 3 gene (PNPLA3), conjugated to N-acetylgalactosamine (AZD2693), sodium salt", "invented_name": "", "therapeutic_area": "Hepatobiliary disorders", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Treatment of metabolic dysfunction-associated steatohepatitis", "routes_of_administration": "Subcutaneous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "21/02/2025", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "AstraZeneca ABEmail: paediatrics@astrazeneca.comTel. +46 855324400", "first_published_date": 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"EMA/PE/0000181778", "active_substance": "rilvegostomig", "invented_name": "", "therapeutic_area": "Gastrointestinal disorders", "pharmaceutical_forms": "All pharmaceutical forms", "condition_indication": "Treatment of gastric and gastroesophageal junction adenocarcinoma", "routes_of_administration": "All routes of administration", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "06/12/2024", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "AstraZeneca ABE-mail: paediatrics@astrazeneca.comTel. +46 8553 27591", "first_published_date": "17/12/2025", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/ema-pe-0000181778" }, { "decision_number": "EMA/PE/0000181518", "pip_number": "EMA/PE/0000181518", "active_substance": "Lerodalcibep", "invented_name": "", "therapeutic_area": "Metabolism and nutrition disorders", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Treatment of hypercholesterolaemia", "routes_of_administration": "Subcutaneous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "06/12/2024", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "LIB Therapeutics Inc.Email: LIBadmin@libtherapeutics.comTel: +1 7347301170", "first_published_date": "30/06/2021", "last_updated_date": "17/12/2025", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/ema-pe-0000181518" }, { "decision_number": "EMA/PE/0000181441", "pip_number": "EMA/PE/0000181441", "active_substance": "telisotuzumab conjugated to (2S)-2-(2-bromoacetamido)-N-[(2S)-1-({3-[(7S)-7-ethyl-7-hydroxy- 8,11-dioxo-7,8,11,13-tetrahydro-2H,10H-[1,3]dioxolo[4,5-g]pyrano[3',4':6,7]indolizino[1,2- b]quinolin-14-yl]bicyclo[1.1.1]pentan-1-yl}amino)-1-oxopropan-2-yl]-3-methylbutanamide", "invented_name": "", "therapeutic_area": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)", "pharmaceutical_forms": "All pharmaceutical forms", "condition_indication": "Treatment of gastric and gastroesophageal junction adenocarcinoma", "routes_of_administration": "All routes of administration", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "06/12/2024", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Abbvie LimitedEmail: paediatricteam@abbvie.com Tel: +44(0) 1628925033", "first_published_date": "17/12/2025", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/ema-pe-0000181441" }, { "decision_number": "EMA/PE/0000221101", "pip_number": "EMA/PE/0000221101", "active_substance": "esepapogene zalarnarepvec", "invented_name": "", "therapeutic_area": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Treatment of human papillomavirus (HPV) 16 positive oropharyngeal squamous cell carcinoma", "routes_of_administration": "Intravenous use", "decision_type": "", "decision_date": "", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Hookipa Biotech GmbHE-mail : mark.winderlich@hookipapharma.comTel :  +43 676846674237 ", "first_published_date": "17/12/2025", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/ema-pe-0000221101" }, { "decision_number": "EMA/PE/0000181335", "pip_number": "EMA/PE/0000181335", "active_substance": "Budesonide;Formoterol (fumarate);glycopyrronium bromide", "invented_name": "Trixeo Aerosphere", "therapeutic_area": "Respiratory, thoracic and mediastinal disorders", "pharmaceutical_forms": "Pressurised inhalation;Suspension", "condition_indication": "Treatment of asthma", "routes_of_administration": "Inhalation use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "05/12/2024", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "AstraZeneca ABEmail: paediatrics@astrazeneca.comTel. +46 855324400", "first_published_date": "05/03/2018", "last_updated_date": "17/12/2025", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/ema-pe-0000181335" }, { "decision_number": "EMA/PE/0000220986", "pip_number": "EMA/PE/0000220986", "active_substance": "tenapanor", "invented_name": "", "therapeutic_area": "Metabolism and nutrition disorders", "pharmaceutical_forms": "Coated tablet", "condition_indication": "Treatment of hyperphosphataemia", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Pharma Gateway ABE-mail : info@ardelyx.com ", "first_published_date": "17/12/2025", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/ema-pe-0000220986" }, { "decision_number": "EMA/PE/0000221175", "pip_number": "EMA/PE/0000221175", "active_substance": "vibegron", "invented_name": "Obgemsa", "therapeutic_area": "Renal and urinary disorders", "pharmaceutical_forms": "Film-coated tablet;Granules", "condition_indication": "Treatment of myoneurogenic bladder disorders", "routes_of_administration": "Oral use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "16/12/2024", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Pierre Fabre Médicament; E-mail: info@urovant.com; Tel: +1 8338768268", "first_published_date": "24/08/2023", "last_updated_date": "17/12/2025", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/ema-pe-0000221175" }, { "decision_number": "P/0360/2021", "pip_number": "EMA/PE/0000181300", "active_substance": "avalglucosidase alfa", "invented_name": "Nexviadyme", "therapeutic_area": "Congenital, familial and genetic disorders", "pharmaceutical_forms": "Powder for concentrate for solution for infusion", "condition_indication": "Treatment of Pompe disease", "routes_of_administration": "Intravenous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "08/09/2021", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Sanofi B.V.E-mail: eumedinfo.gz@sanofi.comTel: +31 (0) 20 245 3917", "first_published_date": "21/04/2017", "last_updated_date": "17/12/2025", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/ema-pe-0000181300" }, { "decision_number": "P/0019/2024", "pip_number": "EMA/PE/0000181294", "active_substance": "tolebrutinib", "invented_name": "", "therapeutic_area": "Nervous system disorders", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Treatment of multiple sclerosis", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "06/12/2024", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Sanofi Winthrop Industrie Email: eumedinfo.gz@sanofi.com Tel. +31 (0)202453917", "first_published_date": "24/06/2021", "last_updated_date": "17/12/2025", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/ema-pe-0000181294" }, { "decision_number": "EMA/PE/0000181238", "pip_number": "EMA/PE/0000181238", "active_substance": "resiquimod", "invented_name": "", "therapeutic_area": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)", "pharmaceutical_forms": "Solution for infusion", "condition_indication": "Treatment of melanoma", "routes_of_administration": "Intravenous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "06/12/2024", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Eikon Therapeutics Inc.Email: vangalas@eikontx.comTel: +1 3417770566 ", "first_published_date": "17/12/2025", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/ema-pe-0000181238" }, { "decision_number": "EMA/PE/0000181236", "pip_number": "EMA/PE/0000181236", "active_substance": "telisotuzumab conjugated to (2S)-2-(2-bromoacetamido)-N-[(2S)-1-({3-[(7S)-7-ethyl-7-hydroxy- 8,11-dioxo-7,8,11,13-tetrahydro-2H,10H-[1,3]dioxolo[4,5-g]pyrano[3',4':6,7]indolizino[1,2- b]quinolin-14-yl]bicyclo[1.1.1]pentan-1-yl}amino)-1-oxopropan-2-yl]-3-methylbutanamide", "invented_name": "", "therapeutic_area": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)", "pharmaceutical_forms": "All pharmaceutical forms", "condition_indication": "Treatment of lung cancer (small cell and non-small cell lung cancer)", "routes_of_administration": "All routes of administration", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "05/12/2024", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Abbvie LimitedEmail: paediatricteam@abbvie.com Tel: +44(0) 1628925033", "first_published_date": "17/12/2025", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/ema-pe-0000181236" }, { "decision_number": "EMA/PE/0000221419", "pip_number": "EMA/PE/0000221419", "active_substance": "pneumococcal polysaccharide serotype 3 - diphtheria CRM197 conjugate;pneumococcal polysaccharide serotype 8 – diphtheria CRM197 conjugate;pneumococcal polysaccharide serotype 15C – diphtheria CRM197 conjugate;pneumococcal polysaccharide serotype 6A – diphtheria CRM197 conjugate;pneumococcal polysaccharide serotype 15A – diphtheria CRM197 conjugate;pneumococcal polysaccharide serotype 16F – diphtheria CRM197 conjugate;pneumococcal polysaccharide serotype 19A – diphtheria CRM197 conjugate;pneumococcal polysaccharide serotype 23A – diphtheria CRM197 conjugate;pneumococcal polysaccharide serotype 24F – diphtheria CRM197 conjugate;pneumococcal polysaccharide serotype 17F – diphtheria CRM197 conjugate;pneumococcal polysaccharide serotype 33F – diphtheria CRM197 conjugate (15-valent pneumococcal polysaccharide conjugate vaccine [V114]);pneumococcal polysaccharide serotype 10A – diphtheria CRM197 conjugate;pneumococcal polysaccharide serotype 12F – diphtheria CRM197 conjugate;pneumococcal polysaccharide serotype 20A – diphtheria CRM197 conjugate;pneumococcal polysaccharide serotype 31 – diphtheria CRM197 conjugate;pneumococcal polysaccharide serotype 35B – diphtheria CRM197 conjugate;pneumococcal polysaccharide serotype 7F – diphtheria CRM197 conjugate;pneumococcal polysaccharide serotype 22F – diphtheria CRM197 conjugate;pneumococcal polysaccharide serotype 9N – diphtheria CRM197 conjugate;pneumococcal polysaccharide serotype 11A – diphtheria CRM197 conjugate;pneumococcal polysaccharide serotype 23B – diphtheria CRM197 conjugate (V116)", "invented_name": "", "therapeutic_area": "Vaccines", "pharmaceutical_forms": "Solution for injection in pre-filled syringe", "condition_indication": "Prevention of disease caused by Streptococcus pneumoniae", "routes_of_administration": "Intramuscular use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "06/12/2024", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Merck Sharp & Dohme (Europe) Inc.Tel.: +33180464738E-mail: pip.information@merck.com", "first_published_date": "13/11/2023", "last_updated_date": "17/12/2025", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/ema-pe-0000221419-0" }, { "decision_number": "P/0470/2022", "pip_number": "EMA/PE/0000181219", "active_substance": "bedaquiline fumarate", "invented_name": "Sirturo; Sirturo", "therapeutic_area": "Infectious diseases", "pharmaceutical_forms": "Tablet;Granules", "condition_indication": "Treatment of multi-drug-resistant tuberculosis", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "06/12/2024", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Janssen Cilag International Email: contact@Janssen-emea.com Tel. +32 14602111", "first_published_date": "08/04/2011", "last_updated_date": "17/12/2025", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/ema-pe-0000181219" }, { "decision_number": "EMA/PE/0000221199", "pip_number": "EMA/PE/0000221199", "active_substance": "bemcentinib", "invented_name": "", "therapeutic_area": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)", "pharmaceutical_forms": "All pharmaceutical forms", "condition_indication": "Treatment of non-small cell lung cancer", "routes_of_administration": "All routes of administration", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "06/12/2024", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Bergenbio ASAEmail : post@bergenbio.comTel:  + 47 559 611 59 ", "first_published_date": "16/12/2025", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/ema-pe-0000221199" }, { "decision_number": "EMA/PE/0000221424", "pip_number": "EMA/PE/0000221424", "active_substance": "dermatophagoides pteronyssinus extract", "invented_name": "", "therapeutic_area": "Immune system disorders", "pharmaceutical_forms": "Solution for skin-prick test", "condition_indication": "Diagnosis of house dust mite allergy", "routes_of_administration": "Intraepidermal use", "decision_type": "RP: decision refers to a refusal on a proposed Paediatric Investigation Plan", "decision_date": "06/12/2024", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "ROXALL Medicina España S.A.E-mail: info@roxall.es Tel.:  +34 944438000", "first_published_date": "16/12/2025", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/ema-pe-0000221424" }, { "decision_number": "EMA/PE/0000221500", "pip_number": "EMA/PE/0000221500", "active_substance": "phleum pratense pollen extract", "invented_name": "", "therapeutic_area": "Immune system disorders", "pharmaceutical_forms": "Solution for skin-prick test", "condition_indication": "Diagnosis of grass pollen allergy", "routes_of_administration": "Intraepidermal use", "decision_type": "RP: decision refers to a refusal on a proposed Paediatric Investigation Plan", "decision_date": "05/12/2024", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "ROXALL Medicina España S.A.E-mail: info@roxall.es Tel.:  +34 944438000", "first_published_date": "16/12/2025", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/ema-pe-0000221500" }, { "decision_number": "EMA/PE/0000221511", "pip_number": "EMA/PE/0000221511", "active_substance": "recombinant human apolipoprotein A-I", "invented_name": "", "therapeutic_area": "Congenital, familial and genetic disorders", "pharmaceutical_forms": "Solution for injection/infusion", "condition_indication": "Treatment of lecithin-cholesterol acyltransferase deficiency", "routes_of_administration": "Intravenous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "06/12/2024", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Abionyx PharmaE-mail: info@abionyx.comTel.:   +33(0) 562 249 706 ", "first_published_date": "16/12/2025", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/ema-pe-0000221511" }, { "decision_number": "EMA/PE/0000221664", "pip_number": "EMA/PE/0000221664", "active_substance": "parietaria judaica pollen extract", "invented_name": "", "therapeutic_area": "Immune system disorders", "pharmaceutical_forms": "Solution for skin-prick test", "condition_indication": "Diagnosis of weed pollen allergy", "routes_of_administration": "Intraepidermal use", "decision_type": "RP: decision refers to a refusal on a proposed Paediatric Investigation Plan", "decision_date": "06/12/2024", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "ROXALL Medicina España S.A.E-mail: info@roxall.es Tel.:  +34 944438000", "first_published_date": "16/12/2025", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/ema-pe-0000221664" }, { "decision_number": "EMA/PE/0000221674", "pip_number": "EMA/PE/0000221674", "active_substance": "xaluritamig", "invented_name": "", "therapeutic_area": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)", "pharmaceutical_forms": "All pharmaceutical forms", "condition_indication": "Treatment of prostate cancer", "routes_of_administration": "All routes of administration", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "06/12/2024", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Amgen Europe B.V.; Tel. +44 (0)1223 420305; E-mail: pipenquiry@amgen.com", "first_published_date": "16/12/2025", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/ema-pe-0000221674" }, { "decision_number": "EMA/PE/0000221695", "pip_number": "EMA/PE/0000221695", "active_substance": "cupressus arizonica pollen extract", "invented_name": "", "therapeutic_area": "Immune system disorders", "pharmaceutical_forms": "Solution for skin-prick test", "condition_indication": "Diagnosis of cypress pollen allergy", "routes_of_administration": "Intraepidermal use", "decision_type": "RP: decision refers to a refusal on a proposed Paediatric Investigation Plan", "decision_date": "05/12/2024", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "ROXALL Medicina España S.A.E-mail: info@roxall.es Tel.:  +34 944438000", "first_published_date": "16/12/2025", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/ema-pe-0000221695" }, { "decision_number": "EMA/PE/0000221772", "pip_number": "EMA/PE/0000221772", "active_substance": "olea europaea pollen extract", "invented_name": "", "therapeutic_area": "Immune system disorders", "pharmaceutical_forms": "Solution for skin-prick test", "condition_indication": "Diagnosis of olive pollen allergy", "routes_of_administration": "Intraepidermal use", "decision_type": "RP: decision refers to a refusal on a proposed Paediatric Investigation Plan", "decision_date": "06/12/2024", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "ROXALL Medicina España S.A.E-mail: info@roxall.es Tel.:  +34 944438000", "first_published_date": "16/12/2025", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/ema-pe-0000221772" }, { "decision_number": "EMA/PE/0000183758", "pip_number": "EMA/PE/0000183758", "active_substance": "zimislecel", "invented_name": "", "therapeutic_area": "Endocrine disorders", "pharmaceutical_forms": "Dispersion for infusion", "condition_indication": "Treatment of type 1 diabetes in individuals with impaired awareness of hypoglycaemia resulting in recurrent severe hypoglycaemia", "routes_of_administration": "Intraportal use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "06/12/2024", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Vertex Pharmaceuticals (Ireland) LimitedE-mail: vertexmedicalinfo@vrtx.comTel: +353 17617299", "first_published_date": "10/12/2025", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/ema-pe-0000183758" }, { "decision_number": "P/0012/2024", "pip_number": "EMA/PE/0000183430", "active_substance": "tralokinumab", "invented_name": "Adtralza", "therapeutic_area": "Skin and subcutaneous tissue disorders", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Treatment of atopic dermatitis", "routes_of_administration": "Subcutaneous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "06/12/2024", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "LEO Pharma A/S E-mail: raleodk@leo-pharma.com Tel. +45 44945888", "first_published_date": "19/06/2018", "last_updated_date": "10/12/2025", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/ema-pe-0000183430" }, { "decision_number": "EMA/PE/0000183866", "pip_number": "EMA/PE/0000183866", "active_substance": "brexpiprazole", "invented_name": "Rxulti", "therapeutic_area": "Psychiatric disorders", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Treatment of schizophrenia", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "05/12/2024", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Otsuka Pharmaceutical Development and Commercialisation Europe GmbH; E-mail: paediatric-info@otsuka-europe.com; Tel. +49 69 955 044 328", "first_published_date": "22/08/2012", "last_updated_date": "10/12/2025", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/ema-pe-0000183866" }, { "decision_number": "EMA/PE/0000184400", "pip_number": "EMA/PE/0000184400", "active_substance": "dapagliflozin;eplerenone", "invented_name": "", "therapeutic_area": "Cardiac disorders", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Treatment of heart failure", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "05/12/2024", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "ELPEN Pharmaceutical Co. Inc; E-mail: regulatoryaffairs@elpen.gr; Tel. +30 2106039326;  ", "first_published_date": "10/12/2025", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/ema-pe-0000184400" }, { "decision_number": "EMA/PE/0000183220", "pip_number": "EMA/PE/0000183220", "active_substance": "iclepertin", "invented_name": "", "therapeutic_area": "Psychiatric disorders", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Treatment of schizophrenia", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "22/11/2024", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Boehringer Ingelheim International GmbH E-mail: COMMSPaediatrics@boehringer-ingelheim.comTel. +49 (0)6132 77 8271", "first_published_date": "22/09/2021", "last_updated_date": "10/12/2025", "pip_url": 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"compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Merck KGaA; Tel. +49 6151 725200; E-mail: service@merckgroup.com", "first_published_date": "14/02/2019", "last_updated_date": "27/11/2025", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002284-pip01-17" }, { "decision_number": "P/0524/2022", "pip_number": "EMEA-003153-PIP01-21", "active_substance": "HIV-1 Maturation Inhibitor (GSK3640254)", "invented_name": "", "therapeutic_area": "Infectious diseases", "pharmaceutical_forms": "Film-coated tablet;Age appropriate oral formulation", "condition_indication": "Treatment of human immunodeficiency virus (HIV-1) infection", "routes_of_administration": "Oral use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "30/12/2022", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", 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"condition_indication": "Treatment of hypoactive sexual desire disorder", "routes_of_administration": "Sublingual use;Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "25/10/2024", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Freya Pharma Solutions Holding B.V.E-mail: info@freyapharmasolutions.comTel:  +31 646237282", "first_published_date": "23/10/2025", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/ema-pe-0000181891" }, { "decision_number": "EMA/PE/0000225106", "pip_number": "EMA/PE/0000225106", "active_substance": "Ibrexafungerp", "invented_name": "", "therapeutic_area": "Infections and infestations", "pharmaceutical_forms": "Tablet", "condition_indication": "Prevention of recurrent vulvovaginal candidiasis;Treatment of vulvovaginal candidiasis", 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"active_substance": "tafasitamab", "invented_name": "Minjuvi", "therapeutic_area": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)", "pharmaceutical_forms": "Powder for concentrate for solution for infusion", "condition_indication": "Treatment of mature B-cell neoplasms excluding diffuse large B-cell lymphoma", "routes_of_administration": "Intravenous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "13/09/2024", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Incyte Biosciences Distribution B.V. E-mail: RA@incyte.comTel. +1 3024252734", "first_published_date": "17/10/2025", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002499-pip03-24" }, { "decision_number": "P/0319/2024", "pip_number": "EMEA-002350-PIP02-20-M01", "active_substance": "deucravacitinib", "invented_name": "Sotyktu", "therapeutic_area": "Musculoskeletal and connective tissue disorders", "pharmaceutical_forms": "Age appropriate oral solid dosage form;Film-coated tablet", "condition_indication": "Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and juvenile idiopathic arthritis)", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "13/09/2024", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Bristol-Myers Squibb International Corporation; E-mail: medical.information@bms.com; Tel. +44 1423 533 610", "first_published_date": "11/05/2023", "last_updated_date": "17/10/2025", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002350-pip02-20-m01" }, { "decision_number": "P/0350/2024", "pip_number": "EMEA-002341-PIP01-18-M03", "active_substance": "ganaxolone", "invented_name": "Ztalmy", "therapeutic_area": "Congenital, familial and genetic disorders", "pharmaceutical_forms": "Oral suspension;Age appropriate oral liquid dosage formulation", "condition_indication": "Treatment of cyclin-dependent kinase-like 5 deficiency disorder", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "27/09/2024", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Immedica Pharma AB; E-mail: info@immedica.comTel. +46 (0)853339500", "first_published_date": "27/03/2020", "last_updated_date": "17/10/2025", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002341-pip01-18-m03" }, { "decision_number": "P/0343/2024", "pip_number": "EMEA-002319-PIP01-17-M03", "active_substance": "rezafungin acetate", "invented_name": "Rezzayo", "therapeutic_area": "Infections and infestations", "pharmaceutical_forms": "Powder for concentrate for solution for infusion;Age appropriate dosage form for parenteral use", "condition_indication": "Treatment of invasive candidiasis", "routes_of_administration": "Intravenous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "13/09/2024", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Mundipharma Corporation (Ireland) Limited; E-mail: regaffairs-enquiries@mundipharma-rd.eu; Tel: +44 (0)1223424211 ", "first_published_date": "24/04/2019", "last_updated_date": "17/10/2025", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002319-pip01-17-m03" }, { "decision_number": "P/0342/2024", "pip_number": "EMEA-002166-PIP01-17-M08", "active_substance": "lasmiditan", "invented_name": "Reyvow", "therapeutic_area": "Nervous system disorders", "pharmaceutical_forms": "Tablet;Orodispersible tablet", "condition_indication": "Treatment of migraine", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "13/09/2024", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Eli Lilly & Company Limited; E-mail: eu_paediatric@lilly.com ; Tel. +44 (0)1276 483000", "first_published_date": "27/11/2018", "last_updated_date": "17/10/2025", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002166-pip01-17-m08" }, { "decision_number": "P/0339/2024", "pip_number": "EMEA-002152-PIP01-17-M04", "active_substance": "daratumumab", "invented_name": "Darzalex", "therapeutic_area": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)", "pharmaceutical_forms": "Solution for 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for solution for infusion", "condition_indication": "Treatment of infections due to aerobic Gram-negative bacteria", "routes_of_administration": "Intravenous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "13/09/2024", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Shionogi Limited; E-mail: shionogiclintrials-admin@shionogi.co.jp; Tel. +44 (0)20 3534 200", "first_published_date": "28/01/2019", "last_updated_date": "17/10/2025", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002133-pip01-17-m04" }, { "decision_number": "P/0330/2024", "pip_number": "EMEA-002106-PIP01-16-M03", "active_substance": "leriglitazone", "invented_name": "", "therapeutic_area": "Congenital, familial and genetic disorders", "pharmaceutical_forms": "Oral suspension", "condition_indication": "Treatment of adrenoleukodystrophy", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "13/09/2024", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Minoryx Therapeutics S.L.; Tel. ++34 935441466; E-mail: umeya@minoryx.com", "first_published_date": "03/03/2021", "last_updated_date": "17/10/2025", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002106-pip01-16-m03" }, { "decision_number": "P/0331/2024", "pip_number": "EMEA-001988-PIP01-16-M02", "active_substance": "macimorelin", "invented_name": "Ghryvelin (previously Macimorelin Aeterna Zentaris)", "therapeutic_area": "Endocrine disorders", "pharmaceutical_forms": "Granules for oral solution", "condition_indication": "Diagnosis of growth hormone deficiency", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "13/09/2024", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Atnahs Pharma Netherlands B.V.; E-mail: nammer@aezsinc.comTel.:+49 69426023228", "first_published_date": "29/05/2017", "last_updated_date": "17/10/2025", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001988-pip01-16-m02" }, { "decision_number": "P/0338/2024", "pip_number": "EMEA-003638-PIP01-24", "active_substance": "rememulgene arelactibac", "invented_name": "", "therapeutic_area": "Skin and subcutaneous tissue disorders", "pharmaceutical_forms": "Concentrate for cutaneous solution", "condition_indication": "Treatment of diabetic foot ulcer;Treatment of venous leg ulcer", "routes_of_administration": "Cutaneous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "13/09/2024", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Aurealis Oy E-mail: clinical@aurealistherapeutics.comTel: +358 503279385", "first_published_date": "16/10/2025", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003638-pip01-24" }, { "decision_number": "P/0326/2024", "pip_number": "EMEA-003632-PIP01-24", "active_substance": "Empagliflozin / Derivative of 3‐phenyl‐3H,4H,6H,7H‐pyrano[3,4‐d]imidazol‐4‐one (BI 690517)", "invented_name": "", "therapeutic_area": "Cardiac disorders", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Treatment of heart failure", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "13/09/2024", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", 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"Treatment of human immunodeficiency virus (HIV-1) infection", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "16/08/2024", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "ViiV Healthcare UK LimitedE-mail: eu.paediatric-plans@gsk.com Tel: +1 4388998201", "first_published_date": "29/03/2016", "last_updated_date": "07/07/2025", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001750-pip01-15-m07" }, { "decision_number": "P/0281/2024", "pip_number": "EMEA-001613-PIP03-21-M01", "active_substance": "tezepelumab", "invented_name": "Tezspire", "therapeutic_area": "Gastrointestinal disorders", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Treatment of eosinophilic esophagitis", "routes_of_administration": "Subcutaneous use", "decision_type": "PM: 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"compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Orexigen Therapeutics Ireland LimitedE-mail: eu-regulatory@orexigen.comTel: +353 87 318 5448", "first_published_date": "09/09/2013", "last_updated_date": "07/07/2025", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001373-pip01-12-m06" }, { "decision_number": "P/0303/2024", "pip_number": "EMEA-001290-PIP01-12-M01", "active_substance": "human normal immunoglobulin (SCNG20%)", "invented_name": "", "therapeutic_area": "Congenital, familial and genetic disorders", "pharmaceutical_forms": "Solution for infusion", "condition_indication": "Treatment of Primary Immunodeficiency (PID)", "routes_of_administration": "Subcutaneous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "16/08/2024", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "LFB BiotechnologiesE-mail: LFB-enregistrement@lfb.fr Tel.: +33 666242239", "first_published_date": "11/02/2013", "last_updated_date": "07/07/2025", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001290-pip01-12-m01" }, { "decision_number": "P/0307/2024", "pip_number": "EMEA-001214-PIP04-19-M01", "active_substance": "Benralizumab", "invented_name": "Fasenra", "therapeutic_area": "Blood and lymphatic system disorders", "pharmaceutical_forms": "Solution for injection;Solution for injection/infusion", "condition_indication": "Treatment of hypereosinophilic syndrome", "routes_of_administration": "Subcutaneous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "16/08/2024", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "AstraZeneca ABEmail: paediatrics@astrazeneca.comTel.  +46 855326000", "first_published_date": "13/03/2024", "last_updated_date": "07/07/2025", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001214-pip04-19-m01" }, { "decision_number": "P/0305/2024", "pip_number": "EMEA-000780-PIP01-09-M08", "active_substance": "Midostaurin", "invented_name": "Rydapt", "therapeutic_area": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)", "pharmaceutical_forms": "Oral solution;Capsule, soft", "condition_indication": "Treatment of acute myeloid leukaemia;Treatment of malignant mastocytosis;Treatment of mast cell leukaemia", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "16/08/2024", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Novartis Europharm LimitedE-mail: paediatric.enquiries@novartis.comTel. +41 613241111", "first_published_date": "07/02/2011", "last_updated_date": "07/07/2025", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000780-pip01-09-m08" }, { "decision_number": "P/0219/2024", "pip_number": "EMEA-003641-PIP01-24", "active_substance": "purified antigen fractions of inactivated split virion influenza virus type A, H1N1;influenza virus type A, H3N2;influenza virus type B, Victoria lineage", "invented_name": "", "therapeutic_area": "Infections and infestations", "pharmaceutical_forms": "Suspension for injection", "condition_indication": "Prevention of influenza infection", "routes_of_administration": "Intramuscular use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "13/06/2024", "compliance_outcome": "Positive", "compliance_opinion_date": "28/06/2024", "compliance_procedure_number": "EMEA-C-003641-PIP01-24", "contact_for_public_enquiries": "GlaxoSmithKline Biologicalse-mail: eu.paediatric-plans@gsk.com tel. +1 4388998201", "first_published_date": "26/06/2025", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003641-pip01-24" }, { "decision_number": "P/0220/2024", "pip_number": "EMEA-003640-PIP01-24", "active_substance": "recombinant Influenza Hemagglutinin-strain A (H1N1 subtype);recombinant Influenza Hemagglutinin-strain A (H3N2 subtype);recombinant influenza hemagglutinin-strain B (RIV3)", "invented_name": "", "therapeutic_area": "Infections and infestations", "pharmaceutical_forms": "Solution for injection in pre-filled syringe", "condition_indication": "Prevention of influenza", "routes_of_administration": "Intramuscular use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "14/06/2024", "compliance_outcome": "Positive", "compliance_opinion_date": "28/06/2024", "compliance_procedure_number": "EMEA-C-003640-PIP01-24", "contact_for_public_enquiries": "Sanofi Winthrop Industrie; E-mail: contact-us@sanofi.com; Tel: +33 4 37 37 57 84", "first_published_date": "26/06/2025", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003640-pip01-24" }, { "decision_number": "P/0210/2024", "pip_number": "EMEA-003582-PIP01-24", "active_substance": "rosuvastatin;ezetimibe", "invented_name": "", "therapeutic_area": "Cardiac disorders", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Prevention of cardiovascular events;Treatment of hypercholesterolaemia", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "14/06/2024", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Verisfield Single Member S.A.Email: pharmacovigilance@verisfield.gr; economou@verisfield.gr Tel: +30 2107475196 ", "first_published_date": "26/06/2025", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003582-pip01-24" }, { "decision_number": "P/0216/2024", "pip_number": "EMEA-003577-PIP01-24", "active_substance": "certepetide", "invented_name": "", "therapeutic_area": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)", "pharmaceutical_forms": "All pharmaceutical forms", "condition_indication": "Treatment of pancreatic cancer", "routes_of_administration": "All routes of administration", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "13/06/2024", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Lisata Therapeutics Ireland LimitedE-mail: info@lisata.comTel: +1 9495352391", "first_published_date": "26/06/2025", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003577-pip01-24" }, { "decision_number": "P/0209/2024", "pip_number": "EMEA-003581-PIP01-24", "active_substance": "derivative of 1,5,6,7-tetrahydro-4H-pyrrolo[3,2-c]pyridin-4-one", "invented_name": "", "therapeutic_area": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)", "pharmaceutical_forms": "All pharmaceutical forms", "condition_indication": "Treatment of lung cancer (small cell and non-small cell lung cancer)", "routes_of_administration": "All routes of administration", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "14/06/2024", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Bayer AG; Email: pediatrics.medical-affairs-europe@bayer.com; Tel. +49 (0)3046815333;  ", "first_published_date": "26/06/2025", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003581-pip01-24" }, { "decision_number": "P/0223/2024", "pip_number": "EMEA-003525-PIP01-23", "active_substance": "mirdametinib", "invented_name": "", "therapeutic_area": "Congenital, familial and genetic disorders", "pharmaceutical_forms": "Capsule, hard;Tablet", "condition_indication": "Treatment of neurofibromatosis type 1", "routes_of_administration": "Oral use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "20/06/2024", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "SpringWorks Therapeutics, Inc; clinical.inquiries@springworkstx.com;  +1 9197901002", "first_published_date": "26/06/2025", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003525-pip01-23" }, { "decision_number": "P/0214/2024", "pip_number": "EMEA-003459-PIP01-23", "active_substance": "recombinant adeno-associated virus Olig001 containing human aspartoacylase cDNA", "invented_name": "", "therapeutic_area": "Congenital, familial and genetic disorders", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Treatment of Canavan disease", "routes_of_administration": "Intracerebral use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "13/06/2024", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Myrtelle Inc. E-mail: info@myrtellegtx.comTel: +1 7816212381", "first_published_date": "26/06/2025", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003459-pip01-23" }, { "decision_number": "P/0197/2024", "pip_number": "EMEA-003462-PIP01-23", "active_substance": "radiprodil", "invented_name": "", "therapeutic_area": "Nervous system disorders", "pharmaceutical_forms": "Oral suspension", "condition_indication": "Treatment of GRIN-related disorder", "routes_of_administration": "Oral use;Naso-gastric use;Gastric use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "13/06/2024", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "E-mail: michael.panzara@grintherapeutics.com Tel. +1 6467776723", "first_published_date": "26/06/2025", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003462-pip01-23" }, { "decision_number": "P/0196/2024", "pip_number": "EMEA-003572-PIP01-23", "active_substance": "sitagliptin;dapagliflozin", "invented_name": "", "therapeutic_area": "Endocrine disorders", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Treatment of type II diabetes mellitus", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "21/06/2024", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Althera Laboratories LimitedEmail: regulatory.eu@altherainc.comTel.: +353 1 906 0479", "first_published_date": "26/06/2025", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003572-pip01-23" }, { "decision_number": "P/0193/2024", "pip_number": "EMEA-003576-PIP01-24", "active_substance": "actinium-225-2-(4,7,10-tris-carboxymethyl-1,4,7,10 tetraaza-cyclododec-1-yl)-pentanedioic acid 3- iodo-D-Tyr-D-Phe-D-Lys-OH)-8-oyl-ε-(HO-Glu-ureido-Lys-OH)", "invented_name": "", "therapeutic_area": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)", "pharmaceutical_forms": "All pharmaceutical forms", "condition_indication": "Treatment of PSMA-expressing prostate cancer", "routes_of_administration": "All routes of administration", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "05/06/2024", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "E-mail: regulatory@fusionpharma.com Tel. +1 (617)4205698", "first_published_date": "25/06/2025", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003576-pip01-24" }, { "decision_number": "P/0192/2024", "pip_number": "EMEA-003574-PIP01-24", "active_substance": "telisotuzumab conjugated to (2S)-2-(2-bromoacetamido)-N-[(2S)-1-({3-[(7S)-7-ethyl-7-hydroxy- 8,11-dioxo-7,8,11,13-tetrahydro-2H,10H-[1,3]dioxolo[4,5-g]pyrano[3',4':6,7]indolizino[1,2- b]quinolin-14-yl]bicyclo[1.1.1]pentan-1-yl}amino)-1-oxopropan-2-yl]-3-methylbutanamide", "invented_name": "", "therapeutic_area": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)", "pharmaceutical_forms": "All pharmaceutical forms", "condition_indication": "Treatment of colorectal carcinoma", "routes_of_administration": "All routes of administration", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "14/06/2024", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "AbbVie LtdE-mail: paediatricteam@abbvie.comTel. +44 (0)1628 408248", "first_published_date": "25/06/2025", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003574-pip01-24" }, { "decision_number": "P/0190/2024", "pip_number": "EMEA-001809-PIP01-15-M05", "active_substance": "imipenem monohydrate;cilastatin sodium;relebactam (MK-7655A)", "invented_name": "Recarbrio", "therapeutic_area": "Infections and infestations", "pharmaceutical_forms": "Powder for solution for infusion", "condition_indication": "Treatment of infections caused by gram-negative organisms", "routes_of_administration": "Parenteral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "14/06/2024", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Merck Sharp & Dohme (Europe) Inc.Tel.: +33180464738E-mail: pip.information@merck.com", "first_published_date": "26/08/2016", "last_updated_date": "25/06/2025", "pip_url": 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"pip_number": "EMEA-001533-PIP01-13-M03", "active_substance": "Ertugliflozin", "invented_name": "Steglatro", "therapeutic_area": "Metabolism and nutrition disorders", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Treatment of type II diabetes mellitus", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "14/06/2024", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Merck Sharp & Dohme (Europe) Inc.Tel.: +33180464738E-mail: pip.information@merck.com", "first_published_date": "30/09/2014", "last_updated_date": "25/06/2025", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001533-pip01-13-m03" }, { "decision_number": "P/0187/2024", "pip_number": "EMEA-000534-PIP03-17-M01", "active_substance": "mecasermin rinfabate", "invented_name": "", "therapeutic_area": 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"condition_indication": "Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and juvenile idiopathic arthritis)", "routes_of_administration": "Subcutaneous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "14/06/2024", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Accelsiors GmbH; Russian Federation; Email: serebryakova@rpharm.ru; Tel. +7 (495) 956-79-37", "first_published_date": "18/09/2012", "last_updated_date": "24/06/2025", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001222-pip01-11-m01" }, { "decision_number": "P/0529/2022", "pip_number": "EMEA-000927-PIP01-10-M08", "active_substance": "linaclotide", "invented_name": "Constella", "therapeutic_area": "Gastrointestinal disorders", "pharmaceutical_forms": "Capsule, hard", "condition_indication": "Treatment of functional constipation", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "14/06/2024", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "AbbVie LtdE-mail: paediatricteam@abbvie.comTel. +44 (0)1628 408248", "first_published_date": "09/06/2011", "last_updated_date": "24/06/2025", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000927-pip01-10-m08" }, { "decision_number": "P/0206/2024", "pip_number": "EMEA-001911-PIP02-22-M01", "active_substance": "inebilizumab", "invented_name": "Uplizna", "therapeutic_area": "Nervous system disorders", "pharmaceutical_forms": "Concentrate for solution for infusion", "condition_indication": "Treatment of myasthenia gravis", "routes_of_administration": "Intravenous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "14/06/2024", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Horizon Therapeutics Ireland DAC  E-mail: medinfointernational@amgen.com Tel.  +44 (0)1223420305", "first_published_date": "07/03/2025", "last_updated_date": "24/06/2025", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001911-pip02-22-m01" }, { "decision_number": "P/0205/2024", "pip_number": "EMEA-003196-PIP01-22-M01", "active_substance": "obefazimod", "invented_name": "", "therapeutic_area": "Gastrointestinal disorders", "pharmaceutical_forms": "Capsule, hard;Age appropriate oral liquid dosage formulation", "condition_indication": "Treatment of ulcerative colitis", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "14/06/2024", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "AbivaxE-mail: Didier.Blondel@abivax.comTel. +33 153830839", "first_published_date": "09/11/2023", "last_updated_date": "24/06/2025", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003196-pip01-22-m01" }, { "decision_number": "P/0203/2024", "pip_number": "EMEA-001821-PIP01-15-M08", "active_substance": "quizartinib", "invented_name": "Vanflyta", "therapeutic_area": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)", "pharmaceutical_forms": "Film-coated tablet;Powder for oral solution", "condition_indication": "Treatment of acute myeloid leukaemia", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "14/06/2024", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Daiichi Sankyo Europe GmbH; Tel. +49 8978080; E-mail: service@daiichi-sankyo.eu", "first_published_date": "22/09/2016", "last_updated_date": "24/06/2025", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001821-pip01-15-m08" }, { "decision_number": "P/0204/2024", "pip_number": "EMEA-003480-PIP01-23", "active_substance": "Derivative of pyrindin-2-yl)cyclopropanecarboxamide hydrochloride", "invented_name": "", "therapeutic_area": "Skin and subcutaneous tissue disorders", "pharmaceutical_forms": "Film-coated tablet;Age-appropriate oral dosage form", "condition_indication": "Treatment of psoriasis", "routes_of_administration": "Oral use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "14/06/2024", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Alumis Inc.; E-mail: info@alumis.com; Tel. +1 (650)2316625", "first_published_date": "24/06/2025", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003480-pip01-23" }, { "decision_number": "P/0202/2024", "pip_number": "EMEA-003586-PIP01-24", "active_substance": "(5aSa,17aRa)-20-Chloro-2-[(2S,5R)-2,5-dimethyl-4-(prop-2-enoyl)piperazin-1-yl]-14,17-difluoro-6- (propan-2-yl)-11,12-dihydro-4H-1,18-(ethanediylidene)pyrido[4,3-e]pyrimido[1,6- g][1,4,7,9]benzodioxadiazacyclododecin-4-one (MK-1084)", "invented_name": "", "therapeutic_area": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)", "pharmaceutical_forms": "Tablet", "condition_indication": "Treatment of all solid and haematological malignancies", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "14/06/2024", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Merck Sharp & Dohme (Europe) Inc.Tel.: +33180464738E-mail: pip.information@merck.com", "first_published_date": "24/06/2025", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003586-pip01-24" }, { "decision_number": "P/0201/2024", "pip_number": "EMEA-003535-PIP02-24", "active_substance": "autologous T-cells from a melanoma metastasis (TM001)", "invented_name": "", "therapeutic_area": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)", "pharmaceutical_forms": "Dispersion for infusion", "condition_indication": "Treatment of melanoma", "routes_of_administration": "Intravenous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "14/06/2024", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Netherlands Cancer Institute; E-mail: i.jedema@nki.nl; Tel. +31 205124002", "first_published_date": "24/06/2025", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003535-pip02-24" }, { "decision_number": "P/0213/2024", "pip_number": "EMEA-003408-PIP02-24", "active_substance": "gallium (68Ga) boclatixafortide", "invented_name": "", "therapeutic_area": "Endocrine disorders", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Subtype diagnosis of primary aldosteronism", "routes_of_administration": "Intravenous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "14/06/2024", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Pentixapharm AGE-mail: info@pentixapharm.com Tel: +49 93199136076", "first_published_date": "24/06/2025", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003408-pip02-24" }, { "decision_number": "P/0212/2024", "pip_number": "EMEA-002536-PIP02-24", "active_substance": "Lebrikizumab", "invented_name": "Ebglyss", "therapeutic_area": "Respiratory, thoracic and mediastinal disorders", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Treatment of nasal polyposis", "routes_of_administration": "Subcutaneous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "14/06/2024", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Almirall S.A.; Tel.  +34 932912958; E-mail: sonia.barange@almirall.com", "first_published_date": "24/06/2025", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002536-pip02-24" }, { "decision_number": "P/0224/2024", "pip_number": "EMEA-002907-PIP01-20-M03", "active_substance": "Epcoritamab", "invented_name": "", "therapeutic_area": "Neoplasms benign, malignant and unspecified (incl cysts and polyps);Oncology", "pharmaceutical_forms": "Concentrate for solution for injection;Solution for injection", "condition_indication": "Treatment of mature B-cell malignancies", "routes_of_administration": "Subcutaneous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "27/06/2024", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "AbbVie LtdE-mail: paediatricteam@abbvie.comTel. +44(0) 1628925033", "first_published_date": "12/09/2022", "last_updated_date": "24/06/2025", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002907-pip01-20-m03" }, { "decision_number": "P/0222/2024", "pip_number": "EMEA-002705-PIP01-19-M02", "active_substance": "iptacopan", "invented_name": "", "therapeutic_area": "Renal and urinary disorders", "pharmaceutical_forms": "Capsule, hard;Age appropriate oral solid dosage form", "condition_indication": "Treatment of C3 glomerulopathy", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "20/06/2024", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Novartis Europharm LimitedE-mail: paediatric.enquiries@novartis.comTel. +41 613241111", "first_published_date": "28/07/2021", "last_updated_date": "24/06/2025", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002705-pip01-19-m02" }, { "decision_number": "P/0218/2024", "pip_number": "EMEA-002418-PIP01-18-M04", "active_substance": "recombinant Influenza Hemagglutinin-strain A (H1N1 subtype);recombinant Influenza Hemagglutinin-strain A (H3N2 subtype);recombinant Influenza Hemagglutinin-strain B (Victoria lineage);recombinant Influenza Hemagglutinin-strain B (Yamagata lineage) (RIV4)", "invented_name": "Supemtek Tetra (previously Supemtek)", "therapeutic_area": "Infections and infestations", "pharmaceutical_forms": "Solution for injection in pre-filled syringe", "condition_indication": "Prevention of influenza infection", "routes_of_administration": "Intramuscular use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "13/06/2024", "compliance_outcome": "Positive", "compliance_opinion_date": "06/09/2024", "compliance_procedure_number": "EMA/PE/0000181685", "contact_for_public_enquiries": "Sanofi Winthrop Industrie; E-mail: contact-us@sanofi.com; Tel: +33 4 37 37 57 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"https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002093-pip02-17-m02" }, { "decision_number": "P/0221/2024", "pip_number": "EMEA-001862-PIP01-15-M04", "active_substance": "brexucabtagene autoleucel", "invented_name": "Tecartus", "therapeutic_area": "Neoplasms benign, malignant and unspecified (incl cysts and polyps);Oncology", "pharmaceutical_forms": "Dispersion for infusion", "condition_indication": "Treatment of acute lymphoblastic leukaemia", "routes_of_administration": "Intravenous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "20/06/2024", "compliance_outcome": "Positive", "compliance_opinion_date": "06/09/2024", "compliance_procedure_number": "EMA/PE/0000183453", "contact_for_public_enquiries": "Kite Pharma EU B.V.; Tel. +1 4242091332; E-mail: regulatory@kitepharma.com", "first_published_date": "28/09/2017", "last_updated_date": "24/06/2025", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001862-pip01-15-m04" }, { "decision_number": "P/0271/2024", "pip_number": "EMEA-002740-PIP01-19-M01", "active_substance": "lenacapavir sodium", "invented_name": "Sunlenca", "therapeutic_area": "Infections and infestations", "pharmaceutical_forms": "Age appropriate oral solid dosage form;Film-coated tablet;Solution for injection", "condition_indication": "Treatment of human immunodeficiency virus (HIV-1) infection", "routes_of_administration": "Oral use;Subcutaneous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "19/07/2024", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Gilead Sciences International Ltd.; Tel. +44 (0)1223 897 300; E-mail: regulatory.pip@gilead.com", "first_published_date": "29/09/2021", "last_updated_date": "24/06/2025", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002740-pip01-19-m01" }, { "decision_number": "P/0269/2024", "pip_number": "EMEA-002827-PIP01-20-M03", "active_substance": "botaretigene sparoparvovec", "invented_name": "", "therapeutic_area": "Congenital, familial and genetic disorders", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Treatment of Retinitis Pigmentosa", "routes_of_administration": "Ophthalmic use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "17/07/2024", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Janssen Cilag International Email: contact@Janssen-emea.com Tel. +32 14602111", "first_published_date": "19/11/2021", "last_updated_date": "24/06/2025", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002827-pip01-20-m03" }, { "decision_number": "P/0268/2024", "pip_number": "EMEA-002707-PIP01-19-M02", "active_substance": "doravirine;Islatravir", "invented_name": "", "therapeutic_area": "Infections and infestations", "pharmaceutical_forms": "Age appropriate oral solid dosage form;Tablet", "condition_indication": "Treatment of human immunodeficiency virus (HIV-1) infection", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "17/07/2024", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Merck Sharp & Dohme (Europe) Inc.Tel.: +33180464738E-mail: pip.information@merck.com", "first_published_date": "19/11/2021", "last_updated_date": "24/06/2025", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002707-pip01-19-m02" }, { "decision_number": "P/0200/2024", "pip_number": "EMEA-003591-PIP01-24", 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"P/0097/2024", "pip_number": "EMEA-003405-PIP01-23", "active_substance": "CX-000359 mRNA encoding the UL128 protein in the CMV glycoprotein complex pentamer;CX- 000594 mRNA encoding the gL protein in the CMV glycoprotein complex pentamer;CX- 000712 mRNA encoding the UL130 protein in the CMV glycoprotein complex pentamer;CX-005128 mRNA encoding the UL131A protein in the CMV glycoprotein complex pentamer;CX-005282 m-RNA encoding the gH protein in the CMV glycoprotein complex pentamer;CX-000667 mRNA encoding CMV gB (mRNA- 1647)", "invented_name": "", "therapeutic_area": "Infections and infestations", "pharmaceutical_forms": "Powder for suspension for injection", "condition_indication": "Prevention of cytomegalovirus infection", "routes_of_administration": "Intramuscular use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "12/04/2024", "compliance_outcome": "", "compliance_opinion_date": "", 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"decision_number": "P/0093/2024", "pip_number": "EMEA-003528-PIP01-23", "active_substance": "empasiprubart", "invented_name": "", "therapeutic_area": "Nervous system disorders", "pharmaceutical_forms": "All pharmaceutical forms", "condition_indication": "Treatment of multifocal motor neuropathy (MMN)", "routes_of_administration": "All routes of administration", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "12/04/2024", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Argenx BVE-mail: regulatory@argenx.comTel: +32 93103400", "first_published_date": "06/06/2025", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003528-pip01-23" }, { "decision_number": "P/0090/2024", "pip_number": "EMEA-002016-PIP05-23", "active_substance": "alpelisib", "invented_name": "Piqray", 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"pharmaceutical_forms": "Age appropriate oral dosage formulation;Film-coated tablet", "condition_indication": "Prevention of thromboembolism in patients with cardiovascular diseases", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "12/04/2024", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Janssen Cilag International NV; Tel. +3214602111; E-mail: contact@Janssen-emea.com", "first_published_date": "02/10/2024", "last_updated_date": "05/06/2025", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003220-pip01-22-m01" }, { "decision_number": "P/0091/2024", "pip_number": "EMEA-003215-PIP01-22-M01", "active_substance": "vamikibart", "invented_name": "", "therapeutic_area": "Eye disorders", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Treatment of uveitic macular oedema", "routes_of_administration": "Intravitreal use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "12/04/2024", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Roche Registration GmbHE-mail: global.eu_regulatory_office@roche.comTel. +49 7624142892", "first_published_date": "05/04/2024", "last_updated_date": "05/06/2025", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003215-pip01-22-m01" }, { "decision_number": "P/0179/2024", "pip_number": "EMEA-003394-PIP01-23", "active_substance": "sevasemten", "invented_name": "", "therapeutic_area": "Congenital, familial and genetic disorders", "pharmaceutical_forms": "Tablet;Age appropriate oral liquid dosage formulation", "condition_indication": "Treatment of dystrophinopathy", "routes_of_administration": "Oral use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "06/05/2024", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "FGK Representative Service GmbHE-mail: regulatory@edgewisetx.comTel.:  +1 7202627002", "first_published_date": "05/06/2025", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003394-pip01-23" }, { "decision_number": "P/0226/2023", "pip_number": "EMEA-003306-PIP01-22", "active_substance": "obeldesivir", "invented_name": "", "therapeutic_area": "Infectious diseases", "pharmaceutical_forms": "Age appropriate oral dosage formulation;Film-coated tablet", "condition_indication": "Treatment of Coronavirus disease 2019 (COVID-19)", "routes_of_administration": "Oral use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "14/06/2023", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Gilead Sciences International Ltd; E-mail: regulatory.pip@gilead.com; Tel. +44 (0)1223 897300", "first_published_date": "10/07/2024", "last_updated_date": "27/05/2025", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003306-pip01-22" }, { "decision_number": "P/0424/2023", "pip_number": "EMEA-003063-PIP03-22", "active_substance": "vibostolimab;pembrolizumab", "invented_name": "", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Concentrate for solution for infusion", "condition_indication": "Treatment of melanoma", "routes_of_administration": "Intravenous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "27/10/2023", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Merck Sharp & Dohme (Europe) Inc.Tel.: +33180464738E-mail: pip.information@merck.com", "first_published_date": "15/11/2024", "last_updated_date": "26/05/2025", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003063-pip03-22" }, { "decision_number": "P/0364/2022", "pip_number": "EMEA-001220-PIP07-20-M01", "active_substance": "baricitinib", "invented_name": "Olumiant", "therapeutic_area": "Infectious diseases", "pharmaceutical_forms": "Age appropriate oral liquid dosage formulation;Film-coated tablet", "condition_indication": "Treatment of Coronavirus disease 2019 (COVID-19)", "routes_of_administration": "Gastric use;Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "09/09/2022", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Eli Lilly & Company Limited; E-mail: eu_paediatric@lilly.com ; Tel. +44 (0)1276 483000", "first_published_date": "16/02/2021", "last_updated_date": "20/05/2025", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001220-pip07-20-m01" }, { "decision_number": "P/0120/2022", "pip_number": "EMEA-001501-PIP09-21", "active_substance": "dupilumab", "invented_name": "Dupixent", "therapeutic_area": "Dermatology", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Treatment of chronic inducible cold urticaria", "routes_of_administration": "Subcutaneous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "15/04/2022", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Sanofi-Aventis Groupe; contact-us@sanofi.com;  +33 169745695", "first_published_date": "17/04/2023", "last_updated_date": "20/05/2025", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001501-pip09-21" }, { "decision_number": "P/0038/2022", "pip_number": "EMEA-001214-PIP07-21", "active_substance": "Benralizumab", "invented_name": "Fasenra", "therapeutic_area": "Gastroentology-Hepatology", "pharmaceutical_forms": "Age appropriate dosage form for parenteral use;Solution for injection;Solution for injection/infusion", "condition_indication": "Treatment of eosinophilic gastritis/eosinophilic gastroenteritis", "routes_of_administration": "Subcutaneous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "31/01/2022", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "AstraZeneca ABEmail: paediatrics@astrazeneca.comTel.  +46 855326000", "first_published_date": "13/03/2024", "last_updated_date": "20/05/2025", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001214-pip07-21" }, { "decision_number": "P/0305/2023", "pip_number": "EMEA-003185-PIP01-22", "active_substance": "MVA-BN-RSV vaccine (construct MVA-mBN294B)", "invented_name": "", "therapeutic_area": "Infectious diseases;Vaccines", "pharmaceutical_forms": "Suspension for injection", "condition_indication": "Prevention of lower respiratory tract disease caused by respiratory syncytial virus", "routes_of_administration": "Intramuscular use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "11/08/2023", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Bavarian Nordic A/S; Email: info@bavarian-nordic.com ; Tel:  +45 61774743", "first_published_date": "02/10/2024", "last_updated_date": "20/05/2025", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003185-pip01-22" }, { "decision_number": "P/0083/2024", "pip_number": "EMEA-003049-PIP01-21-M01", "active_substance": "L-carnitine;glucose;calcium chloride dihydrate;sodium lactate;sodium chloride;magnesium chloride hexahydrate", "invented_name": "", "therapeutic_area": "Renal and urinary disorders", "pharmaceutical_forms": "Solution for peritoneal dialysis", "condition_indication": "Treatment of renal failure with carnitine deficiency", "routes_of_administration": "Intraperitoneal use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "15/03/2024", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Iperboreal Pharma Srl; E-mail: info@iperboreal.com; Tel: +39 0852034834", "first_published_date": "19/04/2023", "last_updated_date": "15/05/2025", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003049-pip01-21-m01" }, { "decision_number": "P/0084/2024", "pip_number": "EMEA-000639-PIP03-16-M03", "active_substance": "chloroprocaine hydrochloride", "invented_name": "Ampres", "therapeutic_area": "Nervous system disorders", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Peripheral nerve block (local anaesthesia by perineural injection)", "routes_of_administration": "Perineural use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "15/03/2024", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Sintetica GmbH; Tel. +41 916404250E-mail: corporate_clinical_rd@sintetica.com", "first_published_date": "17/04/2018", "last_updated_date": "15/05/2025", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000639-pip03-16-m03" }, { "decision_number": "P/0085/2024", "pip_number": "EMEA-000597-PIP03-15-M06", "active_substance": "Mirabegron", "invented_name": "Betmiga; Betmiga", "therapeutic_area": "Renal and urinary disorders", "pharmaceutical_forms": "Prolonged-release granules for oral suspension;Prolonged-release tablet", "condition_indication": "Treatment of neurogenic detrusor overactivity", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "15/03/2024", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Astellas Pharma Europe B.V.Tel. +31 7154 55878E-mail: contact.nl@astellas.com ", "first_published_date": "03/07/2015", "last_updated_date": "14/05/2025", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000597-pip03-15-m06" }, { "decision_number": "P/0086/2024", "pip_number": "EMEA-003170-PIP01-21-M02", "active_substance": "glucagon analogue linked to a human immunoglobulin Fc fragment (HM15136)", "invented_name": "", "therapeutic_area": "Metabolism and nutrition disorders", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Treatment of congenital hyperinsulinism", "routes_of_administration": "Subcutaneous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "21/03/2024", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Hanmi Pharm. Co., Ltd.; Email: hjkim8802@hanmi.co.kr; Tel. +82 24108771", "first_published_date": "12/10/2023", "last_updated_date": "14/05/2025", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003170-pip01-21-m02" }, { "decision_number": "P/0089/2024", "pip_number": "EMEA-003568-PIP01-23", "active_substance": "sargramostim", "invented_name": "", "therapeutic_area": "Injury, poisoning and procedural complications", "pharmaceutical_forms": "Powder for solution for injection", "condition_indication": "Treatment of acute radiation syndrome", "routes_of_administration": "Subcutaneous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "27/03/2024", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Partner Therapeutics Inc.; E-mail: partnertx@medcomminc.com; United States; Tel: +1 857 347 5730 (outside US);       +1 888 479 5385 (within US)", "first_published_date": "13/05/2025", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003568-pip01-23" }, { "decision_number": "P/0088/2024", "pip_number": "EMEA-003603-PIP01-24", "active_substance": "split influenza virus, inactivated containing antigens equivalent to the A/H1N1-like strain/Split influenza virus, inactivated containing antigens equivalent to the A/H3N2-like strain/Split influenza virus, inactivated containing antigens equivalent to B-like strain", "invented_name": "", "therapeutic_area": "Infections and infestations", "pharmaceutical_forms": "Suspension for injection", "condition_indication": "Prevention of influenza", "routes_of_administration": "Subcutaneous use;Intramuscular use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "15/03/2024", "compliance_outcome": "Positive", "compliance_opinion_date": "19/03/2024", "compliance_procedure_number": "EMEA-C-003603-PIP01-24", "contact_for_public_enquiries": "Sanofi Winthrop Industrie; E-mail: contact-us@sanofi.com; Tel: +33 4 37 37 57 84", "first_published_date": "13/05/2025", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003603-pip01-24" }, { "decision_number": "P/0087/2024", "pip_number": "EMEA-002876-PIP02-23", "active_substance": "sodium phenylbutyrate / ursodoxicoltaurine", "invented_name": "", "therapeutic_area": "Nervous system disorders", "pharmaceutical_forms": "All pharmaceutical forms", "condition_indication": "Treatment of progressive supranuclear palsy", "routes_of_administration": "All routes of administration", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "20/03/2024", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Amylyx Pharmaceuticals EMEA B.V.; the Netherlands; E-mail: Amylyx_EMEA@amylyx.com; Tel: +31 20 369 8199", "first_published_date": "13/05/2025", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002876-pip02-23" }, { "decision_number": "P/0081/2024", "pip_number": "EMEA-003176-PIP02-22", "active_substance": "cannabidiol", "invented_name": "", "therapeutic_area": "Congenital, familial and genetic disorders", "pharmaceutical_forms": "Gel", "condition_indication": "Treatment of fragile-X syndrome", "routes_of_administration": "Transdermal use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "15/03/2024", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Zynerba Pharmaceuticals Inc.; United States; E-mail: medicalinformation@zynerba.com; Tel: +1 (484) 581-7505", "first_published_date": "13/05/2025", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003176-pip02-22" }, { "decision_number": "P/0079/2024", "pip_number": "EMEA-001741-PIP04-17-M05", "active_substance": "upadacitinib", "invented_name": "Rinvoq", "therapeutic_area": "Skin and subcutaneous tissue disorders", "pharmaceutical_forms": "Age appropriate oral liquid dosage formulation;Age appropriate oral solid dosage form;Prolonged-release capsule;Prolonged-release tablet", "condition_indication": "Treatment of atopic dermatitis", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "08/03/2024", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "AbbVie LtdE-mail: paediatricteam@abbvie.comTel. +44 (0)1628 408248", "first_published_date": "20/02/2019", "last_updated_date": "12/05/2025", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001741-pip04-17-m05" }, { "decision_number": "P/0080/2024", "pip_number": "EMEA-003130-PIP02-23", "active_substance": "borrelia outer surface protein A (OspA) serotypes (ST1-6) lipidated, fusion protein vaccine", "invented_name": "", "therapeutic_area": "Infections and infestations", "pharmaceutical_forms": "Suspension for injection in pre-filled syringe", "condition_indication": "Prevention of Lyme disease", "routes_of_administration": "Intramuscular use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "15/03/2024", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Pfizer Europe MA EEIGE-mail: PIP_Enquiries@pfizer.com Tel.:  +44 (0)1304616161", "first_published_date": "12/05/2025", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003130-pip02-23" }, { "decision_number": "P/0069/2024", "pip_number": "EMEA-001625-PIP02-21-M03", "active_substance": "satralizumab", "invented_name": "Enspryng", "therapeutic_area": "Nervous system disorders;Neurology", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Treatment of myasthenia gravis", "routes_of_administration": "Subcutaneous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "08/03/2024", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Roche Registration GmbHE-mail: global.eu_regulatory_office@roche.comTel. +49 7624142892", "first_published_date": "06/03/2023", "last_updated_date": "25/04/2025", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001625-pip02-21-m03" }, { "decision_number": "P/0063/2024", "pip_number": "EMEA-002282-PIP01-17-M02", "active_substance": "molgramostim", "invented_name": "", "therapeutic_area": "Respiratory, thoracic and mediastinal disorders;Pneumology-allergology", "pharmaceutical_forms": "Nebuliser solution", "condition_indication": "Treatment of pulmonary alveolar proteinosis", "routes_of_administration": "Inhalation use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "08/03/2024", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Savara ApS; Email: charles.lapree@savarapharma.com    ; Tel. +1 2672499491", "first_published_date": "24/06/2019", "last_updated_date": "25/04/2025", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002282-pip01-17-m02" }, { "decision_number": "P/0074/2024", "pip_number": "EMEA-001270-PIP01-12-M07", "active_substance": "oritavancin (diphosphate)", "invented_name": "Tenkasi (previously Orbactiv)", "therapeutic_area": "Skin and subcutaneous tissue disorders", "pharmaceutical_forms": "Powder for concentrate for solution for infusion;Age appropriate dosage form for parenteral use", "condition_indication": "Treatment of acute bacterial skin and skin structure infections", "routes_of_administration": "Intravenous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "08/03/2024", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Menarini International Operations Luxembourg S.A.; E-mail: scappellini@menarini-ricerche.it; Tel. +39 05556807607/458; +39 3289896201", "first_published_date": "03/05/2013", "last_updated_date": "14/04/2025", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001270-pip01-12-m07" }, { "decision_number": "P/0076/2024", "pip_number": "EMEA-001314-PIP01-12-M02", "active_substance": "Dinutuximab beta", "invented_name": "Qarziba (previously Dinutuximab beta EUSA and Dinutuximab beta Apeiron)", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Solution for infusion;Concentrate for solution for infusion;Powder and solvent for solution for injection;Powder for solution for infusion", "condition_indication": "Treatment of neuroblastoma", "routes_of_administration": "Intravenous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "08/03/2024", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "EUSA Pharma (Netherlands) B.V.; Tel. +44 (0)3305 001155; E-mail: Ignacio.AlvarezRojo@eusapharma.com", "first_published_date": "12/05/2014", "last_updated_date": "14/04/2025", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001314-pip01-12-m02" }, { "decision_number": "P/0077/2024", "pip_number": "EMEA-001539-PIP01-13-M06", "active_substance": "sodium zirconium cyclosilicate", "invented_name": "Lokelma; Lokelma", "therapeutic_area": "Metabolism and nutrition disorders", "pharmaceutical_forms": "Powder for oral suspension", "condition_indication": "Treatment of hyperkalaemia", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "08/03/2024", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "AstraZeneca ABEmail: paediatrics@astrazeneca.comTel. +46 855324400", "first_published_date": "30/09/2014", "last_updated_date": "14/04/2025", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001539-pip01-13-m06" }, { "decision_number": "P/0078/2024", "pip_number": "EMEA-001579-PIP01-13-M06", "active_substance": "eluxadoline", "invented_name": "", "therapeutic_area": "Gastrointestinal disorders", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Treatment of diarrhoea-predominant irritable bowel Syndrome", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "13/04/2022", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "AbbVie LtdE-mail: paediatricteam@abbvie.comTel. +44(0) 1628925033", "first_published_date": "05/03/2015", "last_updated_date": "14/04/2025", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001579-pip01-13-m06" }, { "decision_number": "P/0075/2024", "pip_number": "EMEA-002338-PIP04-23", "active_substance": "ianalumab", "invented_name": "", "therapeutic_area": "Blood and lymphatic system disorders", "pharmaceutical_forms": "Concentrate for solution for infusion", "condition_indication": "Treatment of autoimmune haemolytic anaemia", "routes_of_administration": "Intravenous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "08/03/2024", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Novartis Europharm LimitedE-mail: paediatric.enquiries@novartis.comTel. +41 613241111", "first_published_date": "14/04/2025", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002338-pip04-23" }, { "decision_number": "P/0072/2024", "pip_number": "EMEA-002915-PIP01-20-M03", "active_substance": "SARS-CoV2 prefusion Spike delta TM (CoV-2 preS dTM) adjuvanted with AS03", "invented_name": "VidPrevtyn Beta", "therapeutic_area": "Vaccines", "pharmaceutical_forms": "Solution and emulsion for emulsion for injection", "condition_indication": "Prevention of Coronavirus disease 2019 (COVID-19)", "routes_of_administration": "Intramuscular use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "08/03/2024", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Sanofi PasteurE-mail: contact-us@sanofi.comTel. +33 1 6974 5695", "first_published_date": "19/05/2021", "last_updated_date": "14/04/2025", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002915-pip01-20-m03" }, { "decision_number": "P/0071/2024", "pip_number": "EMEA-003420-PIP01-23", "active_substance": "synthetic double-stranded siRNA oligonucleotide directed against apolipoprotein C-III mRNA and covalently linked to a ligand containing three N-acetylgalactosamine residues", "invented_name": "", "therapeutic_area": "Congenital, familial and genetic disorders", "pharmaceutical_forms": "Concentrate for solution for injection", "condition_indication": "Treatment of familial chylomicronaemia syndrome (type I hyperlipoproteinaemia", "routes_of_administration": "Subcutaneous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "08/03/2024", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "E-mail: smullins@arrowheadpharma.comTel. +1 (626)7346186", "first_published_date": "14/04/2025", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003420-pip01-23" }, { "decision_number": "P/0070/2024", "pip_number": "EMEA-003423-PIP02-23", "active_substance": "volrustomig", "invented_name": "", "therapeutic_area": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)", "pharmaceutical_forms": "Concentrate for solution for injection/infusion", "condition_indication": "Treatment of head and neck epithelial malignant neoplasms", "routes_of_administration": "Intravenous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "08/03/2024", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "AstraZeneca ABE-mail: paediatrics@astrazeneca.com", "first_published_date": "14/04/2025", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003423-pip02-23" }, { "decision_number": "P/0058/2024", "pip_number": "EMEA-002565-PIP02-19-M01", "active_substance": "Difelikefalin", "invented_name": "", "therapeutic_area": "Other", "pharmaceutical_forms": "Solution for injection/infusion", "condition_indication": "Treatment of chronic kidney disease associated pruritus", "routes_of_administration": "Intravenous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "07/03/2024", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Vifor Fresenius Medical Care Renal Pharma France; Tel. +41 588518000; E-mail: difelikefalin_ra@viforpharma.com", "first_published_date": "05/03/2021", "last_updated_date": "02/04/2025", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002565-pip02-19-m01" }, { "decision_number": "P/0059/2024", "pip_number": "EMEA-002656-PIP01-19-M01", "active_substance": "Chikungunya Virus Virus-Like Particle Vaccine / aluminum hydroxide", "invented_name": "", "therapeutic_area": "Infections and infestations;Vaccines", "pharmaceutical_forms": "Suspension for injection", "condition_indication": "Prevention of chikungunya disease", "routes_of_administration": "Intramuscular use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "07/03/2024", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Bavarian Nordic A/S; E-mail: regulatory@bavarian-nordic.com; Tel. +49 89255446300", "first_published_date": "13/01/2022", "last_updated_date": "02/04/2025", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002656-pip01-19-m01" }, { "decision_number": "P/0055/2024", "pip_number": "EMEA-000551-PIP04-21-M03", "active_substance": "givinostat", "invented_name": "", "therapeutic_area": "Congenital, familial and genetic disorders", "pharmaceutical_forms": "Oral suspension", "condition_indication": "Treatment of Duchenne muscular dystrophy", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "08/03/2024", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Italfarmaco S.p.A. E-mail: ITFPIP@italfarmacogroup.comTel. +39 0264432500", "first_published_date": "30/03/2023", "last_updated_date": "02/04/2025", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000551-pip04-21-m03" }, { "decision_number": "P/0054/2024", "pip_number": "EMEA-002121-PIP03-19-M02", "active_substance": "Daridorexant", "invented_name": "Quviviq", "therapeutic_area": "Nervous system disorders", "pharmaceutical_forms": "Age appropriate oral solid dosage form;Film-coated tablet", "condition_indication": "Treatment of insomnia", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "08/03/2024", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Idorsia Pharmaceuticals Deutschland GmbH  E-mail: clinical-trials-disclosure@idorsia.com  Tel. +41 588440000  ", "first_published_date": "03/03/2021", "last_updated_date": "02/04/2025", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002121-pip03-19-m02" }, { "decision_number": "P/0053/2024", "pip_number": "EMEA-000237-PIP01-08-M12", "active_substance": "azilsartan medoxomil", "invented_name": "Edarbi", "therapeutic_area": "Vascular disorders", "pharmaceutical_forms": "Tablet;Granules for oral suspension", "condition_indication": "Treatment of hypertension", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "08/03/2024", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Takeda Development Centre Europe Limited Email: medinfoEMEA@takeda.com Tel.  +44 (0)3333 000181  ", "first_published_date": "04/01/2013", "last_updated_date": "02/04/2025", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000237-pip01-08-m12" }, { "decision_number": "P/0051/2024", "pip_number": "EMEA-002234-PIP01-17-M02", "active_substance": "purified inactivated rabies virus (WISTAR PM/WI 38-1503-3M strain)", "invented_name": "", "therapeutic_area": "Infections and infestations", "pharmaceutical_forms": "Powder and solvent for suspension for injection", "condition_indication": "Prevention of rabies viral infection", "routes_of_administration": "Intramuscular use;Intradermal use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "08/03/2024", "compliance_outcome": "Positive", "compliance_opinion_date": "13/12/2024", "compliance_procedure_number": "EMA/PE/0000227887", "contact_for_public_enquiries": "Sanofi Pasteur Europe Email: contact-us@sanofi.com Tel.  +33 169745789  ", "first_published_date": "27/11/2018", "last_updated_date": "02/04/2025", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002234-pip01-17-m02" }, { "decision_number": "P/0057/2024", "pip_number": "EMEA-003523-PIP01-23", "active_substance": "Interleukin-2/Interleukin-1 beta, human/Granulocyte colony-stimulating factor/Tumour necrosis factoralpha/ Interferon gamma", "invented_name": "", "therapeutic_area": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Treatment of head and neck epithelial malignant neoplasms", "routes_of_administration": "Peritumoral and perilymphatic use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "08/03/2024", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Cel-Sci Corp. Email: feedback@cel-sci.com Tel.  +1 7035069460  ", "first_published_date": "01/04/2025", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003523-pip01-23" }, { "decision_number": "P/0056/2024", "pip_number": "EMEA-003515-PIP01-23", "active_substance": "2-(3,5-dichloro-1-methyl-indazol-4-yl)-1-[(1S,3R)-3-(hydroxymethyl)-5-(1-hydroxy-1-methyl-ethyl)- 1-methyl-3,4-dihydro-1H-isoquinolin-2-yl]ethanone monohydrate", "invented_name": "", "therapeutic_area": "Nervous system disorders", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Treatment of Parkinson's disease", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "08/03/2024", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "UCB Pharma Email: UCBCares.IE@ucb.com Tel.  +35 314632371  ", "first_published_date": "01/04/2025", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003515-pip01-23" }, { "decision_number": "P/0052/2024", "pip_number": "EMEA-003299-PIP02-22", "active_substance": "orforglipron", "invented_name": "", "therapeutic_area": "Metabolism and nutrition disorders", "pharmaceutical_forms": "Capsule, hard;Age appropriate oral solid dosage form", "condition_indication": "Treatment of obesity", "routes_of_administration": "Oral use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "08/03/2024", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Eli Lilly and Company LtdE-mail: eu_paediatric@lilly.com Phone: +44 1256315000", "first_published_date": "01/04/2025", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003299-pip02-22" }, { "decision_number": "P/0050/2024", "pip_number": "EMEA-003522-PIP01-23", "active_substance": "zanzalintinib", "invented_name": "", "therapeutic_area": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Treatment of colorectal cancer;Treatment of head and neck epithelial malignant neoplasms;Treatment of renal cell carcinoma (RCC)", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "08/03/2024", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Exelixis Inc. Email: druginfo@exelixis.com Tel.  +1 6508377400  ", "first_published_date": "01/04/2025", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003522-pip01-23" }, { "decision_number": "P/0049/2024", "pip_number": "EMEA-002205-PIP02-23", "active_substance": "Isatuximab", "invented_name": "Sarclisa", "therapeutic_area": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Treatment of malignant neoplasms of the haematopoietic and lymphoid tissue", "routes_of_administration": "Subcutaneous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "08/03/2024", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Sanofi Winthrop IndustrieE-mail: contact-us@sanofi.comTel: +33 1 69 74 56 95", "first_published_date": "01/04/2025", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002205-pip02-23" }, { "decision_number": "P/0048/2024", "pip_number": "EMEA-003516-PIP01-23", "active_substance": "IIgG-like T cell engager binding to DLL3 and CD3", "invented_name": "", "therapeutic_area": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)", "pharmaceutical_forms": "Solution for infusion", "condition_indication": "Treatment of neuroendocrine carcinoma (excluding neuroblastoma);Treatment of small cell lung carcinoma", "routes_of_administration": "Parenteral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "08/03/2024", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Boehringer Ingelheim International GmbH E-mail: COMMSPaediatrics@boehringer-ingelheim.comTel. +49 (0)6132 77 8271", "first_published_date": "01/04/2025", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003516-pip01-23" }, { "decision_number": "P/0045/2024", "pip_number": "EMEA-003589-PIP01-24", "active_substance": "influenza virus type B, Victoria lineage;Influenza A virus subtype H3N2 haemagglutinin, recombinant;Influenza A virus subtype H1N1 haemagglutinin, recombinant", "invented_name": "", "therapeutic_area": "Infections and infestations", "pharmaceutical_forms": "Nasal spray suspension", "condition_indication": "Prevention of influenza infection", "routes_of_administration": "Nasal use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "09/02/2024", "compliance_outcome": "Positive", "compliance_opinion_date": "19/03/2024", "compliance_procedure_number": "EMEA-C-003589-PIP01-24", "contact_for_public_enquiries": "AstraZeneca ABE-mail: paediatrics@astrazeneca.com", "first_published_date": "26/03/2025", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003589-pip01-24" }, { "decision_number": "P/0016/2024", "pip_number": "EMEA-003512-PIP01-23", "active_substance": "tifcemalimab", "invented_name": "", "therapeutic_area": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)", "pharmaceutical_forms": "All pharmaceutical forms", "condition_indication": "Treatment of lung cancer (small cell and non-small cell lung cancer)", "routes_of_administration": "All routes of administration", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "06/02/2024", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "E-mail: 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"last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003458-pip01-23" }, { "decision_number": "P/0041/2024", "pip_number": "EMEA-003027-PIP02-23", "active_substance": "sepiapterin", "invented_name": "", "therapeutic_area": "Congenital, familial and genetic disorders", "pharmaceutical_forms": "Oral powder", "condition_indication": "Treatment of hyperphenylalaninaemia", "routes_of_administration": "Oral use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "02/02/2024", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "PTC Therapeutics International Limited; Tel. +353 19068700; E-mail: medinfo@ptcbio.com", "first_published_date": "26/03/2025", "last_updated_date": "", "pip_url": 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"pip_number": "EMEA-003514-PIP01-23", "active_substance": "obicetrapib;ezetimibe", "invented_name": "", "therapeutic_area": "Congenital, familial and genetic disorders", "pharmaceutical_forms": "Tablet", "condition_indication": "Treatment of mixed hyperlipidaemia", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "31/01/2024", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "NewAmsterdam Pharma B.V. Email: Marc.ditmarsch@newamsterdampharma.com Tel.  +31 352062971", "first_published_date": "18/03/2025", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003514-pip01-23" }, { "decision_number": "P/0031/2024", "pip_number": "EMEA-003504-PIP01-23", "active_substance": "tinengotinib", "invented_name": "", "therapeutic_area": "Neoplasms 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"decision_date": "29/12/2023", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Viridian Therapeutics Inc. E-mail: viridian-clinical-trials@viridiantherapeutics.comTel: +1 6172724609", "first_published_date": "13/02/2025", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003499-pip01-23" }, { "decision_number": "P/0514/2023", "pip_number": "EMEA-003497-PIP01-23", "active_substance": "oregovomab", "invented_name": "", "therapeutic_area": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)", "pharmaceutical_forms": "Powder for solution for infusion", "condition_indication": "Treatment of fallopian tube cancer;Treatment of ovarian cancer;Treatment of primary peritoneal cancer", "routes_of_administration": "Intravenous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "29/12/2023", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Canariabio Inc. E-mail: ben.yoon@canariabio.comTel: +82 1042678593", "first_published_date": "13/02/2025", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003497-pip01-23" }, { "decision_number": "P/0494/2023", "pip_number": "EMEA-003469-PIP01-23", "active_substance": "Humanized IgG1 blocking monoclonal antibody targeting CD39 (IPH5201)", "invented_name": "", "therapeutic_area": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)", "pharmaceutical_forms": "All pharmaceutical forms", "condition_indication": "Treatment of lung cancer", "routes_of_administration": "All routes of administration", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "01/12/2023", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Innate Pharma SA; E-mail: info@innate-pharma.fr; Tel. +33 430303030", "first_published_date": "13/02/2025", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003469-pip01-23" }, { "decision_number": "P/0521/2023", "pip_number": "EMEA-003419-PIP01-23", "active_substance": "modified messenger ribonucleic acid encoding human propionyl-coenzyme a carboxylase alpha and beta subunits encapsulated into lipid nanoparticles (mRNA-3927)", "invented_name": "", "therapeutic_area": "Endrocrine disorders", "pharmaceutical_forms": "Dispersion for injection", "condition_indication": "Treatment of propionic acidaemia", "routes_of_administration": "Intravenous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "29/12/2023", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Moderna Biotech Spain S.L. E-mail: medinfo@modernatx.comTel: +1 6177146500", "first_published_date": "13/02/2025", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003419-pip01-23" }, { "decision_number": "P/0518/2023", "pip_number": "EMEA-003496-PIP01-23", "active_substance": "allogeneic cultured postnatal thymus-derived tissue", "invented_name": "", "therapeutic_area": "Surgical and medical procedures", "pharmaceutical_forms": "Living tissue equivalent", "condition_indication": "Treatment of congenital athymia", "routes_of_administration": "Implant use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "29/12/2023", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Enzyvant Therapeutics Ireland Limited E-mail: info@us.sumitomo-pharma.comTel: +(877) 3763830", "first_published_date": "13/02/2025", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003496-pip01-23" }, { "decision_number": "P/0517/2023", "pip_number": "EMEA-003396-PIP01-23", "active_substance": "complement factor B antisense oligonucleotide (RO7434656)", "invented_name": "", "therapeutic_area": "Renal and urinary disorders", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Treatment of primary IgA nephropathy", "routes_of_administration": "Subcutaneous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "29/12/2023", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Roche Registration GmbH E-mail: global.eu_regulatory_office@roche.comTel: +41 616879411", "first_published_date": "13/02/2025", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003396-pip01-23" }, { "decision_number": "P/0516/2023", "pip_number": "EMEA-002674-PIP01-19", "active_substance": "3-(4-acetamidophenyl)-2-(S)-methoxypropionic acid, or (S)-3-(4-acetamidophenyl)-2- methoxypropanoic acid (N-Acetyl-GED-0507-34-LEVO)", "invented_name": "", "therapeutic_area": "Skin and subcutaneous tissue disorders", "pharmaceutical_forms": "Gel", "condition_indication": "Treatment of acne vulgaris", "routes_of_administration": "Cutaneous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "29/12/2023", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Nogra Pharma Limited E-mail: sbellinvia@ppmservices.chTel: +41 916961712", "first_published_date": "13/02/2025", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002674-pip01-19" }, { "decision_number": "P/0509/2023", "pip_number": "EMEA-002022-PIP02-23", "active_substance": "DNA plasmid encoding HPV type 16 consensus E6 and E7 proteins (pGX 3001);DNA plasmid encoding HPV type 18 consensus E6 and E7 proteins (pGX3002)", "invented_name": "", "therapeutic_area": "Infections and infestations", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Treatment of squamous intraepithelial lesions of the anus caused by HPV types 16 and 18", "routes_of_administration": "Intramuscular use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "29/12/2023", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Inovio Pharmaceuticals Inc E-mail: Clinical.Trials@inovio.com Tel:  +1 2674344080", "first_published_date": "13/02/2025", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002022-pip02-23" }, { "decision_number": "P/0544/2023", "pip_number": "EMEA-003025-PIP03-23-M01", "active_substance": "haematopoietic stem cells and blood progenitors umbilical cord-derived expanded with (1R,4R)-N1-(2-benzyl-7-(2-methyl-2H-tetrazol-5-yl)-9H-pyrimido[4,5-b]indol-4-yl)cyclohexane-1,4-diamine dihydrobromide dihydrate (ECT-001-CB)", "invented_name": "", "therapeutic_area": "Blood and lymphatic system disorders", "pharmaceutical_forms": "Dispersion for infusion", "condition_indication": "Treatment in haematopoietic stem cell transplantation in patients with haematological malignancies", "routes_of_administration": "Intravenous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "20/12/2023", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "ExCellTheraE-mail: david.millette@excellthera.comTel: +15143432369", "first_published_date": "15/11/2024", "last_updated_date": "13/02/2025", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003025-pip03-23-m01" }, { "decision_number": "P/0541/2023", "pip_number": "EMEA-001299-PIP03-17-M03", "active_substance": "birch bark", "invented_name": "Filsuvez", "therapeutic_area": "Skin and subcutaneous tissue disorders", "pharmaceutical_forms": "Gel", "condition_indication": "Treatment of epidermolysis bullosa", "routes_of_administration": "Cutaneous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "14/12/2023", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Chiesi Farmaceutici S.p.A.; Tel. +39 0521 2791; E-mail: info@chiesi.com", "first_published_date": "23/07/2021", "last_updated_date": "13/02/2025", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001299-pip03-17-m03" }, { "decision_number": "P/0540/2023", "pip_number": "EMEA-003437-PIP01-23", "active_substance": "modified mRNA encoding human methylmalonyl-coenzyme A mutase containing a polymorphism at position 671 (mRNA-3705)", "invented_name": "", "therapeutic_area": "Endocrine disorders", "pharmaceutical_forms": "Dispersion for injection", "condition_indication": "Treatment of methylmalonic acidaemia", "routes_of_administration": "Intravenous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "29/12/2023", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Moderna Biotech Spain S.L. E-mail: medinfo@modernatx.comTel: +1 6177146500", "first_published_date": "13/02/2025", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003437-pip01-23" }, { "decision_number": "P/0539/2023", "pip_number": "EMEA-003486-PIP01-23", "active_substance": "sitagliptin;dapagliflozin", "invented_name": "", "therapeutic_area": "Endocrine disorders", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Treatment of type 2 diabetes mellitus", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "29/12/2023", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "KRKA tovarna zdravil d.d. 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"https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003490-pip01-23" }, { "decision_number": "P/0537/2023", "pip_number": "EMEA-003386-PIP01-22", "active_substance": "taldefgrobep alfa", "invented_name": "", "therapeutic_area": "", "pharmaceutical_forms": "Concentrate for solution for injection/infusion", "condition_indication": "Treatment of spinal muscular atrophy", "routes_of_administration": "Subcutaneous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "29/12/2023", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Biohaven Bioscience Ireland Limited E-mail: medinfo@biohavenpharma.com Tel. +1 2034040410", "first_published_date": "13/02/2025", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003386-pip01-22" }, { "decision_number": "P/0536/2023", "pip_number": "EMEA-003421-PIP01-23", "active_substance": "olutasidenib", "invented_name": "", "therapeutic_area": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)", "pharmaceutical_forms": "Capsule, hard", "condition_indication": "Treatment of acute myeloid leukaemia", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "29/12/2023", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Rigel Pharmaceuticals B.V. E-mail: asiddiqui@rigel.com Tel. +1 6506241162", "first_published_date": "13/02/2025", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003421-pip01-23" }, { "decision_number": "P/0535/2023", "pip_number": "EMEA-003488-PIP01-23", "active_substance": "lotilaner", "invented_name": 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"Treatment of lung cancer", "routes_of_administration": "All routes of administration", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "29/12/2023", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Incyte Biosciences Distribution B.V. E-mail: RA@incyte.comTel. +1 3024252734", "first_published_date": "13/02/2025", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002798-pip04-23" }, { "decision_number": "P/0533/2023", "pip_number": "EMEA-002329-PIP02-20-M03", "active_substance": "Delgocitinib", "invented_name": "", "therapeutic_area": "Skin and subcutaneous tissue disorders", "pharmaceutical_forms": "Cream", "condition_indication": "Treatment of chronic hand eczema", "routes_of_administration": "Cutaneous use", "decision_type": "PM: decision on the application for 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"compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Menarini International Operations Luxembourg S.A.; E-mail: prijli@menarini.it; Tel. +39 0555 680633", "first_published_date": "22/12/2015", "last_updated_date": "13/02/2025", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001731-pip01-14-m04" }, { "decision_number": "P/0273/2024", "pip_number": "EMEA-002862-PIP01-20-M04", "active_substance": "COVID-19 vaccine (ChAdOx1-S [recombinant]) (AZD1222)", "invented_name": "Vaxzevria (previously COVID-19 Vaccine AstraZeneca)", "therapeutic_area": "Vaccines", "pharmaceutical_forms": "Suspension for injection", "condition_indication": "Prevention of Coronavirus disease 2019 (COVID-19)", "routes_of_administration": "Intramuscular use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "14/08/2024", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "AstraZeneca ABEmail: paediatrics@astrazeneca.comTel. +46 855324400", "first_published_date": "05/01/2021", "last_updated_date": "12/02/2025", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002862-pip01-20-m04" }, { "decision_number": "P/0144/2024", "pip_number": "EMEA-003360-PIP01-22", "active_substance": "tozorakimab", "invented_name": "", "therapeutic_area": "Infections and infestations", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Treatment of severe viral lower respiratory tract disease", "routes_of_administration": "Intravenous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "06/05/2024", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "AstraZeneca AB Tel.  +44 7876398360 E-mail: paediatrics@astrazeneca.com  ", "first_published_date": "12/02/2025", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003360-pip01-22" }, { "decision_number": "P/0188/2024", "pip_number": "EMEA-003587-PIP01-24", "active_substance": "trofinetide", "invented_name": "", "therapeutic_area": "Congenital, familial and genetic disorders", "pharmaceutical_forms": "Oral solution", "condition_indication": "Treatment of Rett syndrome", "routes_of_administration": "Oral use;Gastroenteral use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "14/06/2024", "compliance_outcome": "Positive", "compliance_opinion_date": "06/09/2024", "compliance_procedure_number": "EMEA-C-003587-PIP01-24", "contact_for_public_enquiries": "ACADIA Pharmaceuticals Inc.; United States; E-mail: info@acadia-pharm.com; Tel.: +1 8585582871; Fax: +1 8585582872", "first_published_date": "12/02/2025", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003587-pip01-24" }, { "decision_number": "P/252/2010", "pip_number": "EMEA-000802-PIP01-09", "active_substance": "anti-BAFF monoclonal antibody (LY2127399)", "invented_name": "", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Treatment of chronic autoimmune arthritis;Treatment of multiple sclerosis", "routes_of_administration": "Subcutaneous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "26/11/2010", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Eli Lilly & Company Limited; E-mail: eu_paediatric@lilly.com ; Tel. +44 (0)1276 483000", "first_published_date": "21/12/2010", "last_updated_date": "11/02/2025", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000802-pip01-09" }, { "decision_number": "P/87/2010", "pip_number": "EMEA-000532-PIP01-09", "active_substance": "bituminosulphonate (sodium);clindamycin phosphate", "invented_name": "", "therapeutic_area": "Dermatology", "pharmaceutical_forms": "Solution", "condition_indication": "Treatment of acne vulgaris", "routes_of_administration": "Cutaneous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "01/06/2010", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Ichthyol -Gesellschaft Cordes, Hermanni & Co. 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"contact_for_public_enquiries": "Alexion Europe SAS; E-mail: pip.enquiries.eu@alexion.com; Tel. +33 147103621", "first_published_date": "08/09/2022", "last_updated_date": "24/10/2024", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002863-pip01-20" }, { "decision_number": "P/0150/2017", "pip_number": "EMEA-001043-PIP01-10-M03", "active_substance": "sirukumab", "invented_name": "", "therapeutic_area": "Immunology-Rheumatology-Transplantation", "pharmaceutical_forms": "Solution for injection in pre-filled pen;Age appropriate dosage form for parenteral use", "condition_indication": "Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, ankylosing spondylarthritis, psoriatic arthritis and juvenile idiopathic arthritis)", "routes_of_administration": "Subcutaneous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "09/06/2017", "compliance_outcome": "", 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"ViiV Healthcare UK Ltd;  +44 (0)7467 443192; eu.paediatric-plans@gsk.com", "first_published_date": "21/12/2015", "last_updated_date": "07/10/2024", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001687-pip01-14-m07" }, { "decision_number": "P/0341/2023", "pip_number": "EMEA-000311-PIP04-13-M06", "active_substance": "ustekinumab", "invented_name": "Stelara", "therapeutic_area": "Gastroentology-Hepatology", "pharmaceutical_forms": "Solution for injection/infusion;Concentrate for solution for infusion", "condition_indication": "Treatment of Crohn's disease", "routes_of_administration": "Subcutaneous use;Intravenous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "08/09/2023", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Janssen Cilag International NV; Tel. +3214602111; E-mail: contact@Janssen-emea.com", 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"EMEA-002893-PIP01-20-M04", "active_substance": "elasomeran;imelsomeram;davesomeran", "invented_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "therapeutic_area": "Vaccines", "pharmaceutical_forms": "Dispersion for injection", "condition_indication": "Prevention of Coronavirus disease 2019 (COVID-19)", "routes_of_administration": "Intramuscular use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "08/09/2023", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Moderna Biotech Spain, S.L. Tel.  +41 795000903 E-mail: paediatrics@modernatx.com", "first_published_date": "18/12/2020", "last_updated_date": "04/10/2024", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002893-pip01-20-m04" }, { "decision_number": "P/0361/2023", "pip_number": "EMEA-002681-PIP01-19-M02", "active_substance": "rozanolixizumab", 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"first_published_date": "09/08/2012", "last_updated_date": "02/10/2024", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001143-pip01-11-m06" }, { "decision_number": "P/0073/2022", "pip_number": "EMEA-000533-PIP01-08-M11", "active_substance": "tenofovir disoproxil fumarate", "invented_name": "Viread", "therapeutic_area": "Infectious diseases", "pharmaceutical_forms": "Film-coated tablet;Granules", "condition_indication": "Treatment of chronic viral hepatitis B;Treatment of human immunodeficiency virus (HIV-1) infection", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "11/03/2022", "compliance_outcome": "Positive", "compliance_opinion_date": "20/01/2023", "compliance_procedure_number": "EMEA-C-000533-PIP01-08-M11", "contact_for_public_enquiries": "Gilead Sciences International Limited; Tel. +44 (0)1223 897300; E-mail: regulatory.pip@gilead.com;  ", "first_published_date": "15/09/2011", "last_updated_date": "19/09/2024", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000533-pip01-08-m11" }, { "decision_number": "P/0337/2022", "pip_number": "EMEA-000455-PIP02-10-M09", "active_substance": "vortioxetine", "invented_name": "Brintellix", "therapeutic_area": "Psychiatry", "pharmaceutical_forms": "Film-coated tablet;Age appropriate oral liquid dosage formulation", "condition_indication": "Treatment of major depressive disorder", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "10/08/2022", "compliance_outcome": "Positive", "compliance_opinion_date": "20/01/2023", "compliance_procedure_number": "EMEA-C-000455-PIP02-10-M09", "contact_for_public_enquiries": "H. 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E-mail: pip_enquiries@pfizer.com", "first_published_date": "30/03/2020", "last_updated_date": "19/09/2024", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001493-pip03-18-m01" }, { "decision_number": "P/0382/2022", "pip_number": "EMEA-002501-PIP01-18-M03", "active_substance": "Efanesoctocog alfa", "invented_name": "", "therapeutic_area": "Haematology-Hemostaseology", "pharmaceutical_forms": "Powder and solvent for solution for injection", "condition_indication": "Treatment of Haemophilia A", "routes_of_administration": "Intravenous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "10/10/2022", "compliance_outcome": "Positive", "compliance_opinion_date": "26/04/2023", "compliance_procedure_number": "EMEA-C-002501-PIP01-18-M03", "contact_for_public_enquiries": "Swedish Orphan Biovitrum ABE-mail: medical.info@sobi.comTel. +46 8697 2000", "first_published_date": "10/06/2020", "last_updated_date": "19/09/2024", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002501-pip01-18-m03" }, { "decision_number": "P/0220/2021", "pip_number": "EMEA-001835-PIP01-15-M05", "active_substance": "Liquid ethanolic extract 30 per cent (w/w) of Allium cepa L. 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"condition_indication": "Treatment of acute lymphoblastic leukaemia;Treatment of lymphoblastic lymphoma", "routes_of_administration": "Intramuscular use;Intravenous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "29/10/2021", "compliance_outcome": "Positive", "compliance_opinion_date": "26/05/2023", "compliance_procedure_number": "EMEA-C-002934-PIP01-20", "contact_for_public_enquiries": "Jazz Pharmaceuticals Ireland Ltd. E-mail: corporateaffairsmediainfo@jazzpharma.com Tel: +1 35316347800", "first_published_date": "22/03/2022", "last_updated_date": "19/09/2024", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002934-pip01-20" }, { "decision_number": "P/0280/2022", "pip_number": "EMEA-001119-PIP02-12-M08", "active_substance": "lenvatinib", "invented_name": "Lenvima; Kisplyx", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Capsule, hard", "condition_indication": "Treatment of follicular thyroid cancer;Treatment of osteosarcoma;Treatment of papillary thyroid cancer", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "10/08/2022", "compliance_outcome": "Positive", "compliance_opinion_date": "26/05/2023", "compliance_procedure_number": "EMEA-C-001119-PIP02-12-M08", "contact_for_public_enquiries": "Eisai Europe Ltd; E-mail: eumedinfo@eisai.net; Tel. +44 (0)8456 761400", "first_published_date": "24/06/2013", "last_updated_date": "19/09/2024", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001119-pip02-12-m08" }, { "decision_number": "P/0075/2023", "pip_number": "EMEA-002435-PIP01-18-M03", "active_substance": "Eladocagene exuparvovec", "invented_name": "Upstaza", "therapeutic_area": "Neurology", "pharmaceutical_forms": "Solution for infusion", "condition_indication": "Treatment of aromatic 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"routes_of_administration": "Intramuscular use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "15/05/2020", "compliance_outcome": "Positive", "compliance_opinion_date": "26/05/2023", "compliance_procedure_number": "EMEA-C-000599-PIP01-09-M07", "contact_for_public_enquiries": "Seqirus S.r.l.; E-mail: pip.seq@seqirus.com; Tel.  +39 0577096405 / +39 0577096401", "first_published_date": "13/07/2011", "last_updated_date": "19/09/2024", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000599-pip01-09-m07" }, { "decision_number": "P/0049/2022", "pip_number": "EMEA-002475-PIP02-19-M02", "active_substance": "spesolimab", "invented_name": "", "therapeutic_area": "Dermatology", "pharmaceutical_forms": "Solution for infusion;Solution for injection", "condition_indication": "Prevention of generalized pustular psoriasis;Treatment of generalized pustular psoriasis", "routes_of_administration": "Intravenous use;Subcutaneous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "18/02/2022", "compliance_outcome": "Positive", "compliance_opinion_date": "23/06/2023", "compliance_procedure_number": "EMEA-C-002475-PIP02-19-M02", "contact_for_public_enquiries": "Boehringer Ingelheim International GmbH; Tel. +49 6132 778271; Email: Paediatrics@boehringer-ingelheim.com", "first_published_date": "04/03/2021", "last_updated_date": "19/09/2024", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002475-pip02-19-m02" }, { "decision_number": "P/0076/2023", "pip_number": "EMEA-003330-PIP01-22", "active_substance": "clascoterone", "invented_name": "", "therapeutic_area": "Dermatology", "pharmaceutical_forms": "Cream", "condition_indication": "Treatment of acne vulgaris", "routes_of_administration": "Topical use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "10/03/2023", "compliance_outcome": "Positive", "compliance_opinion_date": "23/06/2023", "compliance_procedure_number": "EMEA-C-003330-PIP01-22", "contact_for_public_enquiries": "E-mail: dermatology@cosmopharma.comTelephone: +39 0286891124", "first_published_date": "29/02/2024", "last_updated_date": "19/09/2024", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003330-pip01-22" }, { "decision_number": "P/0103/2023", "pip_number": "EMEA-001734-PIP01-14-M06", "active_substance": "defatted powder of Arachis hypogaea L., semen (peanuts)", "invented_name": "Palforzia", "therapeutic_area": "Pneumology-allergology", "pharmaceutical_forms": "Oral powder;Capsule, hard", "condition_indication": "Treatment of peanut allergy", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "24/03/2023", "compliance_outcome": "Positive", "compliance_opinion_date": "23/06/2023", "compliance_procedure_number": "EMEA-C-001734-PIP01-14-M06", "contact_for_public_enquiries": "Aimmune Nestle Health Science US R&D LLCE-mail: USNHScPharmaregops@us.nestle.comPhone: +16508479108 ", "first_published_date": "19/11/2015", "last_updated_date": "19/09/2024", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001734-pip01-14-m06" }, { "decision_number": "P/0165/2017", "pip_number": "EMEA-001094-PIP01-10-M04", "active_substance": "teriflunomide", "invented_name": "Aubagio; Aubagio", "therapeutic_area": "Neurology", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Treatment of multiple sclerosis", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "03/07/2017", "compliance_outcome": "Positive", "compliance_opinion_date": "23/06/2023", "compliance_procedure_number": "EMEA-C-001094-PIP01-10-M04", "contact_for_public_enquiries": "Genzyme Europe B.V. / Sanofi-Aventis groupe; The Netherlands; Tel. +31 356991299; E-mail: eumedinfo@genzyme.com;  ", "first_published_date": "26/07/2017", "last_updated_date": "19/09/2024", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001094-pip01-10-m04" }, { "decision_number": "P/0170/2023", "pip_number": "EMEA-000973-PIP01-10-M04", "active_substance": "recombinant human N-acetylgalactosamine-6-sulfatase (elosulfase alfa)", "invented_name": "Vimizim", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Concentrate for solution for infusion", "condition_indication": "Treatment of mucopolysaccharidosis, type IVA (Morquio-A syndrome)", "routes_of_administration": "Intravenous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "15/05/2023", "compliance_outcome": "Positive", "compliance_opinion_date": "23/06/2023", "compliance_procedure_number": "EMEA-C-000973-PIP01-10-M04", "contact_for_public_enquiries": "BioMarin International Limited E-mail: girish.dhondge@bmrn.com Tel. +44 2071508590 ", "first_published_date": "12/05/2011", "last_updated_date": "19/09/2024", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000973-pip01-10-m04" }, { "decision_number": "P/0507/2022", "pip_number": "EMEA-000637-PIP02-10-M07", "active_substance": "Lanthanum carbonate hydrate", "invented_name": "Fosrenol and associated names", "therapeutic_area": "Uro-nephrology", "pharmaceutical_forms": "Chewable tablet;Oral powder", "condition_indication": "Treatment of hyperphosphataemia", "routes_of_administration": "Oral use", "decision_type": "RPM: decision refers to a refusal on the application for modification of an agreed PIP", "decision_date": "02/12/2022", "compliance_outcome": "Positive", "compliance_opinion_date": "23/06/2023", "compliance_procedure_number": "EMEA-C-000637-PIP02-10-M07", "contact_for_public_enquiries": "Takeda Pharmaceuticals International AG Ireland BranchE-mail: medinfoemea@takeda.comTel: +44 (0) 3333 000181", "first_published_date": "27/10/2016", "last_updated_date": "19/09/2024", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000637-pip02-10-m07" }, { "decision_number": "P/0101/2022", "pip_number": "EMEA-000317-PIP01-08-M13", "active_substance": "rilpivirine hydrochloride", "invented_name": "Edurant", "therapeutic_area": "Infectious diseases", "pharmaceutical_forms": "Film-coated tablet;Age appropriate solid oral formulation", "condition_indication": "Treatment of human immunodeficiency virus (HIV-1) infection", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "12/08/2020", "compliance_outcome": "Positive", "compliance_opinion_date": "23/06/2023", "compliance_procedure_number": "EMEA-C-000317-PIP01-08-M13", "contact_for_public_enquiries": "Janssen-Cilag International NV; Tel. +32 1460 2111; E-mail: contact@janssen-emea.com", "first_published_date": "17/10/2011", "last_updated_date": "19/09/2024", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000317-pip01-08-m13" }, { "decision_number": "P/0541/2022", "pip_number": "EMEA-001501-PIP04-19-M02", "active_substance": "dupilumab", "invented_name": "Dupixent", "therapeutic_area": "Gastroentology-Hepatology", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Treatment of eosinophilic esophagitis", "routes_of_administration": "Subcutaneous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "30/12/2022", "compliance_outcome": "Positive", "compliance_opinion_date": "21/07/2023", "compliance_procedure_number": "EMEA-C-001501-PIP04-19-M02", "contact_for_public_enquiries": "Regeneron Ireland DAC; Tel. +1 9148 475385; E-mail: clinicaltrials@regeneron.com", "first_published_date": "09/06/2020", "last_updated_date": "19/09/2024", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001501-pip04-19-m02" }, { "decision_number": "P/0479/2021", "pip_number": "EMEA-001301-PIP02-12-M04", "active_substance": "Isavuconazonium sulfate", "invented_name": "Cresemba; Cresemba", "therapeutic_area": "Infectious diseases", "pharmaceutical_forms": "Powder for solution for infusion;Capsule, hard", "condition_indication": "Treatment of invasive aspergillosis;Treatment of mucormycosis", "routes_of_administration": "Intravenous use;Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "03/12/2021", "compliance_outcome": "Positive", "compliance_opinion_date": "21/07/2023", "compliance_procedure_number": "EMEA-C-001301-PIP02-12-M04", "contact_for_public_enquiries": "Basilea Pharmaceutica International Ltd.; Tel. +41 616061400; E-mail: medical.information@basilea.com", "first_published_date": "26/07/2017", "last_updated_date": "19/09/2024", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001301-pip02-12-m04" }, { "decision_number": "P/0066/2022", "pip_number": "EMEA-001082-PIP02-11-M03", "active_substance": "Ex vivo expanded autologous human corneal epithelium cells containing stem cells", "invented_name": "Holoclar", "therapeutic_area": "Ophthalmology", "pharmaceutical_forms": "Living tissue equivalent", "condition_indication": "Treatment of limbal stem cell deficiency due to ocular burns", "routes_of_administration": "Ophthalmic use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "11/03/2022", "compliance_outcome": "Positive", "compliance_opinion_date": "21/07/2023", "compliance_procedure_number": "EMEA-C-001082-PIP02-11-M03", "contact_for_public_enquiries": "Holostem Terapie Avanzate S.r.l.;  +39 3492403930; regulatory@holostem.com", "first_published_date": "18/09/2012", "last_updated_date": "19/09/2024", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001082-pip02-11-m03" }, { "decision_number": "P/0478/2022", "pip_number": "EMEA-000200-PIP01-08-M10", "active_substance": "saxagliptin", "invented_name": "Onglyza; Onglyza", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Treatment of type II diabetes mellitus", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "02/12/2022", "compliance_outcome": "Positive", "compliance_opinion_date": "21/07/2023", "compliance_procedure_number": "EMEA-C-000200-PIP01-08-M10", "contact_for_public_enquiries": "AstraZeneca ABEmail: paediatrics@astrazeneca.comTel. +46 855324400", "first_published_date": "19/04/2010", "last_updated_date": "19/09/2024", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000200-pip01-08-m10" }, { "decision_number": "P/0270/2022", "pip_number": "EMEA-002399-PIP01-18-M01", "active_substance": "bulevirtide", "invented_name": "Hepcludex", "therapeutic_area": "Infectious diseases", "pharmaceutical_forms": "Powder for solution for injection", "condition_indication": "Treatment of chronic hepatitis D infection", "routes_of_administration": "Subcutaneous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "10/08/2022", "compliance_outcome": "Positive", "compliance_opinion_date": "08/09/2023", "compliance_procedure_number": "EMEA-C-002399-PIP01-18-M01", "contact_for_public_enquiries": "Gilead Sciences International Ltd.; Tel. +44 (0)1223 897 300; E-mail: regulatory.pip@gilead.com", "first_published_date": "20/11/2019", "last_updated_date": "19/09/2024", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002399-pip01-18-m01" }, { "decision_number": "P/0038/2023", "pip_number": "EMEA-001219-PIP01-11-M06", "active_substance": "dolutegravir;abacavir;lamivudine", "invented_name": "Triumeq; Triumeq", "therapeutic_area": "Infectious diseases", "pharmaceutical_forms": "Film-coated tablet;Dispersible tablet", "condition_indication": "Treatment of human immunodeficiency virus (HIV-1) infection", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "31/01/2023", "compliance_outcome": "Positive", "compliance_opinion_date": "08/09/2023", "compliance_procedure_number": "EMEA-C-001219-PIP01-11-M06", "contact_for_public_enquiries": "ViiV Healthcare UK LimitedE-mail: eu.paediatric-plans@gsk.com Tel: +1 4388998201", "first_published_date": "07/01/2012", "last_updated_date": "19/09/2024", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001219-pip01-11-m06" }, { "decision_number": "P/0019/2022", "pip_number": "EMEA-000322-PIP01-08-M06", "active_substance": "cysteamine hydrochloride", "invented_name": "Cystadrops; Cystadrops", "therapeutic_area": "Ophthalmology", "pharmaceutical_forms": "Eye drops, solution", "condition_indication": "Treatment of corneal cystine crystal deposits in cystinosis", "routes_of_administration": "Ocular use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "03/02/2022", "compliance_outcome": "Positive", "compliance_opinion_date": "08/09/2023", "compliance_procedure_number": "EMEA-C-000322-PIP01-08-M06", "contact_for_public_enquiries": "Recordati Rare Diseases SARL; fortun.m@recordati.com;  +33 147739373", "first_published_date": "18/05/2009", "last_updated_date": "19/09/2024", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000322-pip01-08-m06" }, { "decision_number": "P/0296/2021", "pip_number": "EMEA-001784-PIP01-15-M04", "active_substance": "nirsevimab", "invented_name": "Beyfortus", "therapeutic_area": "Vaccines", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Prevention of lower respiratory tract disease caused by respiratory syncytial virus", "routes_of_administration": "Intramuscular use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "08/07/2022", "compliance_outcome": "Positive", "compliance_opinion_date": "13/10/2023", "compliance_procedure_number": "EMEA-C-001784-PIP01-15-M04", "contact_for_public_enquiries": "AstraZeneca AB; Tel. +46 855259283; E-mail: paediatrics@astrazeneca.com", "first_published_date": "18/07/2016", "last_updated_date": "19/09/2024", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001784-pip01-15-m04" }, { "decision_number": "P/0528/2022", "pip_number": "EMEA-001119-PIP03-19-M03", "active_substance": "lenvatinib", "invented_name": "Kisplyx; Lenvima", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Capsule, hard", "condition_indication": "Treatment of all conditions included in the category of malignant neoplasms except haematopoietic and lymphoid tissue neoplasms, papillary thyroid cancer, follicular thyroid cancer and osteosarcoma", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "30/12/2022", "compliance_outcome": "Positive", "compliance_opinion_date": "13/10/2023", "compliance_procedure_number": "EMEA-C-001119-PIP03-19-M03", "contact_for_public_enquiries": "Eisai GmbH; E-mail: EUMedInfo@eisai.net; Tel.  +44  8456761400", "first_published_date": "04/03/2021", "last_updated_date": "19/09/2024", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001119-pip03-19-m03" }, { "decision_number": "P/0087/2020", "pip_number": "EMEA-001050-PIP01-10-M05", "active_substance": "ixekizumab", "invented_name": "Taltz", "therapeutic_area": "Dermatology", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Treatment of psoriasis", "routes_of_administration": "Subcutaneous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "18/03/2020", "compliance_outcome": "Positive", "compliance_opinion_date": "13/10/2023", "compliance_procedure_number": "EMEA-C-001050-PIP01-10-M05", "contact_for_public_enquiries": "Eli Lilly Nederland B.V.E-mail: EU_paediatric@lilly.comTel.  +44 1276483000", "first_published_date": "25/06/2012", "last_updated_date": "19/09/2024", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001050-pip01-10-m05" }, { "decision_number": "P/0449/2023", "pip_number": "EMEA-000574-PIP02-12-M04", "active_substance": "blinatumomab", "invented_name": "Blincyto", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Powder for solution for infusion", "condition_indication": "Treatment of acute lymphoblastic leukaemia", "routes_of_administration": "Intravenous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "27/10/2023", "compliance_outcome": "Positive", "compliance_opinion_date": "23/02/2024", "compliance_procedure_number": "EMEA-C-000574-PIP02-12-M04", "contact_for_public_enquiries": "Amgen Europe B.V. ; E-mail: medinfointernational@amgen.com; Tel. +44 (0)1223 420305", "first_published_date": "18/07/2014", "last_updated_date": "19/09/2024", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000574-pip02-12-m04" }, { "decision_number": "P/0527/2021", "pip_number": "EMEA-000901-PIP04-17-M02", "active_substance": "ruxolitinib (phosphate)", "invented_name": "Jakavi", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Tablet;Age appropriate oral solid dosage form", "condition_indication": "Treatment of chronic Graft versus Host Disease (cGvHD)", "routes_of_administration": "Oral use;Gastric use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "03/12/2021", "compliance_outcome": "Positive", "compliance_opinion_date": "13/10/2023", "compliance_procedure_number": "EMEA-C-000901-PIP04-17-M02", "contact_for_public_enquiries": "Novartis Europharm LimitedE-mail: paediatric.enquiries@novartis.comTel. +41 613241111", "first_published_date": "19/06/2018", "last_updated_date": "19/09/2024", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000901-pip04-17-m02" }, { "decision_number": "P/0172/2021", "pip_number": "EMEA-000901-PIP03-16-M02", "active_substance": "ruxolitinib (phosphate)", "invented_name": "Jakavi", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Tablet;Age appropriate dosage form", "condition_indication": "Treatment of acute graft-versus-host disease (aGvHD)", "routes_of_administration": "Oral use;Gastric use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "09/04/2021", "compliance_outcome": "Positive", "compliance_opinion_date": "13/10/2023", "compliance_procedure_number": "EMEA-C-000901-PIP03-16-M02", "contact_for_public_enquiries": "Novartis Europharm LimitedE-mail: paediatric.enquiries@novartis.comTel. +41 613241111", "first_published_date": "05/03/2018", "last_updated_date": "19/09/2024", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000901-pip03-16-m02" }, { "decision_number": "P/0196/2023", "pip_number": "EMEA-000115-PIP01-07-M13", "active_substance": "ataluren", "invented_name": "Translarna", "therapeutic_area": "Neurology", "pharmaceutical_forms": "Granules for oral suspension", "condition_indication": "Treatment of dystrophinopathy", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "15/05/2023", "compliance_outcome": "Positive", "compliance_opinion_date": "13/10/2023", "compliance_procedure_number": "EMEA-C-000115-PIP01-07-M13", "contact_for_public_enquiries": "PTC Therapeutics International Limited; Tel. +353 19068700; E-mail: medinfo@ptcbio.com", "first_published_date": "26/08/2010", "last_updated_date": "19/09/2024", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000115-pip01-07-m13" }, { "decision_number": "P/0551/2022", "pip_number": "EMEA-001313-PIP01-12-M13", "active_substance": "ceftazidime;avibactam", "invented_name": "Zavicefta; Zavicefta", "therapeutic_area": "Infectious diseases", "pharmaceutical_forms": "Powder for concentrate for solution for infusion", "condition_indication": "Treatment of infections due to aerobic Gram-negative bacteria;Treatment of intra-abdominal infections;Treatment of pneumonia;Treatment of urinary tract infections", "routes_of_administration": "Intravenous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "04/01/2023", "compliance_outcome": "Positive", "compliance_opinion_date": "10/11/2023", "compliance_procedure_number": "EMEA-C-001313-PIP01-12-M13", "contact_for_public_enquiries": "Pfizer Europe MA EEIG; Tel. +44 (0)1304 646 607; E-mail: pip_enquiries@pfizer.com", "first_published_date": "31/05/2013", "last_updated_date": "19/09/2024", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001313-pip01-12-m13" }, { "decision_number": "P/0562/2021", "pip_number": "EMEA-001662-PIP01-14-M05", "active_substance": "palovarotene", "invented_name": "", "therapeutic_area": "Other", "pharmaceutical_forms": "Capsule, hard", "condition_indication": "Treatment of fibrodysplasia ossificans progressiva", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "31/12/2021", "compliance_outcome": "Positive", "compliance_opinion_date": "10/11/2023", "compliance_procedure_number": "EMEA-C-001662-PIP01-14-M05", "contact_for_public_enquiries": "Ipsen Pharma; E-mail: abdelali.majdi@ipsen.com; Tel.: +33 158335427", "first_published_date": "06/07/2015", "last_updated_date": "19/09/2024", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001662-pip01-14-m05" }, { "decision_number": 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"condition_indication": "Treatment of low grade glioma", "routes_of_administration": "Oral use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "31/01/2022", "compliance_outcome": "Positive", "compliance_opinion_date": "15/12/2023", "compliance_procedure_number": "EMEA-C-002932-PIP02-21", "contact_for_public_enquiries": "Les Laboratoires ServierE-mail: mail.pip.enquiries@servier.comTel.: +33 155726000", "first_published_date": "05/04/2023", "last_updated_date": "19/09/2024", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002932-pip02-21" }, { "decision_number": "P/0439/2023", "pip_number": "EMEA-002826-PIP01-20-M04", "active_substance": "remdesivir", "invented_name": "Veklury", "therapeutic_area": "Infectious diseases", "pharmaceutical_forms": "Powder for concentrate for solution for infusion", "condition_indication": "Treatment of Coronavirus disease 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"compliance_opinion_date": "15/12/2023", "compliance_procedure_number": "EMEA-C-000520-PIP02-13-M04", "contact_for_public_enquiries": "Glaxo Group Limited; E-mail: eu.paediatrics-plans@gsk.com; Tel. +1 4388998201", "first_published_date": "04/12/2014", "last_updated_date": "19/09/2024", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000520-pip02-13-m04" }, { "decision_number": "P/0358/2023", "pip_number": "EMEA-002326-PIP04-20-M01", "active_substance": "concizumab", "invented_name": "", "therapeutic_area": "Haematology-Hemostaseology", "pharmaceutical_forms": "Solution for injection in pre-filled pen", "condition_indication": "Treatment of congenital haemophilia A;Treatment of congenital haemophilia B", "routes_of_administration": "Subcutaneous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "08/09/2023", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Novo Nordisk A/S; E-mail: paediatrics@novonordisk.com; Tel: +45 44448888;  ", "first_published_date": "10/01/2023", "last_updated_date": "19/09/2024", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002326-pip04-20-m01" }, { "decision_number": "P/0392/2023", "pip_number": "EMEA-002324-PIP01-17-M05", "active_substance": "elexacaftor;tezacaftor;ivacaftor", "invented_name": "Kaftrio", "therapeutic_area": "Other", "pharmaceutical_forms": "Film-coated tablet;Age appropriate oral solid dosage form", "condition_indication": "Treatment of cystic fibrosis", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "28/09/2023", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Vertex Pharmaceuticals (Ireland) LimitedE-mail: vertexmedicalinfo@vrtx.comTel: +353 17617299", "first_published_date": "24/06/2019", "last_updated_date": "19/09/2024", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002324-pip01-17-m05" }, { "decision_number": "P/0352/2023", "pip_number": "EMEA-002023-PIP01-16-M07", "active_substance": "avacopan", "invented_name": "Tavneos", "therapeutic_area": "Immunology-Rheumatology-Transplantation", "pharmaceutical_forms": "Capsule, hard;Age appropriate oral liquid dosage formulation", "condition_indication": "Treatment of antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "08/09/2023", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Amgen Europe B.V. ; E-mail: medinfointernational@amgen.com; Tel. +44 (0)1223 420305", "first_published_date": "03/07/2017", "last_updated_date": "19/09/2024", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002023-pip01-16-m07" }, { "decision_number": "P/0378/2023", "pip_number": "EMEA-001877-PIP01-15-M04", "active_substance": "fremanezumab", "invented_name": "Ajovy", "therapeutic_area": "Neurology", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Prevention of migraine headaches", "routes_of_administration": "Subcutaneous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "08/09/2023", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Teva GmbHE-mail: MedInfo@tevaeu.comTel: +44 (0)2075407117", "first_published_date": "06/01/2017", "last_updated_date": "19/09/2024", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001877-pip01-15-m04" }, { "decision_number": "P/0372/2023", "pip_number": "EMEA-002883-PIP02-22", "active_substance": "trimodulin", "invented_name": "", "therapeutic_area": "Infectious diseases;Neonatology-Paediatric Intensive Care", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Treatment of Coronavirus disease 2019 (COVID-19)", "routes_of_administration": "Intravenous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "08/09/2023", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Biotest AG; Tel. + 49 6103 801497E-mail: clinical.trials@biotest.com", "first_published_date": "19/09/2024", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002883-pip02-22" }, { "decision_number": "P/0367/2023", "pip_number": "EMEA-002342-PIP05-23", "active_substance": "abemaciclib", "invented_name": "Verzenios", "therapeutic_area": "Oncology", "pharmaceutical_forms": "All pharmaceutical forms", "condition_indication": "Treatment of prostate cancer", "routes_of_administration": "All routes of administration", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "08/09/2023", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Eli Lilly and Company LimitedE-mail: eu_paediatric@lilly.com Tel. +44 1344382427", "first_published_date": "19/09/2024", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002342-pip05-23" }, { "decision_number": "P/0385/2023", "pip_number": "EMEA-002299-PIP02-23", "active_substance": "Enfortumab vedotin", "invented_name": "Padcev", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Powder for concentrate for solution for infusion", "condition_indication": "Treatment of head and neck epithelial malignant neoplasms", "routes_of_administration": "Intravenous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "07/09/2023", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Astellas Pharma Europe B.V.E-mail: regulatory.eu@astellas.comTel: +31 715454006", "first_published_date": "19/09/2024", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002299-pip02-23" }, { "decision_number": "P/0381/2023", "pip_number": "EMEA-001973-PIP02-23", "active_substance": "teprotumumab", "invented_name": "", "therapeutic_area": "Ophthalmology", "pharmaceutical_forms": "Powder for concentrate for solution for infusion;Solution for injection", "condition_indication": "Treatment of thyroid eye disease", "routes_of_administration": "Intravenous use;Subcutaneous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "07/09/2023", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Amgen Europe B.V. ; E-mail: medinfointernational@amgen.com; Tel. +44 (0)1223 420305", "first_published_date": "19/09/2024", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001973-pip02-23" }, { "decision_number": "P/0383/2023", "pip_number": "EMEA-001741-PIP07-22", "active_substance": "upadacitinib", "invented_name": "Rinvoq", "therapeutic_area": "Dermatology", "pharmaceutical_forms": "Age appropriate oral dosage formulation;Prolonged-release tablet", "condition_indication": "Treatment of vitiligo", "routes_of_administration": "Oral use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "07/09/2023", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "AbbVie LtdE-mail: paediatricteam@abbvie.comTel. +44 (0)1628 408248", "first_published_date": "19/09/2024", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001741-pip07-22" }, { "decision_number": "P/0388/2023", "pip_number": "EMEA-001943-PIP06-23", "active_substance": "ravulizumab", "invented_name": "Ultomiris", "therapeutic_area": "Uro-nephrology", "pharmaceutical_forms": "Concentrate for solution for infusion", "condition_indication": "Prevention of kidney injury in high-risk patients with chronic kidney disease undergoing cardiopulmonary bypass", "routes_of_administration": "Intravenous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Alexion Europe SAS; E-mail: pip.enquiries.eu@alexion.com; Tel: +33 147100615", "first_published_date": "19/09/2024", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001943-pip06-23" }, { "decision_number": "P/0351/2023", "pip_number": "EMEA-001588-PIP04-23", "active_substance": "Encorafenib", "invented_name": "Braftovi", "therapeutic_area": "Oncology", "pharmaceutical_forms": "All pharmaceutical forms", "condition_indication": "Treatment of lung cancer", "routes_of_administration": "All routes of administration", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "08/09/2023", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Pierre Fabre Médicament; E-mail: medical_information@pierre-fabre.com; Tel. +33 800326326", "first_published_date": "19/09/2024", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001588-pip04-23" }, { "decision_number": "P/0349/2023", "pip_number": "EMEA-001454-PIP06-23", "active_substance": "binimetinib", "invented_name": "Mektovi", "therapeutic_area": "Oncology", "pharmaceutical_forms": "All pharmaceutical forms", "condition_indication": "Treatment of lung cancer", "routes_of_administration": "All routes of administration", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "08/09/2023", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Pierre Fabre Médicament; E-mail: medical_information@pierre-fabre.com; Tel. +33 800326326", "first_published_date": "19/09/2024", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001454-pip06-23" }, { "decision_number": "P/0350/2023", "pip_number": "EMEA-001573-PIP03-23", "active_substance": "pemafibrate", "invented_name": "", "therapeutic_area": "Gastroentology-Hepatology", "pharmaceutical_forms": "All pharmaceutical forms", "condition_indication": "Treatment of primary biliary cholangitis", "routes_of_administration": "All routes of administration", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "08/09/2023", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Kowa Pharmaceuticals Europe AG; Email: 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855324400", "first_published_date": "19/06/2018", "last_updated_date": "22/07/2024", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001435-pip02-16-m02" }, { "decision_number": "P/0130/2023", "pip_number": "EMEA-003257-PIP01-22", "active_substance": "zilovertamab vedotin", "invented_name": "", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Powder for solution for infusion", "condition_indication": "Treatment of all conditions included in the category of malignant neoplasms (except nervous system, haematopoietic and lymphoid tissue);Treatment of malignant neoplasms of haematopoietic and lymphoid tissue", "routes_of_administration": "Intravenous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "13/04/2023", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Merck Sharp 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"https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002544-pip01-18-m02" }, { "decision_number": "P/0145/2023", "pip_number": "EMEA-001984-PIP02-20-M01", "active_substance": "sparsentan", "invented_name": "", "therapeutic_area": "Uro-nephrology", "pharmaceutical_forms": "Tablet;Age appropriate oral liquid dosage formulation", "condition_indication": "Treatment of focal segmental glomerulosclerosis", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "21/04/2023", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Vifor (International) AG; Email: sparsentan_ra@viforpharma.com; Tel: +41588518000", "first_published_date": "16/06/2021", "last_updated_date": "19/07/2024", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001984-pip02-20-m01" }, { "decision_number": "P/0128/2023", "pip_number": "EMEA-001943-PIP02-20-M02", "active_substance": "ravulizumab", "invented_name": "Ultomiris", "therapeutic_area": "Haematology-Hemostaseology;Uro-nephrology", "pharmaceutical_forms": "Concentrate for solution for infusion;Solution for injection", "condition_indication": "Treatment in haematopoietic stem cell transplantation", "routes_of_administration": "Intravenous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "14/04/2023", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Alexion Europe SAS; E-mail: pip.enquiries.eu@alexion.com; Tel: +33 147100615", "first_published_date": "10/01/2023", "last_updated_date": "19/07/2024", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001943-pip02-20-m02" }, { "decision_number": "P/0110/2023", "pip_number": "EMEA-001880-PIP02-19-M04", "active_substance": "remimazolam besilate", "invented_name": "Byfavo", "therapeutic_area": "Anaesthesiology", "pharmaceutical_forms": "Powder for solution for injection or infusion;Orodispersible film;Age appropriate formulation", "condition_indication": "General anaesthesia;Sedation", "routes_of_administration": "Intravenous use;Buccal use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "14/04/2023", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "PAION Deutschland GmbH; E-mail: info@paion.com; Tel: +49 2414453128", "first_published_date": "27/03/2020", "last_updated_date": "19/07/2024", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001880-pip02-19-m04" }, { "decision_number": "P/0273/2023", "pip_number": "EMEA-003413-PIP01-23", "active_substance": "povidone;iodine", "invented_name": "", "therapeutic_area": "Infectious diseases", "pharmaceutical_forms": "Nasal spray (solution)", "condition_indication": "Treatment of acute nasopharyngitis (common cold)", "routes_of_administration": "Nasal use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "14/07/2023", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "ESPL Regulatory Consulting LimitedE-mail: smt@espl-regulatory.com Tel.:  +44 1806242851", "first_published_date": "16/07/2024", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003413-pip01-23" }, { "decision_number": "P/0244/2023", "pip_number": "EMEA-003412-PIP01-23", "active_substance": "amlodipine besilate;rivaroxaban", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Prevention of thromboembolic events;Treatment of hypertension", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "14/07/2023", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Teva B.V. Email: MedAffGenTevaEurope@tevapharm.com Tel. +385 13722001", "first_published_date": "16/07/2024", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003412-pip01-23" }, { "decision_number": "P/0266/2023", "pip_number": "EMEA-003410-PIP01-23", "active_substance": "acetylsalicylic acid;rosuvastatin calcium", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Capsule, hard", "condition_indication": "Prevention of cardiovascular events", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "14/07/2023", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Swyssi AGE-mail: info@swyssi.com Tel: +49 6966554162", "first_published_date": "16/07/2024", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003410-pip01-23" }, { "decision_number": "P/0260/2023", "pip_number": "EMEA-003406-PIP01-23", "active_substance": "opicapone", "invented_name": "Ongentys; Ontilyv", "therapeutic_area": "Neurology", "pharmaceutical_forms": "Capsule, hard", "condition_indication": "Treatment of Parkinson's disease", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "14/07/2023", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "BIAL - Portela & Ca, SA; E-mail: info@bial.com; Tel. +351 229866100", "first_published_date": "16/07/2024", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003406-pip01-23" }, { "decision_number": "P/0256/2023", "pip_number": "EMEA-003403-PIP01-23", "active_substance": "therapeutic DNA plasmid vaccine targeting HPV16 E6 and E7 proteins (VB10.16)", "invented_name": "", "therapeutic_area": "Oncology", "pharmaceutical_forms": "All pharmaceutical forms", "condition_indication": "Treatment of human papilloma virus (HPV) type 16 positive malignancies", "routes_of_administration": "All routes of administration", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "14/07/2023", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Nykode Therapeutics ASAE-mail: info@nykode.com Tel.:  +47 22958193", "first_published_date": "16/07/2024", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003403-pip01-23" }, { "decision_number": "P/0271/2023", "pip_number": "EMEA-003367-PIP01-22", "active_substance": "nizaracianine triflutate", "invented_name": "", "therapeutic_area": "Diagnostic", "pharmaceutical_forms": "Powder for solution for injection", "condition_indication": "", "routes_of_administration": "Intravenous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "14/07/2023", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Curadel Surgical Innovations, Inc.E-mail: regulatory@curadel.com Tel.:  +1 5083052355", "first_published_date": "16/07/2024", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003367-pip01-22" }, { "decision_number": "P/0265/2023", "pip_number": "EMEA-003324-PIP01-22", "active_substance": "bictegravir;lenacapavir", "invented_name": "", "therapeutic_area": "Infectious diseases", "pharmaceutical_forms": "Film-coated tablet;Age appropriate oral solid dosage form", "condition_indication": "Treatment of human immunodeficiency virus type 1 (HIV-1) infection", "routes_of_administration": "Oral use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "14/07/2023", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Gilead Sciences International Limited; Tel. +44 (0)1223 897300; E-mail: regulatory.pip@gilead.com", "first_published_date": "16/07/2024", "last_updated_date": "", "pip_url": 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"contact_for_public_enquiries": "Eli Lilly & Company Limited; E-mail: eu_paediatric@lilly.com ; Tel. +44 (0)1276 483000", "first_published_date": "16/07/2024", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003409-pip01-23" }, { "decision_number": "P/0268/2023", "pip_number": "EMEA-003325-PIP01-22", "active_substance": "izokibep", "invented_name": "", "therapeutic_area": "Immunology-Rheumatology-Transplantation", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, ankylosing spondylarthritis, psoriatic arthritis, and juvenile idiopathic arthritis)", "routes_of_administration": "Subcutaneous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "14/07/2023", "compliance_outcome": "", "compliance_opinion_date": "", 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"last_updated_date": "05/07/2024", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000902-pip01-10-m01" }, { "decision_number": "P/0234/2023", "pip_number": "EMEA-000798-PIP01-09-M04", "active_substance": "ponesimod", "invented_name": "Ponvory", "therapeutic_area": "Neurology;Other", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Treatment of multiple sclerosis", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "14/06/2023", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Janssen-Cilag International NVE-mail: contact@janssen-emea.comTel.:  +44 (0)1494567358", "first_published_date": "07/01/2013", "last_updated_date": "05/07/2024", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000798-pip01-09-m04" }, { "decision_number": "P/0209/2023", "pip_number": "EMEA-000347-PIP02-16-M05", "active_substance": "bilastine", "invented_name": "Bilaxten and associated names", "therapeutic_area": "Ophthalmology", "pharmaceutical_forms": "Eye drops, solution", "condition_indication": "Treatment of allergic conjunctivitis", "routes_of_administration": "Ocular use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "14/06/2023", "compliance_outcome": "Positive", "compliance_opinion_date": "22/03/2024", "compliance_procedure_number": "EMEA-C-000347-PIP02-16-M05", "contact_for_public_enquiries": "Faes Farma S.A.Tel. +34 944818300E-mail: ieguidazu@faes.es; mjarenal@faes.es", "first_published_date": "11/04/2019", "last_updated_date": "05/07/2024", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000347-pip02-16-m05" }, { "decision_number": "P/0206/2023", "pip_number": "EMEA-000207-PIP01-08-M08", "active_substance": "treprostinil", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Solution for infusion", "condition_indication": "Treatment of pulmonary arterial hypertension", "routes_of_administration": "Subcutaneous use;Intravenous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "14/06/2023", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Ferrer Internacional, S.A.; E-mail: registros@ferrer.comTel.:  +34 935044423", "first_published_date": "24/05/2012", "last_updated_date": "05/07/2024", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000207-pip01-08-m08" }, { "decision_number": "P/0165/2023", "pip_number": "EMEA-002935-PIP01-20-M03", "active_substance": "Idrevloride", "invented_name": "", "therapeutic_area": "Pneumology-allergology", "pharmaceutical_forms": "Inhalation solution", "condition_indication": "Treatment of primary ciliary dyskinesia", "routes_of_administration": "Inhalation use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "15/05/2023", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Parion Sciences, Inc.; E-mail: clinicaltrials@parion.com; Tel: +1 919 313 1187", "first_published_date": "11/01/2023", "last_updated_date": "04/07/2024", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002935-pip01-20-m03" }, { "decision_number": "P/0155/2023", "pip_number": "EMEA-002443-PIP01-18-M02", "active_substance": "Gepotidacin", "invented_name": "", "therapeutic_area": "Infectious diseases", "pharmaceutical_forms": "Film-coated tablet;Age appropriate oral formulation", "condition_indication": "Treatment of uncomplicated urinary tract infections", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "12/05/2023", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "GlaxoSmithKline Consumer Trading Services Limited; United Kingdom; E-mail: rd.gskch-paediatric-plans@gsk.com; Tel. +44 (0)19 3282 6987", "first_published_date": "05/03/2021", "last_updated_date": "04/07/2024", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002443-pip01-18-m02" }, { "decision_number": "P/0180/2023", "pip_number": "EMEA-003376-PIP01-22", "active_substance": "recombinant humanized monoclonal antibody (immunoglobulin gamma-1 with kappa light chains, IgG1κ) directed against integrin αvβ8 produced in Chinese Hamster Ovary (CHO) cells", "invented_name": "", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Treatment of head and neck squamous cell carcinoma (HNSCC);Treatment of renal cell carcinoma (RCC)", "routes_of_administration": "Intravenous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "15/05/2024", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Pfizer Europe MA EEIG  E-mail: medical.information@pfizer.com Tel: +44 (0)1304 616161", "first_published_date": "18/06/2024", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003376-pip01-22" }, { "decision_number": "P/0188/2023", "pip_number": "EMEA-003374-PIP01-22", "active_substance": "adeno-associated viral vector serotype 9 expressing codon-optimized human GRN gene (LY3884963)", "invented_name": "", "therapeutic_area": "Neurology", "pharmaceutical_forms": "All pharmaceutical forms", "condition_indication": "Treatment of frontotemporal dementia", "routes_of_administration": "All routes of administration", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "15/05/2023", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "", "first_published_date": "18/06/2024", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003374-pip01-22" }, { "decision_number": "P/0158/2023", "pip_number": "EMEA-003373-PIP01-22", "active_substance": "atorvastatin;ezetimibe", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Treatment of hypercholesterolaemia", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "12/05/2023", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Pharmaplot P.C.; E-mail: info@pharmaplot.com; Tel.  +30 2160047700", "first_published_date": "18/06/2024", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003373-pip01-22" }, { "decision_number": "P/0157/2023", "pip_number": "EMEA-003372-PIP01-22", "active_substance": "ramipril;Indapamide", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Capsule, hard", "condition_indication": "Treatment of hypertension", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "12/05/2023", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Zakłady Farmaceutyczne Polpharma S.A.; E-mail: regulatory@polpharma.com; Tel.  +48 585631600", "first_published_date": "18/06/2024", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003372-pip01-22" }, { "decision_number": "P/0139/2023", "pip_number": "EMEA-003184-PIP01-22", "active_substance": "AV2-cVLP-RBD SARS-CoV-2 (ABNCoV2)", "invented_name": "", "therapeutic_area": "Infectious diseases;Vaccines", "pharmaceutical_forms": "Dispersion for injection", "condition_indication": "Prevention of Coronavirus disease 2019 (COVID-19)", "routes_of_administration": "Intramuscular use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "14/04/2023", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Bavarian Nordic A/S; Email: info@bavarian-nordic.com ; Tel:  +45 61774743", "first_published_date": "07/06/2024", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003184-pip01-22" }, { "decision_number": "P/0117/2023", "pip_number": "EMEA-003099-PIP01-21", "active_substance": "pudexacianinium chloride", "invented_name": "", "therapeutic_area": "Diagnostic;Endocrinology-Gynaecology-Fertility-Metabolism;Gastroentology-Hepatology;Oncology;Uro-nephrology", "pharmaceutical_forms": "Powder for solution for injection", "condition_indication": "", "routes_of_administration": "Intravascular use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Astellas Pharma Europe B.V.Tel. +31 7154 55878E-mail: contact.nl@astellas.com ", "first_published_date": "07/06/2024", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003099-pip01-21" }, { "decision_number": "P/0118/2023", "pip_number": "EMEA-003080-PIP03-22", "active_substance": "vilobelimab", "invented_name": "", "therapeutic_area": "Infectious diseases", "pharmaceutical_forms": "Concentrate for solution for infusion", "condition_indication": "Treatment of Coronavirus disease 2019 (COVID-19)", "routes_of_administration": "Intravenous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "13/04/2023", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "InflaRx GmbH; Email: info@inflarx.de; Tel:  +49 894141897800", "first_published_date": "07/06/2024", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003080-pip03-22" }, { "decision_number": "P/0151/2023", "pip_number": "EMEA-002612-PIP02-22", "active_substance": "2-amino-5-(carbamylamino)pentanoic acid (L-citrulline)", "invented_name": "", "therapeutic_area": "Haematology-Hemostaseology", "pharmaceutical_forms": "Solution for injection/infusion", "condition_indication": "Treatment of sickle cell disease", "routes_of_administration": "Intravenous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "24/04/2024", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "ASK Pharmaceuticals GmbH (ASK); Email: public-enquiry@asklepionpharm.com; Tel:  +1 4105450494 ext 113", "first_published_date": "07/06/2024", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002612-pip02-22" }, { "decision_number": "P/0119/2023", "pip_number": "EMEA-003079-PIP01-22", "active_substance": "tixagevimab;cilgavimab", "invented_name": "Evusheld", "therapeutic_area": "Infectious diseases", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Prevention of Coronavirus disease 2019 (COVID-19);Treatment of Coronavirus disease 2019 (COVID-19)", "routes_of_administration": "Intramuscular use;Intravenous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "13/04/2023", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "AstraZeneca ABE-mail: paediatrics@astrazeneca.comTel. +46 8553 27591", "first_published_date": "07/06/2024", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003079-pip01-22" }, { "decision_number": "P/0116/2023", "pip_number": "EMEA-000032-PIP02-22", "active_substance": "Meningococcal group A oligosaccharide conjugated to Corynebacterium diphteriae CRM197 protein (MenA-CRM) Meningococcal group C oligosaccharide conjugated to Corynebacterium diphteriae CRM197 protein (MenC-CRM) Meningococcal group W-135 oligosaccharide conjugated to Corynebacterium diphteriae CRM197 protein (MenW-CRM) Meningococcal group Y oligosaccharide conjugated to Corynebacterium diphteriae CRM197 protein (MenY-CRM)", "invented_name": "Menveo", "therapeutic_area": "Vaccines", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Prevention of meningococcal meningitis", "routes_of_administration": "Intramuscular use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "13/04/2023", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "GlaxoSmithKline Biologicals Srl; Email: eu.paediatric-plans@gsk.com; Tel: +1 4388998201", "first_published_date": "07/06/2024", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000032-pip02-22" }, { "decision_number": "P/0169/2023", "pip_number": "EMEA-003370-PIP01-22", "active_substance": "Palmitoyl-KSS-MHGDTPTLHEYMLDLQPETT (HPV-16 E7 1-20);Palmitoyl-KSS-YMLDLQPETT (HPV-16 E7 11-20);Palmitoyl-KSS-GQAEPDRAHYNIVTF (HPV-16 E7 43-57);Palmitoyl-KSSKKLLMGTLGIVCPICSQKP (HPV-16 E7 82-98);Palmitoyl-KSS-LLMGTLGIV (HPV-16 E7 82-90);Palmitoyl-KSS-ELQTTIHDIILECVYCKQQLL (HPV-16 E6 25-45) + [(2R)-2,3-bis[[(Z)-octadec-9- enoyl]oxy]propyl]-trimethylazanium chloride (R-DOTAP chloride)", "invented_name": "", "therapeutic_area": "Oncology", "pharmaceutical_forms": "All pharmaceutical forms", "condition_indication": "Treatment of human papilloma virus (HPV) type 16 positive malignancies", "routes_of_administration": "All routes of administration", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "15/05/2023", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "PDS Biotechnology Corp.E-mail: greid@pdsbiotech.com Tel: +1 9083452980", "first_published_date": "07/06/2024", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003370-pip01-22" }, { "decision_number": "P/0181/2023", "pip_number": "EMEA-003364-PIP02-22", "active_substance": "1-((S)-4-((R)-7-(6-amino-4-methyl-3-(trifluoromethyl)pyridin-2-yl)-6-chloro-8-fluoro- 2-(((S)-1-methylpyrrolidin-2-yl)methoxy)quinazolin-4-yl)-3-methylpiperazin-1-yl)prop- 2-en-1-one adipate", "invented_name": "", "therapeutic_area": "Oncology", "pharmaceutical_forms": "All pharmaceutical forms", "condition_indication": "Treatment of non-small cell lung cancer", "routes_of_administration": "All routes of administration", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "15/05/2023", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Roche Registration GmbHE-mail: global.eu_regulatory_office@roche.comTel. +49 7624142892", "first_published_date": "07/06/2024", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003364-pip02-22" }, { "decision_number": "P/0161/2023", "pip_number": "EMEA-003339-PIP02-23", "active_substance": "diclofenac;thiocolchicoside", "invented_name": "", "therapeutic_area": "Pain", "pharmaceutical_forms": "Tablet", "condition_indication": "Treatment of pain", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "12/05/2023", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Verisfield Single Member S.A.Email: pharmacovigilance@verisfield.gr; economou@verisfield.gr Tel: +30 2107475196 ", "first_published_date": "07/06/2024", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003339-pip02-23" }, { "decision_number": "P/0168/2023", "pip_number": "EMEA-003279-PIP01-22", "active_substance": "albaconazole", "invented_name": "", "therapeutic_area": "Infectious diseases", "pharmaceutical_forms": "Capsule, hard", "condition_indication": "Treatment of acute vulvovaginal candidiasis", "routes_of_administration": "Oral use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "15/05/2023", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Palau Pharma, S.L.E-mail: regulatory@noucor.com Tel: +34 937376690", "first_published_date": "07/06/2024", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003279-pip01-22" }, { "decision_number": "P/0184/2023", "pip_number": "EMEA-003251-PIP01-22", "active_substance": "aticaprant", "invented_name": "", "therapeutic_area": "Psychiatry", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Treatment of major depressive disorder", "routes_of_administration": "Oral use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "19/05/2023", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Janssen-Cilag International NV; E-mail: contact@janssen-emea.com; Tel.: +32 14602111", "first_published_date": "07/06/2024", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003251-pip01-22" }, { "decision_number": "P/0178/2023", "pip_number": "EMEA-003208-PIP02-22", "active_substance": "Itolizumab", "invented_name": "", "therapeutic_area": "Immunology-Rheumatology-Transplantation", "pharmaceutical_forms": "Powder for solution for infusion", "condition_indication": "Treatment of acute graft versus host disease", "routes_of_administration": "Intravenous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "15/05/2023", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Biocon Pharma Malta-I LimitedE-mail: Novel.Biologics@biocon.comTel: +91 9717166167", "first_published_date": "07/06/2024", "last_updated_date": "", "pip_url": 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"https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003122-pip01-21-m01" }, { "decision_number": "P/0021/2023", "pip_number": "EMEA-003144-PIP01-21", "active_substance": "asundexian", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Age appropriate oral dosage formulation;Film-coated tablet", "condition_indication": "Prevention of arterial thromboembolism", "routes_of_administration": "Gastric use;Oral use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "31/01/2023", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Bayer AG; E-mail: clinical-trials-contact@bayer.com; Tel. +49 30300139003", "first_published_date": "13/02/2024", "last_updated_date": "", "pip_url": 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"last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002618-pip03-21" }, { "decision_number": "P/0509/2022", "pip_number": "EMEA-002559-PIP06-22", "active_substance": "nipocalimab", "invented_name": "", "therapeutic_area": "Neurology", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Treatment of chronic inflammatory demyelinating polyradiculoneuropathy", "routes_of_administration": "Subcutaneous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "02/12/2022", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Janssen Cilag International NV; Tel. +3214602111; E-mail: contact@Janssen-emea.com", "first_published_date": "10/11/2023", "last_updated_date": "", "pip_url": 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"EMEA-001441-PIP07-21-M01", "active_substance": "semaglutide", "invented_name": "", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Treatment of obesity", "routes_of_administration": "Oral use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "08/09/2023", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Novo Nordisk A/S; E-mail: paediatrics@novonordisk.com ; Tel.: +45 44448888", "first_published_date": "10/11/2023", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001441-pip07-21-m01" }, { "decision_number": "P/0479/2022", "pip_number": "EMEA-003269-PIP01-22", "active_substance": "2-{4-[4-(4-{5-[(1S)-1-amino-1-(4-fluorophenyl) 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"23/09/2021", "last_updated_date": "01/09/2023", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001136-pip02-19-m01" }, { "decision_number": "P/0243/2019", "pip_number": "EMEA-002310-PIP02-17", "active_substance": "(2S,4R)-1-(2-(3-acetyl-5-(2-methylpyrimidin-5-yl)-1H-indazol-1-yl)acetyl)-N-(6-bromopyridin-2-yl)-4- fluoropyrrolidine-2-carboxamide (ACH-0144471)", "invented_name": "", "therapeutic_area": "Uro-nephrology", "pharmaceutical_forms": "Tablet;Age appropriate oral solid dosage form", "condition_indication": "Treatment of C3 glomerulopathy", "routes_of_administration": "Oral use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "17/07/2019", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Achillion Pharmaceuticals, Inc.; Tel.+1 203 624 7000; E-mail: 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"https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000316-pip02-11-m05" }, { "decision_number": "P/0057/2021", "pip_number": "EMEA-001176-PIP01-11-M06", "active_substance": "pitolisant", "invented_name": "Wakix", "therapeutic_area": "Neurology", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Treatment of narcolepsy", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "27/01/2021", "compliance_outcome": "Positive", "compliance_opinion_date": "20/05/2022", "compliance_procedure_number": "EMEA-C-001176-PIP01-11-M06", "contact_for_public_enquiries": "Bioprojet PHARMA; E-mail: contact@bioprojet.com; Tel: +33 147036600;  ", "first_published_date": "18/09/2012", "last_updated_date": "30/06/2023", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001176-pip01-11-m06" }, { "decision_number": "P/0317/2017", "pip_number": "EMEA-000172-PIP01-07-M03", "active_substance": "Methoxy polyethylene glycol-epoetin beta", "invented_name": "Mircera", "therapeutic_area": "Haematology-Hemostaseology", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Treatment of symptomatic anaemia associated with chronic kidney disease", "routes_of_administration": "Intravenous use;Subcutaneous use", "decision_type": "RPM: decision refers to a refusal on the application for modification of an agreed PIP", "decision_date": "31/10/2017", "compliance_outcome": "Positive", "compliance_opinion_date": "20/05/2022", "compliance_procedure_number": "EMEA-C-000172-PIP01-07-M03", "contact_for_public_enquiries": "Roche Registration Limited; Tel. +41 616879411; E-mail: info.paediatrics@roche.com", "first_published_date": "04/01/2013", "last_updated_date": "30/06/2023", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000172-pip01-07-m03" }, { "decision_number": "P/0097/2022", "pip_number": "EMEA-000553-PIP01-09-M05", "active_substance": "Lisdexamfetamine dimesilate", "invented_name": "Elvanse and associated names", "therapeutic_area": "Psychiatry", "pharmaceutical_forms": "Capsule, hard", "condition_indication": "Treatment of Attention Deficit Hyperactivity Disorder (ADHD)", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "17/03/2022", "compliance_outcome": "Positive", "compliance_opinion_date": "25/05/2022", "compliance_procedure_number": "EMEA-C-000553-PIP01-09-M05", "contact_for_public_enquiries": "Takeda Pharmaceuticals International AG, Ireland Branch;  +44 (0)3333 000181; medinfoEMEA@takeda.com", "first_published_date": "26/04/2012", "last_updated_date": "30/06/2023", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000553-pip01-09-m05" }, { "decision_number": "P/0334/2021", "pip_number": "EMEA-002308-PIP01-17-M02", "active_substance": "multivalent, live, recombinant, non-replicating in human cells, Modified Vaccinia Ankara vectored vaccine, expressing the EBOV Mayinga glycoprotein, the Sudan virus Gulu GP, the Marburg virus Musoke GP, and the Taï Forest virus nucleoprotein [MVA-BN-Filo]", "invented_name": "Mvabea", "therapeutic_area": "Infectious diseases;Vaccines", "pharmaceutical_forms": "Suspension for injection", "condition_indication": "Prevention of Ebola virus disease", "routes_of_administration": "Intramuscular use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "19/08/2021", "compliance_outcome": "Positive", "compliance_opinion_date": "24/06/2022", "compliance_procedure_number": "EMEA-C-002308-PIP01-17-M02", "contact_for_public_enquiries": "Janssen Cilag International NV; Tel. +3214602111; E-mail: contact@Janssen-emea.com", "first_published_date": "25/06/2019", "last_updated_date": "30/06/2023", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002308-pip01-17-m02" }, { "decision_number": "P/0307/2021", "pip_number": "EMEA-002307-PIP01-17-M02", "active_substance": "monovalent, live, recombinant, replication-incompetent adenoviral serotype 26 vectored vaccine expressing the full length glycoprotein of the Ebola virus Mayinga variant [Ad26.ZEBOV]", "invented_name": "Zabdeno", "therapeutic_area": "Infectious diseases;Vaccines", "pharmaceutical_forms": "Suspension for injection", "condition_indication": "Prevention of Ebola virus disease", "routes_of_administration": "Intramuscular use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "12/08/2021", "compliance_outcome": "Positive", "compliance_opinion_date": "24/06/2022", "compliance_procedure_number": "EMEA-C-002307-PIP01-17-M02", "contact_for_public_enquiries": "Janssen Cilag International NV; Tel. +3214602111; E-mail: contact@Janssen-emea.com", "first_published_date": "25/06/2019", "last_updated_date": "30/06/2023", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002307-pip01-17-m02" }, { "decision_number": "P/0323/2019", "pip_number": "EMEA-001654-PIP02-17-M01", "active_substance": "tisagenlecleucel", "invented_name": "Kymriah", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Dispersion for infusion", "condition_indication": "Treatment of mature B-cell neoplasms", "routes_of_administration": "Intravenous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "11/09/2019", "compliance_outcome": "Positive", "compliance_opinion_date": "24/06/2022", "compliance_procedure_number": "EMEA-C-001654-PIP02-17-M01", "contact_for_public_enquiries": "Novartis Europharm Limited; E-mail: paediatric.enquiries@novartis.com; Tel. +41 6132 46715", "first_published_date": "24/10/2017", "last_updated_date": "30/06/2023", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001654-pip02-17-m01" }, { "decision_number": "P/0258/2017", "pip_number": "EMEA-001208-PIP01-11-M03", "active_substance": "human fibrinogen", "invented_name": "", "therapeutic_area": "Haematology-Hemostaseology", "pharmaceutical_forms": "Powder and solvent for solution for infusion", "condition_indication": "Treatment of congenital fibrinogen deficiency", "routes_of_administration": "Intravenous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "04/09/2017", "compliance_outcome": "Positive", "compliance_opinion_date": "24/06/2022", "compliance_procedure_number": "EMEA-C-001208-PIP01-11-M03", "contact_for_public_enquiries": "Octapharma Pharmazeutika Produktionsges.m.b.H; Tel. +41 5545 12189; E-mail: cristina.solomon@octapharma.com", "first_published_date": "18/09/2012", "last_updated_date": "30/06/2023", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001208-pip01-11-m03" }, { "decision_number": "P/0198/2020", "pip_number": "EMEA-000183-PIP01-08-M08", "active_substance": "apixaban", "invented_name": "Eliquis; Eliquis", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Film-coated tablet;Age appropriate oral liquid dosage formulation;Age appropriate dosage form, other", "condition_indication": "Prevention of arterial thromboembolism;Prevention of venous thromboembolism", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "20/05/2020", "compliance_outcome": "Positive", "compliance_opinion_date": "24/06/2022", "compliance_procedure_number": "EMEA-C-000183-PIP01-08-M08", "contact_for_public_enquiries": "Bristol-Myers Squibb Pharma EEIG E-mail: medical.information@bms.com Tel. +44 (0)1423 533610", "first_published_date": "27/04/2012", "last_updated_date": "30/06/2023", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000183-pip01-08-m08" }, { "decision_number": "P/0409/2021", "pip_number": "EMEA-000783-PIP01-09-M06", "active_substance": "dulaglutide", "invented_name": "Trulicity", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Solution for injection in pre-filled pen", "condition_indication": "Treatment of type II diabetes mellitus", "routes_of_administration": "Subcutaneous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "29/10/2021", "compliance_outcome": "Positive", "compliance_opinion_date": "24/06/2022", "compliance_procedure_number": "EMEA-C-000783-PIP01-09-M06", "contact_for_public_enquiries": "Eli Lilly & Company Limited; E-mail: eu_paediatric@lilly.com ; Tel. +44 (0)1276 483000", "first_published_date": "24/02/2011", "last_updated_date": "30/06/2023", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000783-pip01-09-m06" }, { "decision_number": "P/0438/2021", "pip_number": "EMEA-001006-PIP05-18-M01", "active_substance": "nintedanib", "invented_name": "Ofev; Vargatef", "therapeutic_area": "Oncology;Pneumology-allergology", "pharmaceutical_forms": "Capsule, soft", "condition_indication": "Treatment of fibrosing Interstitial Lung Diseases (ILD)", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "29/10/2021", "compliance_outcome": "Positive", "compliance_opinion_date": "22/07/2022", "compliance_procedure_number": "EMEA-C-001006-PIP05-18-M01", "contact_for_public_enquiries": "Boehringer Ingelheim International GmbH E-mail: COMMSPaediatrics@boehringer-ingelheim.comTel. +49 (0)6132 77 8271", "first_published_date": "20/06/2019", "last_updated_date": "30/06/2023", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001006-pip05-18-m01" }, { "decision_number": "P/0081/2022", "pip_number": "EMEA-003134-PIP01-21", "active_substance": "nifurtimox", "invented_name": "", "therapeutic_area": "Infectious diseases", "pharmaceutical_forms": "Tablet", "condition_indication": "Treatment of Chagas disease", "routes_of_administration": "Oral use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "11/03/2022", "compliance_outcome": "Positive", "compliance_opinion_date": "09/09/2022", "compliance_procedure_number": "EMEA-C-003134-PIP01-21", "contact_for_public_enquiries": "Bayer AG, Leverkusen; E-mail: clinical-trials-contact@bayer.com; Tel: +49 30300139003", "first_published_date": "20/04/2023", "last_updated_date": "30/06/2023", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003134-pip01-21" }, { "decision_number": "P/0328/2020", "pip_number": "EMEA-002710-PIP01-19", "active_substance": "artesunate", "invented_name": "", "therapeutic_area": "Infectious diseases", "pharmaceutical_forms": "Powder for solution for injection", "condition_indication": "Treatment of malaria", "routes_of_administration": "Intravenous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "14/08/2020", "compliance_outcome": "Positive", "compliance_opinion_date": "09/09/2022", "compliance_procedure_number": "EMEA-C-002710-PIP01-19", "contact_for_public_enquiries": "Amivas Ireland Ltd; E-mail: info@amivas.com; Tel.: + 353 51 347 322", "first_published_date": "22/06/2021", "last_updated_date": "30/06/2023", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002710-pip01-19" }, { "decision_number": "P/0141/2022", "pip_number": "EMEA-002869-PIP03-21", "active_substance": "Influenza virus A/turkey/Turkey/1/2005 (H5N1) NIBRG-23 strain, HA surface antigen", "invented_name": "", "therapeutic_area": "Vaccines", "pharmaceutical_forms": "Suspension for injection", "condition_indication": "Prevention of zoonotic influenza", "routes_of_administration": "Intramuscular use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "13/04/2022", "compliance_outcome": "Positive", "compliance_opinion_date": "09/09/2022", "compliance_procedure_number": "EMEA-C-002869-PIP03-21", "contact_for_public_enquiries": "Seqirus Netherlands B.V.; E-mail: seqirus.clinicaltrials@seqirus.com; Tel: +1 9088587365", "first_published_date": "17/04/2023", "last_updated_date": "30/06/2023", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002869-pip03-21-0" }, { "decision_number": "P/0214/2022", "pip_number": "EMEA-001864-PIP01-15-M07", "active_substance": "Lanadelumab (DX-2930)", "invented_name": "Takhzyro", "therapeutic_area": "Other", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Prevention of hereditary angioedema attacks", "routes_of_administration": "Subcutaneous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "10/06/2022", "compliance_outcome": "Positive", "compliance_opinion_date": "09/09/2022", "compliance_procedure_number": "EMEA-C-001864-PIP01-15-M07", "contact_for_public_enquiries": "Takeda Pharmaceuticals International AG Ireland BranchE-mail: medinfoemea@takeda.comTel: +44 (0) 3333 000181", "first_published_date": "23/11/2016", "last_updated_date": "30/06/2023", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001864-pip01-15-m07" }, { "decision_number": "P/0423/2020", "pip_number": "EMEA-001147-PIP02-20", "active_substance": "dabrafenib", "invented_name": "", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Capsule, hard;Dispersible tablet", "condition_indication": "Treatment of glioma", "routes_of_administration": "Oral use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "23/10/2020", "compliance_outcome": "Positive", "compliance_opinion_date": "27/09/2022", "compliance_procedure_number": "EMEA-C-001147-PIP02-20", "contact_for_public_enquiries": "Novartis Europharm LimitedE-mail: paediatric.enquiries@novartis.comTel. +41 613241111", "first_published_date": "22/07/2021", "last_updated_date": "30/06/2023", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001147-pip02-20" }, { "decision_number": "P/0424/2020", "pip_number": "EMEA-001177-PIP02-20", "active_substance": "trametinib", "invented_name": "", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Film-coated tablet;Powder for oral solution", "condition_indication": "Treatment of glioma", "routes_of_administration": "Oral use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "23/10/2020", "compliance_outcome": "Positive", "compliance_opinion_date": "27/09/2022", "compliance_procedure_number": "EMEA-C-001177-PIP02-20", "contact_for_public_enquiries": "Novartis Europharm LimitedE-mail: paediatric.enquiries@novartis.comTel. +41 613241111", "first_published_date": "22/07/2021", "last_updated_date": "30/06/2023", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001177-pip02-20" }, { "decision_number": "P/0115/2021", "pip_number": "EMEA-001181-PIP01-11-M06", "active_substance": "agomelatine", "invented_name": "Valdoxan and associated names", "therapeutic_area": "Psychiatry", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Treatment of major depressive episodes", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "17/03/2021", "compliance_outcome": "Positive", "compliance_opinion_date": "14/10/2022", "compliance_procedure_number": "EMEA-C-001181-PIP01-11-M06", "contact_for_public_enquiries": "Les Laboratoires ServierE-mail: mail.pip.enquiries@servier.comTel.: +33 155726000", "first_published_date": "25/06/2012", "last_updated_date": "30/06/2023", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001181-pip01-11-m06" }, { "decision_number": "P/0209/2022", "pip_number": "EMEA-001105-PIP01-10-M06", "active_substance": "Dopamine (hydrochloride)", "invented_name": "", "therapeutic_area": "Cardiovascular diseases;Neonatology-Paediatric Intensive Care", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Treatment of vascular hypotensive disorders", "routes_of_administration": "Intravenous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "10/06/2023", "compliance_outcome": "Positive", "compliance_opinion_date": "14/10/2022", "compliance_procedure_number": "EMEA-C-001105-PIP01-10-M06", "contact_for_public_enquiries": "Brepco Biopharma Limited; E-mail: info@ivowen.com; Tel.: +353 526180664", "first_published_date": "19/01/2012", "last_updated_date": "30/06/2023", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001105-pip01-10-m06" }, { "decision_number": "P/0074/2022", "pip_number": "EMEA-000876-PIP05-15-M05", "active_substance": "Eculizumab", "invented_name": "Soliris; Soliris", "therapeutic_area": "Neurology", "pharmaceutical_forms": "Concentrate for solution for infusion", "condition_indication": "Treatment of myasthenia gravis", "routes_of_administration": "Intravenous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "11/03/2022", "compliance_outcome": "Positive", "compliance_opinion_date": "14/10/2022", "compliance_procedure_number": "EMEA-C-000876-PIP05-15-M05", "contact_for_public_enquiries": "Alexion Europe SAS; E-mail: pip.enquiries.eu@alexion.com; Tel: +33 147100615", "first_published_date": "25/04/2016", "last_updated_date": "30/06/2023", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000876-pip05-15-m05" }, { "decision_number": "P/0174/2021", "pip_number": "EMEA-000332-PIP01-08-M16", "active_substance": "Brivaracetam", "invented_name": "Briviact (in Italy: Nubriveo)", "therapeutic_area": "Neurology", "pharmaceutical_forms": "Film-coated tablet;Oral solution;Solution for injection", "condition_indication": "Treatment of epilepsy with partial-onset seizures", "routes_of_administration": "Oral use;Intravenous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "09/04/2021", "compliance_outcome": "Positive", "compliance_opinion_date": "14/10/2022", "compliance_procedure_number": "EMEA-C-000332-PIP01-08-M16", "contact_for_public_enquiries": "UCB Pharma S.A.; E-mail: UCBCares.IE@ucb.com; Tel. +353 1463 2371", "first_published_date": "17/10/2011", "last_updated_date": "30/06/2023", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000332-pip01-08-m16" }, { "decision_number": "P/0311/2021", "pip_number": "EMEA-001220-PIP03-16-M02", "active_substance": "baricitinib", "invented_name": "Olumiant", "therapeutic_area": "Dermatology", "pharmaceutical_forms": "Oral suspension;Tablet", "condition_indication": "Treatment of atopic dermatitis", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "11/08/2021", "compliance_outcome": "Positive", "compliance_opinion_date": "11/11/2022", "compliance_procedure_number": "EMEA-C-001220-PIP03-16-M02", "contact_for_public_enquiries": "Eli Lilly & Company Limited; E-mail: eu_paediatric@lilly.com ; Tel. +44 (0)1276 483000", "first_published_date": "11/01/2019", "last_updated_date": "30/06/2023", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001220-pip03-16-m02" }, { "decision_number": "P/0188/2016", "pip_number": "EMEA-001156-PIP01-11-M07", "active_substance": "recombinant dimer of 6 kD early secretory antigenic target;recombinant 10 kD culture filtrate protein", "invented_name": "", "therapeutic_area": "Diagnostic", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Diagnosis of tuberculosis", "routes_of_administration": "Intradermal use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "15/07/2016", "compliance_outcome": "Positive", "compliance_opinion_date": "11/11/2022", "compliance_procedure_number": "EMEA-C-001156-PIP01-11-M07", "contact_for_public_enquiries": "Statens Serum Institut; Denmark; Tel. +45 32688617; E-mail: lsst@ssi.dk", "first_published_date": "24/02/2012", "last_updated_date": "30/06/2023", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001156-pip01-11-m07" }, { "decision_number": "P/0392/2020", "pip_number": "EMEA-001177-PIP01-11-M06", "active_substance": "trametinib dimethyl sulfoxide", "invented_name": "Mekinist", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Film-coated tablet;Powder for oral solution", "condition_indication": "Treatment of all conditions included in the category of malignant neoplasms (except melanoma, haematopoietic and lymphoid tissue, and glioma);Treatment of melanoma", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "23/10/2020", "compliance_outcome": "Positive", "compliance_opinion_date": "11/11/2022", "compliance_procedure_number": "EMEA-C-001177-PIP01-11-M06", "contact_for_public_enquiries": "Novartis Europharm LimitedE-mail: paediatric.enquiries@novartis.comTel. +41 613241111", "first_published_date": "26/03/2012", "last_updated_date": "30/06/2023", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001177-pip01-11-m06" }, { "decision_number": "P/0410/2020", "pip_number": "EMEA-001147-PIP01-11-M07", "active_substance": "dabrafenib mesilate", "invented_name": "Tafinlar", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Capsule, hard;Dispersible tablet", "condition_indication": "Treatment of melanoma;Treatment of solid malignant tumours (excluding melanoma)", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "23/10/2020", "compliance_outcome": "Positive", "compliance_opinion_date": "11/11/2022", "compliance_procedure_number": "EMEA-C-001147-PIP01-11-M07", "contact_for_public_enquiries": "Novartis Europharm LimitedE-mail: paediatric.enquiries@novartis.comTel. +41 613241111", "first_published_date": "24/02/2012", "last_updated_date": "30/06/2023", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001147-pip01-11-m07" }, { "decision_number": "P/0493/2021", "pip_number": "EMEA-001146-PIP01-11-M07", "active_substance": "naloxegol", "invented_name": "Moventig", "therapeutic_area": "Gastroentology-Hepatology", "pharmaceutical_forms": "Tablet;Age appropriate oral liquid dosage formulation", "condition_indication": "Treatment of opioid-induced constipation", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "03/12/2021", "compliance_outcome": "Positive", "compliance_opinion_date": "11/11/2022", "compliance_procedure_number": "EMEA-C-001146-PIP01-11-M07", "contact_for_public_enquiries": "Kyowa Kirin Pharmaceutical Development Limited; Tel. +44 1896664000; E-mail: medinfo@kyowakirin.com", "first_published_date": "18/09/2012", "last_updated_date": "30/06/2023", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001146-pip01-11-m07" }, { "decision_number": "P/0423/2021", "pip_number": "EMEA-000788-PIP02-11-M11", "active_substance": "edoxaban tosilate", "invented_name": "Lixiana", "therapeutic_area": "Cardiovascular diseases;Haematology-Hemostaseology", "pharmaceutical_forms": "Film-coated tablet;Age appropriate oral dosage formulation", "condition_indication": "Prevention of arterial thromboembolism;Prevention of venous thromboembolism;Treatment of venous thromboembolism", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "29/10/2021", "compliance_outcome": "Positive", "compliance_opinion_date": "11/11/2022", "compliance_procedure_number": "EMEA-C-000788-PIP02-11-M11", "contact_for_public_enquiries": "Daiichi Sankyo Europe GmbH; Tel. +49 8978080; E-mail: service@daiichi-sankyo.eu", "first_published_date": "14/07/2011", "last_updated_date": "30/06/2023", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000788-pip02-11-m11" }, { "decision_number": "P/0257/2020", "pip_number": "EMEA-000496-PIP01-08-M08", "active_substance": "alogliptin", "invented_name": "Vipidia", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Treatment of type II diabetes mellitus", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "15/07/2020", "compliance_outcome": "Positive", "compliance_opinion_date": "11/11/2022", "compliance_procedure_number": "EMEA-C-000496-PIP01-08-M08", "contact_for_public_enquiries": "Takeda Pharma A/STel. +44 (0)3333000181E-mail: medinfoEMEA@takeda.com", "first_published_date": "09/07/2009", "last_updated_date": "30/06/2023", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000496-pip01-08-m08" }, { "decision_number": "P/0460/2021", "pip_number": "EMEA-002392-PIP01-18-M02", "active_substance": "oteseconazole", "invented_name": "", "therapeutic_area": "Infectious diseases", "pharmaceutical_forms": "Capsule, hard", "condition_indication": "Treatment of vulvovaginal candidiasis", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "29/10/2021", "compliance_outcome": "Positive", "compliance_opinion_date": "16/12/2022", "compliance_procedure_number": "EMEA-C-002392-PIP01-18-M02", "contact_for_public_enquiries": "Gedeon Richter Plc.; Tel.  +36 14314675; E-mail: cprichter@richter.hu", "first_published_date": "24/06/2019", "last_updated_date": "30/06/2023", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002392-pip01-18-m02" }, { "decision_number": "P/0188/2020", "pip_number": "EMEA-001830-PIP01-15-M02", "active_substance": "Pandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)", "invented_name": "Foclivia; Foclivia and associated names", "therapeutic_area": "Vaccines", "pharmaceutical_forms": "Suspension for injection", "condition_indication": "Prevention of influenza infection", "routes_of_administration": "Intramuscular use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "15/05/2020", "compliance_outcome": "Positive", "compliance_opinion_date": "16/12/2022", "compliance_procedure_number": "EMEA-C-001830-PIP01-15-M02", "contact_for_public_enquiries": "Seqirus S.r.l.; Tel. +39 0577096405; +39 0577096401; E-mail: pip.seq@seqirus.com", "first_published_date": "25/04/2016", "last_updated_date": "30/06/2023", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001830-pip01-15-m02" }, { "decision_number": "P/0283/2021", "pip_number": "EMEA-000828-PIP01-09-M09", "active_substance": "empagliflozin", "invented_name": "Jardiance; Jardiance", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Treatment of type II diabetes mellitus", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "29/10/2021", "compliance_outcome": "Positive", "compliance_opinion_date": "16/12/2022", "compliance_procedure_number": "EMEA-C-000828-PIP01-09-M09", "contact_for_public_enquiries": "Boehringer Ingelheim International GmbH E-mail: COMMSPaediatrics@boehringer-ingelheim.comTel. +49 (0)6132 77 8271", "first_published_date": "23/02/2011", "last_updated_date": "30/06/2023", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000828-pip01-09-m09" }, { "decision_number": "P/0446/2021", "pip_number": "EMEA-000498-PIP01-08-M10", "active_substance": "linagliptin", "invented_name": "Trajenta; Trajenta", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Treatment of type II diabetes mellitus", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "29/10/2021", "compliance_outcome": "Positive", "compliance_opinion_date": "16/12/2022", "compliance_procedure_number": "EMEA-C-000498-PIP01-08-M10", "contact_for_public_enquiries": "Boehringer Ingelheim International GmbH E-mail: COMMSPaediatrics@boehringer-ingelheim.comTel. +49 (0)6132 77 8271", "first_published_date": "11/08/2009", "last_updated_date": "30/06/2023", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000498-pip01-08-m10" }, { "decision_number": "P/0259/2022", "pip_number": "EMEA-002989-PIP01-21-M01", "active_substance": "leniolisib", "invented_name": "", "therapeutic_area": "Immunology-Rheumatology-Transplantation", "pharmaceutical_forms": "Capsule, hard;Film-coated tablet;Granules", "condition_indication": "Treatment of activated phosphoinositide 3-kinase delta syndrome (APDS)", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "15/07/2022", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Pharming Group N.V.; Tel. +31 715247400; E-mail: info@pharming.com", "first_published_date": "13/03/2023", "last_updated_date": "29/06/2023", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002989-pip01-21-m01" }, { "decision_number": "P/0248/2022", "pip_number": "EMEA-002758-PIP01-19-M02", "active_substance": "Dexmedetomidine hydrochloride", "invented_name": "", "therapeutic_area": "Psychiatry", "pharmaceutical_forms": "Oromucosal film", "condition_indication": "Treatment of bipolar disorder;Treatment of schizophrenia", "routes_of_administration": "Sublingual use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "08/07/2022", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "BioXcel Therapeutics, Inc.E-mail: info@bioxceltherapeutics.comTel.: +1 475 2386837", "first_published_date": "06/10/2021", "last_updated_date": "29/06/2023", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002758-pip01-19-m02" }, { "decision_number": "P/0205/2022", "pip_number": "EMEA-002354-PIP02-18-M01", "active_substance": "zanubrutinib", "invented_name": "Brukinsa", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Capsule, hard", "condition_indication": "Treatment of lymphoplasmacytic lymphoma;Treatment of mature B-cell neoplasms (excluding lymphoplasmacytic lymphoma)", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "10/06/2022", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "BeiGene Ireland Ltd.; E-mail: bg.ireland@beigene.com; Tel. +353 15667660", "first_published_date": "03/04/2020", "last_updated_date": "29/06/2023", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002354-pip02-18-m01" }, { "decision_number": "P/0162/2022", "pip_number": "EMEA-003008-PIP01-21", "active_substance": "virus-like particle of SARS-CoV-2 spike protein (recombinant, adjuvant) (CoVLP)", "invented_name": "", "therapeutic_area": "Vaccines", "pharmaceutical_forms": "Suspension and emulsion for emulsion for injection", "condition_indication": "Prevention of Coronavirus disease 2019 (COVID-19)", "routes_of_administration": "Intramuscular use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "13/05/2022", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Medicago Inc.; Email: atkinsj@medicago.com; Tel. +1 4185694616", "first_published_date": "11/05/2023", "last_updated_date": "29/06/2023", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003008-pip01-21" }, { "decision_number": "P/0231/2022", "pip_number": "EMEA-002344-PIP02-18-M01", "active_substance": "liposomal ciclosporin A (L-CsA)", "invented_name": "", "therapeutic_area": "Immunology-Rheumatology-Transplantation", "pharmaceutical_forms": "Powder for nebuliser solution", "condition_indication": "Treatment of bronchiolitis obliterans syndrome", "routes_of_administration": "Inhalation use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "08/07/2022", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Zambon S.p.A.; E-mail: marzia.michieletto@zambongroup.com ; Tel.:  +39 0266524256", "first_published_date": "23/03/2020", "last_updated_date": "27/06/2023", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002344-pip02-18-m01" }, { "decision_number": "P/0208/2022", "pip_number": "EMEA-001030-PIP01-10-M10", "active_substance": "canagliflozin", "invented_name": "Invokana", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Treatment of type II diabetes mellitus", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "10/06/2022", "compliance_outcome": "Positive", "compliance_opinion_date": "26/04/2024", "compliance_procedure_number": "EMEA-C-001030-PIP01-10-M10", "contact_for_public_enquiries": "Janssen-Cilag International N.V.; Tel. +32 14602111; E-mail: contact@Janssen-emea.com", "first_published_date": "09/08/2011", "last_updated_date": "27/06/2023", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001030-pip01-10-m10" }, { "decision_number": "P/0200/2022", "pip_number": "EMEA-001115-PIP01-10-M08", "active_substance": "loxapine", "invented_name": "Adasuve", "therapeutic_area": "Psychiatry", "pharmaceutical_forms": "Inhalation powder (pre-dispensed)", "condition_indication": "Treatment of bipolar disorder;Treatment of schizophrenia", "routes_of_administration": "Inhalation use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "10/06/2023", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Ferrer Internacional, S.A.; E-mail: registros@ferrer.comTel.:  +34 935044423", "first_published_date": "18/10/2011", "last_updated_date": "27/06/2023", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001115-pip01-10-m08" }, { "decision_number": "P/0260/2022", "pip_number": "EMEA-001696-PIP01-14-M02", "active_substance": "omecamtiv mecarbil", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Modified-release tablet", "condition_indication": "Treatment of heart failure", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "22/07/2022", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Cytokinetics, Inc.; Tel.: +1 650 624 3000; E-mail: regaffairs@cytokinetics.com", "first_published_date": "20/10/2015", "last_updated_date": "23/06/2023", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001696-pip01-14-m02" }, { "decision_number": "P/0237/2022", "pip_number": "EMEA-001410-PIP02-17-M04", "active_substance": "Ixazomib", "invented_name": "Ninlaro", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Powder for solution for injection or infusion;Capsule, hard", "condition_indication": "Treatment of lymphoid malignancies (excluding multiple myeloma);Treatment of Multiple Myeloma", "routes_of_administration": "Intravenous use;Oral use;Gastric use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "08/07/2022", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Takeda Pharm A/S; E-mail: medinfoEMEA@takeda.com​; Tel. +44 (0)3333 000181", "first_published_date": "26/07/2018", "last_updated_date": "23/06/2023", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001410-pip02-17-m04" }, { "decision_number": "P/0226/2022", "pip_number": "EMEA-001217-PIP01-11-M08", "active_substance": "Indacaterol (acetate);mometasone furoate", "invented_name": "Atectura Breezhaler; Bemrist Breezhaler", "therapeutic_area": "Pneumology-allergology", "pharmaceutical_forms": "Inhalation powder;Capsule, hard", "condition_indication": "Treatment of asthma", "routes_of_administration": "Inhalation use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "08/07/2022", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Novartis Europharm LimitedE-mail: paediatric.enquiries@novartis.comTel. +41 613241111", "first_published_date": "07/06/2018", "last_updated_date": "23/06/2023", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001217-pip01-11-m08" }, { "decision_number": "P/0245/2022", "pip_number": "EMEA-001127-PIP02-11-M02", "active_substance": "Hepatitis B (rDNA) surface antigen adjuvanted", "invented_name": "Heplisav B", "therapeutic_area": "Vaccines", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Prevention of hepatitis B virus infection", "routes_of_administration": "Intramuscular use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "08/07/2022", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Dynavax GmbH; E-mail: dynavaxmedinfo@lashgroup.com; Tel. +49 21175845126", "first_published_date": "10/04/2012", "last_updated_date": "23/06/2023", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001127-pip02-11-m02" }, { "decision_number": "P/0223/2022", "pip_number": "EMEA-003190-PIP01-22", "active_substance": "Botulinum toxin type E", "invented_name": "", "therapeutic_area": "Dermatology", "pharmaceutical_forms": "All pharmaceutical forms", "condition_indication": "Treatment of skin wrinkling", "routes_of_administration": "All routes of administration", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "08/07/2022", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Allergan Pharmaceuticals Ireland; ML-EU_Reg_Affairs@Allergan.com ; +44 (0)1628494444", "first_published_date": "21/06/2023", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003190-pip01-22" }, { "decision_number": "P/0227/2022", "pip_number": "EMEA-003181-PIP01-22", "active_substance": "Peptide KLBPVQLWV / Peptide SMPPPGTRV / Peptide YLQLVFGIEV / Peptide RLLQETELV / Peptide YLSGADLNL / Peptide LLTFWNPPV / Peptide IMIGHLVGV / Peptide KVAEIVHFL / Peptide KVFGSLAFV / Pan HLA DR-binding epitope D-Ala-Lys-Cha-Val-Ala-Ala-Trp-Thr-Leu-Lys-Ala-Ala-D-Ala (OSE2101)", "invented_name": "", "therapeutic_area": "Oncology", "pharmaceutical_forms": "All pharmaceutical forms", "condition_indication": "Treatment of lung cancer (small cell and non-small cell lung cancer)", "routes_of_administration": "All routes of administration", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "08/07/2022", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "OSE Immunotherapeutics; gra@ose-immuno.com ; +33 (0)228291010", "first_published_date": "21/06/2023", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003181-pip01-22" }, { "decision_number": "P/0261/2022", "pip_number": "EMEA-003115-PIP01-21", "active_substance": "recombinant COVID-19 subunit nanoparticle (adjuvanted with AS03) (GBP510)", "invented_name": "", "therapeutic_area": "Vaccines", "pharmaceutical_forms": "Emulsion and suspension for emulsion for injection", "condition_indication": "Prevention of Coronavirus disease 2019 (COVID-19)", "routes_of_administration": "Intramuscular use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "15/07/2022", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", 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Email: info@khondrion.com; Tel. +31 243617505", "first_published_date": "29/09/2021", "last_updated_date": "12/05/2023", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002113-pip01-16-m01" }, { "decision_number": "P/0176/2022", "pip_number": "EMEA-003158-PIP01-21", "active_substance": "zandelisib", "invented_name": "", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Capsule, hard", "condition_indication": "Treatment of mature B-cell neoplasms", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "13/05/2012", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Kyowa Kirin Holdings B.V.; Email: comms@kyowakirin.com; Tel. +44 (0)1896664000", "first_published_date": "11/05/2023", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003158-pip01-21" }, { "decision_number": "P/0178/2022", "pip_number": "EMEA-001501-PIP11-21", "active_substance": "dupilumab", "invented_name": "Dupixent", "therapeutic_area": "Dermatology", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Treatment of chronic puritus of unknown origin", "routes_of_administration": "Subcutaneous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "13/05/2012", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Sanofi-Aventis Groupe; contact-us@sanofi.com;  +33 169745695", "first_published_date": "11/05/2023", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001501-pip11-21" }, { "decision_number": "P/0167/2022", "pip_number": "EMEA-002945-PIP02-21", "active_substance": "anti-CD40L humanized monoclonal antibody (SAR441344)", "invented_name": "", "therapeutic_area": "Neurology", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Treatment of progressive multiple sclerosis", "routes_of_administration": "Intravenous use;Subcutaneous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "13/05/2022", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Sanofi Winthrop Industrie; Email: contact-us@sanofi.com; Tel: +31 202 453 703", "first_published_date": "11/05/2023", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002945-pip02-21" }, { "decision_number": "P/0169/2022", "pip_number": "EMEA-002594-PIP03-21", "active_substance": "Infigratinib", "invented_name": "", "therapeutic_area": "Oncology", "pharmaceutical_forms": "All pharmaceutical forms", "condition_indication": "Treatment of urothelial carcinoma", "routes_of_administration": "All routes of administration", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "13/05/2022", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Helsinn Birex Pharmaceuticals Ltd.; Email: Info-HHC@helsinn.com; Tel. +353 18225404", "first_published_date": "11/05/2023", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002594-pip03-21" }, { "decision_number": "P/0165/2022", "pip_number": "EMEA-003040-PIP02-21", "active_substance": "Izaflortaucipir (18F)", "invented_name": "", "therapeutic_area": "Neurology", "pharmaceutical_forms": "All pharmaceutical forms", "condition_indication": "Diagnosis of Alzheimer's disease", "routes_of_administration": "All routes of administration", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "13/05/2022", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Life Molecular Imaging GmbH; Email: gra@life-mi.com; Tel. +49 30461124603", "first_published_date": "11/05/2023", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003040-pip02-21" }, { "decision_number": "P/0158/2022", "pip_number": "EMEA-003159-PIP01-21", "active_substance": "(2S) 4 [2 methoxyethyl [4 (5,6,7,8 tetrahydro 1,8 naphthyridin 2 yl)butyl] amino] 2 (quinazolin 4 ylamino)butanoic acid", "invented_name": "", "therapeutic_area": "Pneumology-allergology", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Treatment of idiopathic pulmonary fibrosis", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "13/05/2022", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Pliant Therapeutics Inc.; Email: info@pliantrx.com; Tel. +1 6504816770", "first_published_date": "11/05/2023", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003159-pip01-21" }, { "decision_number": "P/0186/2022", "pip_number": "EMEA-003058-PIP01-21", "active_substance": "Humanised KLB/FGFR1c monoclonal antibody (MK-3655)", "invented_name": "", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Treatment of non-alcoholic steatohepatitis (NASH)", "routes_of_administration": "Subcutaneous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "16/05/2022", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Merck Sharp & Dohme (Europe), Inc.; Email: pip.information@merck.com; Tel. +31 412663179", "first_published_date": "11/05/2023", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003058-pip01-21" }, { "decision_number": "P/0181/2022", "pip_number": "EMEA-002645-PIP03-21", "active_substance": "sacituzumab govitecan", "invented_name": "Trodelvy", "therapeutic_area": "Oncology", "pharmaceutical_forms": "All pharmaceutical forms", "condition_indication": "Treatment of lung carcinoma (small cell and non-small cell carcinoma)", "routes_of_administration": "All routes of administration", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "13/05/2022", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Gilead Sciences International Ltd. ; 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United Kingdom; E-mail: eu.paediatric-plans@gsk.com; Tel. +1 4388998201; Fax +44 (0)20 8990 3511", "first_published_date": "24/11/2010", "last_updated_date": "13/03/2023", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000409-pip01-08-m06" }, { "decision_number": "P/0143/2019", "pip_number": "EMEA-000306-PIP01-08-M04", "active_substance": "corifollitropin alfa", "invented_name": "Elonva", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Treatment of hypogonadotrophic hypogonadism", "routes_of_administration": "Subcutaneous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "17/04/2019", "compliance_outcome": "Positive", "compliance_opinion_date": "29/01/2021", "compliance_procedure_number": "EMEA-C-000306-PIP01-08-M04", "contact_for_public_enquiries": "Merck, Sharp & Dohme (Europe) Inc.; Tel. +31 412770000; E-mail: regaffairseurope@organon.com", "first_published_date": "22/09/2016", "last_updated_date": "13/03/2023", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000306-pip01-08-m04" }, { "decision_number": "P/0473/2021", "pip_number": "EMEA-002954-PIP02-21", "active_substance": "Neisseria meningitidis serogroup B Protein-based active substance;recombinant Neisseria meningitidis serogroup B protein 1;recombinant Neisseria meningitidis serogroup B protein 2;recombinant Neisseria meningitidis serogroup B protein 3", "invented_name": "", "therapeutic_area": "Vaccines", "pharmaceutical_forms": "Suspension for injection", "condition_indication": "Prevention of Meningococcal disease", "routes_of_administration": "Intramuscular use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "03/12/2021", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Sanofi PasteurE-mail: contact-us@sanofi.comTel. +33 1 6974 5695", "first_published_date": "10/03/2023", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002954-pip02-21" }, { "decision_number": "P/0539/2021", "pip_number": "EMEA-002822-PIP01-20", "active_substance": "2’-O-(2-methoxyethyl) modified antisense oligonucleotide targeting glial fibrillary acidic protein pre-mRNA (ION373)", "invented_name": "", "therapeutic_area": "Neurology", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Treatment of Alexander disease", "routes_of_administration": "Intrathecal use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "31/12/2021", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Ionis Pharmaceuticals; Email: globalregulatoryaffairs@ionisph.com; Tel. 7606032302", "first_published_date": "10/03/2023", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002822-pip01-20" }, { "decision_number": "P/0500/2021", "pip_number": "EMEA-002942-PIP01-20", "active_substance": "Peptide derivative of glucagon-like-peptide 1 and glucagon with fatty acid side chain (BI 456906)", "invented_name": "", "therapeutic_area": "Gastroentology-Hepatology", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Treatment of non-alcoholic steatohepatitis (NASH)", "routes_of_administration": "Subcutaneous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "03/12/2021", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Boehringer Ingelheim International GmbH E-mail: COMMSPaediatrics@boehringer-ingelheim.comTel. +49 (0)6132 77 8271", "first_published_date": "10/03/2023", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002942-pip01-20" }, { "decision_number": "P/0537/2021", "pip_number": "EMEA-002947-PIP01-20", "active_substance": "Exebacase", "invented_name": "", "therapeutic_area": "Infectious diseases", "pharmaceutical_forms": "Solution for infusion", "condition_indication": "Treatment of Staphylococcus aureus bacteraemia", "routes_of_administration": "Intravenous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "09/12/2021", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "ContraFect Corporation; Email: clinicalstudies@contrafect.com; Tel. +1 (914)2072300;  ", "first_published_date": "10/03/2023", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002947-pip01-20" }, { "decision_number": "P/0329/2019", "pip_number": "EMEA-001215-PIP01-11-M07", "active_substance": "lonoctocog alfa", "invented_name": "Afstyla", "therapeutic_area": "Haematology-Hemostaseology", "pharmaceutical_forms": "Powder and solvent for solution for injection", "condition_indication": "Haemophilia A (congenital Factor VIII deficiency)", "routes_of_administration": "Intravenous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "10/09/2019", "compliance_outcome": "Positive", "compliance_opinion_date": "10/09/2021", "compliance_procedure_number": "EMEA-C-001215-PIP01-11-M07", "contact_for_public_enquiries": "CSL Behring GmbH; Tel. +49 6421393290; E-mail: marburg.rfVIII@cslbehring.com;  ", "first_published_date": "26/07/2017", "last_updated_date": "10/03/2023", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001215-pip01-11-m07" }, { "decision_number": "P/0142/2017", "pip_number": "EMEA-001174-PIP02-12-M02", "active_substance": "turoctocog alfa pegol", "invented_name": "", "therapeutic_area": "Haematology-Hemostaseology", "pharmaceutical_forms": "Powder and solvent for solution for injection", "condition_indication": "Treatment of hereditary factor VIII deficiency", "routes_of_administration": "Intravenous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "07/06/2017", "compliance_outcome": "Positive", "compliance_opinion_date": "23/07/2021", "compliance_procedure_number": "EMEA-C-001174-PIP02-12-M02", "contact_for_public_enquiries": "Novo Nordisk A/S; Denmark; Tel. +45 44448888; E-mail: paediatrics@novonordisk.com", "first_published_date": "26/07/2017", "last_updated_date": "10/03/2023", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001174-pip02-12-m02" }, { "decision_number": "P/0248/2016", "pip_number": "EMEA-001362-PIP01-12-M03", "active_substance": "cerliponase alfa", "invented_name": "", "therapeutic_area": "Neurology", "pharmaceutical_forms": "Concentrate for solution for infusion", "condition_indication": "Treatment of Neuronal Ceroid Lipofuscinosis type 2", "routes_of_administration": "Intracerebral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "05/09/2016", "compliance_outcome": "Positive", "compliance_opinion_date": "26/02/2021", "compliance_procedure_number": "EMEA-C-001362-PIP01-12-M03", "contact_for_public_enquiries": "BioMarin International Limited; Ireland; Tel. +44 2074200800; Fax +44 2074200829; E-mail: biomarin-europe@bmrn.com", "first_published_date": "15/11/2013", "last_updated_date": "10/03/2023", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001362-pip01-12-m03" }, { "decision_number": "P/0479/2020", "pip_number": "EMEA-000482-PIP01-08-M06", "active_substance": "teduglutide", "invented_name": "Revestive; Revestive", "therapeutic_area": "Gastroentology-Hepatology", "pharmaceutical_forms": "Powder and solvent for solution for injection", "condition_indication": "Treatment of short bowel syndrome", "routes_of_administration": "Subcutaneous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "01/12/2020", "compliance_outcome": "Positive", "compliance_opinion_date": "26/03/2021", "compliance_procedure_number": "EMEA-C-000482-PIP01-08-M06", "contact_for_public_enquiries": "Takeda Pharmaceuticals International AG Ireland BranchE-mail: medinfoemea@takeda.comTel: +44 (0) 3333 000181", "first_published_date": "20/12/2010", "last_updated_date": "10/03/2023", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000482-pip01-08-m06" }, { "decision_number": "P/0134/2021", "pip_number": "EMEA-001356-PIP02-12-M04", "active_substance": "citric acid (as citric acid anhydrous);macrogol 4000;potassium chloride;simeticone;sodium chloride;sodium citrate;sodium sulfate (as sodium sulfate anhydrous)", "invented_name": "Clensia", "therapeutic_area": "Gastroentology-Hepatology", "pharmaceutical_forms": "Powder for oral suspension", "condition_indication": "Bowel cleansing prior to clinical procedures", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "14/04/2021", "compliance_outcome": "Positive", "compliance_opinion_date": "17/12/2021", "compliance_procedure_number": "EMEA-C-001356-PIP02-12-M04", "contact_for_public_enquiries": "Alfasigma S.p.A.; E-mail: Antonietta.Pazardjiklian@alfasigma.com; Tel.: +39 0516489602", "first_published_date": "16/04/2014", "last_updated_date": "10/03/2023", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001356-pip02-12-m04" }, { "decision_number": "P/0432/2020", "pip_number": "EMEA-001407-PIP01-12-M03", "active_substance": "nivolumab", "invented_name": "Opdivo", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Concentrate for solution for infusion", "condition_indication": "Treatment of all conditions included in the category of malignant neoplasms (except nervous system, haematopoietic and lymphoid tissue)", "routes_of_administration": "Intravenous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "05/11/2020", "compliance_outcome": "Positive", "compliance_opinion_date": "21/01/2022", "compliance_procedure_number": "EMEA-C-001407-PIP01-12-M03", "contact_for_public_enquiries": "Bristol-Myers Squibb Pharma EEIG E-mail: medical.information@bms.com Tel. +44 (0)1423 533610", "first_published_date": "16/04/2014", "last_updated_date": "10/03/2023", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001407-pip01-12-m03" }, { "decision_number": "P/0031/2020", "pip_number": "EMEA-001107-PIP01-10-M04", "active_substance": "albutrepenonacog alfa", "invented_name": "Idelvion", "therapeutic_area": "Haematology-Hemostaseology", "pharmaceutical_forms": "Powder and solvent for solution for infusion;Powder and solvent for solution for injection", "condition_indication": "Treatment of hereditary factor IX deficiency", "routes_of_administration": "Intravenous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "29/01/2020", "compliance_outcome": "", "compliance_opinion_date": "21/01/2022", "compliance_procedure_number": "EMEA-C-001107-PIP01-10-M04", "contact_for_public_enquiries": "CSL Behring GmbH; Tel.: +49 6421393304; E-mail: rix-fp@cslbehring.com", "first_published_date": "29/11/2011", "last_updated_date": "10/03/2023", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001107-pip01-10-m04" }, { "decision_number": "P/0014/2020", "pip_number": "EMEA-001024-PIP01-10-M02", "active_substance": "Human-cell-line recombinant human factor VIII (human-cl rhFVIII);human Coagulation Factor VIII (rDNA)", "invented_name": "Nuwiq and associated names", "therapeutic_area": "Haematology-Hemostaseology", "pharmaceutical_forms": "Powder and solvent for solution for injection", "condition_indication": "Treatment of haemophilia A (congenital factor-VIII deficiency)", "routes_of_administration": "Intravenous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "06/01/2020", "compliance_outcome": "Positive", "compliance_opinion_date": "26/03/2021", "compliance_procedure_number": "EMEA-C-001024-PIP01-10-M02", "contact_for_public_enquiries": "Octapharma Pharmazeutika Produktionsges.m.b.H; E-mail: sigurd.knaub@octapharma.ch; Tel. +41 554512141", "first_published_date": "12/05/2011", "last_updated_date": "10/03/2023", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001024-pip01-10-m02" }, { "decision_number": "P/0436/2020", "pip_number": "EMEA-001142-PIP01-11-M04", "active_substance": "ceftolozane;tazobactam", "invented_name": "Zerbaxa", "therapeutic_area": "Infectious diseases", "pharmaceutical_forms": "Powder for concentrate for solution for infusion", "condition_indication": "Treatment of intra-abdominal infections;Treatment of urinary tract infections", "routes_of_administration": "Intravenous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "13/11/2020", "compliance_outcome": "Positive", "compliance_opinion_date": "25/06/2021", "compliance_procedure_number": "EMEA-C-001142-PIP01-11-M04", "contact_for_public_enquiries": "Merck Sharp & Dohme (Europe) Inc.Tel.: +33180464738E-mail: pip.information@merck.com", "first_published_date": "07/01/2012", "last_updated_date": "10/03/2023", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001142-pip01-11-m04" }, { "decision_number": "P/0119/2021", "pip_number": "EMEA-001425-PIP01-13-M05", "active_substance": "Cobimetinib", "invented_name": "Cotellic", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Film-coated tablet;Age appropriate oral formulation", "condition_indication": "Treatment of all conditions included in the category of malignant neoplasms (except haematopoietic and lymphoid tissue) with Ras, Raf or MEK pathway activation", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "17/03/2021", "compliance_outcome": "Positive", "compliance_opinion_date": "25/06/2021", "compliance_procedure_number": "EMEA-C-001425-PIP01-13-M05", "contact_for_public_enquiries": "Roche Registration GmbHE-mail: global.eu_regulatory_office@roche.comTel. +49 7624142892", "first_published_date": "20/02/2014", "last_updated_date": "10/03/2023", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001425-pip01-13-m05" }, { "decision_number": "P/0407/2020", "pip_number": "EMEA-001056-PIP02-12-M01", "active_substance": "velmanase alfa", "invented_name": "Lamzede", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Powder for solution for injection", "condition_indication": "Treatment of alpha-mannosidosis", "routes_of_administration": "Intravenous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "23/10/2020", "compliance_outcome": "Positive", "compliance_opinion_date": "23/04/2021", "compliance_procedure_number": "EMEA-C-001056-PIP02-12-M01", "contact_for_public_enquiries": "Chiesi Farmaceutici S.p.A.; Tel. +39 0521 2791; E-mail: info@chiesi.com", "first_published_date": "05/06/2014", "last_updated_date": "10/03/2023", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001056-pip02-12-m01" }, { "decision_number": "P/0177/2020", "pip_number": "EMEA-000832-PIP01-10-M05", "active_substance": "dimethyl fumarate", "invented_name": "Tecfidera", "therapeutic_area": "Neurology", "pharmaceutical_forms": "Capsule, hard", "condition_indication": "Treatment of multiple sclerosis", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "15/05/2020", "compliance_outcome": "Positive", "compliance_opinion_date": "14/06/2021", "compliance_procedure_number": "EMEA-C-000832-PIP01-10-M05", "contact_for_public_enquiries": "Biogen Idec LtdTel.  +01 628501000E-mail: pip.enquiries@biogen.com", "first_published_date": "25/07/2017", "last_updated_date": "10/03/2023", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000832-pip01-10-m05" }, { "decision_number": "P/0060/2018", "pip_number": "EMEA-001064-PIP01-10-M03", "active_substance": "octocog alfa", "invented_name": "Iblias; Kovaltry; Iblias; Kovaltry", "therapeutic_area": "Haematology-Hemostaseology", "pharmaceutical_forms": "Powder and solvent for solution for injection", "condition_indication": "Treatment of hereditary factor VIII deficiency", "routes_of_administration": "Intravenous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "16/03/2018", "compliance_outcome": "Positive", "compliance_opinion_date": "23/07/2021", "compliance_procedure_number": "EMEA-C-001064-PIP01-10-M03", "contact_for_public_enquiries": "Bayer AG; E-mail: clinical-trials-contact@bayer.com; Tel. +49 30300139003", "first_published_date": "14/07/2011", "last_updated_date": "10/03/2023", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001064-pip01-10-m03" }, { "decision_number": "P/0346/2020", "pip_number": "EMEA-000883-PIP01-10-M05", "active_substance": "treosulfan", "invented_name": "Trecondi", "therapeutic_area": "Immunology-Rheumatology-Transplantation;Oncology", "pharmaceutical_forms": "Powder for solution", "condition_indication": "Conditioning treatment prior to haematopoietic-progenitor-cell transplantation", "routes_of_administration": "Intravenous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "09/09/2020", "compliance_outcome": "Positive", "compliance_opinion_date": "25/03/2022", "compliance_procedure_number": "EMEA-C-000883-PIP01-10-M05", "contact_for_public_enquiries": "medac Gesellschaft für klinische Spezialpräparate mbH; Germany; Tel. +49 (0) 401380060; E-mail: dra@medac.de", "first_published_date": "14/07/2011", "last_updated_date": "10/03/2023", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000883-pip01-10-m05" }, { "decision_number": "P/0013/2021", "pip_number": "EMEA-000980-PIP01-10-M07", "active_substance": "Brentuximab vedotin", "invented_name": "Adcetris", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Powder for concentrate for solution for infusion", "condition_indication": "Treatment of anaplastic large cell lymphoma;Treatment of Hodgkin lymphoma", "routes_of_administration": "Intravenous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "28/01/2021", "compliance_outcome": "Positive", "compliance_opinion_date": "25/06/2021", "compliance_procedure_number": "EMEA-C-000980-PIP01-10-M07", "contact_for_public_enquiries": "Takeda Pharma A/S; Tel.  +45(0) 46771111; E-mail: paediatrics@tgrd.com", "first_published_date": "07/01/2013", "last_updated_date": "10/03/2023", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000980-pip01-10-m07" }, { "decision_number": "P/0064/2021", "pip_number": "EMEA-000689-PIP01-09-M11", "active_substance": "exenatide", "invented_name": "Bydureon; Byetta", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Solution for injection;Powder and solvent for prolonged-release suspension for injection;Solution for injection in pre-filled injector", "condition_indication": "Treatment of type II diabetes mellitus", "routes_of_administration": "Subcutaneous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "18/02/2021", "compliance_outcome": "Positive", "compliance_opinion_date": "21/05/2021", "compliance_procedure_number": "EMEA-C-000689-PIP01-09-M11", "contact_for_public_enquiries": "AstraZeneca ABE-mail: paediatrics@astrazeneca.comTel. +46 8553 27591", "first_published_date": "17/10/2011", "last_updated_date": "10/03/2023", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000689-pip01-09-m11" }, { "decision_number": "P/0257/2021", "pip_number": "EMEA-001856-PIP02-16-M02", "active_substance": "peramivir", "invented_name": "Alpivab", "therapeutic_area": "Infectious diseases", "pharmaceutical_forms": "Concentrate for solution for infusion", "condition_indication": "Treatment of influenza", "routes_of_administration": "Intravenous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "07/07/2021", "compliance_outcome": "Positive", "compliance_opinion_date": "17/12/2021", "compliance_procedure_number": "EMEA-C-001856-PIP02-16-M02", "contact_for_public_enquiries": "BioCryst Ireland Limited; Tel. +1 9194505809; E-mail: pip.enquiries@biocryst.com", "first_published_date": "06/01/2017", "last_updated_date": "09/03/2023", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001856-pip02-16-m02" }, { "decision_number": "P/0070/2021", "pip_number": "EMEA-002727-PIP01-19-M01", "active_substance": "nivolumab;relatlimab", "invented_name": "", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Concentrate for solution for infusion", "condition_indication": "Treatment of melanoma", "routes_of_administration": "Intravenous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "17/03/2021", "compliance_outcome": "Positive", "compliance_opinion_date": "10/09/2021", "compliance_procedure_number": "EMEA-C-002727-PIP01-19-M01", "contact_for_public_enquiries": "Bristol-Myers Squibb International Corporation; E-mail: medical.information@bms.com; Tel. +44 1423 533 610", "first_published_date": "22/06/2021", "last_updated_date": "09/03/2023", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002727-pip01-19-m01" }, { "decision_number": "P/0329/2021", "pip_number": "EMEA-001501-PIP01-13-M07", "active_substance": "dupilumab", "invented_name": "Dupixent; 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Email: medinfo@biohavenpharma.com; Tel. +1 2034040410", "first_published_date": "07/03/2023", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002708-pip02-21" }, { "decision_number": "P/0548/2021", "pip_number": "EMEA-002730-PIP03-21", "active_substance": "autologous CD34+ hematopoietic stem cells with a CRISPR-edited erythroid enhancer region of the BCL11A gene", "invented_name": "", "therapeutic_area": "Haematology-Hemostaseology", "pharmaceutical_forms": "Dispersion for infusion", "condition_indication": "Treatment of sickle cell disease", "routes_of_administration": "Intravenous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "31/12/2021", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Vertex Pharmaceuticals (Ireland) LimitedE-mail: vertexmedicalinfo@vrtx.comTel: +353 17617299", "first_published_date": "07/03/2023", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002730-pip03-21" }, { "decision_number": "P/0563/2021", "pip_number": "EMEA-002506-PIP03-21", "active_substance": "human monoclonal antibody targeting Staphylococcus aureus alpha-toxin (tosatoxumab)", "invented_name": "", "therapeutic_area": "Infectious diseases;Pneumology-allergology", "pharmaceutical_forms": "Solution for infusion", "condition_indication": "Treatment of Staphylococcus aureus pneumonia", "routes_of_administration": "Intravenous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "31/12/2021", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Aridis Pharmaceuticals Inc; Email: mmscltd@gmail.com    ; Tel. +1 9252003089", "first_published_date": "07/03/2023", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002506-pip03-21" }, { "decision_number": "P/0538/2021", "pip_number": "EMEA-002597-PIP07-21", "active_substance": "efgartigimod alfa", "invented_name": "", "therapeutic_area": "Dermatology", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Treatment of pemphigus", "routes_of_administration": "Subcutaneous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "31/12/2021", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Argenx BVE-mail: regulatory@argenx.comTel: +32 93103400", "first_published_date": "07/03/2023", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002597-pip07-21" }, { "decision_number": "P/0482/2021", "pip_number": "EMEA-002270-PIP04-20", "active_substance": "Marzeptacog alfa (activated)", "invented_name": "", "therapeutic_area": "Haematology-Hemostaseology", "pharmaceutical_forms": "Powder for solution for injection", "condition_indication": "Treatment of Haemophilia B", "routes_of_administration": "Subcutaneous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "03/12/2021", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Catalyst Biosciences, Inc.; Email: cdemocko@catbio.com    ; Tel. +1 4153054942", "first_published_date": "06/03/2023", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002270-pip04-20" }, { "decision_number": "P/0481/2021", "pip_number": "EMEA-002270-PIP03-20", "active_substance": "Marzeptacog alfa (activated)", "invented_name": "", "therapeutic_area": "Haematology-Hemostaseology", "pharmaceutical_forms": "Powder for solution for injection", "condition_indication": "Treatment of Haemophilia A", "routes_of_administration": "Subcutaneous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "03/12/2021", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Catalyst Biosciences, Inc.; Email: cdemocko@catbio.com    ; Tel. +1 4153054942", "first_published_date": "06/03/2023", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002270-pip03-20" }, { "decision_number": "P/0499/2021", "pip_number": "EMEA-001525-PIP02-21", "active_substance": "human alpha1-proteinase inhibitor", "invented_name": "", "therapeutic_area": "Pneumology-allergology", "pharmaceutical_forms": "All pharmaceutical forms", "condition_indication": "Treatment of emphysema secondary to congenital deficiency of alpha-1 antitrypsin", "routes_of_administration": "All routes of administration", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "03/12/2021", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Kamada Ireland LimitedEmail: oritp@kamada.com    Tel: +972 89406472;  +972 522660030", "first_published_date": "02/03/2023", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001525-pip02-21" }, { "decision_number": "P/0560/2021", "pip_number": "EMEA-000380-PIP08-21", "active_substance": "secukinumab", "invented_name": "Cosentyx", "therapeutic_area": "Immunology-Rheumatology-Transplantation", "pharmaceutical_forms": "Powder for solution for injection;Solution for injection", "condition_indication": "Treatment of vasculitides", "routes_of_administration": "Subcutaneous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "03/12/2021", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Novartis Europharm LimitedE-mail: paediatric.enquiries@novartis.comTel. +41 613241111", "first_published_date": "02/03/2023", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000380-pip08-21" }, { "decision_number": "P/0497/2021", "pip_number": "EMEA-001214-PIP08-21", "active_substance": "Benralizumab", "invented_name": "Fasenra", "therapeutic_area": "Pneumology-allergology", "pharmaceutical_forms": "Age appropriate dosage form for parenteral use;Solution for injection", "condition_indication": "Treatment of non-cystic fibrosis bronchiectasis with an eosinophilic phenotype", "routes_of_administration": "Subcutaneous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "03/12/2021", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "AstraZeneca ABEmail: paediatrics@astrazeneca.comTel.  +46 855326000", "first_published_date": "02/03/2023", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001214-pip08-21" }, { "decision_number": "P/0544/2021", "pip_number": "EMEA-000095-PIP02-21", "active_substance": "plitidepsin", "invented_name": "", "therapeutic_area": "Infectious diseases", "pharmaceutical_forms": "Powder and solvent for concentrate for solution for infusion", "condition_indication": "Treatment of Coronavirus disease 2019 (COVID-19)", "routes_of_administration": "Intravenous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "03/12/2021", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Pharma Mar, S.A.; 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E-mail: regulatory@telethon.it; Tel: +39 06 440151", "first_published_date": "17/03/2017", "last_updated_date": "01/07/2022", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001933-pip01-16-m01" }, { "decision_number": "P/0134/2013", "pip_number": "EMEA-001301-PIP01-12", "active_substance": "Isavuconazonium sulfate", "invented_name": "", "therapeutic_area": "Infectious diseases", "pharmaceutical_forms": "Powder for solution for infusion;Capsule, hard", "condition_indication": "Treatment of Candida infections", "routes_of_administration": "Intravenous use;Oral use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "14/06/2013", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Basilea Medical Ltd; E-mail: medical.information@basilea.com; Tel. +41 616061400; Fax +41 616061216", "first_published_date": "23/07/2013", "last_updated_date": "29/06/2022", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001301-pip01-12" }, { "decision_number": "P/0202/2016", "pip_number": "EMEA-001540-PIP01-13-M01", "active_substance": "recombinant human beta-glucuronidase (rhGUS, UX003)", "invented_name": "", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Solution for injection/infusion", "condition_indication": "Treatment of Mucopolysaccharidosis type VII", "routes_of_administration": "Intravenous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "28/07/2016", "compliance_outcome": "Positive", "compliance_opinion_date": "11/12/2019", "compliance_procedure_number": "EMEA-C-001540-PIP01-13-M01", "contact_for_public_enquiries": "Ultragenyx Germany GmbH; E-mail: medinfo@ultragenyx.com; Tel. : +4930590083651", "first_published_date": "22/07/2014", "last_updated_date": "16/06/2022", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001540-pip01-13-m01" }, { "decision_number": "P/0268/2014", "pip_number": "EMEA-000802-PIP02-11-M01", "active_substance": "tabalumab", "invented_name": "", "therapeutic_area": "Immunology-Rheumatology-Transplantation", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Treatment of Systemic Lupus Erythematosus (SLE)", "routes_of_administration": "Subcutaneous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "27/10/2014", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Eli Lilly & Company Limited; E-mail: eu_paediatric@lilly.com ; Tel. +44 (0)1276 483000", "first_published_date": "25/06/2012", "last_updated_date": "14/06/2022", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000802-pip02-11-m01" }, { "decision_number": "P/20/2010", "pip_number": "EMEA-000635-PIP01-09", "active_substance": "expanded human autologous mesenchymal adult stem cells extracted from adipose tissue (CX-401)", "invented_name": "", "therapeutic_area": "Gastroentology-Hepatology", "pharmaceutical_forms": "Suspension for injection", "condition_indication": "Treatment of anal fistula of Crohn´s disease associated aetiology;Treatment of anal fistula of cryptoglandular aetiology (Non-Crohn);Treatment of non-inflammatory anal fistula", "routes_of_administration": "Intralesional use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "19/02/2010", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "TiGenix S.A.U.; E-mail: info@tigenix.com; Tel: +34 918049264; Fax:+34 918049263", "first_published_date": "19/04/2010", "last_updated_date": "14/06/2022", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000635-pip01-09" }, { "decision_number": "P/0168/2014", "pip_number": "EMEA-001097-PIP01-10-M02", "active_substance": "Insulin peglispro", "invented_name": "", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Treatment of type I diabetes mellitus;Treatment of type II diabetes mellitus", "routes_of_administration": "Subcutaneous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "08/07/2014", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Eli Lilly & Company Limited; E-mail: eu_paediatric@lilly.com ; Tel. +44 (0)1276 483000", "first_published_date": "25/06/2012", "last_updated_date": "14/06/2022", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001097-pip01-10-m02" }, { "decision_number": "P/0027/2015", "pip_number": "EMEA-001634-PIP01-14", "active_substance": "recombinant human heparan-N-sulfatase", "invented_name": "", "therapeutic_area": "Neurology", "pharmaceutical_forms": "Solution for injection/infusion", "condition_indication": "Treatment of mucopolysaccharidosis type IIIA (Sanfilippo A syndrome)", "routes_of_administration": "Intrathecal use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "30/01/2015", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Shire Human Genetic Therapies AB; Sweden; E-mail: medinfoeuceemea@shire.com; Tel. +80066838470; Fax +01 245 550 389", "first_published_date": "05/03/2015", "last_updated_date": "14/06/2022", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001634-pip01-14" }, { "decision_number": "P/0115/2014", "pip_number": "EMEA-000698-PIP02-10-M01", "active_substance": "Methyl aminolevulinate hydrochloride", "invented_name": "", "therapeutic_area": "Dermatology", "pharmaceutical_forms": "Cream", "condition_indication": "Treatment of acne vulgaris", "routes_of_administration": "Cutaneous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "06/05/2014", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Photocure AS; Norway; E-mail: info@photocur.no; Tel. +47 2206 2210; Fax +47 2206 2218", "first_published_date": "24/02/2012", "last_updated_date": "14/06/2022", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000698-pip02-10-m01" }, { "decision_number": "P/0012/2021", "pip_number": "EMEA-001748-PIP03-19", "active_substance": "arimoclomol citrate", "invented_name": "", "therapeutic_area": "Neurology", "pharmaceutical_forms": "Capsule, hard", "condition_indication": "Treatment of amyotrophic lateral sclerosis", "routes_of_administration": "Oral use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "28/01/2021", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Orphazyme A/S; Email: contact@orphazyme.com; Tel. +45 39178272", "first_published_date": "29/09/2021", "last_updated_date": "10/06/2022", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001748-pip03-19" }, { "decision_number": "P/0240/2013", "pip_number": "EMEA-001389-PIP01-12", "active_substance": "Deleobuvir", "invented_name": "", "therapeutic_area": "Infectious diseases", "pharmaceutical_forms": "Film-coated tablet;Oral solution", "condition_indication": "Treatment of chronic viral hepatitis C", "routes_of_administration": "Oral use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "24/09/2013", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Boehringer Ingelheim International GmbH; Tel. +49 6132 778271; Email: Paediatrics@boehringer-ingelheim.com", "first_published_date": "15/11/2013", "last_updated_date": "09/06/2022", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001389-pip01-12" }, { "decision_number": "P/0252/2017", "pip_number": "EMEA-001868-PIP03-16", "active_substance": "selonsertib", "invented_name": "", "therapeutic_area": "Gastroentology-Hepatology", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Treatment of non-alcoholic steatohepatitis (NASH)", "routes_of_administration": "Oral use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "04/09/2017", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Gilead Sciences International Ltd; Tel. +44 (0)1223 897300; E-mail: regulatory.pip@gilead.com", "first_published_date": "24/10/2017", "last_updated_date": "07/06/2022", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001868-pip03-16" }, { "decision_number": "P/0455/2021", "pip_number": "EMEA-002926-PIP01-20", "active_substance": "Glepaglutide", "invented_name": "", "therapeutic_area": "Gastroentology-Hepatology", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Treatment of short bowel syndrome", "routes_of_administration": "Subcutaneous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "29/10/2021", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Zealand Pharma A/S; Zealand Pharma A/S; Tel. +45 88 77 36 00; E-mail: info@zealandpharma.com", "first_published_date": "12/05/2022", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002926-pip01-20" }, { "decision_number": "P/0226/2021", "pip_number": "EMEA-001517-PIP02-14-M03", "active_substance": "sotagliflozin", "invented_name": "Zynquista", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Granules;Film-coated tablet", "condition_indication": "Treatment of type I diabetes mellitus", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "08/06/2021", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Guidehouse Germany GmbH; 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E-mail: pip.enquiries.eu@alexion.com; Tel: +33 147100615", "first_published_date": "26/04/2022", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001943-pip03-20-m01" }, { "decision_number": "P/0070/2018", "pip_number": "EMEA-001635-PIP03-17", "active_substance": "tanezumab", "invented_name": "", "therapeutic_area": "Pain", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Treatment of chronic musculoskeletal pain;Treatment of chronic pain (excluding musculoskeletal pain)", "routes_of_administration": "Subcutaneous use;Intravenous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "16/03/2018", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Pfizer Limited; Tel. + 44 1304646607; E-mail: pip_enquiries@pfizer.com", "first_published_date": "19/06/2018", "last_updated_date": "12/04/2022", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001635-pip03-17" }, { "decision_number": "P/0212/2021", "pip_number": "EMEA-002986-PIP01-21", "active_substance": "zorecimeran", "invented_name": "", "therapeutic_area": "Vaccines", "pharmaceutical_forms": "Concentrate and solvent for dispersion for injection", "condition_indication": "Prevention of Coronavirus disease 2019 (COVID-19)", "routes_of_administration": "Intramuscular use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "17/05/2021", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "CureVac AG; Tel.  +49 7071 9880-0; E-mail: info@curevac.com", "first_published_date": "17/06/2021", "last_updated_date": "11/04/2022", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002986-pip01-21" }, { "decision_number": "P/0357/2021", "pip_number": "EMEA-002117-PIP01-17-M02", "active_substance": "pevonedistat", "invented_name": "", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Concentrate for solution for infusion", "condition_indication": "Treatment of acute myeloid leukaemia;Treatment of myelodysplastic syndromes", "routes_of_administration": "Intravenous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "08/09/2021", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Takeda Pharma A/S; Tel.  +45(0) 46771111; E-mail: paediatrics@tgrd.com", "first_published_date": "19/06/2018", "last_updated_date": "25/03/2022", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002117-pip01-17-m02" }, { "decision_number": "P/0003/2019", "pip_number": "EMEA-001975-PIP01-16-M02", "active_substance": "Pimodivir", "invented_name": "", "therapeutic_area": "Infectious diseases", "pharmaceutical_forms": "Age appropriate oral solid dosage form", "condition_indication": "Treatment of influenza", "routes_of_administration": "Oral use;Gastric use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "03/01/2019", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Janssen-Cilag International NV; 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Tel. +49 151 44162443; E-mail: PIP.CSLBehring@cslbehring.com", "first_published_date": "20/03/2014", "last_updated_date": "21/03/2022", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001371-pip01-12" }, { "decision_number": "P/0207/2021", "pip_number": "EMEA-001879-PIP01-15-M03", "active_substance": "Birch pollen extract (Betula verrucosa)", "invented_name": "ITULAZAX", "therapeutic_area": "Pneumology-allergology", "pharmaceutical_forms": "Oral lyophilisate", "condition_indication": "Treatment of allergic rhinitis / rhino-conjunctivitis", "routes_of_administration": "Sublingual use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "10/05/2021", "compliance_outcome": "Positive", "compliance_opinion_date": "22/03/2024", "compliance_procedure_number": "EMEA-C-001879-PIP01-15-M03", "contact_for_public_enquiries": "ALK Abelló A/S; Tel. +45 4574 7576; E-mail: alkmrp@alk.net", "first_published_date": "10/01/2017", "last_updated_date": "17/02/2022", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001879-pip01-15-m03" }, { "decision_number": "P/0196/2021", "pip_number": "EMEA-001207-PIP01-11-M01", "active_substance": "obinutuzumab", "invented_name": "Gazyvaro", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Concentrate for solution for infusion", "condition_indication": "Treatment of acute lymphoblastic leukaemia;Treatment of mature B-cell lymphoma", "routes_of_administration": "Intravenous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "10/05/2021", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Roche Registration GmbHE-mail: global.eu_regulatory_office@roche.comTel. +49 7624142892", "first_published_date": "30/04/2013", "last_updated_date": "17/02/2022", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001207-pip01-11-m01" }, { "decision_number": "P/0189/2021", "pip_number": "EMEA-000142-PIP02-09-M11", "active_substance": "concentrate of proteolytic enzymes in bromelain", "invented_name": "NexoBrid", "therapeutic_area": "Other", "pharmaceutical_forms": "Powder and gel for gel", "condition_indication": "Treatment for burns", "routes_of_administration": "Cutaneous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "10/05/2021", "compliance_outcome": "Positive", "compliance_opinion_date": "18/10/2024", "compliance_procedure_number": "EMA/PE/0000182558", "contact_for_public_enquiries": "MediWound Germany GmbH; Tel. +972 779714168; E-mail: ayaby@mediwound.com", "first_published_date": "20/12/2010", "last_updated_date": "16/02/2022", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000142-pip02-09-m11" }, { "decision_number": "P/0208/2021", "pip_number": "EMEA-002959-PIP01-21", "active_substance": "sumatriptan;naproxen (sodium)", "invented_name": "", "therapeutic_area": "Neurology", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Treatment of migraine headaches", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "10/05/2021", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Orion Corporation; E-mail: orionra@orionpharma.com; Tel: +358 982564248", "first_published_date": "15/02/2022", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002959-pip01-21" }, { "decision_number": "P/0192/2021", "pip_number": "EMEA-002949-PIP01-20", "active_substance": "quavonlimab;pembrolizumab", "invented_name": "", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Concentrate for solution for infusion", "condition_indication": "Treatment of all conditions included in the category of malignant neoplasms (except nervous system, haematopoietic and lymphoid tissue neoplasms and melanoma);Treatment of malignant neoplasms of the central nervous system", "routes_of_administration": "Intravenous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "10/05/2021", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Merck, Sharp & Dohme (Europe) Inc.; 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Tel.  +44 1753777100; E-mail: UCBCares.UK@ucb.com", "first_published_date": "12/01/2022", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002189-pip03-19" }, { "decision_number": "P/130/2021", "pip_number": "EMEA-002066-PIP02-20", "active_substance": "talazoparib", "invented_name": "Talzenna", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Capsule, hard;Capsule, soft", "condition_indication": "Treatment of breast malignant neoplasms;Treatment of prostate malignant neoplasms", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "14/04/2021", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Pfizer Europe MA EEIG; Tel. +44 (0)1304 646 607; E-mail: pip_enquiries@pfizer.com", "first_published_date": "12/01/2022", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002066-pip02-20" }, { "decision_number": "P/150/2021", "pip_number": "EMEA-002187-PIP01-17", "active_substance": "pioglitazone hydrochloride;spironolactone metformin hydrochloride", "invented_name": "", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Treatment of polycystic ovary syndrome", "routes_of_administration": "Oral use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "16/04/2021", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Katholieke Universiteit Leuven (KUL) Research & Development; Tel.: +32 16 32 65 00; E-mail: lrd.ip@kuleuven.be", "first_published_date": "12/01/2022", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002187-pip01-17" }, { "decision_number": "P/0058/2020", "pip_number": "EMEA-002153-PIP01-17-M01", "active_substance": "fluticasone furoate;umeclidinium bromide;vilanterol trifenatate", "invented_name": "Trelegy Ellipta; Temybric Ellipta; Elebrato Ellipta", "therapeutic_area": "Pneumology-allergology", "pharmaceutical_forms": "Inhalation powder (pre-dispensed)", "condition_indication": "Treatment of asthma", "routes_of_administration": "Inhalation use", "decision_type": "RPM: decision refers to a refusal on the application for modification of an agreed PIP", "decision_date": "14/02/2020", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "GlaxoSmithKline Trading Services Limited; Tel. +1 438-899-8201; E-mail: eu.paediatric-plans@gsk.com", "first_published_date": "19/06/2018", "last_updated_date": "10/12/2021", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002153-pip01-17-m01" }, { "decision_number": "P/0363/2016", "pip_number": "EMEA-001780-PIP01-15", "active_substance": "Dipalmitoylphosphatidylcholine;1-palmitoyl-2-oleoyl-sn-glycero-3-phosphoglycerol sodium salt;synthetic surfactant protein C analogue;synthetic surfactant protein B analogue (CHF 5633)", "invented_name": "", "therapeutic_area": "Neonatology-Paediatric Intensive Care", "pharmaceutical_forms": "Endotracheopulmonary instillation;Suspension", "condition_indication": "Treatment of respiratory distress syndrome", "routes_of_administration": "Endotracheopulmonary use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "21/12/2016", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Chiesi Farmaceutici SpA; 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Tel. +1 4388998201; E-mail: eu.paediatric-plans@gsk.com", "first_published_date": "07/10/2013", "last_updated_date": "01/12/2021", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001359-pip01-12-m03" }, { "decision_number": "P/0055/2020", "pip_number": "EMEA-002515-PIP01-18", "active_substance": "human immunoglobulin G2 isotype antibody to IL-33R", "invented_name": "", "therapeutic_area": "Pneumology-allergology", "pharmaceutical_forms": "Powder for solution for injection", "condition_indication": "Treatment of asthma", "routes_of_administration": "Intravenous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "10/02/2020", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "GlaxoSmithKline Trading Services Limited; Tel. +1 438-899-8201; E-mail: eu.paediatric-plans@gsk.com", "first_published_date": "10/06/2020", "last_updated_date": "01/12/2021", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002515-pip01-18" }, { "decision_number": "P/0360/2016", "pip_number": "EMEA-001384-PIP01-12", "active_substance": "octenidine dihydrochloride", "invented_name": "", "therapeutic_area": "Neonatology-Paediatric Intensive Care", "pharmaceutical_forms": "Cutaneous solution", "condition_indication": "Skin disinfection", "routes_of_administration": "Cutaneous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "21/12/2016", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Schülke & Mayr GmbH; Germany; E-mail: mail@schuelke.com; Tel.: +49 40521000", "first_published_date": "30/01/2017", "last_updated_date": "29/11/2021", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001384-pip01-12" }, { "decision_number": "EMEA-000753-PIP02-16", "pip_number": "EMEA-000753-PIP02-16", "active_substance": "susoctocog alfa", "invented_name": "Obizur; Obizur", "therapeutic_area": "Haematology-Hemostaseology", "pharmaceutical_forms": "Powder and solvent for solution for injection", "condition_indication": "Treatment of congenital haemophilia A with antibodies (inhibitors) to human factor VIII", "routes_of_administration": "Intravenous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "19/12/2017", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Baxalta Innovations GmbHE-mail: medinfoEMEA@takeda.comTel. +44 (0)3333 000181", "first_published_date": "05/03/2018", "last_updated_date": "29/11/2021", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000753-pip02-16" }, { "decision_number": "P/0148/2020", "pip_number": "EMEA-002333-PIP02-19", "active_substance": "2-[[2-ethyl-6-[4-[2-(3-hydroxyazetidin-1-yl)-2-oxoethyl]piperazin-1-yl]-8-methylimidazo[1,2-a]pyridin-3-yl](methyl)amino]-4-(4-fluorophenyl)-1,3-thiazole-5-carbonitrile", "invented_name": "", "therapeutic_area": "Pneumology-allergology", "pharmaceutical_forms": "Film-coated tablet;Age appropriate formulation", "condition_indication": "Treatment of interstitial pulmonary diseases with fibrosis", "routes_of_administration": "Oral use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "18/04/2020", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Galapagos NV; Tel. +32 15342900; E-mail: medicalinfo@glpg.com", "first_published_date": "03/03/2021", "last_updated_date": "29/11/2021", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002333-pip02-19" }, { "decision_number": "P/108/2009", "pip_number": "Carisbamate", "active_substance": "carisbamate", "invented_name": "", "therapeutic_area": "Neurology", "pharmaceutical_forms": "Film-coated tablet;Oral suspension;Intravenous formulation", "condition_indication": "Infantile spasms (West Syndrome);Lennox-Gastaut Syndrome;Localization-related (focal)(partial) symptomatic epilepsy and epileptic syndromes with simple partial seizures;Neonatal seizures;Other paediatric epilepsy syndromes such as Dravet Syndrome, myoclonic astatic syndrome, epilepsy with continuous sharp-waves in sleep, idiopathic partial epilepsy, absence epilepsy", "routes_of_administration": "Oral use;Intravenous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "09/06/2009", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Janssen Cilag International NV (Belgium); E-mail: bbyl@its.jnj.com; Country: Belgium; Phone: +32 14607172; Fax: +3214606377", "first_published_date": "11/08/2009", "last_updated_date": "22/11/2021", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/carisbamate" }, { "decision_number": "P/0097/2021", "pip_number": "EMEA-002824-PIP01-20", "active_substance": "telitacicept", "invented_name": "", "therapeutic_area": "Immunology-Rheumatology-Transplantation", "pharmaceutical_forms": "Powder for solution for injection", "condition_indication": "Treatment of Systemic Lupus Erythematosus (SLE)", "routes_of_administration": "Subcutaneous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "19/03/2021", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "RemeGen, Ltd.; E-mail: long.cheng@remegen.cn; Tel: +86 18663830001", "first_published_date": "19/11/2021", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002824-pip01-20" }, { "decision_number": "P/0090/2021", "pip_number": "EMEA-002586-PIP01-19-M01", "active_substance": "bintrafusp alfa", "invented_name": "", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Concentrate for solution for infusion", "condition_indication": "Treatment of all conditions included in the category of malignant neoplasms (except central nervous system tumours, haematopoietic and lymphoid tissue neoplasms)", "routes_of_administration": "Intravenous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "17/03/2021", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Merck Europe B.V.; 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E-mail: medinfo@neurocrine.com; Tel. +01 8776 413461", "first_published_date": "05/11/2021", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002700-pip01-19" }, { "decision_number": "P/0122/2021", "pip_number": "EMEA-002016-PIP04-20", "active_substance": "alpelisib", "invented_name": "Piqray", "therapeutic_area": "Oncology", "pharmaceutical_forms": "All pharmaceutical forms", "condition_indication": "Treatment of Fallopian tube carcinoma (excluding rhabdomyosarcoma and germ cell tumours);Treatment of ovarian carcinoma (excluding rhabdomyosarcoma and germ cell tumours);Treatment of peritoneal carcinoma (excluding blastomas and sarcomas)", "routes_of_administration": "All routes of administration", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "17/03/2021", "compliance_outcome": "Positive", "compliance_opinion_date": "20/09/2019", "compliance_procedure_number": "", "contact_for_public_enquiries": "Novartis Europharm Limited; 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Humenza", "therapeutic_area": "Vaccines", "pharmaceutical_forms": "Suspension and emulsion for injection", "condition_indication": "Prevention of influenza", "routes_of_administration": "Intramuscular use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "04/01/2019", "compliance_outcome": "Positive", "compliance_opinion_date": "26/04/2019", "compliance_procedure_number": "EMEA-C-000669-PIP01-09-M02", "contact_for_public_enquiries": "Sanofi Pasteur SA; E-mail: Piplan@sanofipasteur.com; Country: France; Phone: +33 437375038", "first_published_date": "18/05/2010", "last_updated_date": "21/09/2021", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000669-pip01-09-m02" }, { "decision_number": "P/0401/2018", "pip_number": "EMEA-000055-PIP01-07-M06", "active_substance": "rabeprazole (sodium)", "invented_name": "Pariet and associated names", "therapeutic_area": "Gastroentology-Hepatology", "pharmaceutical_forms": "Gastro-resistant granules;Gastro-resistant tablet", "condition_indication": "Treatment of duodenal ulcer;Treatment of gastric ulcer;Treatment of gastro-oesophageal reflux disease;Treatment of Helicobacter pylori in patients with peptic ulcer disease;Treatment of Zollinger-Ellison syndrome", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "03/12/2018", "compliance_outcome": "Positive", "compliance_opinion_date": "01/02/2019", "compliance_procedure_number": "EMEA-C-000055-PIP01-07-M06", "contact_for_public_enquiries": "Eisai Limited; E-mail: eumedinfo@eisai.net; Tel.: +44 845 6765400", "first_published_date": "20/04/2012", "last_updated_date": "21/09/2021", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000055-pip01-07-m06" }, { "decision_number": "P/0159/2018", "pip_number": "EMEA-000548-PIP01-09-M08", "active_substance": "beclometasone dipropionate;formoterol fumarate dihydrate", "invented_name": "Foster and associated names; Kantos and associated names; Kantos Master and associated names; Inuvair and associated names", "therapeutic_area": "Pneumology-allergology", "pharmaceutical_forms": "Inhalation powder;Pressurised inhalation (solution)", "condition_indication": "Treatment of asthma", "routes_of_administration": "Inhalation use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "15/06/2018", "compliance_outcome": "Positive", "compliance_opinion_date": "26/04/2019", "compliance_procedure_number": "EMEA-C-000548-PIP01-09-M08", "contact_for_public_enquiries": "Chiesi Farmaceutici S.p.A.; Tel. +39 0521 2791; E-mail: info@chiesi.com", "first_published_date": "15/09/2011", "last_updated_date": "21/09/2021", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000548-pip01-09-m08" }, { "decision_number": "P/0053/2017", "pip_number": "EMEA-000469-PIP01-08-M07", "active_substance": "anidulafungin", "invented_name": "Ecalta; Ecalta", "therapeutic_area": "Infectious diseases", "pharmaceutical_forms": "Powder for concentrate for solution for infusion", "condition_indication": "Treatment of invasive candidiasis", "routes_of_administration": "Intravenous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "17/03/2017", "compliance_outcome": "Positive", "compliance_opinion_date": "26/04/2019", "compliance_procedure_number": "EMEA-C-000469-PIP01-08-M07", "contact_for_public_enquiries": "Pfizer Limited; Tel. + 44 1304646607; E-mail: pip_enquiries@pfizer.com", "first_published_date": "12/05/2011", "last_updated_date": "21/09/2021", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000469-pip01-08-m07" }, { "decision_number": "P/0343/2018", "pip_number": "EMEA-000367-PIP01-08-M08", "active_substance": "Conestat alfa", "invented_name": "Ruconest; Ruconest", "therapeutic_area": "Other", "pharmaceutical_forms": "Powder for solution for injection;Powder and solvent for solution for injection", "condition_indication": "Treatment of hereditary angioedema", "routes_of_administration": "Intravenous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "08/11/2018", "compliance_outcome": "Positive", "compliance_opinion_date": "01/03/2019", "compliance_procedure_number": "EMEA-C-000367-PIP01-08-M08", "contact_for_public_enquiries": "Pharming Group N.V.; Tel. +31 715247400; E-mail: info@pharming.com", "first_published_date": "16/09/2009", "last_updated_date": "21/09/2021", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000367-pip01-08-m08" }, { "decision_number": "P/0172/2018", "pip_number": "EMEA-001276-PIP01-12-M02", "active_substance": "sofosbuvir", "invented_name": "Sovaldi; Sovaldi", "therapeutic_area": "Infectious diseases", "pharmaceutical_forms": "Film-coated tablet;Age appropriate oral solid dosage form;Other", "condition_indication": "Treatment of chronic hepatitis C", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "15/06/2018", "compliance_outcome": "Positive", "compliance_opinion_date": "26/04/2019", "compliance_procedure_number": "EMEA-C-001276-PIP01-12-M02", "contact_for_public_enquiries": "Gilead Sciences International Ltd; E-mail: regulatory.pip@gilead.com; Tel. +44 (0)1223 897300", "first_published_date": "08/02/2013", "last_updated_date": "21/09/2021", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001276-pip01-12-m02" }, { "decision_number": "P/0089/2015", "pip_number": "EMEA-000429-PIP01-08-M04", "active_substance": "Neisseria meningitidis group A polysaccharide conjugated to tetanus toxoid;Neisseria meningitidis group C polysaccharide conjugated to tetanus toxoid;Neisseria meningitidis group W polysaccharide conjugated to tetanus toxoid;N. meningitidis serogroup Y polysaccharide conjugated to tetanus toxoid", "invented_name": "Nimenrix; Nimenrix", "therapeutic_area": "Vaccines", "pharmaceutical_forms": "Powder and solvent for solution for injection", "condition_indication": "Prevention of Meningococcal disease", "routes_of_administration": "Intramuscular use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "08/05/2015", "compliance_outcome": "Positive", "compliance_opinion_date": "26/04/2019", "compliance_procedure_number": "EMEA-C-000429-PIP01-08-M04", "contact_for_public_enquiries": "GlaxoSmithKline Biologicals SA; Tel. +44 (0)20 8966 3220; E-mail: eu.paediatric-plans@gsk.com", "first_published_date": "21/12/2011", "last_updated_date": "21/09/2021", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000429-pip01-08-m04" }, { "decision_number": "P/0064/2019", "pip_number": "EMEA-000308-PIP01-08-M04", "active_substance": "rituximab", "invented_name": "MabThera; MabThera", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Concentrate for solution for infusion;Solution for injection", "condition_indication": "Treatment of autoimmune arthritis;Treatment of diffuse large B-cell lymphoma", "routes_of_administration": "Intravenous use;Subcutaneous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "22/03/2019", "compliance_outcome": "Positive", "compliance_opinion_date": "29/05/2019", "compliance_procedure_number": "EMEA-C-000308-PIP01-08-M04", "contact_for_public_enquiries": "Roche Registration GmbHE-mail: global.paediatrics@roche.comTel. +41 6169 79411", "first_published_date": "17/10/2011", "last_updated_date": "21/09/2021", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000308-pip01-08-m04" }, { "decision_number": "P/0003/2016", "pip_number": "EMEA-000311-PIP01-08-M04", "active_substance": "ustekinumab", "invented_name": "Stelara; Stelara", "therapeutic_area": "Immunology-Rheumatology-Transplantation", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Treatment of chronic plaque psoriasis", "routes_of_administration": "Subcutaneous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "15/01/2016", "compliance_outcome": "Positive", "compliance_opinion_date": "29/05/2019", "compliance_procedure_number": "EMEA-C-000311-PIP01-08-M04", "contact_for_public_enquiries": "Janssen-Cilag International NV; Belgium; E-mail: mojanen@its.jnj.com; Tel. +34 917228079", "first_published_date": "29/10/2010", "last_updated_date": "21/09/2021", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000311-pip01-08-m04" }, { "decision_number": "P/0149/2016", "pip_number": "EMEA-001114-PIP01-10-M03", "active_substance": "efmoroctocog alfa", "invented_name": "Elocta", "therapeutic_area": "Haematology-Hemostaseology", "pharmaceutical_forms": "Powder and solvent for solution for injection", "condition_indication": "Treatment of hereditary factor-VIII deficiency", "routes_of_administration": "Intravenous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "14/06/2016", "compliance_outcome": "Positive", "compliance_opinion_date": "29/05/2019", "compliance_procedure_number": "EMEA-C-001114-PIP01-10-M03", "contact_for_public_enquiries": "Biogen Idec LtdTel. +44 (0) 16285 12609 / 44 (0)7557057823E-mail: amit.patel@biogen.cpm", "first_published_date": "09/08/2011", "last_updated_date": "21/09/2021", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001114-pip01-10-m03" }, { "decision_number": "P/0143/2018", "pip_number": "EMEA-000298-PIP01-08-M06", "active_substance": "peginterferon alfa-2a", "invented_name": "Pegasys; Pegasys", "therapeutic_area": "Infectious diseases", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Treatment of chronic hepatitis B;Treatment of chronic hepatitis C", "routes_of_administration": "Subcutaneous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "07/05/2018", "compliance_outcome": "Positive", "compliance_opinion_date": "29/05/2019", "compliance_procedure_number": "EMEA-C-000298-PIP01-08-M06", "contact_for_public_enquiries": "Roche Registration GmbHE-mail: global.paediatrics@roche.comTel. +41 6169 79411", "first_published_date": "21/12/2011", "last_updated_date": "21/09/2021", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000298-pip01-08-m06" }, { "decision_number": "P/0126/2019", "pip_number": "EMEA-000430-PIP01-08-M11", "active_substance": "rivaroxaban", "invented_name": "Xarelto", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Oral suspension;Film-coated tablet", "condition_indication": "Prevention of thromboembolic events;Treatment of thromboembolic events", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "17/04/2019", "compliance_outcome": "Positive", "compliance_opinion_date": "20/09/2019", "compliance_procedure_number": "EMEA-C-000430-PIP01-08-M11", "contact_for_public_enquiries": "Bayer Pharma AG; Tel. +49 3046 815333; E-mail: pediatrics.medical-affairs-europe@bayer.com", "first_published_date": "25/07/2017", "last_updated_date": "21/09/2021", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000430-pip01-08-m11" }, { "decision_number": "P/0399/2018", "pip_number": "EMEA-000081-PIP01-07-M11", "active_substance": "dabigatran etexilate mesilate", "invented_name": "Pradaxa; Pradaxa", "therapeutic_area": "Cardiovascular diseases;Haematology-Hemostaseology", "pharmaceutical_forms": "Capsule, hard;Age appropriate dosage form, other", "condition_indication": "Prevention of thromboembolic events;Treatment of thromboembolic events", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "07/12/2018", "compliance_outcome": "Positive", "compliance_opinion_date": "23/08/2019", "compliance_procedure_number": "EMEA-C-000081-PIP01-07-M11", "contact_for_public_enquiries": "", "first_published_date": "10/08/2011", "last_updated_date": "21/09/2021", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000081-pip01-07-m11" }, { "decision_number": "P/0221/2019", "pip_number": "EMEA-001259-PIP02-13-M02", "active_substance": "terbinafine hydrochloride", "invented_name": "", "therapeutic_area": "Dermatology", "pharmaceutical_forms": "Medicated nail lacquer", "condition_indication": "Treatment of onychomycosis", "routes_of_administration": "Topical use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "17/06/2019", "compliance_outcome": "Positive", "compliance_opinion_date": "26/07/2019", "compliance_procedure_number": "EMEA-C-001259-PIP02-13-M02", "contact_for_public_enquiries": "Polichem S.A. (Spain); Tel.: +34 932913512; E-mail: anna.pares@almirall.com", "first_published_date": "09/08/2013", "last_updated_date": "21/09/2021", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001259-pip02-13-m02" }, { "decision_number": "P/0294/2018", "pip_number": "EMEA-001157-PIP01-11-M02", "active_substance": "Caplacizumab", "invented_name": "", "therapeutic_area": "Haematology-Hemostaseology", "pharmaceutical_forms": "Powder and solvent for solution for injection", "condition_indication": "Treatment of thrombotic thrombocytopenic purpura (TTP)", "routes_of_administration": "Subcutaneous use;Intravenous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "12/09/2018", "compliance_outcome": "Positive", "compliance_opinion_date": "23/08/2019", "compliance_procedure_number": "EMEA-C-001157-PIP01-11-M02", "contact_for_public_enquiries": "Ablynx NV; E-mail: bernard.delaey@ablynx.com; Tel. +32 2620 000", "first_published_date": "19/04/2012", "last_updated_date": "21/09/2021", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001157-pip01-11-m02" }, { "decision_number": "P/0196/2018", "pip_number": "EMEA-001061-PIP01-10-M03", "active_substance": "sucroferric oxyhydroxide", "invented_name": "Velphoro; Velphoro", "therapeutic_area": "Uro-nephrology", "pharmaceutical_forms": "Powder for oral suspension;Chewable tablet", "condition_indication": "Treatment of hyperphosphataemia", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "17/07/2018", "compliance_outcome": "Positive", "compliance_opinion_date": "20/09/2019", "compliance_procedure_number": "EMEA-C-001061-PIP01-10-M03", "contact_for_public_enquiries": "Vifor Fresenius Medical Care Renal Pharma France; E-mail: info@viforpharma.com ; Tel. +41 5885 18000", "first_published_date": "21/12/2011", "last_updated_date": "21/09/2021", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001061-pip01-10-m03" }, { "decision_number": "P/0207/2019", "pip_number": "EMEA-001638-PIP01-14-M02", "active_substance": "atezolizumab", "invented_name": "Tecentriq", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Concentrate for solution for infusion", "condition_indication": "Treatment of all conditions included in the category of malignant neoplasms (except central nervous system tumours, haematopoietic and lymphoid tissue neoplasms)", "routes_of_administration": "Intravenous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "12/06/2019", "compliance_outcome": "Positive", "compliance_opinion_date": "20/09/2019", "compliance_procedure_number": "EMEA-C-001638-PIP01-14-M02", "contact_for_public_enquiries": "Roche Registration GmbHE-mail: global.paediatrics@roche.comTel. +41 6169 79411", "first_published_date": "07/05/2015", "last_updated_date": "21/09/2021", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001638-pip01-14-m02" }, { "decision_number": "P/0139/2018", "pip_number": "EMEA-001577-PIP03-17", "active_substance": "emtricitabine;tenofovir alafenamide", "invented_name": "Descovy; Descovy", "therapeutic_area": "Infectious diseases", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Prevention of human immunodeficiency virus (HIV-1) infection", "routes_of_administration": "Oral use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "07/05/2018", "compliance_outcome": "Positive", "compliance_opinion_date": "20/09/2019", "compliance_procedure_number": "EMEA-C-001577-PIP03-17", "contact_for_public_enquiries": "Gilead Sciences International Ltd; E-mail: regulatory.pip@gilead.com; Tel. +44 (0)1223 897300", "first_published_date": "27/11/2018", "last_updated_date": "21/09/2021", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001577-pip03-17" }, { "decision_number": "P/0234/2017", "pip_number": "EMEA-000555-PIP01-09-M06", "active_substance": "decitabine", "invented_name": "Dacogen; Dacogen", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Powder for solution for infusion", "condition_indication": "Treatment of acute myeloid leukaemia", "routes_of_administration": "Intravenous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "09/08/2017", "compliance_outcome": "Positive", "compliance_opinion_date": "18/10/2019", "compliance_procedure_number": "EMEA-C-000555-PIP01-09-M06", "contact_for_public_enquiries": "Janssen-Cilag International NV; Ireland; Tel. +353 857446696; E-mail: nbuhl@its.jnj.com;  ", "first_published_date": "26/04/2012", "last_updated_date": "21/09/2021", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000555-pip01-09-m06" }, { "decision_number": "P/0176/2019", "pip_number": "EMEA-000987-PIP01-10-M04", "active_substance": "asfotase alfa", "invented_name": "Strensiq", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Treatment of hypophosphatasia", "routes_of_administration": "Subcutaneous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "15/05/2019", "compliance_outcome": "Positive", "compliance_opinion_date": "18/10/2019", "compliance_procedure_number": "EMEA-C-000987-PIP01-10-M04", "contact_for_public_enquiries": "Alexion Europe SAS; Tel. +33 153643800; E-mail: pip.enquiries.eu@alexion.com", "first_published_date": "02/05/2013", "last_updated_date": "21/09/2021", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000987-pip01-10-m04" }, { "decision_number": "P/0016/2019", "pip_number": "EMEA-000671-PIP01-09-M10", "active_substance": "sildenafil", "invented_name": "Revatio; Revatio", "therapeutic_area": "Other", "pharmaceutical_forms": "Film-coated tablet;Powder for oral solution;Solution for injection", "condition_indication": "Treatment of pulmonary arterial hypertension", "routes_of_administration": "Oral use;Intravenous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "03/01/2019", "compliance_outcome": "Positive", "compliance_opinion_date": "20/09/2019", "compliance_procedure_number": "EMEA-C-000671-PIP01-09-M10", "contact_for_public_enquiries": "Pfizer Europe MA EEIG; Tel. +44 (0)1304 646 607; E-mail: pip_enquiries@pfizer.com", "first_published_date": "07/06/2011", "last_updated_date": "21/09/2021", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000671-pip01-09-m10" }, { "decision_number": "P/0359/2019", "pip_number": "EMEA-001230-PIP01-11-M05", "active_substance": "Lurasidone hydrochloride", "invented_name": "Latuda; Latuda", "therapeutic_area": "Psychiatry", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Treatment of schizophrenia", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "04/11/2019", "compliance_outcome": "Positive", "compliance_opinion_date": "11/12/2019", "compliance_procedure_number": "EMEA-C-001230-PIP01-11-M05", "contact_for_public_enquiries": "AZIENDE CHIMICHE RIUNITE ANGELINI FRANCESCO - A.C.R.A.F. S.p.A.; Tel. +3906780531; E-mail: angeliniregulatoryaffairs@angelinipharma.com", "first_published_date": "22/08/2012", "last_updated_date": "21/09/2021", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001230-pip01-11-m05" }, { "decision_number": "P/0269/2019", "pip_number": "EMEA-001514-PIP01-13-M01", "active_substance": "octenidine dihydrochloride", "invented_name": "Laryngomedin Octenidin Antisept and associated names", "therapeutic_area": "Oto-rhino-laryngology", "pharmaceutical_forms": "Lozenge", "condition_indication": "Treatment of upper respiratory tract infections", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "14/08/2019", "compliance_outcome": "Positive", "compliance_opinion_date": "11/12/2019", "compliance_procedure_number": "EMEA-C-001514-PIP01-13-M01", "contact_for_public_enquiries": "Cassella-med GmbH & Co. KG; Tel. +49 221165200; E-mail: pediatrics@cassella-med.de; regulatory@Klosterfrau-Group.de", "first_published_date": "25/04/2016", "last_updated_date": "21/09/2021", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001514-pip01-13-m01" }, { "decision_number": "P/0128/2019", "pip_number": "EMEA-001832-PIP01-15-M02", "active_substance": "glecaprevir;pibrentasvir", "invented_name": "Maviret", "therapeutic_area": "Infectious diseases", "pharmaceutical_forms": "Tablet;Age appropriate oral solid dosage form", "condition_indication": "Treatment of chronic hepatitis C", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "17/04/2019", "compliance_outcome": "Positive", "compliance_opinion_date": "11/12/2019", "compliance_procedure_number": "EMEA-C-001832-PIP01-15-M02", "contact_for_public_enquiries": "AbbVie LtdE-mail: paediatricteam@abbvie.comTel. +44(0) 1628925033", "first_published_date": "26/08/2016", "last_updated_date": "21/09/2021", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001832-pip01-15-m02" }, { "decision_number": "P/0368/2019", "pip_number": "EMEA-002147-PIP02-17-M01", "active_substance": "sodium thiosulfate", "invented_name": "", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Solution for infusion", "condition_indication": "Prevention of platinum-induced ototoxic hearing loss", "routes_of_administration": "Intravenous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "08/11/2019", "compliance_outcome": "Positive", "compliance_opinion_date": "11/12/2019", "compliance_procedure_number": "EMEA-C-002147-PIP02-17-M01", "contact_for_public_enquiries": "Fennec Pharmaceuticals, Inc.; E-mail: info@s-cubed.co.uk; Tel. +44 1235772260", "first_published_date": "28/01/2019", "last_updated_date": "21/09/2021", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002147-pip02-17-m01" }, { "decision_number": "P/0299/2019", "pip_number": "EMEA-000160-PIP01-07-M05", "active_substance": "purified antigen fractions of inactivated split virion Influenza A/Vietnam/1194/2004 (H5N1) like strain used (NIBRG-14);purified antigen fractions of inactivated split virion Influenza A/Indonesia/05/2005 (H5N1) like strain used (PR8-IBCDC-RG2)", "invented_name": "Prepandrix; Adjupanrix", "therapeutic_area": "Vaccines", "pharmaceutical_forms": "Emulsion and suspension for emulsion for injection", "condition_indication": "Prevention of influenza infection", "routes_of_administration": "Intramuscular use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "14/08/2019", "compliance_outcome": "Positive", "compliance_opinion_date": "31/01/2020", "compliance_procedure_number": "EMEA-C-000160-PIP01-07-M05", "contact_for_public_enquiries": "GlaxoSmithKline Biologicals S.A.; E-mail: eu.paediatric-plans@gsk.com; Tel.: +1 438 899 8201", "first_published_date": "10/06/2009", "last_updated_date": "21/09/2021", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000160-pip01-07-m05" }, { "decision_number": "P/0358/2019", "pip_number": "EMEA-000470-PIP01-08-M11", "active_substance": "sitagliptin", "invented_name": "Januvia", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Treatment of type II diabetes mellitus", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "04/10/2019", "compliance_outcome": "Positive", "compliance_opinion_date": "28/02/2020", "compliance_procedure_number": "EMEA-C-000470-PIP01-08-M11", "contact_for_public_enquiries": "Merck Sharp and Dohme (Europe), Inc.; Tel. +44 (0)1992 452396; E-mail: paul.robinson@merck.com;  ", "first_published_date": "14/07/2011", "last_updated_date": "21/09/2021", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000470-pip01-08-m11" }, { "decision_number": "P/0300/2018", "pip_number": "EMEA-000069-PIP04-13-M02", "active_substance": "Mepolizumab", "invented_name": "Nucala", "therapeutic_area": "Pneumology-allergology", "pharmaceutical_forms": "Powder for solution for injection or infusion;Solution for injection", "condition_indication": "Treatment of vasculitides", "routes_of_administration": "Subcutaneous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "12/09/2018", "compliance_outcome": "Positive", "compliance_opinion_date": "28/02/2020", "compliance_procedure_number": "EMEA-C-000069-PIP04-13-M02", "contact_for_public_enquiries": "GSK Trading Services Limited; Tel. +1 4388998201; E-mail: eu.paediatric-plans@gsk.com", "first_published_date": "23/02/2015", "last_updated_date": "21/09/2021", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000069-pip04-13-m02" }, { "decision_number": "P/0363/2019", "pip_number": "EMEA-000245-PIP01-08-M06", "active_substance": "Lubiprostone", "invented_name": "Amitiza", "therapeutic_area": "Gastroentology-Hepatology", "pharmaceutical_forms": "Capsule, soft", "condition_indication": "Treatment of constipation", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "04/11/2019", "compliance_outcome": "Positive", "compliance_opinion_date": "28/02/2020", "compliance_procedure_number": "EMEA-C-000245-PIP01-08-M06", "contact_for_public_enquiries": "Sucampo AG; E-mail: medinfo@mnk.com; Tel.  +800 55444777", "first_published_date": "12/05/2011", "last_updated_date": "21/09/2021", "pip_url": 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420305", "first_published_date": "29/10/2010", "last_updated_date": "21/09/2021", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000653-pip01-09-m05" }, { "decision_number": "P/0470/2020", "pip_number": "EMEA-002849-PIP01-20", "active_substance": "amlodipine besilate;Indapamide;perindopril arginine", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Tablet", "condition_indication": "Treatment of hypertension", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "04/12/2020", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Teva B.V. Email: MedAffGenTevaEurope@tevapharm.com Tel. +385 13722001", "first_published_date": "20/09/2021", "last_updated_date": "", "pip_url": 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"pip_number": "EMEA-002843-PIP02-20", "active_substance": "2-(6-azaspiro[2.5]octan-6-yl)-N-[2-(4,4-difluoropiperidin-1-yl)-6-methylpyrimidin-4-yl]- 4-[(2- hydroxyethanesulfonyl)amino]benzamide hydrochloride", "invented_name": "", "therapeutic_area": "Haematology-Hemostaseology;Oncology", "pharmaceutical_forms": "Tablet", "condition_indication": "Treatment of breast cancer", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "01/12/2020", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Amgen Europe BV; E-mail: medinfointernational@amgen.com; Tel. +44 (0)1223 420305", "first_published_date": "20/09/2021", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002843-pip02-20" }, { "decision_number": "P/0448/2020", "pip_number": 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cardiovascular events in patients with atherosclerosis", "routes_of_administration": "Subcutaneous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "22/12/2020", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Novo Nordisk A/S; E-mail: paediatrics@novonordisk.com ; Tel.: +45 44444848", "first_published_date": "20/09/2021", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002840-pip01-20" }, { "decision_number": "P/0501/2020", "pip_number": "EMEA-002759-PIP01-19", "active_substance": "olinciguat", "invented_name": "", "therapeutic_area": "Haematology-Hemostaseology", "pharmaceutical_forms": "Tablet;Age appropriate oral solid dosage form", "condition_indication": "Treatment of sickle cell disease", "routes_of_administration": "Oral use", "decision_type": "P: decision 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"https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000694-pip06-20" }, { "decision_number": "P/0028/2020", "pip_number": "EMEA-000057-PIP01-07-M07", "active_substance": "zoledronic acid", "invented_name": "Aclasta", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Solution for infusion", "condition_indication": "Treatment of osteoporosis;Treatment of Paget’s disease of the bone", "routes_of_administration": "Intravenous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "17/01/2020", "compliance_outcome": "Positive", "compliance_opinion_date": "30/04/2020", "compliance_procedure_number": "EMEA-C-000057-PIP01-07-M07", "contact_for_public_enquiries": "Novartis Europharm LimitedE-mail: paediatric.enquiries@novartis.comTel. +41 613241111", "first_published_date": "07/10/2010", "last_updated_date": "16/09/2021", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000057-pip01-07-m07" }, { "decision_number": "P/0174/2019", "pip_number": "EMEA-000366-PIP02-09-M06", "active_substance": "adalimumab", "invented_name": "Humira", "therapeutic_area": "Gastroentology-Hepatology", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Treatment of ulcerative colitis", "routes_of_administration": "Subcutaneous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "15/05/2019", "compliance_outcome": "Positive", "compliance_opinion_date": "30/04/2020", "compliance_procedure_number": "EMEA-C-000366-PIP02-09-M06", "contact_for_public_enquiries": "AbbVie LtdE-mail: paediatricteam@abbvie.comTel. +44(0) 1628925033", "first_published_date": "08/03/2011", "last_updated_date": "16/09/2021", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000366-pip02-09-m06" }, { "decision_number": "P/0034/2020", "pip_number": "EMEA-001019-PIP01-10-M05", "active_substance": "lipegfilgrastim", "invented_name": "Lonquex", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Prevention of chemotherapy-induced febrile neutropenia;Treatment of chemotherapy-induced neutropenia", "routes_of_administration": "Subcutaneous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "29/01/2020", "compliance_outcome": "Positive", "compliance_opinion_date": "30/04/2020", "compliance_procedure_number": "EMEA-C-001019-PIP01-10-M05", "contact_for_public_enquiries": "UAB \"Sicor Biotech\"; Tel. +44 (0)20 7540 7117; E-mail: med.info@tevapharm.com", "first_published_date": "09/06/2011", "last_updated_date": "16/09/2021", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001019-pip01-10-m05" }, { "decision_number": "P/0065/2020", "pip_number": "EMEA-001545-PIP01-13-M02", "active_substance": "live, attenuated, chimeric dengue virus, serotype 1;live, attenuated, chimeric dengue virus, serotype 2;live, attenuated, chimeric dengue virus, serotype 3;live, attenuated, chimeric dengue virus, serotype 4", "invented_name": "Dengvaxia", "therapeutic_area": "Vaccines", "pharmaceutical_forms": "Powder and solvent for suspension for injection", "condition_indication": "Prevention of dengue fever", "routes_of_administration": "Subcutaneous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "21/02/2020", "compliance_outcome": "Positive", "compliance_opinion_date": "29/05/2020", "compliance_procedure_number": "EMEA-C-001545-PIP01-13-M02", "contact_for_public_enquiries": "Sanofi PasteurE-mail: contact-us@sanofi.comTel. +33 1 6974 5695", "first_published_date": "06/06/2014", "last_updated_date": "16/09/2021", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001545-pip01-13-m02" }, { "decision_number": "P/0333/2019", "pip_number": "EMEA-000601-PIP01-09-M06", "active_substance": "pazopanib", "invented_name": "Votrient", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Film-coated tablet;Age appropriate oral formulation", "condition_indication": "Treatment of Ewing sarcoma family of tumours;Treatment of non-rhabdomyosarcoma soft tissue sarcoma;Treatment of rhabdomyosarcoma", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "11/09/2019", "compliance_outcome": "Positive", "compliance_opinion_date": "24/07/2020", "compliance_procedure_number": "EMEA-C-000601-PIP01-09-M06", "contact_for_public_enquiries": "Novartis Europharm LimitedE-mail: paediatric.enquiries@novartis.comTel. +41 613241111", "first_published_date": "25/07/2017", "last_updated_date": "16/09/2021", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000601-pip01-09-m06" }, { "decision_number": "P/0125/2020", "pip_number": "EMEA-001039-PIP02-12-M04", "active_substance": "Clostridium Botulinum neurotoxin type A (150 kD), free from complexing proteins", "invented_name": "Xeomin; Bocouture", "therapeutic_area": "Neurology;Ophthalmology", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Treatment of sialorrhoea", "routes_of_administration": "Intraglandular use;Intramuscular use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "30/03/2020", "compliance_outcome": "Positive", "compliance_opinion_date": "24/07/2020", "compliance_procedure_number": "EMEA-C-001039-PIP02-12-M04", "contact_for_public_enquiries": "Merz Pharmaceuticals GmbH; Tel. +49 6915031; E-mail: contact@merz.de", "first_published_date": "09/08/2013", "last_updated_date": "16/09/2021", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001039-pip02-12-m04" }, { "decision_number": "P/0271/2019", "pip_number": "EMEA-001113-PIP01-10-M06", "active_substance": "Delamanid", "invented_name": "Deltyba; Deltyba", "therapeutic_area": "Infectious diseases", "pharmaceutical_forms": "Film-coated tablet;Dispersible tablet", "condition_indication": "Treatment of multi-drug-resistant tuberculosis", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "14/08/2019", "compliance_outcome": "Positive", "compliance_opinion_date": "24/07/2020", "compliance_procedure_number": "EMEA-C-001113-PIP01-10-M06", "contact_for_public_enquiries": "Otsuka Pharmaceutical Development & Commercialisation Europe GmbH; Tel. +49 6995 5044321; E-mail: paediatric-info@otsuka.de", "first_published_date": "21/12/2011", "last_updated_date": "16/09/2021", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001113-pip01-10-m06" }, { "decision_number": "P/0161/2018", "pip_number": "EMEA-001264-PIP01-12-M02", "active_substance": "spheroids of human autologous matrix-associated chondrocytes", "invented_name": "Spherox", "therapeutic_area": "Other", "pharmaceutical_forms": "Implantation suspension", "condition_indication": "Treatment of cartilage disorders", "routes_of_administration": "Intra-articular use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "15/06/2018", "compliance_outcome": "Positive", "compliance_opinion_date": "24/07/2020", "compliance_procedure_number": "EMEA-C-001264-PIP01-12-M02", "contact_for_public_enquiries": "CO.DON AG; Tel.  +49 30240352330; E-mail: pr@codon.de", "first_published_date": "11/01/2013", "last_updated_date": "16/09/2021", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001264-pip01-12-m02" }, { "decision_number": "P/0176/2013", "pip_number": "EMEA-001391-PIP01-12", "active_substance": "glucarpidase", "invented_name": "", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Powder for solution for infusion", "condition_indication": "Treatment of methotrexate toxicity", "routes_of_administration": "Intravenous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "30/07/2013", "compliance_outcome": "Positive", "compliance_opinion_date": "24/07/2020", "compliance_procedure_number": "EMEA-C-001391-PIP01-12", "contact_for_public_enquiries": "BTG International Ltd ; United Kingdom ; E-mail: ashley.tapp@btgplc.com ; Tel. +44 (0)20 7575 0000", "first_published_date": "03/09/2013", "last_updated_date": "16/09/2021", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001391-pip01-12" }, { "decision_number": "P/0151/2019", "pip_number": "EMEA-001438-PIP01-13-M01", "active_substance": "idarucizumab", "invented_name": "Praxbind; Praxbind", "therapeutic_area": "Other", "pharmaceutical_forms": "Solution for injection/infusion", "condition_indication": "Prevention of dabigatran associated haemorrhage;Treatment of dabigatran associated haemorrhage", "routes_of_administration": "Intravenous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "17/04/2019", "compliance_outcome": "Positive", "compliance_opinion_date": "24/07/2020", "compliance_procedure_number": "EMEA-C-001438-PIP01-13-M01", "contact_for_public_enquiries": "Boehringer Ingelheim International GmbH; Tel. +49 6132 778271; Email: Paediatrics@boehringer-ingelheim.com", "first_published_date": "16/04/2014", "last_updated_date": "16/09/2021", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001438-pip01-13-m01" }, { "decision_number": "P/0290/2018", "pip_number": "EMEA-001244-PIP01-11-M02", "active_substance": "autologous haematopoietic stem cells transduced with lentiviral vector Lenti-D encoding the human ATP-binding cassette, sub-family D (ALD), member 1 (ABCD1) from cDNA", "invented_name": "", "therapeutic_area": "Neurology", "pharmaceutical_forms": "Dispersion for infusion", "condition_indication": "Treatment of adrenoleukodystrophy", "routes_of_administration": "Intravenous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "12/09/2018", "compliance_outcome": "Positive", "compliance_opinion_date": "04/09/2020", "compliance_procedure_number": "EMEA-C-001244-PIP01-11-M02", "contact_for_public_enquiries": "Bluebird bio France; Tel. +1 41 415615437; E-mail: CDeCoster@bluebirdio.com", "first_published_date": "21/06/2013", "last_updated_date": "16/09/2021", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001244-pip01-11-m02" }, { "decision_number": "P/0211/2018", "pip_number": "EMEA-001782-PIP01-15-M03", "active_substance": "Influenza virus surface antigens (haemagglutinin and neuraminidase) of the following strains: A/(H1N1), A/(H3N2), B/Yamagata lineage, B/Victoria lineage", "invented_name": "Influvac Tetra", "therapeutic_area": "Vaccines", "pharmaceutical_forms": "Suspension for injection", "condition_indication": "Prevention of influenza infection", "routes_of_administration": "Intramuscular use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "17/07/2018", "compliance_outcome": "Positive", "compliance_opinion_date": "04/09/2020", "compliance_procedure_number": "EMEA-C-001782-PIP01-15-M03", "contact_for_public_enquiries": "Abbott Biologicals B.V.Email: hind.ounis@abbott.comTel. +41 6148 70374", "first_published_date": "24/09/2015", "last_updated_date": "16/09/2021", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001782-pip01-15-m03" }, { "decision_number": "P/0006/2020", "pip_number": "EMEA-001822-PIP01-15-M01", "active_substance": "sofosbuvir;velpatasvir;voxilaprevi", "invented_name": "Vosevi", "therapeutic_area": "Infectious diseases", "pharmaceutical_forms": "Film-coated tablet;Age appropriate oral solid dosage form", "condition_indication": "Treatment of chronic hepatitis C", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "06/01/2020", "compliance_outcome": "Positive", "compliance_opinion_date": "16/10/2020", "compliance_procedure_number": "EMEA-C-001822-PIP01-15-M01", "contact_for_public_enquiries": "Gilead Sciences Ireland UCE-mail: regulatory.pip@gilead.comTel. +44 1223897300", "first_published_date": "02/06/2016", "last_updated_date": "16/09/2021", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001822-pip01-15-m01" }, { "decision_number": "P/0264/2019", "pip_number": "EMEA-001853-PIP01-15-M02", "active_substance": "human normal immunoglobulin", "invented_name": "", "therapeutic_area": "Immunology-Rheumatology-Transplantation", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Treatment of Primary Immunodeficiency (PID)", "routes_of_administration": "Subcutaneous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "18/11/2019", "compliance_outcome": "Positive", "compliance_opinion_date": "13/11/2020", "compliance_procedure_number": "EMEA-C-001853-PIP01-15-M02", "contact_for_public_enquiries": "Grifols Therapeutics Inc.; Tel. +49 69660593405; E-mail: bernhard.lauven@grifols.com", "first_published_date": "02/06/2016", "last_updated_date": "16/09/2021", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001853-pip01-15-m02" }, { "decision_number": "P/0008/2017", "pip_number": "EMEA-000294-PIP02-12-M01", "active_substance": "idursulfase", "invented_name": "", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Treatment of mucopolysaccharidosis II (Hunter syndrome)", "routes_of_administration": "Intrathecal use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "31/01/2017", "compliance_outcome": "Positive", "compliance_opinion_date": "11/12/2020", "compliance_procedure_number": "EMEA-C-000294-PIP02-12-M01", "contact_for_public_enquiries": "Shire Human Genetic Therapies AB; United States; Tel. +1 7814826558; E-mail: dalexanderia@shire.com", "first_published_date": "08/10/2013", "last_updated_date": "16/09/2021", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000294-pip02-12-m01" }, { "decision_number": "P/0086/2020", "pip_number": "EMEA-000694-PIP01-09-M08", "active_substance": "dapagliflozin", "invented_name": "Forxiga", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Treatment of type II diabetes mellitus", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "18/03/2020", "compliance_outcome": "Positive", "compliance_opinion_date": "11/12/2020", "compliance_procedure_number": "EMEA-C-000694-PIP01-09-M08", "contact_for_public_enquiries": "AstraZeneca AB (Sweden); Tel. +46 8 5532791; E-mail: paediatrics@astrazeneca.com", "first_published_date": "29/07/2010", "last_updated_date": "16/09/2021", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000694-pip01-09-m08" }, { "decision_number": "P/0289/2016", "pip_number": "EMEA-000718-PIP01-09-M06", "active_substance": "riociguat", "invented_name": "Adempas; Adempas", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Film-coated tablet;Oral liquid", "condition_indication": "Treatment of pulmonary hypertension", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "04/11/2016", "compliance_outcome": "Positive", "compliance_opinion_date": "11/12/2020", "compliance_procedure_number": "EMEA-C-000718-PIP01-09-M06", "contact_for_public_enquiries": "Bayer Pharma AG; Germany; Tel. +49 3030 0139003; Fax +49 3046 895333; E-mail: clinical-trials-contact@bayer.com", "first_published_date": "03/10/2011", "last_updated_date": "16/09/2021", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000718-pip01-09-m06" }, { "decision_number": "P/0255/2017", "pip_number": "EMEA-001604-PIP01-13-M03", "active_substance": "grazoprevir;elbasvir", "invented_name": "Zepatier; Zepatier", "therapeutic_area": "Infectious diseases", "pharmaceutical_forms": "Film-coated tablet;Granules", "condition_indication": "Treatment of chronic hepatitis C", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "04/09/2017", "compliance_outcome": "Positive", "compliance_opinion_date": "11/12/2020", "compliance_procedure_number": "EMEA-C-001604-PIP01-13-M03", "contact_for_public_enquiries": "Merck Sharp & Dohme (Europe) Inc.Tel.: +33180464738E-mail: pip.information@merck.com", "first_published_date": "05/03/2015", "last_updated_date": "16/09/2021", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001604-pip01-13-m03" }, { "decision_number": "P/0214/2017", "pip_number": "EMEA-001203-PIP02-14-M02", "active_substance": "Coagulation Factor VIIa (Recombinant)", "invented_name": "", "therapeutic_area": "Haematology-Hemostaseology", "pharmaceutical_forms": "Powder and solvent for solution for injection", "condition_indication": "Treatment of acquired haemophilia;Treatment of congenital coagulation disorders", "routes_of_administration": "Intravenous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "09/08/2017", "compliance_outcome": "Positive", "compliance_opinion_date": "04/09/2020", "compliance_procedure_number": "EMEA-C-001203-PIP02-14-M02", "contact_for_public_enquiries": "LFB SA; France; Tel. +33 169827344; E-mail: nogierm@lfb.fr", "first_published_date": "23/03/2015", "last_updated_date": "16/09/2021", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001203-pip02-14-m02" }, { "decision_number": "P/0275/2020", "pip_number": "EMEA-002692-PIP01-19", "active_substance": "Lonapegsomatropin", "invented_name": "", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Powder and solvent for solution for injection", "condition_indication": "Treatment of growth hormone deficiency", "routes_of_administration": "Subcutaneous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "15/07/2020", "compliance_outcome": "", "compliance_opinion_date": "04/09/2020", "compliance_procedure_number": "EMEA-C-002692-PIP01-19", "contact_for_public_enquiries": "Ascendis Pharma Endocrinology Division A/S; E-mail: MedicalAffairs@ascendispharma.com; Tel. +45 70222244", "first_published_date": "16/06/2021", "last_updated_date": "16/09/2021", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002692-pip01-19" }, { "decision_number": "P/0398/2020", "pip_number": "EMEA-002645-PIP02-20", "active_substance": "sacituzumab govitecan", "invented_name": "", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Powder and solvent for solution for infusion", "condition_indication": "Treatment of urothelial carcinoma", "routes_of_administration": "Intravenous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "23/10/2020", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Immunomedics GmbH; E-mail: Regulatory.Pip@gilead.com; Tel: +44 1223897300", "first_published_date": "09/09/2021", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002645-pip02-20" }, { "decision_number": "P/0444/2020", "pip_number": "EMEA-000694-PIP05-20", "active_substance": "dapagliflozin", "invented_name": "Forxiga", "therapeutic_area": "Infectious diseases", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Treatment of Coronavirus disease 2019 (COVID-19)", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "01/12/2020", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "AstraZeneca ABE-mail: paediatrics@astrazeneca.comTel. +46 8553 27591", "first_published_date": "19/08/2021", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000694-pip05-20" }, { "decision_number": "P/0412/2020", "pip_number": "EMEA-002721-PIP02-20", "active_substance": "tiragolumab", "invented_name": "", "therapeutic_area": "Oncology", "pharmaceutical_forms": 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E-mail: arne.jensen@brainrepair.eu​​​​​​​; Tel. +49 2345881960", "first_published_date": "06/07/2021", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001799-pip03-19" }, { "decision_number": "P/0378/2020", "pip_number": "EMEA-001613-PIP02-20", "active_substance": "tezepelumab", "invented_name": "", "therapeutic_area": "Oto-rhino-laryngology", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Treatment of nasal polyposis", "routes_of_administration": "Subcutaneous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "09/09/2020", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "AstraZeneca ABE-mail: paediatrics@astrazeneca.comTel. +46 8553 27591", "first_published_date": "06/07/2021", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001613-pip02-20" }, { "decision_number": "P/0344/2020", "pip_number": "EMEA-000643-PIP02-20", "active_substance": "Dronabinol", "invented_name": "", "therapeutic_area": "Neurology", "pharmaceutical_forms": "Oral solution", "condition_indication": "Treatment of spasticity", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "09/09/2020", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Bionorica Ethics GmbH; 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Tel. +46 760293911; E-mail: roger.tell@isofolmedical.com", "first_published_date": "04/03/2021", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002223-pip01-19" }, { "decision_number": "P/0176/2020", "pip_number": "EMEA-002455-PIP01-18", "active_substance": "Livoletide", "invented_name": "", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Concentrate for solution for injection", "condition_indication": "Treatment of Prader-Willi syndrome", "routes_of_administration": "Subcutaneous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "13/05/2020", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Millendo Therapeutics SAS; Tel. +33 472180924; E-mail: allas@millendo.com", "first_published_date": "04/03/2021", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002455-pip01-18" }, { "decision_number": "P/0180/2020", "pip_number": "EMEA-002060-PIP02-17-M01", "active_substance": "alicaforsen", "invented_name": "", "therapeutic_area": "Gastroentology-Hepatology", "pharmaceutical_forms": "Rectal solution", "condition_indication": "Treatment of pouchitis", "routes_of_administration": "Rectal use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "15/05/2020", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Atlantic Healthcare Europe B.V.; Tel. +44 1799513391; E-mail: ann.mccormack@atlantichc.com", "first_published_date": "28/01/2019", "last_updated_date": "04/03/2021", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002060-pip02-17-m01" }, { "decision_number": "P/0194/2020", "pip_number": "EMEA-001768-PIP02-15-M03", "active_substance": "rolapitant", "invented_name": "Varuby; Varuby", "therapeutic_area": "Haematology-Hemostaseology", "pharmaceutical_forms": "Film-coated tablet;Age appropriate oral dosage formulation", "condition_indication": "Prevention of nausea and vomiting", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "15/05/2020", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Tesaro Bio Netherlands B.V.; Tel. +41 415880618; E-mail: lenerose.x.arfelt@gsk.com", "first_published_date": "22/04/2016", "last_updated_date": "04/03/2021", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001768-pip02-15-m03" }, { "decision_number": "P/0216/2020", "pip_number": "EMEA-000639-PIP06-20", "active_substance": "chloroprocaine hydrochloride", "invented_name": "Ampres", "therapeutic_area": "Anaesthesiology", "pharmaceutical_forms": "Eye gel", "condition_indication": "Ocular surface anaesthesia", "routes_of_administration": "Ocular use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "17/06/2020", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Sintetica GmbH; Tel. +41 916404250E-mail: corporate_clinical_rd@sintetica.com", "first_published_date": "04/03/2021", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000639-pip06-20" }, { "decision_number": "P/0219/2020", "pip_number": "EMEA-000347-PIP05-20", "active_substance": "bilastine", "invented_name": "Bilaxten and associated names", "therapeutic_area": "Dermatology;Oto-rhino-laryngology;Pneumology-allergology", "pharmaceutical_forms": "Oral solution;Orodispersible tablet;Solution for injection;Tablet", "condition_indication": "Treatment of acute type I hypersensitivity reactions", "routes_of_administration": "Oral use;Intramuscular use;Intravenous use", "decision_type": "RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)", "decision_date": "17/06/2020", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Faes Farma S.A.; E-mail: ieguidazu@faes.es, mjarenal@faes.es; Tel. +34 944818300", "first_published_date": "04/03/2021", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000347-pip05-20" }, { "decision_number": "P/0157/2020", "pip_number": "EMEA-002595-PIP01-19", "active_substance": "Polymyxin B", "invented_name": "", "therapeutic_area": "Infectious diseases", "pharmaceutical_forms": "Powder for solution for injection", "condition_indication": "Treatment of infections due to aerobic Gram-negative bacteria", "routes_of_administration": "Intravenous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "17/04/2020", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "The GARDP Foundation; Tel.: +41 229077623; E-mail: sally.ellis@gardp.org", "first_published_date": "04/03/2021", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002595-pip01-19" }, { "decision_number": "P/0126/2020", "pip_number": "EMEA-002567-PIP01-19", "active_substance": "pracinostat", "invented_name": "", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Capsule, hard;Granules for oral suspension", "condition_indication": "Treatment of acute myeloid leukaemia", "routes_of_administration": "Oral use;Gastric use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "03/04/2020", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Helsinn Birex Pharmaceuticals limited; Tel.: +41 919852167; E-mail: giuseppina.fusetti@helsinn.com", "first_published_date": "04/03/2021", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002567-pip01-19" }, { "decision_number": "P/0313/2015", "pip_number": "EMEA-001603-PIP01-13-M01", "active_substance": "elbasvir", "invented_name": "", "therapeutic_area": "Infectious diseases", "pharmaceutical_forms": "Film-coated tablet;Granules", "condition_indication": "Treatment of chronic hepatitis C", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "21/12/2015", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Merck Sharp & Dohme (Europe) Inc.Tel.: +33180464738E-mail: pip.information@merck.com", "first_published_date": "05/03/2015", "last_updated_date": "04/03/2021", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001603-pip01-13-m01" }, { "decision_number": "P/0312/2015", "pip_number": "EMEA-001602-PIP01-13-M01", "active_substance": "grazoprevir", "invented_name": "", "therapeutic_area": "Infectious diseases", "pharmaceutical_forms": "Film-coated tablet;Granules", "condition_indication": "Treatment of chronic hepatitis C", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "21/12/2015", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Merck Sharp & Dohme (Europe) Inc.Tel.: +33180464738E-mail: pip.information@merck.com", "first_published_date": "05/03/2015", "last_updated_date": "04/03/2021", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001602-pip01-13-m01" }, { "decision_number": "P/0128/2020", "pip_number": "EMEA-002511-PIP02-19", "active_substance": "glycerol;urea", "invented_name": "", "therapeutic_area": "Dermatology", "pharmaceutical_forms": "Cream", "condition_indication": "Treatment of dry skin", "routes_of_administration": "Cutaneous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "15/04/2020", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "ACO Hud Nordic AB; Tel.: +46 732744113; E-mail: tina.holm@perrigo.com", "first_published_date": "04/03/2021", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002511-pip02-19" }, { "decision_number": "P/0129/2020", "pip_number": "EMEA-002364-PIP03-19", "active_substance": "Dihomo-y-linolenic acid", "invented_name": "", "therapeutic_area": "Dermatology", "pharmaceutical_forms": "Age appropriate oral liquid dosage formulation;Capsule, soft", "condition_indication": "Treatment of atopic dermatitis", "routes_of_administration": "Oral use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "15/04/2020", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "DS Biopharma Ltd; Tel.:  +353 12946383; E-mail: dsbiopharma.regulatory@dsbiopharma.com", "first_published_date": "03/03/2021", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002364-pip03-19" }, { "decision_number": "P/0140/2020", "pip_number": "EMEA-001864-PIP02-19", "active_substance": "lanadelumab", "invented_name": "Takhzyro", "therapeutic_area": "Other", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Prevention of acquired angioedema attacks", "routes_of_administration": "Subcutaneous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "18/04/2020", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Takeda Pharmaceuticals International AG Ireland BranchE-mail: medinfoemea@takeda.comTel: +44 (0) 3333 000181", "first_published_date": "03/03/2021", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001864-pip02-19" }, { "decision_number": "P/0161/2020", "pip_number": "EMEA-002716-PIP01-19", "active_substance": "propan-2-yl 2-[5-( acryloylamino )-4-{ [2-( dimethylamino )ethyl] ( methyl)amino }-2-methoxyanilino ]-4- ( 1 methyl-1 H-indol-3-yl)pyrimidine-5-carboxylate", "invented_name": "", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Capsule, hard", "condition_indication": "Treatment of all conditions included in the category of malignant neoplasms (except haematopoietic and lymphoid tissue neoplasms)", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "16/04/2020", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Takeda Pharma A/STel. +44 (0)3333000181E-mail: medinfoEMEA@takeda.com", "first_published_date": "03/03/2021", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002716-pip01-19" }, { "decision_number": "P/0127/2020", "pip_number": "EMEA-002725-PIP01-19", "active_substance": "lazertinib (mesilate)", "invented_name": "", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Treatment of lung carcinoma (small cell and non-small cell carcinoma)", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "15/04/2020", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Takeda Pharma A/S; Tel.: +353 857446696; E-mail: nbuhl@its.jnj.com", "first_published_date": "03/03/2021", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002725-pip01-19" }, { "decision_number": "P/0347/2019", "pip_number": "EMEA-002468-PIP04-18", "active_substance": "belantamab mafodotin", "invented_name": "", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Powder for concentrate for solution for infusion", "condition_indication": "Treatment of Multiple Myeloma", "routes_of_administration": "Intravenous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "11/09/2020", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "GlaxoSmithKline Trading Services Limited; Tel. +1 438-899-8201; E-mail: eu.paediatric-plans@gsk.com", "first_published_date": "25/03/2020", "last_updated_date": "19/02/2021", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002468-pip04-18" }, { "decision_number": "P/0038/2017", "pip_number": "EMEA-002030-PIP01-16", "active_substance": "ambrisentan", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Treatment of pulmonary arterial hypertension", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "30/01/2017", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Glaxo Group Limited; United Kingdom; Tel. +1 4388998201; E-mail: eu.paediatric-plans@gsk.com", "first_published_date": "17/03/2017", "last_updated_date": "19/02/2021", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002030-pip01-16" }, { "decision_number": "P/0272/2016", "pip_number": "EMEA-001175-PIP01-11-M04", "active_substance": "albiglutide", "invented_name": "Eperzan; Eperzan", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Powder and solvent for solution for injection", "condition_indication": "Treatment of type II diabetes mellitus", "routes_of_administration": "Subcutaneous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "07/10/2016", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Glaxo Group Limited; E-mail: eu.paediatrics-plans@gsk.com; Tel. +1 4388998201", "first_published_date": "09/08/2012", "last_updated_date": "19/02/2021", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001175-pip01-11-m04" }, { "decision_number": "P/0239/2017", "pip_number": "EMEA-000069-PIP02-10-M08", "active_substance": "Mepolizumab", "invented_name": "Nucala", "therapeutic_area": "Pneumology-allergology", "pharmaceutical_forms": "Solution for injection;Powder for solution for injection or infusion", "condition_indication": "Treatment of asthma", "routes_of_administration": "Intravenous use;Subcutaneous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "11/08/2017", "compliance_outcome": "Positive", "compliance_opinion_date": "10/11/2017", "compliance_procedure_number": "EMEA-C-000069-PIP02-10-M08", "contact_for_public_enquiries": "GlaxoSmithKline Trading Services; 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Inc; E-mail: regulatoryaffairs@elpen.gr; Tel. +30 2106039326;  ", "first_published_date": "06/04/2020", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002649-pip01-19" }, { "decision_number": "P/0416/2019", "pip_number": "EMEA-002633-PIP01-19", "active_substance": "sitravatinib (malate)", "invented_name": "", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Capsule, hard", "condition_indication": "Treatment of non-small cell lung cancer", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "04/12/2019", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Mirati Therapeutics, Inc.; E-mail: cheni@mirati.com; Tel.  +1 8583323428", "first_published_date": "06/04/2020", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002633-pip01-19" }, { "decision_number": "P/0392/2019", "pip_number": "EMEA-002629-PIP01-19", "active_substance": "", "invented_name": "", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Solution for infusion", "condition_indication": "Treatment of breast cancer;Treatment of lung cancer;Treatment of neuroendocrine tumours (excluding neuroblastoma)", "routes_of_administration": "Intravenous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "04/12/2019", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Ipsen Pharma; E-mail: caroline.pallardy@ipsen.com; Tel. +33 671197553", "first_published_date": "06/04/2020", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002629-pip01-19" }, { "decision_number": "P/0390/2019", "pip_number": "EMEA-002632-PIP01-19", "active_substance": "satoreotide trizoxetan", "invented_name": "", "therapeutic_area": "Diagnostic", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Diagnosis of breast cancer;Diagnosis of lung cancer;Diagnosis of neuroendocrine tumours (excluding neuroblastoma)", "routes_of_administration": "Intravenous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "04/12/2019", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Ipsen Pharma; E-mail: caroline.pallardy@ipsen.com; Tel. +33 671197553", "first_published_date": "06/04/2020", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002632-pip01-19" }, { "decision_number": "P/0427/2019", "pip_number": "EMEA-002627-PIP01-19", "active_substance": "savolitinib", "invented_name": "", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Treatment of lung cancer", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "04/12/2019", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "AstraZeneca ABE-mail: paediatrics@astrazeneca.com", "first_published_date": "06/04/2020", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002627-pip01-19" }, { "decision_number": "P/0417/2019", "pip_number": "EMEA-002626-PIP01-19", "active_substance": "loxoprofen (sodium hydrate)", "invented_name": "", "therapeutic_area": "Pain", "pharmaceutical_forms": "Medicated plaster", "condition_indication": "Treatment of pain", "routes_of_administration": "Topical use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "04/12/2019", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Lead Chemical Co. 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E-mail: nbuhl@its.jnj.com; Tel. +353 8574 46696", "first_published_date": "03/04/2020", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002615-pip01-19" }, { "decision_number": "P/0428/2019", "pip_number": "EMEA-002587-PIP01-19", "active_substance": "duvelisib", "invented_name": "", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Capsule, hard", "condition_indication": "Treatment of mature B cell malignancies", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "06/12/2019", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Verastem, Inc.; E-mail: va@eraconsulting.com; Tel. +49 516198900", "first_published_date": "03/04/2020", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002587-pip01-19" }, { "decision_number": "P/0397/2019", "pip_number": "EMEA-002580-PIP01-19", "active_substance": "diclofenac (sodium);thiocolchicoside", "invented_name": "", "therapeutic_area": "Pain", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Treatment of pain", "routes_of_administration": "Intramuscular use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "04/12/2019", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Win Medica S.A.; 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Tel. +31 365227201; E-mail: ace@ace-pharm.nl", "first_published_date": "03/04/2020", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002402-pip02-18" }, { "decision_number": "P/0380/2019", "pip_number": "EMEA-002267-PIP02-19", "active_substance": "gefapixant (citrate)", "invented_name": "", "therapeutic_area": "Pneumology-allergology", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Treatment of unexplained or chronic refractory cough", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "04/12/2019", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Merck Sharp & Dohme (Europe) Inc.Tel.: +33180464738E-mail: pip.information@merck.com", "first_published_date": "03/04/2020", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002267-pip02-19" }, { "decision_number": "P/0406/2019", "pip_number": "EMEA-002247-PIP02-17", "active_substance": "Ivosidenib", "invented_name": "", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Film-coated tablet;Age appropriate oral solid dosage form", "condition_indication": "Treatment of all conditions included in the category of malignant neoplasms (except central nervous system tumours, haematopoietic and lymphoid tissue neoplasms);Treatment of malignant neoplasms of the central nervous system", "routes_of_administration": "Oral use;Naso-gastric use", "decision_type": "RP: decision refers to a refusal on a proposed Paediatric Investigation Plan", "decision_date": "04/12/2019", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Les Laboratoires ServierE-mail: mail.pip.enquiries@servier.comTel.: +33 155726000", "first_published_date": "02/04/2020", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002247-pip02-17" }, { "decision_number": "P/0414/2019", "pip_number": "EMEA-002178-PIP01-17-M01", "active_substance": "Itacitinib", "invented_name": "", "therapeutic_area": "Immunology-Rheumatology-Transplantation", "pharmaceutical_forms": "Prolonged-release tablet;Age appropriate oral solid dosage form", "condition_indication": "Treatment of acute graft versus host disease", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "06/12/2019", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Incyte Biosciences Distribution B.V.; E-mail: globalmedinfo@incyte.com; Tel. +800 0002 7423", "first_published_date": "27/11/2018", "last_updated_date": "02/04/2020", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002178-pip01-17-m01" }, { "decision_number": "P/0412/2019", "pip_number": "EMEA-001066-PIP02-11-M03", "active_substance": "aciclovir", "invented_name": "Sitavig and associated names", "therapeutic_area": "Infectious diseases", "pharmaceutical_forms": "Muco-adhesive buccal tablet", "condition_indication": "Treatment of herpes simplex labialis", "routes_of_administration": "Gingival use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "04/12/2019", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Vectans Pharma; Tel. +33 631268926; E-mail: christiane.bober@vectans.com", "first_published_date": "26/07/2017", "last_updated_date": "01/04/2020", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001066-pip02-11-m03" }, { "decision_number": "P/0433/2019", "pip_number": "EMEA-001862-PIP02-19", "active_substance": "autologous peripheral blood T cells CD4 and CD8 selected and CD3 and CD28 activated transduced with retroviral vector expressing anti CD19 CD28/CD3-zeta chimeric antigen receptor and cultured (KTE-X19)", "invented_name": "", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Dispersion for infusion", "condition_indication": "Treatment of mantle cell lymphoma", "routes_of_administration": "Intravenous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "06/12/2019", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Kite Pharma EU B.V.; 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Tel. +39 3462545935; E-mail: dalila.dolfi@seqirus.com", "first_published_date": "10/01/2017", "last_updated_date": "30/03/2020", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001894-pip01-15-m01" }, { "decision_number": "P/0367/2019", "pip_number": "EMEA-001191-PIP01-11-M03", "active_substance": "Daclatasvir", "invented_name": "Daklinza", "therapeutic_area": "Infectious diseases", "pharmaceutical_forms": "Chewable tablet;Film-coated tablet", "condition_indication": "Treatment of chronic hepatitis C", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "08/11/2019", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Bristol-Myers Squibb Pharma EEIG E-mail: medical.information@bms.com Tel. +44 (0)1423 533610", "first_published_date": "23/08/2012", "last_updated_date": "30/03/2020", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001191-pip01-11-m03" }, { "decision_number": "P/0366/2019", "pip_number": "EMEA-000060-PIP07-19", "active_substance": "canakinumab", "invented_name": "Ilaris", "therapeutic_area": "Immunology-Rheumatology-Transplantation", "pharmaceutical_forms": "Powder for solution for injection;Solution for injection", "condition_indication": "Treatment of gout", "routes_of_administration": "Subcutaneous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "07/11/2019", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Novartis Europharm LimitedE-mail: paediatric.enquiries@novartis.comTel. +41 613241111", "first_published_date": "27/03/2020", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000060-pip07-19" }, { "decision_number": "P/0340/2019", "pip_number": "EMEA-002027-PIP02-17-M01", "active_substance": "Influenza virus surface antigens (haemagglutinin) of strain A (H1N1);influenza virus surface antigens (haemagglutinin) of strain A (H3N2);influenza virus surface antigens (haemagglutinin) of strain B  (Victoria lineage);influenza virus surface antigens (haemagglutinin) of strain B (Yamagata lineage)", "invented_name": "", "therapeutic_area": "Infectious diseases", "pharmaceutical_forms": "Suspension for injection", "condition_indication": "Prevention of influenza infection", "routes_of_administration": "Intramuscular use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "10/09/2019", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Adimmune Corporation (Taiwan); 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(323)747-7472; E-mail: support@mandoshealth.com", "first_published_date": "17/03/2017", "last_updated_date": "26/03/2020", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001866-pip01-15-m04" }, { "decision_number": "P/0334/2019", "pip_number": "EMEA-000139-PIP01-07-M03", "active_substance": "recombinant Neisseria meningitidis group B NHBA fusion protein;recombinant Neisseria meningitidis group B NadA protein;recombinant Neisseria meningitidis group B fHbp fusion protein;Outer Membrane Vesicles (OMV) from Neisseria meningitidis group B strain NZ98/254 measured as amount of total protein containing the PorA P1.4", "invented_name": "Bexsero", "therapeutic_area": "Vaccines", "pharmaceutical_forms": "Suspension for injection", "condition_indication": "Meningococcal meningitis", "routes_of_administration": "Intramuscular use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "11/09/2019", "compliance_outcome": "Positive", "compliance_opinion_date": "15/11/2019", "compliance_procedure_number": "EMEA-C-000139-PIP01-07-M03", "contact_for_public_enquiries": "GSK Vaccines S.r.l.; Tel. +1 438 899 8201; Email: eu.paediatric-plans@gsk.com", "first_published_date": "28/07/2010", "last_updated_date": "26/03/2020", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000139-pip01-07-m03" }, { "decision_number": "P/0357/2019", "pip_number": "EMEA-002608-PIP01-19", "active_substance": "2-(3-(1-carboxy-5-[(6-[18F]fluoropyridine-3-carbonyl)-amino]-pentyl)-ureido)-pentanedioic acid", "invented_name": "", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Diagnosis of prostate cancer", "routes_of_administration": "Intravenous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "04/10/2019", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Curium Netherlands B.V.; E-mail: regulatory.cyclopharma@curiumpharma.com; Tel. +33 473632713", "first_published_date": "25/03/2020", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002608-pip01-19" }, { "decision_number": "P/0353/2019", "pip_number": "EMEA-002585-PIP01-19", "active_substance": "autologous human T cells genetically modified ex-vivo with a lentiviral vector encoding a chimeric antigen receptor (CAR) for B-cell maturation antigen (BCMA) (JNJ-68284528)", "invented_name": "", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Dispersion for infusion", "condition_indication": "Treatment of Multiple Myeloma", "routes_of_administration": "Intravenous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "04/10/2019", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Janssen-Cilag International N.V; 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E-mail: fda_emalex@emalexbiosciences.com; Tel. +1 3127773741", "first_published_date": "25/03/2020", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002564-pip01-19" }, { "decision_number": "P/0307/2019", "pip_number": "EMEA-002628-PIP01-19", "active_substance": "Botulinum toxin type A", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Powder for solution for injection", "condition_indication": "Prevention of post-operative atrial fibrillation in patients undergoing open-chest cardiac surgery", "routes_of_administration": "Intramuscular use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "10/09/2020", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Allergan Pharmaceuticals International Limited; E-mail: ml-eu_reg_affairs@allergan.com; Tel. +44 (0)1628 4944444", "first_published_date": "25/03/2020", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002628-pip01-19" }, { "decision_number": "P/0354/2019", "pip_number": "EMEA-002424-PIP02-19", "active_substance": "7-(2-methoxy-3,5-dimethylpyridin-4-yl)-1-[(3S)-tetrahydrofuran-3-yl]-1,5-dihydro-4H-pyrazolo[4,3-c]quinolin-4-one maleate", "invented_name": "", "therapeutic_area": "Neurology", "pharmaceutical_forms": "Capsule, hard", "condition_indication": "Treatment of dementia with Lewy bodies", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "04/10/2019", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Eisai Ltd; E-mail: lmedInfo@eisai.net; Tel. +44 2086001400", "first_published_date": "25/03/2020", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002424-pip02-19" }, { "decision_number": "P/0356/2019", "pip_number": "EMEA-001978-PIP02-19", "active_substance": "aprocitentan", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Treatment of hypertension", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "04/10/2019", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Idorsia Pharmaceuticals Deutschland GmbH  E-mail: clinical-trials-disclosure@idorsia.com  Tel. +41 588440000  ", "first_published_date": "25/03/2020", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001978-pip02-19" }, { "decision_number": "P/0301/2019", "pip_number": "EMEA-002594-PIP01-19", "active_substance": "Infigratinib", "invented_name": "", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Capsule, hard", "condition_indication": "Treatment of cholangiocarcinoma", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "10/09/2020", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "QED Therapeutics; Tel. +1 6502314088; E-mail: susan.moran@qedtx.com", "first_published_date": "25/03/2020", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002594-pip01-19" }, { "decision_number": "P/0346/2019", "pip_number": "EMEA-002598-PIP01-19", "active_substance": "Fexapotide (friflutate)", "invented_name": "", "therapeutic_area": "Uro-nephrology", "pharmaceutical_forms": "Powder and solvent for solution for injection", "condition_indication": "Treatment of benign prostatic hyperplasia", "routes_of_administration": "Intraprostatic use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "11/09/2020", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "FGK Representative Service GmbH; E-mail: info@nymox.com; Tel. +1 8009369669", "first_published_date": "25/03/2020", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002598-pip01-19" }, { "decision_number": "P/0308/2019", "pip_number": "EMEA-002593-PIP01-19", "active_substance": "zofenopril;nebivolol", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Treatment of hypertension", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "10/09/2020", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Menarini Ricerche S.p.A.; E-mail: prijli@menarini.it; Tel. + 39 0555680633", "first_published_date": "25/03/2020", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002593-pip01-19" }, { "decision_number": "P/0309/2019", "pip_number": "EMEA-002570-PIP01-19", "active_substance": "atropine sulfate;obidoxime (chloride)", "invented_name": "", "therapeutic_area": "Other", "pharmaceutical_forms": "", "condition_indication": "Treatment of organophosphorus poisoning", "routes_of_administration": "Intramuscular use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "10/09/2020", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Emergent Netherlands B.V.; Tel.: +1 2406313200; E-mail: productinquiries@ebsi.com", "first_published_date": "25/03/2020", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002570-pip01-19" }, { "decision_number": "P/0352/2019", "pip_number": "EMEA-001931-PIP02-19", "active_substance": "human fibrinogen", "invented_name": "", "therapeutic_area": "Haematology-Hemostaseology", "pharmaceutical_forms": "Powder for solution for injection or infusion", "condition_indication": "Treatment of acquired fibrinogen deficiency", "routes_of_administration": "Intravenous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "04/10/2019", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Biotest AG; Tel. + 49 6103 801497E-mail: clinical.trials@biotest.com", "first_published_date": "25/03/2020", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001931-pip02-19" }, { "decision_number": "P/0343/2019", "pip_number": "EMEA-002569-PIP04-19", "active_substance": "rosuvastatin;ramipril", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Capsule, hard", "condition_indication": "Prevention of cardiovascular events;Treatment of hypertension;Treatment of lipid metabolism disorders", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "11/09/2020", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "EGIS Pharmaceuticals PLC ; Tel. +36 18032414; E-mail: registry@registry.hu", "first_published_date": "25/03/2020", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002569-pip04-19" }, { "decision_number": "P/0343/2019", "pip_number": "EMEA-002569-PIP04-19", "active_substance": "rosuvastatin;ramipril", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Capsule, hard", "condition_indication": "Prevention of cardiovascular events;Treatment of hypertension;Treatment of lipid metabolism disorders", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "11/09/2020", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "EGIS Pharmaceuticals PLC ; Tel. +36 18032414; E-mail: registry@registry.hu", "first_published_date": "25/03/2020", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002569-pip04-19-0" }, { "decision_number": "P/0304/2019", "pip_number": "EMEA-002444-PIP02-18", "active_substance": "Equine immunoglobulin F(ab')2 fragments targeting Shiga toxin", "invented_name": "", "therapeutic_area": "Infectious diseases", "pharmaceutical_forms": "Solution for infusion", "condition_indication": "Prevention of haemolytic uraemic syndrome", "routes_of_administration": "Intravenous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "10/09/2020", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Chemo Research S.L.E-mail: enrico.coli@exeltis.com Tel.: +34 913021560", "first_published_date": "23/03/2020", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002444-pip02-18" }, { "decision_number": "P/0342/2019", "pip_number": "EMEA-002157-PIP01-17", "active_substance": "recombinant hepatitis B vaccine", "invented_name": "", "therapeutic_area": "Vaccines", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Prevention of hepatitis B virus infection", "routes_of_administration": "Intramuscular use", "decision_type": "RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)", "decision_date": "10/09/2019", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "VBI Vaccines Inc.; 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Tel. +61 386147707; E-mail: Niall.Morrissey@maynepharma.com", "first_published_date": "20/03/2020", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001492-pip02-18" }, { "decision_number": "P/0283/2019", "pip_number": "EMEA-002547-PIP01-19", "active_substance": "human chorionic gonadotrophin", "invented_name": "", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Powder and solvent for solution for injection", "condition_indication": "Treatment of female infertility", "routes_of_administration": "Intramuscular use;Subcutaneous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "16/08/2019", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Regulis Consulting Europe Ltd; E-mail: regulatory@regulis.com; Tel. +44(0) 1442 890909", "first_published_date": "20/11/2019", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002547-pip01-19" }, { "decision_number": "P/0270/2019", "pip_number": "EMEA-002540-PIP01-18", "active_substance": "Istradefylline", "invented_name": "", "therapeutic_area": "Neurology", "pharmaceutical_forms": "Tablet", "condition_indication": "Treatment of Parkinson's disease", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "14/08/2019", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Kyowa Kirin Limited; 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Tel.: +31 202454000; E-mail: eumedinfo.gz@sanofi.com", "first_published_date": "07/11/2019", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002407-pip01-18" }, { "decision_number": "P/0202/2019", "pip_number": "EMEA-002342-PIP03-18", "active_substance": "abemaciclib", "invented_name": "Verzenios", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Treatment of breast cancer", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "12/06/2019", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Eli Lilly and Company Limited (US); Tel.: +1 31 75448941; E-mail: wagle_asvari@lilly.com", "first_published_date": "07/11/2019", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002342-pip03-18" }, { "decision_number": "P/0222/2019", "pip_number": "EMEA-002318-PIP03-19", "active_substance": "tilsotolimod", "invented_name": "", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Treatment of malignant melanoma", "routes_of_administration": "Intratumoral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "21/06/2019", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Idera Pharmaceuticals Inc.; 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E-mail: info@pharmapatent.hu; Tel. +36 16306182", "first_published_date": "29/10/2019", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002553-pip01-19" }, { "decision_number": "P/0184/2019", "pip_number": "EMEA-002548-PIP01-19", "active_substance": "amoxicillin", "invented_name": "", "therapeutic_area": "Other", "pharmaceutical_forms": "Tablet", "condition_indication": "Treatment of Helicobacter spp. infections", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "15/05/2019", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Micro Labs GmbH; Tel.:  +91 8025731936 / 37 Ext.302; E-mail: microeu@microlabs.in", "first_published_date": "29/10/2019", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002548-pip01-19" }, { "decision_number": "P/0183/2019", "pip_number": "EMEA-002549-PIP01-19", "active_substance": "clarithromycin", "invented_name": "", "therapeutic_area": "Other", "pharmaceutical_forms": "Tablet", "condition_indication": "Treatment of Helicobacter spp. infections", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "15/05/2019", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Micro Labs GmbH; 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Tel. +1 8585500780; E-mail: pbitar@traconpharma.com; sbenedict@traconpharma.com; ppathak@traconpharma.com", "first_published_date": "05/03/2018", "last_updated_date": "25/06/2019", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002138-pip01-17-m01" }, { "decision_number": "P/0118/2019", "pip_number": "EMEA-001729-PIP02-18", "active_substance": "cenegermin", "invented_name": "Oxervate", "therapeutic_area": "Ophthalmology", "pharmaceutical_forms": "Eye drops, solution", "condition_indication": "Treatment of dry eye disease", "routes_of_administration": "Ocular use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "17/04/2019", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Dompé farmaceutici S.p.A.; E-mail: annabella.amatulli@dompe.com; Tel. +39 2583 83230", "first_published_date": "25/06/2019", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001729-pip02-18" }, { "decision_number": "P/0098/2019", "pip_number": "EMEA-001037-PIP02-11-M05", "active_substance": "Neisseria meningitidis serogroup B recombinant lipoprotein (rLP2086; 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Tel. +49 2772981354; E-mail: ina.pieter@symbio.de", "first_published_date": "24/06/2019", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002442-pip01-18" }, { "decision_number": "P/0103/2019", "pip_number": "EMEA-001741-PIP06-18", "active_substance": "upadacitinib", "invented_name": "", "therapeutic_area": "Immunology-Rheumatology-Transplantation", "pharmaceutical_forms": "Prolonged-release tablet", "condition_indication": "Treatment of vasculitides", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "25/03/2019", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "AbbVie LtdE-mail: paediatricteam@abbvie.comTel. +44 (0)1628 408248", "first_published_date": "24/06/2019", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001741-pip06-18" }, { "decision_number": "P/0156/2019", "pip_number": "EMEA-002439-PIP01-18", "active_substance": "rogaratinib", "invented_name": "", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Treatment of urothelial carcinoma", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "17/04/2019", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Bayer AG; Tel. +49 3046815333; E-mail: pediatrics.medical-affairs-europe@bayer.com", "first_published_date": "24/06/2019", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002439-pip01-18" }, { "decision_number": "P/0108/2019", "pip_number": "EMEA-002428-PIP01-18", "active_substance": "relugolix;estradiol;norethisterone acetate", "invented_name": "", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Tablet", "condition_indication": "Treatment of leiomyoma of uterus", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "22/03/2019", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Myovant Sciences Ireland Limited; Tel.+1 6502380250; E-mail: PIPrelugolix@myovant.com", "first_published_date": "24/06/2019", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002428-pip01-18" }, { "decision_number": "P/0121/2019", "pip_number": "EMEA-000222-PIP01-08-M09", "active_substance": "Etravirine", "invented_name": "Intelence; 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E-mail: info-medical-isotopes@itm.ag; Tel. +49 89 329 8986 600", "first_published_date": "24/04/2019", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002436-pip01-18" }, { "decision_number": "P/0005/2019", "pip_number": "EMEA-002146-PIP02-18", "active_substance": "Palbociclib", "invented_name": "Ibrance", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Capsule, hard;Age appropriate oral dosage formulation;Tablet", "condition_indication": "Treatment of breast malignant neoplasms", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "03/01/2019", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Pfizer Europe MA EEIG; Tel. +44 (0)1304 646 607; E-mail: pip_enquiries@pfizer.com", "first_published_date": "12/04/2019", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002146-pip02-18" }, { "decision_number": "P/0038/2019", "pip_number": "EMEA-002048-PIP02-18", "active_substance": "Givosiran", "invented_name": "", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Treatment of Acute Hepatic Porphyria", "routes_of_administration": "Subcutaneous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "29/01/2019", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Alnylam UK Limited; 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Tel. +33 800326326; E-mail: medical_information@pierre-fabre.com", "first_published_date": "11/04/2019", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001588-pip03-18" }, { "decision_number": "P/0037/2019", "pip_number": "EMEA-001454-PIP05-18", "active_substance": "binimetinib", "invented_name": "Mektovi", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Treatment of colorectal carcinoma", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "29/01/2019", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Pierre Fabre Médicament; Tel. +33 800326326; E-mail: medical_information@pierre-fabre.com", "first_published_date": "11/04/2019", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001454-pip05-18" }, { "decision_number": "P/0046/2019", "pip_number": "EMEA-001174-PIP03-18", "active_substance": "turoctocog alfa pegol", "invented_name": "", "therapeutic_area": "Haematology-Hemostaseology", "pharmaceutical_forms": "Powder and solvent for solution for injection", "condition_indication": "Treatment of congenital haemophilia A", "routes_of_administration": "Subcutaneous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "29/01/2019", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Novo Nordisk A/S; 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E-mail: axel_breitstadt@merck.com; Country: Belgium; Phone: +32 27766045; Fax: +32 27766288", "first_published_date": "09/07/2009", "last_updated_date": "08/03/2019", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000275-pip01-08" }, { "decision_number": "P/0221/2015", "pip_number": "EMEA-001684-PIP01-14", "active_substance": "adenovirus associated viral vector serotype 2 containing the human RPE65 gene", "invented_name": "", "therapeutic_area": "Ophthalmology", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Treatment of genetic congenital retinal disorders", "routes_of_administration": "Intraocular use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "02/10/2015", "compliance_outcome": "Positive", "compliance_opinion_date": "21/04/2017", "compliance_procedure_number": "EMEA-001684-PIP01-14", "contact_for_public_enquiries": "Novartis Europharm LimitedE-mail: paediatric.enquiries@novartis.comTel. +41 613241111", "first_published_date": "19/11/2015", "last_updated_date": "07/03/2019", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001684-pip01-14" }, { "decision_number": "P/0160/2016", "pip_number": "EMEA-001213-PIP02-12-M02", "active_substance": "ferric citrate coordination complex", "invented_name": "Fexeric; 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Tel.  +44 (0) 1628 644513; E-mail: robyn.hall@abbott.com", "first_published_date": "28/11/2018", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002276-pip01-17" }, { "decision_number": "P/0134/2018", "pip_number": "EMEA-002291-PIP01-17", "active_substance": "(2R)-2-amino-1-[3-( {2-[p-( 4-{3-[ (3,S-diamino-6-chloro-2-pyrazinyl)ca rbonyl ]guanidino }butyl )phenoxy ]ethyl}{ 3-[ ( 2R)-2-am ino-6-guanidinohexanoyla mino] propyl }amino )propylamino ]-6-guanidino-1-hexanone hexahydrochloride", "invented_name": "", "therapeutic_area": "Ophthalmology", "pharmaceutical_forms": "Eye drops, solution", "condition_indication": "Treatment of dry eye disease", "routes_of_administration": "Ophthalmic use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "07/05/2018", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Shire Pharmaceuticals Ireland Limited; 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KG); Tel. +49 404418090; E-mail: regaffairs@aet.eu", "first_published_date": "28/11/2018", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002309-pip01-17" }, { "decision_number": "P/0218/2018", "pip_number": "EMEA-002322-PIP01-17", "active_substance": "patidegib", "invented_name": "", "therapeutic_area": "Dermatology", "pharmaceutical_forms": "Gel", "condition_indication": "Treatment of naevoid basal-cell carcinoma syndrome (Gorlin syndrome)", "routes_of_administration": "Topical use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "17/07/2018", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Pellepharm, Inc; Tel.  +33 182731004; E-mail: leclere.marie-caroline@blue-reg.com", "first_published_date": "28/11/2018", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002322-pip01-17" }, { "decision_number": "P/0213/2018", "pip_number": "EMEA-001748-PIP01-15-M01", "active_substance": "arimoclomol citrate", "invented_name": "", "therapeutic_area": "Neurology", "pharmaceutical_forms": "Capsule, hard", "condition_indication": "Treatment of Niemann-Pick disease, type C", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "17/07/2018", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Orphazyme A/S; 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Tel.  +49 8990414910; E-mail: contact@breath-therapeutics.com", "first_published_date": "27/11/2018", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002344-pip01-18" }, { "decision_number": "P/0191/2018", "pip_number": "EMEA-000297-PIP02-12-M02", "active_substance": "Glycerol phenylbutyrate", "invented_name": "Ravicti; Ravicti", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Oral liquid", "condition_indication": "Treatment of urea cycle disorders", "routes_of_administration": "Oral use;Gastroenteral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "17/07/2018", "compliance_outcome": "Positive", "compliance_opinion_date": "21/09/2018", "compliance_procedure_number": "EMEA-C-000297-PIP02-12-M02", "contact_for_public_enquiries": "Horizon Pharma Ireland Limited; E-mail: regulatory-eu@horizonpharma.com; Tel.  +353 1772 2100", "first_published_date": "08/10/2013", "last_updated_date": "27/11/2018", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000297-pip02-12-m02" }, { "decision_number": "P/0214/2018", "pip_number": "EMEA-001535-PIP01-13-M01", "active_substance": "potassium citrate monohydrated;potassium hydrogen carbonate (ADV7103)", "invented_name": "", "therapeutic_area": "Uro-nephrology", "pharmaceutical_forms": "Prolonged-release granules", "condition_indication": "Treatment of cystinuria", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "17/07/2018", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Advicenne; E-mail: infomed@advicenne.com; Tel. +33 4660 55420", "first_published_date": "05/11/2014", "last_updated_date": "27/11/2018", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001535-pip01-13-m01" }, { "decision_number": "P/0155/2018", "pip_number": "EMEA-002353-PIP01-18", "active_substance": "split influenza virus, inactivated containing antigens equivalent to the A/H1N1-like strain;split influenza virus, inactivated containing antigens equivalent to the A/H3N2-like strain;split influenza virus, inactivated containing antigens equivalent to the B-like strain", "invented_name": "", "therapeutic_area": "Vaccines", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Prevention of influenza infection", "routes_of_administration": "Intramuscular use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "25/05/2018", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Sanofi pasteur; Email: piplan@sanofipasteur.com; Tel. +33 4373 75038", "first_published_date": "27/11/2018", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002353-pip01-18" }, { "decision_number": "P/0145/2018", "pip_number": "EMEA-002192-PIP02-17", "active_substance": "amlodipine;irbesartan", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Treatment of hypertension", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "07/05/2018", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Win Medica S.A.; E-mail: info@winmedica.gr; Tel. +30 2107488821", "first_published_date": "27/11/2018", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002192-pip02-17" }, { "decision_number": "P/0135/2018", "pip_number": "EMEA-002002-PIP02-17", "active_substance": "Ibuprofen;paracetamol", "invented_name": "", "therapeutic_area": "Pain", "pharmaceutical_forms": "Oral suspension", "condition_indication": "Treatment of febrile disorders;Treatment of pain", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "07/05/2018", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Farmalider, S.A; E-mail: carloscalandria@farmalider.com; Tel. +34 9166 12335", "first_published_date": "27/11/2018", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002002-pip02-17" }, { "decision_number": "P/0178/2018", "pip_number": "EMEA-001469-PIP02-17", "active_substance": "somapacitan", "invented_name": "", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Treatment of short stature", "routes_of_administration": "Subcutaneous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "15/06/2018", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Novo Nordisk A/S; E-mail: paediatrics@novonordisk.com; Tel. +45 4444 8888", "first_published_date": "27/11/2018", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001469-pip02-17" }, { "decision_number": "P/0187/2018", "pip_number": "EMEA-001741-PIP05-17", "active_substance": "upadacitinib", "invented_name": "", "therapeutic_area": "", "pharmaceutical_forms": "Tablet", "condition_indication": "Treatment of vasculitides", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "17/07/2018", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "AbbVie LtdE-mail: paediatricteam@abbvie.comTel. +44(0) 1628925033", "first_published_date": "27/11/2018", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001741-pip05-17" }, { "decision_number": "P/0202/2018", "pip_number": "EMEA-000694-PIP03-17", "active_substance": "dapagliflozin", "invented_name": "Forxiga; Forxiga", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Prevention of cardiovascular events in patients with chronic heart failure", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "19/07/2018", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "AstraZeneca AB (UK); Tel. +44 2037496236; E-mail: paediatrics@astrazeneca.com", "first_published_date": "27/11/2018", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000694-pip03-17" }, { "decision_number": "P/0148/2018", "pip_number": "EMEA-001080-PIP01-10", "active_substance": "Delafloxacin", "invented_name": "", "therapeutic_area": "Infectious diseases", "pharmaceutical_forms": "Powder for solution for infusion;Capsule, hard;Tablet", "condition_indication": "Treatment of local infections of skin and subcutaneous tissues", "routes_of_administration": "Intravenous use;Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "18/05/2018", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "A.Menarini - IndustrieFarmaceutiche Riunite - s.r.I.; E-mail: prijli@menarini.it; Tel. +39 0555 680633", "first_published_date": "27/11/2018", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001080-pip01-10-0" }, { "decision_number": "P/0195/2018", "pip_number": "EMEA-001196-PIP02-17", "active_substance": "Fostamatinib", "invented_name": "", "therapeutic_area": "Other", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Treatment of idiopathic thrombocytopenic purpura as a model for immunomodulation", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Rigel Pharmaceuticals Ltd; E-mail: dvance@rigel.com; Tel. +44 (0)1603 693204", "first_published_date": "27/11/2018", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001196-pip02-17" }, { "decision_number": "P/0147/2018", "pip_number": "EMEA-000342-PIP01-08-M07", "active_substance": "sunitinib", "invented_name": "Sutent; Sutent", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Capsule, hard", "condition_indication": "Treatment of gastro-intestinal stromal tumours", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "07/05/2018", "compliance_outcome": "Positive", "compliance_opinion_date": "29/06/2018", "compliance_procedure_number": "EMEA-C-000342-PIP01-08-M07", "contact_for_public_enquiries": "Pfizer Limited; Tel. + 44 1304646607; E-mail: pip_enquiries@pfizer.com", "first_published_date": "23/04/2009", "last_updated_date": "27/11/2018", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000342-pip01-08-m07" }, { "decision_number": "P/0226/2018", "pip_number": "EMEA-001417-PIP01-12-M04", "active_substance": "febuxostat", "invented_name": "Adenuric; Adenuric", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Prevention of hyperuricaemia", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "20/07/2018", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Menarini International Operations Luxembourg S.A.; E-mail: prijli@menarini.it; Tel. +39 0555 680633", "first_published_date": "05/06/2014", "last_updated_date": "22/11/2018", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001417-pip01-12-m04" }, { "decision_number": "P/0142/2018", "pip_number": "EMEA-000527-PIP05-17", "active_substance": "ranibizumab", "invented_name": "Lucentis; Lucentis", "therapeutic_area": "Ophthalmology", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Diabetic retinopathy", "routes_of_administration": "Intravitreal use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "07/05/2018", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Novartis Europharm LimitedE-mail: paediatric.enquiries@novartis.comTel. +41 613241111", "first_published_date": "22/11/2018", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000527-pip05-17" }, { "decision_number": "P/0206/2018", "pip_number": "EMEA-000347-PIP03-18", "active_substance": "bilastine", "invented_name": "Bilaxten and associated names", "therapeutic_area": "Dermatology", "pharmaceutical_forms": "Orodispersible film", "condition_indication": "Treatment of allergic rhinoconjunctivitis;Treatment of urticaria", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "19/07/2018", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Faes Farma S.A.; E-mail: ieguidazu@faes.es, mjarenal@faes.es; Tel. +34 944818300", "first_published_date": "22/11/2018", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000347-pip03-18" }, { "decision_number": "P/0183/2018", "pip_number": "EMEA-000118-PIP04-17", "active_substance": "abatacept", "invented_name": "Orencia; Orencia", "therapeutic_area": "Immunology-Rheumatology-Transplantation", "pharmaceutical_forms": "Powder for concentrate for solution for infusion;Solution for injection", "condition_indication": "", "routes_of_administration": "Intravenous use;Subcutaneous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "22/06/2018", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Bristol-Myers Squibb Pharma EEIG E-mail: medical.information@bms.com Tel. +44 (0)1423 533610", "first_published_date": "22/11/2018", "last_updated_date": "", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000118-pip04-17" }, { "decision_number": "P/245/2011", "pip_number": "EMEA-000982-PIP01-10", "active_substance": "furosemide", "invented_name": "", "therapeutic_area": "Uro-nephrology", "pharmaceutical_forms": "Orodispersible tablet", "condition_indication": "Treatment of fluid retention", "routes_of_administration": "Oral use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "21/10/2011", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "KidzPharma Inc.; United Kingdom; george.overend@orsoxford.co.uk; +44 1844279600; +44 1844279602", "first_published_date": "28/11/2011", "last_updated_date": "02/10/2018", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000982-pip01-10" }, { "decision_number": "P/0148/2014", "pip_number": "EMEA-001487-PIP01-13", "active_substance": "Gevokizumab", "invented_name": "", "therapeutic_area": "Ophthalmology", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Treatment of chronic non-infectious uveitis", "routes_of_administration": "Subcutaneous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "13/06/2014", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Les Laboratoires ServierE-mail: cafaro@xoma.comTel. +1 5105415034", "first_published_date": "18/07/2014", "last_updated_date": "02/10/2018", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001487-pip01-13" }, { "decision_number": "P/0131/2018", "pip_number": "EMEA-001039-PIP03-17", "active_substance": "Clostridium Botulinum neurotoxin type A (150 kD), free from complexing proteins", "invented_name": "Xeomin; Bocouture", "therapeutic_area": "Ophthalmology", "pharmaceutical_forms": "Powder for solution for injection", "condition_indication": "Treatment of hemifacial spasm", "routes_of_administration": "Intramuscular use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "13/04/2018", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Merz Pharmaceuticals GmbH; Tel.: +49 6915031; E-mail: contact@merz.de", "first_published_date": "26/07/2018", "last_updated_date": "26/07/2018", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001039-pip03-17" }, { "decision_number": "P/0126/2018", "pip_number": "EMEA-001344-PIP02-17", "active_substance": "ezetimibe;rosuvastatin", "invented_name": "Zenon; Suvezen", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Tablet", "condition_indication": "Prevention of cardiovascular events", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "11/04/2018", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Zentiva, k.s.; Czech Republic; blanka.zoubkova@zentiva.com; Tel. +42 0267243574", "first_published_date": "26/07/2018", "last_updated_date": "26/07/2018", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001344-pip02-17" }, { "decision_number": "P/0118/2018", "pip_number": "EMEA-002220-PIP01-17", "active_substance": "Influenza virus H1 haemagglutinin;influenza virus haemagglutinin from strain B Yamagata lineage (expressed as virus-like particle [VLP]);influenza virus H3 haemagglutinin;influenza virus haemagglutinin from strain B Victoria lineage", "invented_name": "", "therapeutic_area": "Vaccines", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Prevention of influenza", "routes_of_administration": "Intramuscular use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "11/04/2018", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Medicago Inc.; Tel.: +418 6589393 ext 156; E-mail: martrejl@medicago.com", "first_published_date": "26/07/2018", "last_updated_date": "26/07/2018", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002220-pip01-17" }, { "decision_number": "P/0117/2018", "pip_number": "EMEA-002255-PIP01-17", "active_substance": "polatuzumab vedotin", "invented_name": "", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Concentrate for solution for infusion", "condition_indication": "Treatment of mature B-cell neoplasms", "routes_of_administration": "Intravenous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "11/04/2018", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Roche Registration Limited; Tel. +41 616879411; E-mail: global.paediatrics@roche.com", "first_published_date": "25/07/2018", "last_updated_date": "25/07/2018", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002255-pip01-17" }, { "decision_number": "P/0116/2018", "pip_number": "EMEA-002292-PIP01-17", "active_substance": "rovalpituzumab tesirine", "invented_name": "", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Powder and solvent for concentrate for solution for infusion", "condition_indication": "Treatment of lung carcinoma (small cell and non-small cell carcinoma)", "routes_of_administration": "Intravenous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "11/04/2018", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "AbbVie LtdE-mail: paediatricteam@abbvie.comTel. +44(0) 1628925033", "first_published_date": "25/07/2018", "last_updated_date": "25/07/2018", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002292-pip01-17" }, { "decision_number": "P/0115/2018", "pip_number": "EMEA-002293-PIP01-17", "active_substance": "Calcium, N,N'-1,2-ethanediylbis[N-[[3-(hydroxy-2-methyl-5-[(phosphonooxy)methyl]-4-pyridinyl]methyl]glycine] manganese complexes", "invented_name": "", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Solution for infusion", "condition_indication": "Prevention of oxaliplatin induced peripheral neuropathy", "routes_of_administration": "Intravenous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "11/04/2018", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "PledPharma AB; Tel.: +46 708368702; E-mail: malin.nittve@pledpharma.se", "first_published_date": "25/07/2018", "last_updated_date": "25/07/2018", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002293-pip01-17" }, { "decision_number": "P/0104/2018", "pip_number": "EMEA-001304-PIP03-17", "active_substance": "obeticholic acid", "invented_name": "Ocaliva; Ocaliva", "therapeutic_area": "Gastroentology-Hepatology", "pharmaceutical_forms": "Age appropriate oral solid dosage form;Tablet", "condition_indication": "Treatment of non-alcoholic steatohepatitis (NASH)", "routes_of_administration": "Oral use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "11/04/2018", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Intercept Pharma Ltd.; Tel.: +1 6195417227; E-mail: reginfo@interceptpharma.com", "first_published_date": "25/07/2018", "last_updated_date": "25/07/2018", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001304-pip03-17" }, { "decision_number": "P/0346/2023", "pip_number": "EMEA-001523-PIP02-14-M03", "active_substance": "Guselkumab", "invented_name": "Tremfya; Tremfya", "therapeutic_area": "Immunology-Rheumatology-Transplantation", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Treatment of psoriasis", "routes_of_administration": "Subcutaneous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "08/09/2023", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Janssen Cilag International NV; Tel. +3214602111; E-mail: contact@Janssen-emea.com", "first_published_date": "25/04/2016", "last_updated_date": "25/07/2018", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001523-pip02-14-m03" }, { "decision_number": "P/023/2018", "pip_number": "EMEA-001448-PIP01-13-M03", "active_substance": "nusinersen", "invented_name": "Spinraza; Spinraza", "therapeutic_area": "Neurology", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Treatment of spinal muscular atrophy", "routes_of_administration": "Intrathecal use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "11/04/2018", "compliance_outcome": "Positive", "compliance_opinion_date": "29/06/2018", "compliance_procedure_number": "EMEA-C-001448-PIP01-13-M03", "contact_for_public_enquiries": "Biogen Idec Ltd; Tel. +44 1628501014; E-mail: pip.enquiries@biogenidec.com", "first_published_date": "13/05/2014", "last_updated_date": "25/07/2018", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001448-pip01-13-m03" }, { "decision_number": "P/0227/2014", "pip_number": "EMEA-000362-PIP01-08-M04", "active_substance": "aliskiren", "invented_name": "Rasilez; Rasilez", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Film-coated tablet;Granules", "condition_indication": "Heart Failure;Treatment of hypertension", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "06/09/2014", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Novartis Europharm Ltd; E-mail: marine.lafargue@iqvia.com; Tel. +33 1748 82008", "first_published_date": "17/10/2011", "last_updated_date": "16/07/2018", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000362-pip01-08-m04" }, { "decision_number": "P/62/2008", "pip_number": "Thrombin alfa", "active_substance": "thrombin alfa", "invented_name": "", "therapeutic_area": "Haematology-Hemostaseology", "pharmaceutical_forms": "Powder and solvent for reconstitution", "condition_indication": "Haemorrhage complicating a surgical procedure", "routes_of_administration": "Epilesional use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "14/08/2008", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Bayer HealthCare AG; Tel. +49 30346815333; Fax +49 3046895333; E-mail: pediatrics.medical-affairs-europe@bayerhealthcare.com", "first_published_date": "18/09/2008", "last_updated_date": "06/07/2018", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/thrombin-alfa" }, { "decision_number": "P/0112/2017", "pip_number": "EMEA-001965-PIP01-16", "active_substance": "olodaterol (hydrochloride)", "invented_name": "Striverdi; Respimat", "therapeutic_area": "Pneumology-allergology", "pharmaceutical_forms": "Inhalation solution", "condition_indication": "Treatment of cystic fibrosis", "routes_of_administration": "Inhalation use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "11/04/2017", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Boehringer Ingelheim International GmbH; Tel. +49 6132 778271; Email: Paediatrics@boehringer-ingelheim.com", "first_published_date": "29/05/2017", "last_updated_date": "05/07/2018", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001965-pip01-16" }, { "decision_number": "P/0089/2018", "pip_number": "EMEA-002263-PIP01-17", "active_substance": "trazodone (hydrochloride);gabapentin", "invented_name": "", "therapeutic_area": "Pain", "pharmaceutical_forms": "Capsule, hard", "condition_indication": "Treatment of painful diabetic neuropathy", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "16/03/2018", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. - S.p.A.; Tel. +39 0691045249; E-mail: m.gatto@angelini.it;  ", "first_published_date": "19/06/2018", "last_updated_date": "19/06/2018", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002263-pip01-17" }, { "decision_number": "P/0063/2018", "pip_number": "EMEA-000499-PIP04-17", "active_substance": "veliparib", "invented_name": "", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Capsule, hard;Age appropriate oral liquid dosage formulation;Tablet", "condition_indication": "Treatment of lung carcinoma (small cell and non-small cell carcinoma)", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "16/03/2018", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "AbbVie LtdE-mail: paediatricteam@abbvie.comTel. +44(0) 1628925033", "first_published_date": "19/06/2018", "last_updated_date": "19/06/2018", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000499-pip04-17" }, { "decision_number": "P/0059/2018", "pip_number": "EMEA-001151-PIP02-17", "active_substance": "dapagliflozin;metformin hydrochloride", "invented_name": "", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Modified-release tablet", "condition_indication": "Treatment of type II diabetes mellitus", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "16/03/2018", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "AstraZeneca AB (UK); Tel. +44 1625230700; E-mail: paediatrics@astrazeneca.com;  ", "first_published_date": "19/06/2018", "last_updated_date": "19/06/2018", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001151-pip02-17" }, { "decision_number": "P/0086/2018", "pip_number": "EMEA-002302-PIP01-17", "active_substance": "Ibuprofen", "invented_name": "", "therapeutic_area": "Other", "pharmaceutical_forms": "Solution for infusion", "condition_indication": "Treatment of febrile disorders;Treatment of pain", "routes_of_administration": "Intravenous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "16/03/2018", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Farmalíder, S.A.; Tel. +34 916612335; E-mail: carloscalandria@farmalider.com", "first_published_date": "19/06/2018", "last_updated_date": "19/06/2018", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002302-pip01-17" }, { "decision_number": "P/0093/2018", "pip_number": "EMEA-002248-PIP01-17", "active_substance": "Candesartan cilexetil;amlodipine besilate", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Tablet", "condition_indication": "Treatment of hypertension", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "16/03/2018", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Midas Pharma GmbH; E-mail: info@midas-pharma.com; Tel. +49 6132 9900", "first_published_date": "19/06/2018", "last_updated_date": "19/06/2018", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002248-pip01-17" }, { "decision_number": "P/0087/2018", "pip_number": "EMEA-002272-PIP01-17", "active_substance": "Entinostat Polymorph B", "invented_name": "", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Treatment of breast malignant neoplasms", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "16/03/2018", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Syndax Pharmaceuticals, Inc.; Tel. +44(0) 7723045990", "first_published_date": "19/06/2018", "last_updated_date": "19/06/2018", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002272-pip01-17" }, { "decision_number": "P/0066/2018", "pip_number": "EMEA-001716-PIP02-17", "active_substance": "venglustat", "invented_name": "", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Capsule, hard", "condition_indication": "Treatment of Parkinson's disease", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "16/03/2018", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Genzyme Europe B.V.; Tel. +31 356991499; E-mail: eumedinfo.gz@sanofi.com", "first_published_date": "19/06/2018", "last_updated_date": "19/06/2018", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001716-pip02-17" }, { "decision_number": "P/0091/2018", "pip_number": "EMEA-002252-PIP01-17", "active_substance": "T-cell bispecific antibody targeting carcinoembryonic antigen expressed on tumor cells and CD3 epsilon chain present on T-cells", "invented_name": "", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Concentrate for solution for infusion", "condition_indication": "Treatment of all conditions included in the category of malignant neoplasms (except central nervous system tumours, haematopoietic and lymphoid tissue neoplasms)", "routes_of_administration": "Intravenous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "16/03/2018", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Roche Registration Limited; Tel. +41 616879411; E-mail: global.paediatrics@roche.com", "first_published_date": "19/06/2018", "last_updated_date": "19/06/2018", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002252-pip01-17" }, { "decision_number": "P/0094/2018", "pip_number": "EMEA-002254-PIP01-17", "active_substance": "treprostinil sodium", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Solution for infusion", "condition_indication": "Treatment of chronic thromboembolic pulmonary hypertension", "routes_of_administration": "Subcutaneous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "16/03/2018", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "SciPharm Sàrl; Tel. +352 271127017; E-mail: office@scipharm.eu", "first_published_date": "19/06/2018", "last_updated_date": "19/06/2018", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002254-pip01-17" }, { "decision_number": "P/0088/2018", "pip_number": "EMEA-002268-PIP01-17", "active_substance": "niraparib", "invented_name": "", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Capsule, hard", "condition_indication": "Treatment of prostate malignant neoplasms", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "16/03/2018", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Janssen Research & Development; Tel. +353 857446696; E-mail: nbuhl@its.jnj.com", "first_published_date": "19/06/2018", "last_updated_date": "19/06/2018", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002268-pip01-17" }, { "decision_number": "P/0090/2018", "pip_number": "EMEA-002257-PIP01-17", "active_substance": "rosuvastatin;ezetimibe", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Treatment of hypercholesterolaemia", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "16/03/2018", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "ELPEN Pharmaceutical Co. 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Tel. +44 1753677251; E-mail: kenneth.johnson@ucb.com", "first_published_date": "25/07/2017", "last_updated_date": "17/04/2018", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000402-pip02-11-m05" }, { "decision_number": "P/0004/2018", "pip_number": "EMEA-000341-PIP02-09-M05", "active_substance": "L-asparaginase encapsulated in erythrocytes", "invented_name": "", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Dispersion for injection", "condition_indication": "Treatment of acute lymphoblastic leukaemia", "routes_of_administration": "Intravenous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "04/01/2018", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Erytech pharma S.A.; Tel. +33 4787 44438; E-mail: vsemareg@erytech.com", "first_published_date": "25/11/2010", "last_updated_date": "17/04/2018", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000341-pip02-09-m05" }, { "decision_number": "P/0002/2018", "pip_number": "EMEA-000153-PIP01-07-M05", "active_substance": "artenimol;piperaquine phosphate anhydride", "invented_name": "Eurartesim; 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Tel. +1 2153139618; E-mail: Chris.Coughlin@immunocore.com", "first_published_date": "07/03/2018", "last_updated_date": "07/03/2018", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002197-pip01-17" }, { "decision_number": "P/0368/2017", "pip_number": "EMEA-002195-PIP01-17", "active_substance": "vonapanitase", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Irrigation solution", "condition_indication": "Prevention of arteriovenous access dysfunction", "routes_of_administration": "Epilesional use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "01/12/2017", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Proteon Therapeutics Limited; Tel. +44 1635576298; E-mail: info@proteontx.com", "first_published_date": "07/03/2018", "last_updated_date": "07/03/2018", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002195-pip01-17" }, { "decision_number": "P/0367/2017", "pip_number": "EMEA-002196-PIP01-17", "active_substance": "human Neutrophil Elastase Inhibitor (CHF6333)", "invented_name": "", "therapeutic_area": "Pneumology-allergology", "pharmaceutical_forms": "Pressurised inhalation (suspension)", "condition_indication": "Treatment of bronchiectasis", "routes_of_administration": "Inhalation use", "decision_type": "RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)", "decision_date": "01/12/2017", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Chiesi Farmaceutici S.p.A; 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Tel. +49 173 2393159; E-mail: markus.rothenburger@mallinckrodt.com", "first_published_date": "13/08/2013", "last_updated_date": "06/03/2018", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001340-pip01-12-m03" }, { "decision_number": "P/0355/2017", "pip_number": "EMEA-000018-PIP01-07-M14", "active_substance": "tapentadol hydrochloride", "invented_name": "Palexia and associated names; Yantil and associated names; Tapentadol and associated names", "therapeutic_area": "Pain", "pharmaceutical_forms": "Film-coated tablet;Oral solution;Solution for injection/infusion", "condition_indication": "Treatment of acute pain", "routes_of_administration": "Oral use;Intravenous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "01/12/2017", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Grünenthal GmbH; Tel.: +49 2415690; E-mail: pediatrics@grunenthal.com ", "first_published_date": "03/07/2017", "last_updated_date": "05/03/2018", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000018-pip01-07-m14" }, { "decision_number": "P/0389/2017", "pip_number": "EMEA-000971-PIP01-10-M03", "active_substance": "human coagulation factor X", "invented_name": "Coagadex; Coagadex", "therapeutic_area": "Haematology-Hemostaseology", "pharmaceutical_forms": "Powder for solution for injection or infusion", "condition_indication": "Treatment of hereditary factor X deficiency", "routes_of_administration": "Intravenous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "19/12/2017", "compliance_outcome": "Positive", "compliance_opinion_date": "26/01/2018", "compliance_procedure_number": "EMEA-C-000971-PIP01-10-M03", "contact_for_public_enquiries": "Bio Products Laboratory Limited; Tel. +44 2089572200; E-mail: medinfo@bpl.co.uk", "first_published_date": "08/04/2011", "last_updated_date": "05/03/2018", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000971-pip01-10-m03" }, { "decision_number": "P/0391/2017", "pip_number": "EMEA-000794-PIP01-09-M01", "active_substance": "aluminium hydroxide adsorbed, depigmented glutaraldehyde polymerised, allergic extract of equal amounts of Phleum pratense, Dactylis glomerata, Festuca elatior, Lolium perenne and Poa pratensis pollen (Grasses-Mix) (1/5) each", "invented_name": "", "therapeutic_area": "Pneumology-allergology", "pharmaceutical_forms": "Suspension for injection", "condition_indication": "Treatment of allergic rhinitis;Treatment of rhino-conjuctivitis", "routes_of_administration": "Subcutaneous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "19/12/2017", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "LETI Pharma GmbH; Tel. +49 89121400290; E-mail: paediatrics@leti.de", "first_published_date": "21/12/2010", "last_updated_date": "05/03/2018", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000794-pip01-09-m01" }, { "decision_number": "P/0392/2017", "pip_number": "EMEA-000792-PIP01-09-M01", "active_substance": "aluminium hydroxide adsorbed, depigmented glutaraldehyde polymerised, allergic extract of equal amounts of Phleum pratense, Dactylis glomerata, Festuca elatior, Lolium perenne and Poa pratensis pollen (Grasses-Mix) and Secale cereale (cultivated rye) pollen (50/50)", "invented_name": "", "therapeutic_area": "Pneumology-allergology", "pharmaceutical_forms": "Suspension for injection", "condition_indication": "Treatment of allergic rhinitis;Treatment of rhino-conjuctivitis", "routes_of_administration": "Subcutaneous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "19/12/2017", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "LETI Pharma GmbH; Tel. +49 89121400290; E-mail: paediatrics@leti.de", "first_published_date": "21/12/2010", "last_updated_date": "05/03/2018", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000792-pip01-09-m01" }, { "decision_number": "P/0390/2017", "pip_number": "EMEA-000795-PIP01-09-M01", "active_substance": "aluminium hydroxide adsorbed, depigmented glutaraldehyde polymerised, allergic extract of Phleum pratense pollen", "invented_name": "", "therapeutic_area": "Pneumology-allergology", "pharmaceutical_forms": "Suspension for injection", "condition_indication": "Treatment of allergic rhinitis;Treatment of rhino-conjuctivitis", "routes_of_administration": "Subcutaneous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "19/12/2017", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "LETI Pharma GmbH; Tel. +49 89121400290; E-mail: paediatrics@leti.de", "first_published_date": "21/12/2010", "last_updated_date": "05/03/2018", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000795-pip01-09-m01" }, { "decision_number": "P/0354/2017", "pip_number": "EMEA-000239-PIP01-08-M03", "active_substance": "telavancin hydrochloride", "invented_name": "Vibativ; 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Tel. +49 70719755721; E-mail: info@cumdente.de", "first_published_date": "05/03/2018", "last_updated_date": "05/03/2018", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002170-pip01-17" }, { "decision_number": "P/0372/2017", "pip_number": "EMEA-002094-PIP01-16", "active_substance": "Iron hydroxyethyl amylopectin heptonate", "invented_name": "", "therapeutic_area": "Haematology-Hemostaseology", "pharmaceutical_forms": "Solution for injection/infusion", "condition_indication": "Treatment of iron deficiency or iron deficiency anaemia", "routes_of_administration": "Intravenous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "01/12/2017", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "iron4u; Tel. +45 45475040; E-mail: ovn@iron4u.com", "first_published_date": "05/03/2018", "last_updated_date": "05/03/2018", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002094-pip01-16" }, { "decision_number": "P/0278/2017", "pip_number": "EMEA-000559-PIP01-09-M04", "active_substance": "Japanese encephalitis virus, inactivated (attenuated strain SA14-14-2 grown in vero cells)", "invented_name": "Ixiaro; 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Sycrest", "therapeutic_area": "Psychiatry", "pharmaceutical_forms": "Sublingual tablet", "condition_indication": "Treatment of bipolar I disorder", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "24/11/2014", "compliance_outcome": "Positive", "compliance_opinion_date": "18/08/2017", "compliance_procedure_number": "EMEA-C-000228-PIP01-08-M04", "contact_for_public_enquiries": "N.V. Organon; E-mail: regaffairseurope@organon.com; Tel: +31 412770000", "first_published_date": "03/10/2011", "last_updated_date": "02/03/2018", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000228-pip01-08-m04" }, { "decision_number": "P/0050/2017", "pip_number": "EMEA-000087-PIP01-07-M05", "active_substance": "fingolimod hydrochloride ", "invented_name": "Gilenya; Gilenya", "therapeutic_area": "Neurology", "pharmaceutical_forms": "Capsule, hard", "condition_indication": "Treatment of multiple sclerosis", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "03/04/2017", "compliance_outcome": "Positive", "compliance_opinion_date": "10/11/2017", "compliance_procedure_number": "EMEA-C-000087-PIP01-07-M05", "contact_for_public_enquiries": "Novartis Europharm LimitedE-mail: paediatric.enquiries@novartis.comTel. +41 613241111", "first_published_date": "04/01/2013", "last_updated_date": "02/03/2018", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000087-pip01-07-m05" }, { "decision_number": "P/0129/2017", "pip_number": "EMEA-001254-PIP01-11-M02", "active_substance": "split influenza virus, inactivated containing antigens equivalent to the B-like strain (B/Yamagata lineage);split influenza virus, inactivated containing antigens equivalent to the B-like strain (B/Victoria lineage);split influenza virus, inactivated (B/Victoria lineage);split influenza virus, inactivated containing antigens equivalent to the A/H1N1-like strain;split influenza virus, inactivated containing antigens equivalent to the A/H3N2-like strain", "invented_name": "", "therapeutic_area": "Vaccines", "pharmaceutical_forms": "Suspension for injection", "condition_indication": "Prevention of influenza infection", "routes_of_administration": "Subcutaneous use;Intramuscular use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "08/05/2017", "compliance_outcome": "Positive", "compliance_opinion_date": "23/06/2017", "compliance_procedure_number": "EMEA-C-001254-PIP01-11-M02", "contact_for_public_enquiries": "Sanofi Pasteur SP; France; Tel. +33 4373 75038; E-mail: piplan@sanofipasteur.com", "first_published_date": "18/09/2012", "last_updated_date": "02/03/2018", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001254-pip01-11-m02" }, { "decision_number": "P/0306/2012", "pip_number": "EMEA-000876-PIP02-11-M01", "active_substance": "Eculizumab", "invented_name": "Soliris; Soliris", "therapeutic_area": "Immunology-Rheumatology-Transplantation", "pharmaceutical_forms": "Concentrate for solution for infusion", "condition_indication": "Treatment of Shiga-toxin-producing Escherichia coli haemolytic uraemic syndrome", "routes_of_administration": "Intravenous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "21/12/2012", "compliance_outcome": "Positive", "compliance_opinion_date": "02/06/2015", "compliance_procedure_number": "EMEA-000876-PIP01-10-M01", "contact_for_public_enquiries": "Alexion Europe SASEmail: pip.enquiries.eu@alxn.com Tel. +33 1 47 10 06 06", "first_published_date": "23/08/2012", "last_updated_date": "02/03/2018", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000876-pip02-11-m01" }, { "decision_number": "P/0083/2017", "pip_number": "EMEA-000717-PIP02-13-M02", "active_substance": "vigabatrin", "invented_name": "", "therapeutic_area": "Neurology", "pharmaceutical_forms": "Soluble tablet", "condition_indication": "Treatment of epilepsy", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "16/03/2017", "compliance_outcome": "Positive", "compliance_opinion_date": "21/07/2017", "compliance_procedure_number": "EMEA-C-000717-PIP02-13-M02", "contact_for_public_enquiries": "Orphelia Pharma SA; France; E-mail: contact@orphelia-pharma.eu; Tel. +33 1427 70818", "first_published_date": "31/07/2014", "last_updated_date": "02/03/2018", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000717-pip02-13-m02" }, { "decision_number": "P/0280/2016", "pip_number": "EMEA-001729-PIP01-14-M01", "active_substance": "recombinant human nerve growth factor", "invented_name": "", "therapeutic_area": "Ophthalmology", "pharmaceutical_forms": "Eye drops, solution", "condition_indication": "Treatment of neurotrophic keratitis", "routes_of_administration": "Ocular use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "12/10/2016", "compliance_outcome": "Positive", "compliance_opinion_date": "10/11/2017", "compliance_procedure_number": "EMEA-C-001729-PIP01-14-M01", "contact_for_public_enquiries": "Dompé farmaceutici SpA; Italy; Tel.: +39 3669018586; Email: lamberto.dionigi@dompe.com", "first_published_date": "22/09/2015", "last_updated_date": "02/03/2018", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001729-pip01-14-m01" }, { "decision_number": "P/0157/2016", "pip_number": "EMEA-001039-PIP01-10-M02", "active_substance": "Clostridium Botulinum neurotoxin type A (150 kD), free from complexing proteins", "invented_name": "Xeomin; Bocouture", "therapeutic_area": "Neurology", "pharmaceutical_forms": "Powder for solution for injection", "condition_indication": "Treatment of dystonia;Treatment of muscle spasticity;Treatment of muscle-induced wrinkles", "routes_of_administration": "Intramuscular use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "15/06/2016", "compliance_outcome": "Positive", "compliance_opinion_date": "15/12/2017", "compliance_procedure_number": "EMEA-C-001039-PIP01-10-M02", "contact_for_public_enquiries": "Merz Pharmaceuticals GmbH ; Germany; Tel. +49 6915031 ; Fax +49 691503200; E-mail: contact@merz.de", "first_published_date": "06/05/2015", "last_updated_date": "02/03/2018", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001039-pip01-10-m02" }, { "decision_number": "P/0346/2017", "pip_number": "EMEA-001363-PIP01-12-M01", "active_substance": "thrombomodulin alfa", "invented_name": "", "therapeutic_area": "Infectious diseases", "pharmaceutical_forms": "Solution for infusion", "condition_indication": "Treatment of sepsis", "routes_of_administration": "Intravenous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "01/12/2017", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Asahi Kasei Pharma America Corporation; Tel. +1 7814191940; E-mail: RegInquiry@akpamerica.com", "first_published_date": "08/10/2013", "last_updated_date": "02/03/2018", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001363-pip01-12-m01" }, { "decision_number": "P/0270/2013", "pip_number": "EMEA-001382-PIP01-12", "active_substance": "eptacog alfa (activated)", "invented_name": "", "therapeutic_area": "Haematology-Hemostaseology", "pharmaceutical_forms": "Powder and solvent for solution for injection", "condition_indication": "Treatment of congenital coagulation disorders", "routes_of_administration": "Intravenous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "30/10/2013", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Baxalta Innovations GmbH; Austria; E-mail: johannes.braun@baxalta.com; Tel. +43 1201002472542", "first_published_date": "15/11/2013", "last_updated_date": "26/02/2018", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001382-pip01-12" }, { "decision_number": "P/0246/2015", "pip_number": "EMEA-000674-PIP02-11-M01", "active_substance": "volasertib", "invented_name": "", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Solution for infusion", "condition_indication": "Treatment of acute myeloid leukaemia", "routes_of_administration": "Intravenous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "30/10/2015", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Boehringer Ingelheim International GmbH; Tel. +49 6132 778271; Email: Paediatrics@boehringer-ingelheim.com", "first_published_date": "30/04/2013", "last_updated_date": "23/02/2018", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000674-pip02-11-m01" }, { "decision_number": "P/257/2011", "pip_number": "EMEA-001078-PIP01-10", "active_substance": "Lixivaptan", "invented_name": "", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Capsule, hard", "condition_indication": "Treatment of hyponatraemia", "routes_of_administration": "Oral use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "26/10/2011", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Cardiokine Biopharma, LLC ; USA; struocchio@cardiokine.com; +1 2153991219; +1 2153991230", "first_published_date": "29/11/2011", "last_updated_date": "23/02/2018", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001078-pip01-10" }, { "decision_number": "P/0321/2017", "pip_number": "EMEA-000782-PIP01-09-M04", "active_substance": "tralokinumab", "invented_name": "", "therapeutic_area": "Pneumology-allergology", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Treatment of asthma", "routes_of_administration": "Subcutaneous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "31/10/2017", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "MedImmune Ltd; Tel. +44 (0)1582836181; E-mail: paediatrics@medimmune.com", "first_published_date": "21/12/2011", "last_updated_date": "23/02/2018", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000782-pip01-09-m04" }, { "decision_number": "P/0021/2014", "pip_number": "EMEA-001406-PIP01-12", "active_substance": "Mesalazine;prednisolone metasulphobenzoate", "invented_name": "", "therapeutic_area": "Gastroentology-Hepatology", "pharmaceutical_forms": "Rectal suspension", "condition_indication": "Treatment of ulcerative colitis", "routes_of_administration": "Rectal use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "22/01/2014", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Disphar International B.V.; The Netherlands; E-mail: mcguinness@disphar.com; Tel. +31 3552 80400; Fax +31 3554 80585", "first_published_date": "20/02/2014", "last_updated_date": "23/02/2018", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001406-pip01-12" }, { "decision_number": "P/0042/2018", "pip_number": "EMEA-000567-PIP01-09-M05", "active_substance": "dasatinib", "invented_name": "Sprycel; Sprycel", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Film-coated tablet;Age appropriate oral formulation", "condition_indication": "Treatment of Philadelphia-chromosome (BCR-ABL translocation)-positive acute lymphoblastic leukaemia;Treatment of Philadelphia-chromosome (BCR-ABL translocation)-positive chronic myeloid leukaemia", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "16/02/2018", "compliance_outcome": "Positive", "compliance_opinion_date": "23/02/2018", "compliance_procedure_number": "EMEA-C-000567-PIP01-09-M05", "contact_for_public_enquiries": "Bristol-Myers Squibb Pharma EEIG E-mail: medical.information@bms.com Tel. +44 (0)1423 533610", "first_published_date": "15/09/2011", "last_updated_date": "16/02/2018", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000567-pip01-09-m05" }, { "decision_number": "P/0321/2017", "pip_number": "EMEA-001418-PIP01-15-M01", "active_substance": "cabotegravir", "invented_name": "", "therapeutic_area": "Infectious diseases", "pharmaceutical_forms": "Suspension for injection;Tablet;Age appropriate oral dosage formulation", "condition_indication": "Treatment of human immunodeficiency virus (HIV-1) infection", "routes_of_administration": "Oral use;Intramuscular use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "30/10/2017", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "ViiV Healthcare UK Limited; 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Tel. +42 267242361; E-mail: dana.petrikova@sanofi.com", "first_published_date": "12/02/2018", "last_updated_date": "12/02/2018", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002174-pip01-17" }, { "decision_number": "P/0289/2017", "pip_number": "EMEA-002082-PIP01-16", "active_substance": "Phenyl- and piperidin-containing derivative of amiloride (BI 443651)", "invented_name": "", "therapeutic_area": "Pneumology-allergology", "pharmaceutical_forms": "Inhalation solution", "condition_indication": "Treatment of cystic fibrosis", "routes_of_administration": "Inhalation use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "04/10/2017", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Boehringer Ingelheim International GmbH; Tel. +49 6132 778271; Email: Paediatrics@boehringer-ingelheim.com", "first_published_date": "12/02/2018", "last_updated_date": "12/02/2018", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002082-pip01-16" }, { "decision_number": "P/0263/2016", "pip_number": "EMEA-001979-PIP01-16", "active_substance": "Lifitegrast", "invented_name": "", "therapeutic_area": "Ophthalmology", "pharmaceutical_forms": "Eye drops, solution;Solution", "condition_indication": "Treatment of dry eye disease", "routes_of_administration": "Ophthalmic use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "05/10/2016", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Shire Pharmaceuticals Ireland Limited; 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Tel. +46 8 5532791; E-mail: paediatrics@astrazeneca.com", "first_published_date": "28/09/2017", "last_updated_date": "28/09/2017", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002125-pip01-17" }, { "decision_number": "P/0215/2017", "pip_number": "EMEA-001032-PIP02-17", "active_substance": "macitentan", "invented_name": "Opsumit; Opsumit", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Dispersible tablet;Film-coated tablet", "condition_indication": "Treatment of chronic thromboembolic pulmonary hypertension (CTEPH)", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "09/08/2017", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Actelion Registration LtdTel. +41 615656565E-mail: clinical-trials-disclosure@its.jnj.com", "first_published_date": "28/09/2017", "last_updated_date": "28/09/2017", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001032-pip02-17" }, { "decision_number": "P/0202/2017", "pip_number": "EMEA-002120-PIP01-17", "active_substance": "Methacholine chloride", "invented_name": "Provocholine", "therapeutic_area": "Diagnostic", "pharmaceutical_forms": "Powder for nebuliser solution", "condition_indication": "Diagnosis of asthma", "routes_of_administration": "Inhalation use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "09/08/2017", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "MWK Healthcare Ltd; United Kingdom; Tel. +44 1691664243; E-mail: mark@mwkhealthcare.co.uk ", "first_published_date": "28/09/2017", "last_updated_date": "28/09/2017", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002120-pip01-17" }, { "decision_number": "P/0199/2017", "pip_number": "EMEA-002077-PIP01-16", "active_substance": "Fc- and CDR-modified humanised monoclonal antibody against C5 (ravulizumab)", "invented_name": "", "therapeutic_area": "Haematology-Hemostaseology", "pharmaceutical_forms": "Concentrate for solution for infusion", "condition_indication": "Treatment of paroxysmal nocturnal haemoglobinuria", "routes_of_administration": "Intravenous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "14/07/2017", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Alexion Europe SASEmail: pip.enquiries.eu@alxn.com Tel. +33 1 47 10 06 06", "first_published_date": "28/09/2017", "last_updated_date": "28/09/2017", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002077-pip01-16" }, { "decision_number": "P/0201/2017", "pip_number": "EMEA-002124-PIP01-17", "active_substance": "pexastimogene devacirepvec", "invented_name": "", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Suspension for injection", "condition_indication": "Treatment of hepatocellular carcinoma", "routes_of_administration": "Intratumoral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "14/07/2017", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Transgene S.A.; France; Tel. +33 388279155; E-mail: clinical.trials@transgene.fr", "first_published_date": "28/09/2017", "last_updated_date": "28/09/2017", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002124-pip01-17" }, { "decision_number": "P/0203/2017", "pip_number": "EMEA-002132-PIP01-17", "active_substance": "diclofenac (sodium)", "invented_name": "Pennsaid", "therapeutic_area": "Pain", "pharmaceutical_forms": "Cutaneous solution", "condition_indication": "Treatment of inflammation;Treatment of pain", "routes_of_administration": "Cutaneous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "09/08/2017", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Dimethaid (UK) Limited; Tel. +1 9056 733623; E-mail: bchiasson@nuvopharm.com", "first_published_date": "28/09/2017", "last_updated_date": "28/09/2017", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002132-pip01-17" }, { "decision_number": "P/0220/2017", "pip_number": "EMEA-002149-PIP01-17", "active_substance": "DaxibotulinumtoxinA", "invented_name": "", "therapeutic_area": "Other", "pharmaceutical_forms": "Powder for solution for injection", "condition_indication": "Treatment of glabellar lines", "routes_of_administration": "Intramuscular use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "09/08/2017", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Revance Therapeutics Inc; 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S.r.l.; Italy; Tel. +39 0573474007; Fax +39 0573474963; Email: g.delorenzo@bencospa.it", "first_published_date": "25/07/2017", "last_updated_date": "25/07/2017", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002135-pip01-17" }, { "decision_number": "P/0186/2017", "pip_number": "EMEA-002131-PIP01-17", "active_substance": "ezetimibe;rosuvastatin calcium", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Tablet", "condition_indication": "Treatment of elevated cholesterol", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "30/06/2017", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Errekappa Euroterapici S.p.A.; Italy; Tel. +39 057320877; Fax +39 0573475188; E-mail: regolatorio1@errekappa.it;  ", "first_published_date": "25/07/2017", "last_updated_date": "25/07/2017", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002131-pip01-17" }, { "decision_number": "P/0174/2017", "pip_number": "EMEA-002111-PIP01-17", "active_substance": "Miridesap", "invented_name": "", "therapeutic_area": "Haematology-Hemostaseology", "pharmaceutical_forms": "Concentrate for solution for infusion", "condition_indication": "Treatment of systemic light chain amyloidosis", "routes_of_administration": "Intravenous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "03/07/2017", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "GlaxoSmithKline Trading Services Limited; Tel.: +1 4388998201; E-mail: eu.paediatric-plans@gsk.com", "first_published_date": "25/07/2017", "last_updated_date": "25/07/2017", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002111-pip01-17" }, { "decision_number": "P/0184/2017", "pip_number": "EMEA-002143-PIP01-17", "active_substance": "benzydamine (hydrochloride);econazole nitrate", "invented_name": "", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Pessary", "condition_indication": "Treatment of vulvovaginal candidiasis", "routes_of_administration": "Vaginal use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "30/06/2017", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A.; Italy; Tel. +39 0691045249; E-mail: ma.gatto@angelini.it; m.gatto@angelini.it", "first_published_date": "25/07/2017", "last_updated_date": "25/07/2017", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002143-pip01-17" }, { "decision_number": "P/0188/2017", "pip_number": "EMEA-002136-PIP01-17", "active_substance": "rosuvastatin;amlodipine", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Capsule, hard", "condition_indication": "Prevention of cardiovascular events;Treatment of dyslipidaemia;Treatment of hypertension;Treatment of ischemic coronary artery disorders", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "03/07/2017", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Errekappa Euroterapici S.p.A.; Italy; Tel. +39 057320877; Fax +39 0573475188; E-mail: regolatorio1@errekappa.it;  ", "first_published_date": "25/07/2017", "last_updated_date": "25/07/2017", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002136-pip01-17" }, { "decision_number": "P/0187/2017", "pip_number": "EMEA-002111-PIP02-17", "active_substance": "Miridesap", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Concentrate for solution for infusion", "condition_indication": "Treatment of transthyretin amyloidosis (ATTR)", "routes_of_administration": "Intravenous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "03/07/2017", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "GlaxoSmithKline Trading Services Limited; Tel. +1 4388998201; E-mail: eu.paediatric-plans@gsk.com", "first_published_date": "25/07/2017", "last_updated_date": "25/07/2017", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002111-pip02-17" }, { "decision_number": "P/0189/2017", "pip_number": "EMEA-002130-PIP01-17", "active_substance": "rosuvastatin;amlodipine", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Capsule, hard", "condition_indication": "Prevention of cardiovascular events;Treatment of dyslipidaemia;Treatment of hypertension;Treatment of ischemic coronary artery disorders", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "03/07/2017", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "CIPROS S.R.L.; Italy; Tel. +39 0573474010; Fax +39 0573475188; E- mail: regolatorio@ciprossrl.it;  ", "first_published_date": "25/07/2017", "last_updated_date": "25/07/2017", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002130-pip01-17" }, { "decision_number": "P/0152/2017", "pip_number": "EMEA-000065-PIP01-07-M05", "active_substance": "telbivudine", "invented_name": "Sebivo; Sebivo", "therapeutic_area": "Gastroentology-Hepatology", "pharmaceutical_forms": "Film-coated tablet;Oral solution", "condition_indication": "Treatment of chronic hepatitis B", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "07/06/2017", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Novartis Europharm LimitedE-mail: paediatric.enquiries@novartis.comTel. +41 613241111", "first_published_date": "25/07/2017", "last_updated_date": "25/07/2017", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000065-pip01-07-m05" }, { "decision_number": "P/0130/2017", "pip_number": "EMEA-002118-PIP01-17", "active_substance": "ezetimibe;rosuvastatin calcium", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Tablet", "condition_indication": "Treatment of hypercholesterolaemia", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "07/06/2017", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Neopharmed Gentili S.r.l; Tel. +39 06 77209020; E-mail: direnzo@direnzo.biz", "first_published_date": "25/07/2017", "last_updated_date": "25/07/2017", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002118-pip01-17" }, { "decision_number": "P/0191/2017", "pip_number": "EMEA-002114-PIP01-16", "active_substance": "abacavir;lamivudine;efavirenz", "invented_name": "", "therapeutic_area": "Infectious diseases", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Treatment of human immunodeficiency virus (HIV-1) infection", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "30/06/2017", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Lek Pharmaceuticals d.d.; Tel.  +41 613241111; E-mail: enquiries.paediatrics@sandoz.com;  ", "first_published_date": "25/07/2017", "last_updated_date": "25/07/2017", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002114-pip01-16" }, { "decision_number": "P/0177/2017", "pip_number": "EMEA-002104-PIP01-16", "active_substance": "olmesartan medoxomil;hydrochlorothiazide;amlodipine besilate", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Tablet", "condition_indication": "Treatment of hypertension", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "03/07/2017", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Accord Healthcare S.L.U.; E-mail: regulatory_EU@accord-healthcare.com; Tel. +34 933010064", "first_published_date": "24/07/2017", "last_updated_date": "24/07/2017", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002104-pip01-16" }, { "decision_number": "P/0131/2017", "pip_number": "EMEA-002099-PIP01-16", "active_substance": "buprenorphine hydrochloride", "invented_name": "", "therapeutic_area": "Psychiatry", "pharmaceutical_forms": "Implant", "condition_indication": "Treatment of opioid dependence", "routes_of_administration": "Subdermal use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "07/06/2017", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Titan Pharmaceuticals Inc; United States; Tel. +1 6502444990; E-mail: paediatrics@titanpharm.com", "first_published_date": "24/07/2017", "last_updated_date": "24/07/2017", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002099-pip01-16" }, { "decision_number": "P/0159/2017", "pip_number": "EMEA-002102-PIP01-16", "active_substance": "Ibuprofen;pseudoephedrine", "invented_name": "", "therapeutic_area": "Infectious diseases", "pharmaceutical_forms": "Oral suspension", "condition_indication": "Treatment of nasal congestion and inflammations;Treatment of febrile disorders;Treatment of pain", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "30/06/2017", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Farmalider, S.A.; Spain; Tel. +34 916612335; Fax +34 916610442; E-mail: carloscalandria@farmalider.com", "first_published_date": "24/07/2017", "last_updated_date": "24/07/2017", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002102-pip01-16" }, { "decision_number": "P/0169/2017", "pip_number": "EMEA-000560-PIP02-15", "active_substance": "omadacycline", "invented_name": "", "therapeutic_area": "Infectious diseases", "pharmaceutical_forms": "Powder for concentrate for solution for infusion;Film-coated tablet;Granules", "condition_indication": "Treatment of acute bacterial skin and skin structure infections", "routes_of_administration": "Intravenous use;Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "03/07/2017", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Paratek UK Limited; E-mail: info@paratekpharma.com; Tel. +1 6178 076600", "first_published_date": "24/07/2017", "last_updated_date": "24/07/2017", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000560-pip02-15" }, { "decision_number": "P/0175/2017", "pip_number": "EMEA-002110-PIP02-17", "active_substance": "Dezamizumab", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Concentrate for solution for infusion", "condition_indication": "Treatment of systemic light chain amyloidosis", "routes_of_administration": "Intravenous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "03/07/2017", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "GlaxoSmithKline Trading Services Limited; Tel. +1 4388998201; E-mail: eu.paediatric-plans@gsk.com", "first_published_date": "24/07/2017", "last_updated_date": "24/07/2017", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002110-pip02-17" }, { "decision_number": "P/0134/2017", "pip_number": "EMEA-002053-PIP01-16", "active_substance": "Polihexanide", "invented_name": "", "therapeutic_area": "Ophthalmology", "pharmaceutical_forms": "Eye drops, solution;Solution", "condition_indication": "Treatment of Acanthamoeba keratitis", "routes_of_administration": "Ocular use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "07/06/2017", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Società Industria Farmaceutica Italiana (S.I.F.I.) SpA; Italy; Tel. +39 0957922111; E-mail: antonino.asero@sifigroup.com", "first_published_date": "24/07/2017", "last_updated_date": "24/07/2017", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002053-pip01-16" }, { "decision_number": "P/0133/2017", "pip_number": "EMEA-002067-PIP02-17", "active_substance": "Medium-chain triglycerides;olive oil;Fish oil;acetyl-cysteine;alanine;histidine;Isoleucin;leucine;Lysine acetate;methionine;phenylalanine;proline;tryptophan;tyrosine;valine;glucose;calcium chloride;potassium chloride;sodium acetate;zinc sulfate;Malic acid;arginine;glycine;serine;threonine;sodium glycerophosphate;soya bean oil;magnesium sulfate", "invented_name": "", "therapeutic_area": "Nutrition", "pharmaceutical_forms": "Emulsion for infusion", "condition_indication": "Parenteral nutrition", "routes_of_administration": "Intravenous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "07/06/2017", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Fresenius Kabi Deutschland GmbH; Germany; Tel. +49 61726080; Fax +49 61726082294; E-mail: pr-fe@fresenius.com;  ", "first_published_date": "24/07/2017", "last_updated_date": "24/07/2017", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002067-pip02-17" }, { "decision_number": "P/0132/2017", "pip_number": "EMEA-002097-PIP01-16", "active_substance": "nimodipine", "invented_name": "", "therapeutic_area": "Neurology", "pharmaceutical_forms": "Powder and solvent for prolonged-release suspension for injection", "condition_indication": "Treatment of aneurysmal subarchnoidal haemorrhage", "routes_of_administration": "Intraventricular use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "07/06/2017", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Edge Therapeutics, Inc; United States; Tel. +1 9083245257; E-mail: afaulkner@edgetherapeutics.com", "first_published_date": "24/07/2017", "last_updated_date": "24/07/2017", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002097-pip01-16" }, { "decision_number": "P/0178/2017", "pip_number": "EMEA-001986-PIP01-16", "active_substance": "radium (223Ra) dichloride", "invented_name": "Xofigo; Xofigo", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Treatment of Multiple Myeloma;Treatment of all conditions included in the category of malignant neoplasms (except central nervous system tumours, haematopoietic and lymphoid tissue neoplasms)", "routes_of_administration": "Intravenous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "03/07/2017", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Bayer AG; Tel. +49 30300139003; E-mail: clinical-trials-contact@bayer.com", "first_published_date": "24/07/2017", "last_updated_date": "24/07/2017", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001986-pip01-16" }, { "decision_number": "P/0176/2017", "pip_number": "EMEA-002110-PIP01-17", "active_substance": "Dezamizumab", "invented_name": "", "therapeutic_area": "Haematology-Hemostaseology", "pharmaceutical_forms": "Concentrate for solution for infusion", "condition_indication": "Treatment of transthyretin amyloidosis (ATTR)", "routes_of_administration": "Intravenous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "03/07/2017", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "GlaxoSmithKline Trading Services Limited; Tel.: +1 4388998201; E-mail: eu.paediatric-plans@gsk.com", "first_published_date": "24/07/2017", "last_updated_date": "24/07/2017", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002110-pip01-17" }, { "decision_number": "P/0125/2017", "pip_number": "EMEA-002081-PIP01-16", "active_substance": "ramipril;Indapamide", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Modified-release tablet", "condition_indication": "Treatment of hypertension", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "05/05/2017", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Pharmaceutical Works Polpharma SA; Poland; Tel.: +48 58 563 89 44; E-mail: iwona.nowak@polpharma.com", "first_published_date": "04/07/2017", "last_updated_date": "04/07/2017", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002081-pip01-16" }, { "decision_number": "P/0126/2017", "pip_number": "EMEA-002042-PIP01-16", "active_substance": "Erdafitinib", "invented_name": "", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Treatment of urothelial carcinoma", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "05/05/2017", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Janssen-Cilag International N.V; Tel.: +353 857446696; E-mail: nbuhl@ITS.JNJ.com", "first_published_date": "03/07/2017", "last_updated_date": "03/07/2017", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002042-pip01-16" }, { "decision_number": "P/0124/2017", "pip_number": "EMEA-001006-PIP03-16", "active_substance": "nintedanib", "invented_name": "Vargatef; Ofev; Vargatef; Ofev", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Capsule, soft", "condition_indication": "Treatment of lung carcinoma (small cell and non-small cell carcinoma);Treatment of mesothelioma", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "05/05/2017", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Boehringer Ingelheim International GmbH; Tel. +49 6132 778271; Email: Paediatrics@boehringer-ingelheim.com", "first_published_date": "03/07/2017", "last_updated_date": "03/07/2017", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001006-pip03-16" }, { "decision_number": "P/0122/2017", "pip_number": "EMEA-002061-PIP01-16", "active_substance": "small interfering RNA targeting human TRPV1 mRNA", "invented_name": "", "therapeutic_area": "Ophthalmology", "pharmaceutical_forms": "Eye drops, solution;Solution", "condition_indication": "Treatment of dry eye disease", "routes_of_administration": "Ocular use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "05/05/2017", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Sylentis SAU; United Kingdom; Tel.: +44 1844210690; E-mail: steve.pinder@envestia.com, vruz@sylentis.com", "first_published_date": "03/07/2017", "last_updated_date": "03/07/2017", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002061-pip01-16" }, { "decision_number": "P/0121/2017", "pip_number": "EMEA-001152-PIP02-16", "active_substance": "recombinant modified human growth hormone", "invented_name": "", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Treatment of growth hormone deficiency", "routes_of_administration": "Subcutaneous use", "decision_type": "RP: decision refers to a refusal on a proposed Paediatric Investigation Plan", "decision_date": "05/05/2017", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Richardson Associates Regulatory Affairs Ltd; Israel; Tel.: +972 89300051; Fax: +972 89300091; E-mail: contact_opkobiologics@opko.com", "first_published_date": "03/07/2017", "last_updated_date": "03/07/2017", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001152-pip02-16" }, { "decision_number": "P/0119/2017", "pip_number": "EMEA-000069-PIP05-16", "active_substance": "Mepolizumab", "invented_name": "Nucala; Nucala", "therapeutic_area": "Pneumology-allergology", "pharmaceutical_forms": "Solution for injection;Powder for solution for injection", "condition_indication": "Treatment of nasal polyposis", "routes_of_administration": "Subcutaneous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "05/05/2017", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "GSK Trading Services Limited; United Kingdom; Tel.: +44 2089904891; Fax: +44 2089903501; E-mail: eu.paediatric-plans.gsk.com", "first_published_date": "03/07/2017", "last_updated_date": "03/07/2017", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000069-pip05-16" }, { "decision_number": "P/0170/2015", "pip_number": "EMEA-001054-PIP01-10-M03", "active_substance": "L-Cysteinyl-L-prolyl-L-alanyl-L-valyl-L-lysyl-L-arginyl-L-aspartyl-L-valyl-L-aspartyl-L-leucyl-L-phenylalanyl-L-leucyl-L-threonine, acetate salt;L-glutamyl-L-glutaminyl-L-valyl-L-alanyl-Lglutaminyl-L-tyrosyl-L-lysyl-L-alanyl-L-leucyl-L-prolyl-L-valyl-L-valyl-L-leucyl-L-glutamyl-L-asparaginyl-L-alanine, acetate salt;L-lysyl-L-alanyl-L-leucyl-L-prolyl-L-valyl-L-valyl-L-leucyl-L-glutamyl-L-asparaginyl-L-alanyl-L-arginyl-L-isoleucyl-L-leucyl-L-lysyl-L-asparaginyl-L-cysteinyl-L-valine, acetate salt...", "invented_name": "Katclari", "therapeutic_area": "Oto-rhino-laryngology", "pharmaceutical_forms": "Powder for solution for injection", "condition_indication": "Treatment of perennial allergic rhinitis", "routes_of_administration": "Intradermal use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "07/08/2015", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Circassia Limited ; 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United Kingdom; E-mail: talin@neurim.com; Tel. +972 37684902; Fax +972 36494568", "first_published_date": "08/08/2012", "last_updated_date": "29/05/2017", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000440-pip02-11-m05" }, { "decision_number": "P/0114/2017", "pip_number": "EMEA-000184-PIP03-16", "active_substance": "tobramycin", "invented_name": "Tobi Podhaler; Tobi Podhaler", "therapeutic_area": "Infectious diseases", "pharmaceutical_forms": "Inhalation powder;Capsule, hard", "condition_indication": "Treatment of Pseudomonas aeruginosa pulmonary colonisation in patients with bronchiectasis", "routes_of_administration": "Inhalation use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "11/04/2017", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Mylan IRE Healthcare Limited; E-mail: info.uk@viatris.com; 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France; E-mail: Carpentier.Helene@ethypharm.com; Tel.: +33 (0)141121740", "first_published_date": "21/04/2017", "last_updated_date": "21/04/2017", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001549-pip02-14" }, { "decision_number": "P/0081/2017", "pip_number": "EMEA-002047-PIP01-16", "active_substance": "ezetimibe;atorvastatin calcium", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Tablet", "condition_indication": "Treatment of elevated cholesterol", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "17/03/2017", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Midas Pharma GmbH; E-mail: pv@midas-pharma.com; Tel. +49 6132 990583", "first_published_date": "21/04/2017", "last_updated_date": "21/04/2017", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002047-pip01-16" }, { "decision_number": "P/0080/2017", "pip_number": "EMEA-002034-PIP01-16", "active_substance": "Methylphenidate (hydrochloride)", "invented_name": "", "therapeutic_area": "Neurology", "pharmaceutical_forms": "Prolonged-release capsule;Capsule, hard", "condition_indication": "Treatment of Attention Deficit Hyperactivity Disorder (ADHD)", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "16/03/2017", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Mundipharma Research Limited; United Kingdom; E-mail: paediatric@mundipharma-rd.eu; Tel.: +44 (0)1223424900", "first_published_date": "21/04/2017", "last_updated_date": "21/04/2017", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002034-pip01-16" }, { "decision_number": "P/0079/2017", "pip_number": "EMEA-002016-PIP02-16", "active_substance": "alpelisib", "invented_name": "", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Treatment of breast cancer", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "16/03/2017", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Novartis Europharm LimitedE-mail: paediatric.enquiries@novartis.comTel. +41 613241111", "first_published_date": "21/04/2017", "last_updated_date": "21/04/2017", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002016-pip02-16" }, { "decision_number": "P/0078/2017", "pip_number": "EMEA-001980-PIP01-16", "active_substance": "T-lymphocytes enriched leukocyte preparation depleted ex vivo of host host-alloreactive T cells using photodynamic treatment (ATIR101)", "invented_name": "", "therapeutic_area": "Immunology-Rheumatology-Transplantation", "pharmaceutical_forms": "Cell suspension for infusion", "condition_indication": "Adjunctive treatment in haematopoietic stem cell transplantation for a malignant disease", "routes_of_administration": "Intravenous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "16/03/2017", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Kiadis Pharma Netherlands B.V.; The Netherlands; E-mail: clinicaltrials@kiadis.com; Tel.: +31 203140250; Fax: +31 203140251", "first_published_date": "21/04/2017", "last_updated_date": "21/04/2017", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001980-pip01-16" }, { "decision_number": "P/0072/2017", "pip_number": "EMEA-001868-PIP02-16", "active_substance": "5-(4-cyclopropyl-1H-imidazol-1-yl)-2-fluoro-N-(6-(4-isopropyl-4H-1,2,4-triazol-3-yl)pyridi-2-yl)-4-methylbenzamide", "invented_name": "", "therapeutic_area": "Gastroentology-Hepatology", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Treatment of alcoholic hepatitis", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "17/03/2017", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Gilead Sciences International Ltd.; United Kingdom; E-mail: regulatory.pip@gilead.com; Tel.: +44 1223897300; Fax: +44 (0)1223897284", "first_published_date": "21/04/2017", "last_updated_date": "21/04/2017", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001868-pip02-16" }, { "decision_number": "P/0068/2017", "pip_number": "EMEA-001469-PIP01-13", "active_substance": "somapacitan", "invented_name": "", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Treatment of growth hormone deficiency", "routes_of_administration": "Subcutaneous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "17/03/2017", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Novo Nordisk A/S; E-mail: paediatrics@novonordisk.com; Tel. +45 4444 8888", "first_published_date": "21/04/2017", "last_updated_date": "21/04/2017", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001469-pip01-13" }, { "decision_number": "P/0010/2017", "pip_number": "EMEA-000527-PIP04-13-M01", "active_substance": "ranibizumab", "invented_name": "Lucentis; 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Tesavel", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Treatment of type II diabetes mellitus", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "21/05/2016", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Merck Sharp and Dohme (Europe), Inc.; Belgium; E-mail: paul.robinson@merck.com; Tel. +44 1992452396; Fax +44 1992468175", "first_published_date": "01/03/2017", "last_updated_date": "28/02/2017", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/sitagliptin-phosphate-monohydrate" }, { "decision_number": "P/0358/2016", "pip_number": "EMEA-001198-PIP02-16", "active_substance": "Fosnetupitant;palonosetron", "invented_name": "Akynzeo; Akynzeo", "therapeutic_area": "Other", "pharmaceutical_forms": "Powder for solution for infusion", "condition_indication": "Prevention of chemotherapy-induced nausea and vomiting", "routes_of_administration": "Intravenous use", "decision_type": "RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)", "decision_date": "21/12/2016", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Helsinn Birex Pharmaceuticals Limited; Switzerland; E-mail: paediatrics-netu@helsinn.com; Tel.: +41 919851950; Fax: +41 919852195", "first_published_date": "31/01/2017", "last_updated_date": "31/01/2017", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001198-pip02-16" }, { "decision_number": "P/0369/2016", "pip_number": "EMEA-002038-PIP01-16", "active_substance": "Botulinum toxin, Type A", "invented_name": "", "therapeutic_area": "Dermatology", "pharmaceutical_forms": "Powder for solution for injection", "condition_indication": "Treatment of glabellar lines", "routes_of_administration": "Intramuscular use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "21/12/2016", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Evolus Inc.; United States; E-mail: Medical-Information@evolusinc.com; Tel.: +1 8055902340; Fax: +1 8055902342", "first_published_date": "30/01/2017", "last_updated_date": "30/01/2017", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002038-pip01-16" }, { "decision_number": "P/0368/2016", "pip_number": "EMEA-002037-PIP01-16", "active_substance": "netarsudil", "invented_name": "", "therapeutic_area": "Ophthalmology", "pharmaceutical_forms": "Eye drops, solution;Solution", "condition_indication": "Treatment of glaucoma", "routes_of_administration": "Ocular use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "21/12/2016", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Aerie Pharmaceuticals Ireland Ltd; Tel. +1 9495268700; E-mail: info@aeriepharma.com", "first_published_date": "30/01/2017", "last_updated_date": "30/01/2017", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002037-pip01-16" }, { "decision_number": "P/0367/2016", "pip_number": "EMEA-002022-PIP01-16", "active_substance": "DNA plasmid encoding HPV type 16 consensus E6 and E7 proteins (pGX3001);DNA plasmid encoding HPV type 18 consensus E6 and E7 proteins (pGX3002)", "invented_name": "", "therapeutic_area": "Infectious diseases", "pharmaceutical_forms": "Intramuscular use", "condition_indication": "Treatment of squamous intraepithelial lesions of the cervix caused by HPV types 16 and 18", "routes_of_administration": "Solution for injection (in cartridge)", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "21/12/2016", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Inovio Pharmaceuticals Inc.E-mail: jrichardson@inovio.comTel.: +1 2674404211", "first_published_date": "30/01/2017", "last_updated_date": "30/01/2017", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002022-pip01-16" }, { "decision_number": "P/0366/2016", "pip_number": "EMEA-002017-PIP01-16", "active_substance": "Ibuprofen", "invented_name": "", "therapeutic_area": "Other", "pharmaceutical_forms": "Prolonged-release tablet", "condition_indication": "Treatment of febrile disorders;Treatment of pain", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "20/12/2016", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Strides Shasun Limited (Formulation Division); India; E-mail: Mohanlal.S@stridesshasun.com; Tel.: +91 8067840217 / +91 9900590513; Fax: +91 8067840700", "first_published_date": "30/01/2017", "last_updated_date": "30/01/2017", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002017-pip01-16" }, { "decision_number": "P/0365/2016", "pip_number": "EMEA-001860-PIP04-16", "active_substance": "Galcanezumab", "invented_name": "", "therapeutic_area": "Neurology", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Prevention of cluster headaches", "routes_of_administration": "Subcutaneous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "21/12/2016", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Eli Lilly & Company Limited; E-mail: eu_paediatric@lilly.com ; Tel. +44 (0)1276 483000", "first_published_date": "30/01/2017", "last_updated_date": "30/01/2017", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001860-pip04-16" }, { "decision_number": "P/0351/2016", "pip_number": "EMEA-001688-PIP03-16", "active_substance": "Pimavanserin", "invented_name": "", "therapeutic_area": "Psychiatry", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Treatment of schizophrenia and other psychotic disorders", "routes_of_administration": "Oral use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "02/12/2016", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "ACADIA Pharmaceuticals Inc.; United States; E-mail: info@acadia-pharm.com; Tel.: +1 8585582871; Fax: +1 8585582872", "first_published_date": "30/01/2017", "last_updated_date": "30/01/2017", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001688-pip03-16" }, { "decision_number": "P/0350/2016", "pip_number": "EMEA-001154-PIP02-15", "active_substance": "antithrombin alfa", "invented_name": "Recombinant human antithrombin", "therapeutic_area": "Haematology-Hemostaseology", "pharmaceutical_forms": "Powder for solution for infusion", "condition_indication": "Treatment of antithrombin deficiency", "routes_of_administration": "Intravenous use", "decision_type": "RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)", "decision_date": "02/12/2016", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "GTC Biotherapeutics UK Limited; France; E-mail: metenanizi@lfb.fr; Tel.: +33 169821029; Fax: +33 183711978", "first_published_date": "30/01/2017", "last_updated_date": "30/01/2017", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001154-pip02-15" }, { "decision_number": "P/0349/2016", "pip_number": "EMEA-002015-PIP01-16", "active_substance": "terguride (hydrogenmaleate)", "invented_name": "", "therapeutic_area": "Immunology-Rheumatology-Transplantation", "pharmaceutical_forms": "Tablet", "condition_indication": "Treatment of systemic sclerosis", "routes_of_administration": "Oral use", "decision_type": "RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)", "decision_date": "02/12/2016", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "medac Gesellschaft für klinische Spezialpräparate mbH; Germany; E-mail: dra@medac.de; Tel.: +49 401380060; Fax: +49 401380068255", "first_published_date": "30/01/2017", "last_updated_date": "30/01/2017", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002015-pip01-16" }, { "decision_number": "P/0348/2016", "pip_number": "EMEA-002011-PIP01-16", "active_substance": "chlorhexidine gluconate;isopropyl alcohol", "invented_name": "", "therapeutic_area": "Dermatology", "pharmaceutical_forms": "Cutaneous solution", "condition_indication": "Prevention of infections prior to invasive procedures", "routes_of_administration": "Cutaneous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "02/12/2016", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "GAMA Healthcare Ltd; United Kingdom; E-mail: pb@gamahealthcare.com; Tel.: +44 20 79930030; Fax: +44 2082028097", "first_published_date": "30/01/2017", "last_updated_date": "30/01/2017", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002011-pip01-16" }, { "decision_number": "P/0347/2016", "pip_number": "EMEA-001993-PIP01-16", "active_substance": "synthetic double-stranded siRNA oligonucleotide directed against p53 mRNA (QPI-1002)", "invented_name": "", "therapeutic_area": "Immunology-Rheumatology-Transplantation", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Prevention of delayed graft function (DGF) after kidney transplantation", "routes_of_administration": "Solution for injection", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "05/12/2016", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Quark Pharmaceuticals Inc.; 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Italy; E-mail: info@kedrion.com; Tel. + 39 0583 1969697", "first_published_date": "04/01/2013", "last_updated_date": "23/01/2017", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000454-pip01-08-m07" }, { "decision_number": "P/0292/2016", "pip_number": "EMEA-001168-PIP01-11-M03", "active_substance": "serelaxin", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Solution for infusion", "condition_indication": "Treatment of acute heart failure", "routes_of_administration": "Intravenous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "04/11/2016", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Novartis Europharm Ltd; United Kingdom; E-mail: clinicaltrial.enquiries@novartis.com; Tel. +41 613241111; Fax +41 613248001", "first_published_date": "04/01/2013", "last_updated_date": "19/01/2017", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001168-pip01-11-m03" }, { "decision_number": "P/0309/2016", "pip_number": "EMEA-000970-PIP01-10-M01", "active_substance": "elvitegravir;emtricitabine;cobicistat;tenofovir disoproxil fumarate", "invented_name": "", "therapeutic_area": "Infectious diseases", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Treatment of human immunodeficiency virus (HIV-1) infection", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "04/11/2016", "compliance_outcome": "Positive", "compliance_opinion_date": "16/12/2016", "compliance_procedure_number": "EMEA-C-000970-PIP01-10-M01", "contact_for_public_enquiries": "Gilead Sciences International Ltd.; Tel. +44 (0)1223 897 300; E-mail: regulatory.pip@gilead.com", "first_published_date": "14/07/2011", "last_updated_date": "19/01/2017", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000970-pip01-10-m01" }, { "decision_number": "P/0308/2016", "pip_number": "EMEA-002014-PIP01-16", "active_substance": "Candesartan;amlodipine", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Capsule, hard", "condition_indication": "Treatment of hypertension", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "04/11/2016", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "CIPROS S.r.l.; Italy; Tel. +39 5732 0877; Fax +39 5734 75188; E-mail: regolatorio@ciprossrl.it;  ", "first_published_date": "10/01/2017", "last_updated_date": "10/01/2017", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002014-pip01-16" }, { "decision_number": "P/0307/2016", "pip_number": "EMEA-002006-PIP01-16", "active_substance": "amlodipine;valsartan;hydrochlorothiazide", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Treatment of hypertension", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "04/11/2016", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "ELPEN Pharmaceutical Co. 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Italy; Tel. +39 5734 74010; Fax +39 5734 75188; E-mail: regolatorio1@errekappa.it", "first_published_date": "10/01/2017", "last_updated_date": "10/01/2017", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001968-pip01-16" }, { "decision_number": "P/0291/2016", "pip_number": "EMEA-001043-PIP02-16", "active_substance": "sirukumab", "invented_name": "", "therapeutic_area": "Immunology-Rheumatology-Transplantation", "pharmaceutical_forms": "Solution for injection;Solution for injection/infusion", "condition_indication": "Treatment of vasculitides", "routes_of_administration": "Subcutaneous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "04/11/2016", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Janssen-Cilag International N.V.; United Kingdom; Tel. +44 (0)1494 567567; Fax +44 (0)1494 658084; E-mail: ldobell@its.jnj.com", "first_published_date": "06/01/2017", "last_updated_date": "06/01/2017", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001043-pip02-16" }, { "decision_number": "P/0290/2016", "pip_number": "EMEA-001140-PIP02-15", "active_substance": "allogeneic Mesenchymal Precursor Cells (rexlemestrocel-L)", "invented_name": "", "therapeutic_area": "Other", "pharmaceutical_forms": "Suspension for injection", "condition_indication": "Treatment of intervertebral disc disorder", "routes_of_administration": "Intradiscal use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "04/11/2016", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Mesoblast UK Limited; Australia; Tel. +61 3963 96036; Fax +61 3963 96030; E-mail: michelle.coffey@mesoblast.com", "first_published_date": "06/01/2017", "last_updated_date": "06/01/2017", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001140-pip02-15" }, { "decision_number": "P/0096/2016", "pip_number": "EMEA-000300-PIP01-08-M04", "active_substance": "pitavastatin (calcium)", "invented_name": "Alipza and associated names", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Treatment of disorders of lipoprotein metabolism and other lipidaemias", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "15/04/2016", "compliance_outcome": "Positive", "compliance_opinion_date": "19/08/2016", "compliance_procedure_number": "EMEA-C-000300-PIP01-08-M04", "contact_for_public_enquiries": "Kowa Pharmaceutical Europe Company Ltd; United Kingdom; Tel. +44 (0)1189229000; E-mail: regulatory@kowa.co.uk", "first_published_date": "21/07/2008", "last_updated_date": "21/12/2016", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000300-pip01-08-m04" }, { "decision_number": "P/0243/2015", "pip_number": "EMEA-000408-PIP01-08-M05", "active_substance": "icatibant acetate", "invented_name": "Firazyr; Firazyr", "therapeutic_area": "Other", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Treatment of hereditary angioedema", "routes_of_administration": "Subcutaneous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "30/10/2015", "compliance_outcome": "Positive", "compliance_opinion_date": "19/08/2016", "compliance_procedure_number": "EMEA-C-000408-PIP01-08-M05", "contact_for_public_enquiries": "Shire Orphan Therapies GmbH; Switzerland; Tel. +43 1 20100 2471359; E-mail: magdalena.toro-cortes@shire.com", "first_published_date": "17/10/2011", "last_updated_date": "21/12/2016", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000408-pip01-08-m05" }, { "decision_number": "P/0297/2015", "pip_number": "EMEA-000290-PIP01-08-M04", "active_substance": "nilotinib", "invented_name": "Tasigna; 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Tel. +31 365227201; E-mail: ace@ace-pharm.nl", "first_published_date": "25/04/2016", "last_updated_date": "21/12/2016", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001885-pip01-15-m01" }, { "decision_number": "P/0031/2013", "pip_number": "EMEA-001283-PIP01-12", "active_substance": "hydrocortisone", "invented_name": "", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Granules", "condition_indication": "Treatment of adrenocortical insufficiency", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "26/02/2013", "compliance_outcome": "Positive", "compliance_opinion_date": "14/10/2016", "compliance_procedure_number": "EMEA-C-001283-PIP01-12", "contact_for_public_enquiries": "Diurnal Limited; E-mail: martinwhitaker@diurnal.co.uk; Country: United Kingdom; Tel. + 44 (0) 8717168848", "first_published_date": "23/04/2013", "last_updated_date": "21/12/2016", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001283-pip01-12" }, { "decision_number": "P/0095/2016", "pip_number": "EMEA-000054-PIP01-07-M04", "active_substance": "pitavastatin (calcium)", "invented_name": "Livazo and associated names", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Treatment of disorders of lipoprotein metabolism and other lipidaemias", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "15/04/2016", "compliance_outcome": "Positive", "compliance_opinion_date": "19/08/2016", "compliance_procedure_number": "EMEA-C-000054-PIP01-07-M04", "contact_for_public_enquiries": "Kowa Pharmaceutical Europe Co. 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Tel. + 44 1304646607; E-mail: pip_enquiries@pfizer.com", "first_published_date": "13/05/2014", "last_updated_date": "07/12/2016", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001430-pip01-13" }, { "decision_number": "P/0146/2016", "pip_number": "EMEA-001813-PIP01-15", "active_substance": "recombinant humanized anti-MMP9 monoclonal antibody IgG4 (GS-5745)", "invented_name": "", "therapeutic_area": "Gastroentology-Hepatology", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Treatment of Crohn's disease;Treatment of ulcerative colitis", "routes_of_administration": "Subcutaneous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "27/05/2016", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Gilead Sciences International Ltd; E-mail: regulatory.pip@gilead.com; Tel. +44 (0)1223 897300", "first_published_date": "18/07/2016", "last_updated_date": "24/11/2016", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001813-pip01-15" }, { "decision_number": "P/0259/2016", "pip_number": "EMEA-000506-PIP01-08-M02", "active_substance": "selepressin", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Concentrate for solution for infusion", "condition_indication": "Treatment of septic shock", "routes_of_administration": "Intravenous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "05/10/2016", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Ferring Pharmaceuticals A/S; Tel.: +1 8622865200; E-mail: Dk0-Disclosure@ferring.com", "first_published_date": "29/10/2010", "last_updated_date": "24/11/2016", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000506-pip01-08-m02" }, { "decision_number": "P/0257/2016", "pip_number": "EMEA-001453-PIP01-13-M01", "active_substance": "zuretinol (acetate)", "invented_name": "", "therapeutic_area": "Ophthalmology", "pharmaceutical_forms": "Oral solution", "condition_indication": "Treatment of Leber's Congenital Amaurosis;Treatment of Retinitis Pigmentosa", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "05/10/2016", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "QLT Ophthalmics (UK) Ltd; E-mail: marco@retinagenix.com; Tel. +1 7863 5214 99", "first_published_date": "20/02/2014", "last_updated_date": "24/11/2016", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001453-pip01-13-m01" }, { "decision_number": "P/0274/2016", "pip_number": "EMEA-000968-PIP02-11-M05", "active_substance": "elvitegravir", "invented_name": "Vitekta; Vitekta", "therapeutic_area": "Infectious diseases", "pharmaceutical_forms": "Film-coated tablet;Dispersible tablet", "condition_indication": "Treatment of human immunodeficiency virus (HIV-1) infection", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "07/10/2016", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Gilead Sciences International Ltd; E-mail: regulatory.pip@gilead.com; Tel. +44 (0)1223 897300", "first_published_date": "24/02/2012", "last_updated_date": "24/11/2016", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000968-pip02-11-m05" }, { "decision_number": "P/0271/2016", "pip_number": "EMEA-001982-PIP01-16", "active_substance": "gentamicin sulfate", "invented_name": "", "therapeutic_area": "Dermatology", "pharmaceutical_forms": "Medicated sponge", "condition_indication": "Treatment of infected diabetic foot ulcers", "routes_of_administration": "Topical use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "07/10/2016", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Innocoll; Ireland; Tel. +353 906486834; E-mail: info@innocoll.com", "first_published_date": "23/11/2016", "last_updated_date": "23/11/2016", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001982-pip01-16" }, { "decision_number": "P/0267/2016", "pip_number": "EMEA-002002-PIP01-16", "active_substance": "Ibuprofen;paracetamol", "invented_name": "", "therapeutic_area": "Pain", "pharmaceutical_forms": "Granules;Tablet", "condition_indication": "Treatment of pain", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "05/10/2016", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Farmalider, S.A; E-mail: carloscalandria@farmalider.com; Tel. +34 9166 12335", "first_published_date": "23/11/2016", "last_updated_date": "23/11/2016", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002002-pip01-16" }, { "decision_number": "P/0258/2016", "pip_number": "EMEA-001966-PIP01-16", "active_substance": "recombinant respiratory syncytial virus vaccine", "invented_name": "", "therapeutic_area": "Infectious diseases", "pharmaceutical_forms": "Powder for solution for injection", "condition_indication": "Prevention of lower respiratory tract disease caused by respiratory syncytial virus", "routes_of_administration": "Intramuscular use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "05/10/2016", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "MedImmune Limited; United Kingdom; Tel. +44 1582836181; E-mail: paediatrics@medimmune.com", "first_published_date": "23/11/2016", "last_updated_date": "23/11/2016", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001966-pip01-16" }, { "decision_number": "P/0266/2016", "pip_number": "EMEA-001881-PIP01-15", "active_substance": "Ragweed pollen extract (Ambrosia artemisiifolia)", "invented_name": "", "therapeutic_area": "Pneumology-allergology", "pharmaceutical_forms": "Oral lyophilisate", "condition_indication": "Treatment of allergic rhinitis / rhino-conjunctivitis", "routes_of_administration": "Sublingual use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "05/10/2016", "compliance_outcome": "Positive", "compliance_opinion_date": "15/11/2019", "compliance_procedure_number": "EMEA-C-001881-PIP01-15", "contact_for_public_enquiries": "ALK Abelló A/S; Tel. +45 4574 7576; E-mail: alkmrp@alk.net", "first_published_date": "23/11/2016", "last_updated_date": "23/11/2016", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001881-pip01-15" }, { "decision_number": "P/0277/2016", "pip_number": "EMEA-001977-PIP02-16", "active_substance": "fluoromisonidazole (18F)", "invented_name": "", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Imaging of hypoxic tissue in gliomas for diagnostic purposes;Imaging of hypoxic tissue in head and neck squamous cell carcinoma for diagnostic purposes;Imaging of hypoxic tissue in non-small cell lung cancer for diagnostic purposes;Imaging of hypoxic tissue in renal cell carcinoma for diagnostic purposes", "routes_of_administration": "Intravenous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "05/10/2016", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "RadioMedic s.r.o.; Czech Republic; Tel. +42 0266173253; Fax +42 0220940151; E-mail: info@radiomedic.cz;  ", "first_published_date": "23/11/2016", "last_updated_date": "23/11/2016", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001977-pip02-16" }, { "decision_number": "P/0268/2016", "pip_number": "EMEA-001730-PIP02-15", "active_substance": "Guadecitabine", "invented_name": "", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Powder and solvent for solution for injection", "condition_indication": "Treatment of acute myeloid leukaemia", "routes_of_administration": "Subcutaneous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "07/10/2016", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Otsuka Europe Development and Commercialisation Ltd.; United Kingdom; Tel. +44 2037475000; Fax +44 1895207115; E-mail: info@otsuka-europe.com", "first_published_date": "23/11/2016", "last_updated_date": "23/11/2016", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001730-pip02-15" }, { "decision_number": "P/0226/2016", "pip_number": "EMEA-001942-PIP01-16", "active_substance": "ramipril;amlodipine;hydrochlorothiazide", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Capsule, hard", "condition_indication": "Treatment of hypertension", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "12/08/2016", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Adamed Sp. z o.o.; Tel. +48227327736; E-mail: joanna.pawlak@adamed.com.pl", "first_published_date": "28/10/2016", "last_updated_date": "28/10/2016", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001942-pip01-16" }, { "decision_number": "P/0228/2016", "pip_number": "EMEA-001909-PIP01-15", "active_substance": "cathine (hydrochloride)", "invented_name": "", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Oral drops (solution)", "condition_indication": "Treatment of obesity", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "12/08/2016", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Schuck GmbH; Germany; Tel. +49 30338427532; Fax +49 383517688121; E-mail: schroederd@riemser.com", "first_published_date": "28/10/2016", "last_updated_date": "28/10/2016", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001909-pip01-15" }, { "decision_number": "P/0225/2016", "pip_number": "EMEA-001935-PIP01-16", "active_substance": "amlodipine;rosuvastatin", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Capsule, hard", "condition_indication": "Treatment of cardiovascular disease", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "12/08/2016", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Adamed Sp. z o.o.; Tel. +48227327736; E-mail: joanna.pawlak@adamed.com.pl", "first_published_date": "28/10/2016", "last_updated_date": "28/10/2016", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001935-pip01-16" }, { "decision_number": "P/0224/2016", "pip_number": "EMEA-001905-PIP01-15", "active_substance": "Lusutrombopag", "invented_name": "", "therapeutic_area": "Haematology-Hemostaseology", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Treatment of thrombocytopenia secondary to liver disease", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "12/08/2016", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Shionogi Limited; United Kingdom; Tel. +44 (0)203 053 4200; E-mail: shionogiclintrials-admin@shionogi.co.jp", "first_published_date": "28/10/2016", "last_updated_date": "28/10/2016", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001905-pip01-15" }, { "decision_number": "P/0164/2016", "pip_number": "EMEA-001841-PIP01-15", "active_substance": "bexagliflozin", "invented_name": "", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Tablet", "condition_indication": "Treatment of type II diabetes mellitus", "routes_of_administration": "Oral use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "15/06/2016", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Theracos Sub, LLC; United States; Tel. +1 6177264236; Fax +1 6176438203;  ", "first_published_date": "28/10/2016", "last_updated_date": "28/10/2016", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001841-pip01-15" }, { "decision_number": "P/0249/2016", "pip_number": "EMEA-001476-PIP01-13-M01", "active_substance": "sapropterin dihydrochloride", "invented_name": "Kuvan; Kuvan", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Soluble tablet;Powder for oral solution", "condition_indication": "Treatment of hyperphenylalaninemia", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "09/09/2016", "compliance_outcome": "Positive", "compliance_opinion_date": "10/10/2014", "compliance_procedure_number": "EMEA-C-001476-PIP01-13", "contact_for_public_enquiries": "BioMarin International Limited; Tel. +44 (0)20 7420 0800; E-mail: biomarin-europe@bmrn.com", "first_published_date": "15/11/2013", "last_updated_date": "27/10/2016", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001476-pip01-13-m01" }, { "decision_number": "P/0208/2013", "pip_number": "EMEA-001285-PIP01-12-M02", "active_substance": "Dinutuximab", "invented_name": "Unituxin; Unituxin", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Solution for infusion", "condition_indication": "Treatment of neuroblastoma", "routes_of_administration": "Intravenous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "12/08/2016", "compliance_outcome": "Positive", "compliance_opinion_date": "16/12/2016", "compliance_procedure_number": "EMEA-C-001285-PIP01-12-M02", "contact_for_public_enquiries": "United Therapeutics Europe Limited; United Kingdom; Tel. +44 (0)1932 573800; Fax +44 (0)1932 571110; E-mail: info1@unither.com", "first_published_date": "08/02/2013", "last_updated_date": "27/10/2016", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001285-pip01-12-m02" }, { "decision_number": "P/0210/2016", "pip_number": "EMEA-000978-PIP01-10-M01", "active_substance": "vemurafenib", "invented_name": "Zelboraf; Zelboraf", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Treatment of melanoma", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "12/08/2016", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Roche Registration Limited; Switzerland; Tel. +41 6168794 11; Fax +41 616879411; E-mail: info.paediatrics@roche.com", "first_published_date": "12/05/2011", "last_updated_date": "27/10/2016", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000978-pip01-10-m01" }, { "decision_number": "P/0244/2016", "pip_number": "EMEA-001962-PIP01-16", "active_substance": "Humanized IgG1, kappa anti-serum amyloid A and anti-AL amyloid antibody", "invented_name": "", "therapeutic_area": "Haematology-Hemostaseology", "pharmaceutical_forms": "Powder for solution for infusion", "condition_indication": "Treatment of systemic light chain amyloidosis", "routes_of_administration": "Intravenous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "09/09/2016", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Prothena Therapeutics Limited; Ireland; Tel. +353 12362505; Fax +353 1 6865675; E-mail: patrick.murphy@prothena.com", "first_published_date": "27/10/2016", "last_updated_date": "27/10/2016", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001962-pip01-16" }, { "decision_number": "P/0209/2016", "pip_number": "EMEA-000673-PIP01-09-M09", "active_substance": "Pneumococcal polysaccharide serotype 1 conjugated to protein D (derived from non-typeable Haemophilus influenzae) carrier protein;pneumococcal polysaccharide serotype 4 conjugated to protein D (derived from non-typeable Haemophilus influenzae) carrier protein;pneumococcal polysaccharide serotype 5 conjugated to protein D (derived from non-typeable Haemophilus influenzae) carrier protein...", "invented_name": "Synflorix; Synflorix", "therapeutic_area": "Vaccines", "pharmaceutical_forms": "Suspension for injection", "condition_indication": "Prevention of acute otitis media caused by non-typeable Haemophilus influenzae", "routes_of_administration": "Intramuscular use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "12/08/2016", "compliance_outcome": "Positive", "compliance_opinion_date": "27/01/2017", "compliance_procedure_number": "EMEA-000673-PIP01-09-M09", "contact_for_public_enquiries": "GlaxoSmithKline Biologicals S.A. 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United States; Tel. +1 9143474300; Fax +1 9143474560 ; E-mail: info@acorda.com;  ", "first_published_date": "02/06/2016", "last_updated_date": "02/06/2016", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001874-pip01-15" }, { "decision_number": "P/0113/2016", "pip_number": "EMEA-001878-PIP01-15", "active_substance": "Finasteride", "invented_name": "", "therapeutic_area": "Dermatology", "pharmaceutical_forms": "Cutaneous spray;Solution", "condition_indication": "Treatment of androgenetic alopecia", "routes_of_administration": "Cutaneous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "15/04/2016", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Polichem S.A.; Tel. + 34 93 291 35 06 / + 34 609 907 326; E-mail: xavier.llaurado@almirall.com", "first_published_date": "02/06/2016", "last_updated_date": "02/06/2016", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001878-pip01-15" }, { "decision_number": "P/0123/2016", "pip_number": "EMEA-001825-PIP01-15", "active_substance": "darunavir;cobicistat;emtricitabine;tenofovir alafenamide", "invented_name": "", "therapeutic_area": "Infectious diseases", "pharmaceutical_forms": "Film-coated tablet;Age appropriate oral solid dosage form", "condition_indication": "Treatment of human immunodeficiency virus (HIV-1) infection", "routes_of_administration": "Oral use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "12/05/2016", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Janssen-Cilag International NV; 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Belgium; Tel. +32 10394300; Fax +32 10394301; E-mail: contact@promethera.com", "first_published_date": "05/02/2014", "last_updated_date": "02/06/2016", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001155-pip01-11-m03" }, { "decision_number": "P/0288/2014", "pip_number": "EMEA-001519-PIP01-13", "active_substance": "(R)-7-Chloro-benzo[b]thiophene-2-carboxylic acid (1-aza-bicyclo[2.2.2]oct-3-yl)-amide hydrochloride hydrate (EVP-6124)", "invented_name": "", "therapeutic_area": "Neurology", "pharmaceutical_forms": "Tablet", "condition_indication": "Treatment of schizophrenia", "routes_of_administration": "Oral use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "12/12/2014", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "FORUM Pharmaceuticals, Inc. ; United States ; E-mail: cboislcair@forumpharma.com ; 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United Kingdom; Email: info@xention.com; Tel.: +44 (0)1223 493900; Fax: +44 (0)1223 493901", "first_published_date": "22/09/2015", "last_updated_date": "25/05/2016", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001752-pip01-15" }, { "decision_number": "P/0091/2016", "pip_number": "EMEA-000495-PIP01-08-M09", "active_substance": "tapentadol hydrochloride", "invented_name": "Palexia and associated names; Yantil and associated names; Tapentadol and associated names", "therapeutic_area": "Pain", "pharmaceutical_forms": "Film-coated tablet;Oral solution;Solution for injection/infusion", "condition_indication": "Treatment of acute pain", "routes_of_administration": "Oral use;Intravenous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "18/03/2016", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Grünenthal GmbH; 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United Kingdom; Tel. +44 (0)20 8654 0555; E-mail: jwhitehead@apvo.com", "first_published_date": "24/05/2012", "last_updated_date": "26/04/2016", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000661-pip01-09-m07" }, { "decision_number": "P/0052/2016", "pip_number": "EMEA-001506-PIP02-14-M01", "active_substance": "basmisanil", "invented_name": "", "therapeutic_area": "Psychiatry", "pharmaceutical_forms": "Granules", "condition_indication": "Treatment of down syndrome", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "18/03/2016", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Roche Registration Ltd; Switzerland; Tel. +41 616879411; E-mail: info.paediatrics@roche.com", "first_published_date": "07/05/2015", "last_updated_date": "26/04/2016", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001506-pip02-14-m01" }, { "decision_number": "P/0092/2016", "pip_number": "EMEA-000494-PIP01-08-M09", "active_substance": "tapentadol hydrochloride", "invented_name": "Palexia and associated names; 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Germany; Tel. +49 30590083249 ; Fax +49 30590083230; Email: brigitte.hoch@humedics.de", "first_published_date": "22/04/2016", "last_updated_date": "22/04/2016", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001844-pip01-15" }, { "decision_number": "P/0006/2016", "pip_number": "EMEA-000067-PIP02-11-M02", "active_substance": "human heterologous liver cells", "invented_name": "", "therapeutic_area": "Gastroentology-Hepatology", "pharmaceutical_forms": "Suspension for infusion", "condition_indication": "Treatment of urea cycle disorders", "routes_of_administration": "Intravenous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "21/01/2016", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Cytonet GmbH & Co KG; Germany; E-mail: info@cytonet.de; Tel. +49 6201 25980; Fax +49 6201 259828", "first_published_date": "27/11/2012", "last_updated_date": "29/03/2016", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000067-pip02-11-m02" }, { "decision_number": "P/0034/2016", "pip_number": "EMEA-001854-PIP01-15", "active_substance": "(3Z,5S)-5-(hydroxymethyl)-1-[(2'-methyl[1,1'-biphenyl]-4-yl)-carbonyl]-3-pyrrolidinone-O-methyloxime", "invented_name": "", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Dispersible tablet", "condition_indication": "Treatment of female infertility", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "29/01/2016", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "ObsEva Ireland Limited; 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United States; E-mail: www.dipexiumpharmaceuticals.com; Tel.: +1 2122692724", "first_published_date": "29/03/2016", "last_updated_date": "29/03/2016", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001847-pip01-15" }, { "decision_number": "P/0031/2016", "pip_number": "EMEA-001836-PIP01-15", "active_substance": "revusiran", "invented_name": "", "therapeutic_area": "Neurology", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Treatment of transthyretin-related amyloidosis (ATTR amyloidosis)", "routes_of_administration": "Subcutaneous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "29/01/2016", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Alnylam Pharmaceuticals, Inc.; United States; E-mail: clinicaltrials@alnylam.com; Tel.: +1 8663300326", "first_published_date": "29/03/2016", "last_updated_date": "29/03/2016", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001836-pip01-15" }, { "decision_number": "P/0028/2016", "pip_number": "EMEA-001718-PIP01-14", "active_substance": "17 beta-estradiol;etonogestrel", "invented_name": "", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Vaginal delivery system", "condition_indication": "Treatment of dysmenorrhea;Prevention of pregnancy", "routes_of_administration": "Vaginal use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "29/01/2016", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Merck Sharp & Dohme (Europe), Inc.; 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United Kingdom; Tel. +44 (0)20 8600 1400; Fax +44 (0)20 8676 1504; E-mail: LMedinfo@eisai.net", "first_published_date": "18/10/2011", "last_updated_date": "04/02/2016", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001098-pip01-10-m01" }, { "decision_number": "P/0299/2015", "pip_number": "EMEA-000568-PIP01-09-M06", "active_substance": "C1 inhibitor (human)", "invented_name": "Cinryze; Cinryze", "therapeutic_area": "Immunology-Rheumatology-Transplantation", "pharmaceutical_forms": "Powder and solvent for solution for injection", "condition_indication": "Treatment of C1 inhibitor deficiency", "routes_of_administration": "Intravenous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "21/12/2015", "compliance_outcome": "Positive", "compliance_opinion_date": "26/02/2016", "compliance_procedure_number": "EMEA-C-000568-PIP01-09-M06", "contact_for_public_enquiries": "NPS Pharma Holdings Limited; United Kingdom; Tel. +80066838470; E-mail: medinfoeuceemea@shire.com", "first_published_date": "23/02/2011", "last_updated_date": "02/02/2016", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000568-pip01-09-m06" }, { "decision_number": "P/0296/2015", "pip_number": "EMEA-001450-PIP01-13-M01", "active_substance": "vosaroxin", "invented_name": "", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Treatment of acute myeloid leukaemia", "routes_of_administration": "Intravenous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "04/12/2015", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Sunesis Europe Ltd ; Belgium; Tel. +1 6502663728 ; Fax +1 6502663528; E-mail: dthomas@sunesis.com", "first_published_date": "22/08/2014", "last_updated_date": "02/02/2016", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001450-pip01-13-m01" }, { "decision_number": "P/0295/2015", "pip_number": "EMEA-000830-PIP02-10-M02", "active_substance": "human normal immunoglobulin", "invented_name": "Gammaplex", "therapeutic_area": "Immunology-Rheumatology-Transplantation", "pharmaceutical_forms": "Solution for infusion", "condition_indication": "Treatment of idiopathic thrombocytopenic purpura as a model for immunomodulation;Treatment of primary immunodeficiency (PID) as model for replacement therapy", "routes_of_administration": "Intravenous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "03/12/2015", "compliance_outcome": "Positive", "compliance_opinion_date": "29/01/2016", "compliance_procedure_number": "EMEA-C-000830-PIP02-10-M02", "contact_for_public_enquiries": "Bio Products Laboratory Limited; United Kingdom; Tel. +44 (0)20 8957 2622; Fax +44 (0)20 8957 2608; E-mail: Omotayo.Onabaworin@bpl.co.uk;  ", "first_published_date": "14/07/2011", "last_updated_date": "02/02/2016", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000830-pip02-10-m02" }, { "decision_number": "P/0311/2015", "pip_number": "EMEA-001501-PIP03-15", "active_substance": "dupilumab", "invented_name": "", "therapeutic_area": "Oto-rhino-laryngology", "pharmaceutical_forms": "Solution for injection in pre-filled pen", "condition_indication": "Treatment of nasal polyposis", "routes_of_administration": "Subcutaneous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "21/12/2015", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "sanofi-aventis recherche & développement; Tel. +33 1697 45695; E-mail: contact-us@sanofi.com", "first_published_date": "02/02/2016", "last_updated_date": "02/02/2016", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001501-pip03-15" }, { "decision_number": "P/0320/2015", "pip_number": "EMEA-001850-PIP01-15", "active_substance": "Inactivated Type 1 poliovirus (Brunhilde);Inactivated Type 3 Poliovirus (Saukett);Inactivated Type 2 Poliovirus (MEF-1)", "invented_name": "", "therapeutic_area": "Vaccines", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Prevention of poliomyelitis", "routes_of_administration": "Intramuscular use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "21/12/2015", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Statens Serum Institut; Denmark; Tel. +4541714897; E-mail: regaffairs@ajvaccines.com", "first_published_date": "02/02/2016", "last_updated_date": "02/02/2016", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001850-pip01-15" }, { "decision_number": "P/0319/2015", "pip_number": "EMEA-001849-PIP01-15", "active_substance": "recombinant human monoclonal IgG1 antibody directed against Programmed Death Ligand-1 (anti-PD-L1) (MSB0010718C)", "invented_name": "", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Concentrate for solution for infusion", "condition_indication": "Treatment of Merkel cell carcinoma", "routes_of_administration": "Intravenous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "21/12/2015", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Merck KGaA; Germany; E-mail: service@merck.de; Tel. +49 6151725200; Fax +49 615172200", "first_published_date": "02/02/2016", "last_updated_date": "02/02/2016", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001849-pip01-15" }, { "decision_number": "P/0318/2015", "pip_number": "EMEA-001840-PIP01-15", "active_substance": "telotristat etiprate", "invented_name": "", "therapeutic_area": "Gastroentology-Hepatology", "pharmaceutical_forms": "Coated tablet", "condition_indication": "Treatment of carcinoid syndrome", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "21/12/2015", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Ipsen Pharma; E-mail: paediatrics.plans@ipsen.com; Tel. +33 158335000", "first_published_date": "02/02/2016", "last_updated_date": "02/02/2016", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001840-pip01-15" }, { "decision_number": "P/0317/2015", "pip_number": "EMEA-001783-PIP02-15", "active_substance": "ketoprofen", "invented_name": "", "therapeutic_area": "Pain", "pharmaceutical_forms": "Medicated plaster", "condition_indication": "Treatment of musculoskeletal and connective tissue pain", "routes_of_administration": "Cutaneous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "21/12/2015", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Promo International S.r.l.; Italy; Tel. +39 382530059; E-mail: regulatory@gbpharma.it", "first_published_date": "02/02/2016", "last_updated_date": "02/02/2016", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001783-pip02-15" }, { "decision_number": "P/0315/2015", "pip_number": "EMEA-001617-PIP01-14", "active_substance": "ethosuximide", "invented_name": "", "therapeutic_area": "Neurology", "pharmaceutical_forms": "Age appropriate oral solid dosage form", "condition_indication": "Treatment of childhood absence epilepsy", "routes_of_administration": "Oral use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "21/12/2015", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "", "first_published_date": "02/02/2016", "last_updated_date": "02/02/2016", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001617-pip01-14" }, { "decision_number": "P/0294/2015", "pip_number": "EMEA-001091-PIP02-15", "active_substance": "emtricitabine;tenofovir disoproxil fumarate", "invented_name": "Truvada; Truvada", "therapeutic_area": "", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Treatment of human immunodeficiency virus (HIV-1) infection", "routes_of_administration": "Oral use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "03/12/2015", "compliance_outcome": "Positive", "compliance_opinion_date": "16/12/2016", "compliance_procedure_number": "EMEA-C-001091-PIP02-15", "contact_for_public_enquiries": "Gilead Sciences International Ltd; United Kingdom; Tel. +44 1223 897342; E-mail: regulatory.pip@gilead.com", "first_published_date": "02/02/2016", "last_updated_date": "02/02/2016", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001091-pip02-15" }, { "decision_number": "P/0266/2015", "pip_number": "EMEA-000309-PIP01-08-M07", "active_substance": "tocilizumab", "invented_name": "RoActemra; RoActemra", "therapeutic_area": "Immunology-Rheumatology-Transplantation", "pharmaceutical_forms": "Concentrate for solution for infusion", "condition_indication": "Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and juvenile idiopathic arthritis)", "routes_of_administration": "Intravenous use;Subcutaneous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "27/11/2015", "compliance_outcome": "Positive", "compliance_opinion_date": "23/02/2018", "compliance_procedure_number": "EMEA-C-000309-PIP01-08-M07", "contact_for_public_enquiries": "Roche Registration Limited; United Kingdom; Tel. +41 6168 79411; Fax +41 6168 79233; E-mail: info.paediatrics@roche.com", "first_published_date": "21/12/2011", "last_updated_date": "07/01/2016", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000309-pip01-08-m07" }, { "decision_number": "P/0293/2015", "pip_number": "EMEA-001852-PIP01-15", "active_substance": "olmesartan medoxomil;amlodipine besilate", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Treatment of hypertension", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "27/11/2015", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Krka, d.d., Novo mesto; Slovenia; Tel. +386 7331 2055; Fax +386 7332 2742; E-mail: tomaz.kralj@krka.biz", "first_published_date": "07/01/2016", "last_updated_date": "07/01/2016", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001852-pip01-15" }, { "decision_number": "P/0292/2015", "pip_number": "EMEA-001824-PIP01-15", "active_substance": "(R)-N-({5-[3-(2,5-Difluorophenyl)-2-(2,3-dihydro-1H-benzimidazol-2-ylidene)-3- oxopropanoyl]-2-fluorophenyl}sulfonyl)-2-hydroxypropanimidamide", "invented_name": "", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Treatment of endometriosis", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "27/11/2015", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Astellas Pharma Europe B.V.Tel. +31 7154 55878E-mail: contact.nl@astellas.com ", "first_published_date": "07/01/2016", "last_updated_date": "07/01/2016", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001824-pip01-15" }, { "decision_number": "P/0291/2015", "pip_number": "EMEA-001820-PIP01-15", "active_substance": "recombinant human growth hormone fused to hybrid Fc composed of the hinge region and N-terminal of CH2 domain of IgD and C-terminal of CH2 and full CH3 domain of IgG4", "invented_name": "", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Treatment of growth hormone deficiency", "routes_of_administration": "Subcutaneous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "27/11/2015", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Genexine, Inc.; Hungary; Tel. +82 31628 3278; Fax +82 31628 3229; E-mail: yjlee@genexine.com", "first_published_date": "07/01/2016", "last_updated_date": "07/01/2016", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001820-pip01-15" }, { "decision_number": "P/0231/2015", "pip_number": "EMEA-000639-PIP02-09-M02", "active_substance": "chloroprocaine hydrochloride", "invented_name": "", "therapeutic_area": "Anaesthesiology", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Intrathecal anaesthesia", "routes_of_administration": "Intrathecal use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "27/10/2015", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Sintetica Italia S.r.l.; Switzerland; Tel. +39 3466 632572; Fax +41 9164 68561; E-mail: italia@sintetica.com, edonati@sintetica.com", "first_published_date": "26/08/2010", "last_updated_date": "06/01/2016", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000639-pip02-09-m02" }, { "decision_number": "P/0057/2015", "pip_number": "EMEA-000060-PIP04-14-M01", "active_substance": "canakinumab", "invented_name": "Ilaris; Ilaris", "therapeutic_area": "Immunology-Rheumatology-Transplantation", "pharmaceutical_forms": "Solution for injection;Powder for solution for injection;Powder and solvent for solution for injection", "condition_indication": "Treatment of familial Mediterranean fever;Treatment of hyperimmunoglobulin D syndrome", "routes_of_administration": "Subcutaneous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "30/10/2015", "compliance_outcome": "Positive", "compliance_opinion_date": "26/02/2016", "compliance_procedure_number": "EMEA-C-000060-PIP04-14-M01", "contact_for_public_enquiries": "Novartis Europharm LimitedE-mail: paediatric.enquiries@novartis.comTel. +41 613241111", "first_published_date": "07/05/2015", "last_updated_date": "06/01/2016", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000060-pip04-14-m01" }, { "decision_number": "P/0239/2015", "pip_number": "EMEA-000060-PIP05-14-M01", "active_substance": "canakinumab", "invented_name": "Ilaris", "therapeutic_area": "Immunology-Rheumatology-Transplantation", "pharmaceutical_forms": "Solution for injection;Powder for solution for injection;Powder and solvent for solution for injection", "condition_indication": "Treatment of tumour necrosis factor receptor associated periodic syndrome", "routes_of_administration": "Subcutaneous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "30/10/2015", "compliance_outcome": "Positive", "compliance_opinion_date": "26/02/2016", "compliance_procedure_number": "EMEA-C-000060-PIP05-14-M01", "contact_for_public_enquiries": "Novartis Europharm LimitedE-mail: paediatric.enquiries@novartis.comTel. +41 613241111", "first_published_date": "07/05/2015", "last_updated_date": "06/01/2016", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000060-pip05-14-m01" }, { "decision_number": "P/0237/2015", "pip_number": "EMEA-000020-PIP01-07-M05", "active_substance": "maraviroc", "invented_name": "Celsentri; Celsentri", "therapeutic_area": "Infectious diseases", "pharmaceutical_forms": "Film-coated tablet;Oral solution", "condition_indication": "Treatment of human immunodeficiency virus (HIV-1) infection", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "30/10/2015", "compliance_outcome": "Positive", "compliance_opinion_date": "29/04/2016", "compliance_procedure_number": "EMEA-C-000020-PIP01-07-M05", "contact_for_public_enquiries": "ViiV Healthcare UK Ltd; United Kingdom; Tel. +44 (0)20 8380 6215; E-mail: neil.p.shortman@viivhealthcare.com", "first_published_date": "29/01/2009", "last_updated_date": "06/01/2016", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000020-pip01-07-m05" }, { "decision_number": "P/0287/2015", "pip_number": "EMEA-001721-PIP01-14", "active_substance": "dimethyl fumarate", "invented_name": "", "therapeutic_area": "Dermatology", "pharmaceutical_forms": "Gastro-resistant tablet", "condition_indication": "Treatment of psoriasis", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "26/11/2015", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Almirall S.A.Tel. +34 9329 13190Fax +34 9329 13531E-mail: paediatrics@almirall.com", "first_published_date": "22/12/2015", "last_updated_date": "22/12/2015", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001721-pip01-14" }, { "decision_number": "P/0259/2015", "pip_number": "EMEA-001810-PIP01-15", "active_substance": "L-Cysteine, L-leucyl-L-α-glutamyl-L-α-glutamyl-L-lysyl-L-lysylglycyl-L-asparaginyl-L-tyrosyl-L-valyl-L-valyl-L-threonyl-L-α -aspartyl-L-histidyl-S-[1-[(4-carboxycyclohexyl)methyl]-2,5-dioxo-3-pyrrolidinyl]-, complex with keyhole limpet haemocyanin", "invented_name": "", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Powder for solution for injection", "condition_indication": "Treatment of high-grade glioma", "routes_of_administration": "Intradermal use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "30/10/2015", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Celldex Therapeutics, Inc.; Germany; Tel. +1 7814 333111; Fax +1 7814 333133; E-mail: aelnatan@celldex.com", "first_published_date": "22/12/2015", "last_updated_date": "22/12/2015", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001810-pip01-15" }, { "decision_number": "P/0262/2015", "pip_number": "EMEA-001817-PIP01-15", "active_substance": "Fluoroestradiol (18F)", "invented_name": "", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Detection of pathological expression of estrogen receptors in organs and tissues", "routes_of_administration": "Intravenous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "30/10/2015", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Laboratoires Cyclopharma; France; Tel. +33 4736 32700; E-mail: jmdecomps@cyclopharma.fr", "first_published_date": "22/12/2015", "last_updated_date": "22/12/2015", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001817-pip01-15" }, { "decision_number": "P/0261/2015", "pip_number": "EMEA-001816-PIP02-15", "active_substance": "mogamulizumab", "invented_name": "", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Concentrate for solution for infusion", "condition_indication": "Treatment of Cutaneous T-Cell Lymphoma", "routes_of_administration": "Intravenous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "30/10/2015", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "ProStrakan Ltd; United Kingdom; Tel. +1 6099 191100; Fax +1 6099 191111; E-mail: kw-0761@kyowa-kirin-pharma.com", "first_published_date": "22/12/2015", "last_updated_date": "22/12/2015", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001816-pip02-15" }, { "decision_number": "P/0264/2015", "pip_number": "EMEA-001845-PIP01-15", "active_substance": "telmisartan;amlodipine besilate", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Tablet", "condition_indication": "Treatment of hypertension", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "30/10/2015", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Krka, d.d. 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KG; Germany; Tel. +49 6431 701453; Fax +49 6431 7018453; E-mail: barbara.riechert@mundipharma-rd.eu", "first_published_date": "19/11/2015", "last_updated_date": "17/12/2015", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001762-pip01-15" }, { "decision_number": "P/0225/2015", "pip_number": "EMEA-001790-PIP01-15", "active_substance": "alpha Connexin C-terminal 1 peptide", "invented_name": "", "therapeutic_area": "Dermatology", "pharmaceutical_forms": "Gel", "condition_indication": "Treatment of diabetic foot ulcer;Treatment of venous leg ulcer", "routes_of_administration": "Cutaneous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "02/10/2015", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "FirstString Research Inc; United States; Tel. +1 8438 608372; E-mail: info@firststring.com", "first_published_date": "19/11/2015", "last_updated_date": "17/12/2015", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001790-pip01-15" }, { "decision_number": "P/0200/2015", "pip_number": "EMEA-001761-PIP01-15", "active_substance": "hydrochlorothiazide;nebivolol (hydrochloride)", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Treatment of hypertension", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "04/09/2015", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Actavis Group PTC ehf; Iceland; Tel. +354 5503482; E-mail: hrefna.haraldsdottir@actavis.com", "first_published_date": "20/10/2015", "last_updated_date": "17/12/2015", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001761-pip01-15" }, { "decision_number": "P/0168/2015", "pip_number": "EMEA-000980-PIP02-15", "active_substance": "Brentuximab vedotin", "invented_name": "Adcetris; Adcetris", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Powder for concentrate for solution for infusion", "condition_indication": "Treatment of Cutaneous T-Cell Lymphoma", "routes_of_administration": "Intravenous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "07/08/2015", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Takeda Pharma A/S; United Kingdom; Email: bharti.navsariwala@takeda.com; Tel.: +44 (0) 2031 168000", "first_published_date": "22/09/2015", "last_updated_date": "17/12/2015", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000980-pip02-15" }, { "decision_number": "P/0180/2015", "pip_number": "EMEA-001754-PIP01-15", "active_substance": "rifamycin", "invented_name": "", "therapeutic_area": "Infectious diseases", "pharmaceutical_forms": "Prolonged-release tablet", "condition_indication": "Treatment of acute infectious diarrhoea", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "07/08/2015", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Dr. Falk Pharma GmbH; Email: zentrale@drfalkpharma.de; Tel.: +49 76115140", "first_published_date": "24/09/2015", "last_updated_date": "17/12/2015", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001754-pip01-15" }, { "decision_number": "P/0199/2015", "pip_number": "EMEA-001759-PIP01-15", "active_substance": "torasemide;lisinopril", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Tablet", "condition_indication": "Treatment of heart failure;Treatment of hypertension", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "04/09/2015", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Accupharma spółka z ograniczoną odpowiedzialnością; Poland; E-mail: biuro@accupharma.pl; Tel. +48 224905162; Fax +48 224905153", "first_published_date": "20/10/2015", "last_updated_date": "17/12/2015", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001759-pip01-15" }, { "decision_number": "P/0218/2015", "pip_number": "EMEA-001461-PIP02-14", "active_substance": "acotiamide", "invented_name": "", "therapeutic_area": "Gastroentology-Hepatology", "pharmaceutical_forms": "Coated tablet", "condition_indication": "Treatment of functional dyspepsia", "routes_of_administration": "Oral use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "02/10/2015", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Zeria Pharmaceutical Co Ltd; tomoharu-miyagawa@zeria.co.jp; Tel. +44 (0)7528 697428", "first_published_date": "19/11/2015", "last_updated_date": "17/12/2015", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001461-pip02-14" }, { "decision_number": "P/0204/2015", "pip_number": "EMEA-001779-PIP01-15", "active_substance": "enclomifene citrate", "invented_name": "", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Capsule, hard", "condition_indication": "Treatment of hypogonadotrophic hypogonadism", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "07/09/2015", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Renable Pharma Limited; United Kingdom; E-mail: carole.pugh@eudrac.com; Tel. +44 1865893274; Fax +44 1865893333", "first_published_date": "20/10/2015", "last_updated_date": "17/12/2015", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001779-pip01-15" }, { "decision_number": "P/0224/2015", "pip_number": "EMEA-001788-PIP01-15", "active_substance": "Botulinum Neurotoxin Type A", "invented_name": "", "therapeutic_area": "", "pharmaceutical_forms": "Powder for solution for injection", "condition_indication": "Treatment of muscle induced wrinkles", "routes_of_administration": "Intramuscular use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "02/10/2015", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Croma Pharma GmbH; Austria; Tel. +43 2262 684680; Fax +43 2262 68468165; E-mail: office@croma.at", "first_published_date": "19/11/2015", "last_updated_date": "17/12/2015", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001788-pip01-15" }, { "decision_number": "P/0228/2015", "pip_number": "EMEA-001805-PIP01-15", "active_substance": "Dasabuvir;ombitasvir;paritaprevir;ritonavir", "invented_name": "", "therapeutic_area": "Infectious diseases", "pharmaceutical_forms": "Tablet", "condition_indication": "Treatment of chronic hepatitis C", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "02/10/2015", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "AbbVie LtdE-mail: ukpaediatricteam@abbvie.comTel. +44 1628 644474", "first_published_date": "19/11/2015", "last_updated_date": "17/12/2015", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001805-pip01-15" }, { "decision_number": "P/0203/2015", "pip_number": "EMEA-001777-PIP01-15", "active_substance": "azithromycin", "invented_name": "", "therapeutic_area": "Ophthalmology", "pharmaceutical_forms": "Eye drops, solution;Solution", "condition_indication": "Treatment of bacterial conjunctivitis", "routes_of_administration": "Topical use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "04/09/2015", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Laboratoires Doliage (Groupe Nicox); 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United Kingdom; E-mail: admin@therakind.com; Tel. + 44 (0)20 8346 6035; Fax + 44 (0)20 8346 7305", "first_published_date": "03/05/2013", "last_updated_date": "25/09/2015", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001316-pip01-12-m01" }, { "decision_number": "P/0178/2015", "pip_number": "EMEA-001743-PIP01-14", "active_substance": "carvedilol;ivabradine hydrochloride", "invented_name": "", "therapeutic_area": "", "pharmaceutical_forms": "Tablet", "condition_indication": "Treatment of heart failure;Treatment of ischaemic coronary artery disorders", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "07/08/2015", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Les Laboratoires ServierE-mail: mail.pip.enquiries@servier.comTel.: +33 155726000", "first_published_date": "22/09/2015", "last_updated_date": "22/09/2015", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001743-pip01-14" }, { "decision_number": "P/0124/2015", "pip_number": "EMEA-001601-PIP01-13", "active_substance": "misoprostol", "invented_name": "", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Tablet", "condition_indication": "Induction of labour", "routes_of_administration": "Oral use;Sublingual use;Vaginal use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "05/06/2015", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Azanta Danmark A/S; Denmark; Tel. +45 70259545; Fax +45 70259546; E-mail: cm@azanta.com", "first_published_date": "03/07/2015", "last_updated_date": "02/09/2015", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001601-pip01-13" }, { "decision_number": "P/0135/2015", "pip_number": "EMEA-000309-PIP02-14", "active_substance": "tocilizumab", "invented_name": "RoActemra; RoActemra", "therapeutic_area": "Immunology-Rheumatology-Transplantation", "pharmaceutical_forms": "Solution for injection in pre-filled syringe", "condition_indication": "Treatment of vasculitides", "routes_of_administration": "Subcutaneous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "15/06/2015", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Roche Registration Limited; United Kingdom; Tel. +41 6168 79411; Fax +41 6168 79233; E-mail: info.paediatrics@roche.com", "first_published_date": "03/07/2015", "last_updated_date": "02/09/2015", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000309-pip02-14" }, { "decision_number": "P/0128/2015", "pip_number": "EMEA-001724-PIP01-14", "active_substance": "levomilnacipran", "invented_name": "", "therapeutic_area": "Neurology", "pharmaceutical_forms": "Prolonged-release capsule;Capsule, hard", "condition_indication": "Treatment of stroke", "routes_of_administration": "Oral use", "decision_type": "RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)", "decision_date": "05/06/2015", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Pierre Fabre Medicament; France; Tel. +33 149108081", "first_published_date": "06/07/2015", "last_updated_date": "02/09/2015", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001724-pip01-14" }, { "decision_number": "P/0151/2015", "pip_number": "EMEA-001547-PIP01-13", "active_substance": "atorvastatin;perindopril;acetylsalicylic acid", "invented_name": "", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Capsule, hard", "condition_indication": "Treatment of elevated cholesterol;Treatment of ischemic coronary artery disorders", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "10/07/2015", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Les Laboratoires ServierE-mail: mail.pip.enquiries@servier.comTel.: +33 155726000", "first_published_date": "25/08/2015", "last_updated_date": "25/08/2015", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001547-pip01-13" }, { "decision_number": "P/0142/2015", "pip_number": "EMEA-000575-PIP01-09-M03", "active_substance": "ciclosporin", "invented_name": "", "therapeutic_area": "Ophthalmology", "pharmaceutical_forms": "Eye drops, emulsion", "condition_indication": "Treatment of keratoconjunctivitis sicca;Treatment of vernal keratoconjunctivitis", "routes_of_administration": "Ocular use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "10/07/2015", "compliance_outcome": "Positive", "compliance_opinion_date": "29/04/2016", "compliance_procedure_number": "EMEA-C-000575-PIP01-09-M03", "contact_for_public_enquiries": "Santen SAS; 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Tel. +44 (0)1895 523740; E-mail: medical.information@bms.com", "first_published_date": "22/08/2014", "last_updated_date": "20/08/2015", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001485-pip01-13-m01" }, { "decision_number": "P/0100/2015", "pip_number": "EMEA-001693-PIP01-14", "active_substance": "reparixin", "invented_name": "", "therapeutic_area": "Immunology-Rheumatology-Transplantation", "pharmaceutical_forms": "Concentrate for solution for infusion", "condition_indication": "Prevention of graft rejection", "routes_of_administration": "Intravenous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "08/05/2015", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Dompé farmaceutici SpA ; Italy; Tel. +39 0258383559; E-mail: lamberto.dionigi@dompe.com", "first_published_date": "16/06/2015", "last_updated_date": "20/08/2015", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001693-pip01-14" }, { "decision_number": "P/0101/2015", "pip_number": "EMEA-001719-PIP01-14", "active_substance": "L-Pyr-L-Glu-L-Gln-L-Leu-L-Glu-L-Arg-L-Ala-L-Leu-L-Asn-L-Ser-L-Ser", "invented_name": "", "therapeutic_area": "Neurology", "pharmaceutical_forms": "Powder for solution for injection", "condition_indication": "Treatment of sarcoidosis", "routes_of_administration": "Subcutaneous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "08/05/2015", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Araim Pharna Europe Ltd; United Kingdom; Tel. +1 9147627586201 ; Fax +1 9142944170; E-mail: rkirk@araimpharma.com", "first_published_date": "16/06/2015", "last_updated_date": "20/08/2015", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001719-pip01-14" }, { "decision_number": "P/0104/2015", "pip_number": "EMEA-001663-PIP01-14", "active_substance": "Ibodutant", "invented_name": "", "therapeutic_area": "Gastroentology-Hepatology", "pharmaceutical_forms": "Tablet;Film-coated tablet", "condition_indication": "Treatment of diarrhoea-predominant irritable bowel Syndrome", "routes_of_administration": "Oral use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "11/05/2015", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Menarini Ricerche S.p.A. ; Italy; Tel. +39 0555680633; E-mail: prijli@menarini.it", "first_published_date": "16/06/2015", "last_updated_date": "20/08/2015", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001663-pip01-14" }, { "decision_number": "P/0097/2015", "pip_number": "EMEA-001556-PIP01-13", "active_substance": "Human recombinant interleukin-2", "invented_name": "", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Powder for solution for injection", "condition_indication": "Treatment of type I diabetes mellitus", "routes_of_administration": "Subcutaneous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "08/05/2015", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Iltoo Pharma ; 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United Kingdom; Tel. +44 (0)1223 897300 ; Fax +44 (0)1223 897284; E-mail: regulatory.pip@gilead.com", "first_published_date": "16/06/2015", "last_updated_date": "20/08/2015", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001511-pip02-13" }, { "decision_number": "P/0098/2014", "pip_number": "EMEA-000804-PIP01-09-M02", "active_substance": "atazanavir (as sulfate)", "invented_name": "Reyataz; Reyataz", "therapeutic_area": "Infectious diseases", "pharmaceutical_forms": "Capsule;Hard oral powder", "condition_indication": "Treatment of human immunodeficiency virus (HIV-1) infection", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "10/04/2014", "compliance_outcome": "Positive", "compliance_opinion_date": "13/02/2015", "compliance_procedure_number": "EMEA-C-000804-PIP01-09-M02", "contact_for_public_enquiries": "Bristol-Myers Squibb Pharma EEIG E-mail: medical.information@bms.com Tel. +44 (0)1423 533610", "first_published_date": "20/12/2010", "last_updated_date": "27/07/2015", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000804-pip01-09-m02" }, { "decision_number": "P/0260/2014", "pip_number": "EMEA-000573-PIP01-09-M05", "active_substance": "solifenacin (succinate)", "invented_name": "", "therapeutic_area": "Uro-nephrology", "pharmaceutical_forms": "Oral suspension;Film-coated tablet", "condition_indication": "Treatment of idiopathic overactive bladder", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "29/09/2014", "compliance_outcome": "Positive", "compliance_opinion_date": "22/05/2015", "compliance_procedure_number": "EMEA-C-000573-PIP01-09-M05", "contact_for_public_enquiries": "Astellas Pharma Europe B.V.Tel. +31 7154 55878E-mail: contact.nl@astellas.com ", "first_published_date": "27/07/2010", "last_updated_date": "27/07/2015", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000573-pip01-09-m05" }, { "decision_number": "P/208/2011", "pip_number": "EMEA-000060-PIP01-07-M03", "active_substance": "canakinumab", "invented_name": "Ilaris", "therapeutic_area": "Immunology-Rheumatology-Transplantation", "pharmaceutical_forms": "Powder for solution for injection;Powder and solvent for solution for injection;Solution for injection", "condition_indication": "Cryopyrin Associated Periodic Syndromes (CAPS);Familial Cold Autoinflammatory Syndrome (FCAS) / Familial Cold Urticaria (FCU);Muckle-Wells Syndrome (MWS);Neonatal-Onset Multisystem Inflammatory Disease (NOMID) / Chronic Infantile Neurological, Cutaneous, Articular Syndrome (CINCA)", "routes_of_administration": "Subcutaneous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "03/09/2011", "compliance_outcome": "Positive", "compliance_opinion_date": "19/06/2015", "compliance_procedure_number": "EMEA-C-000060-PIP01-07-M03", "contact_for_public_enquiries": "Novartis Europharm LimitedE-mail: paediatric.enquiries@novartis.comTel. +41 613241111", "first_published_date": "17/10/2011", "last_updated_date": "27/07/2015", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000060-pip01-07-m03" }, { "decision_number": "P/0144/2012", "pip_number": "EMEA-001005-PIP01-10-M01", "active_substance": "lopinavir;ritonavir", "invented_name": "Kaletra; Kaletra", "therapeutic_area": "Infectious diseases", "pharmaceutical_forms": "Oral solution;Capsule, soft;Film-coated tablet", "condition_indication": "Treatment of human immunodeficiency virus (HIV-1) infection", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "23/07/2012", "compliance_outcome": "Positive", "compliance_opinion_date": "17/07/2015", "compliance_procedure_number": "EMEA-C-001005-PIP01-10-M01", "contact_for_public_enquiries": "AbbVie LtdE-mail: paediatricteam@abbvie.comTel. +44 (0)1628 408248", "first_published_date": "13/09/2011", "last_updated_date": "27/07/2015", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001005-pip01-10-m01" }, { "decision_number": "P/0033/2015", "pip_number": "EMEA-000319-PIP01-08-M03", "active_substance": "House dust mites allergen extracts", "invented_name": "", "therapeutic_area": "Pneumology-allergology", "pharmaceutical_forms": "Sublingual tablet", "condition_indication": "Treatment of allergic rhinitis;Treatment of asthma", "routes_of_administration": "Sublingual use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "06/03/2015", "compliance_outcome": "Positive", "compliance_opinion_date": "19/06/2015", "compliance_procedure_number": "EMEA-C-000319-PIP01-08-M03", "contact_for_public_enquiries": "Stallergenes; France; E-mail: mites.development@stallergenes.fr; Tel. +33 155592633; Fax +33 155592068", "first_published_date": "11/08/2011", "last_updated_date": "27/07/2015", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000319-pip01-08-m03" }, { "decision_number": "P/0274/2014", "pip_number": "EMEA-000312-PIP01-08-M07", "active_substance": "human coagulation factor VIII;von Willebrand factor", "invented_name": "Voncento; Voncento", "therapeutic_area": "Haematology-Hemostaseology", "pharmaceutical_forms": "Powder and solvent for solution for injection;Powder and solvent for solution for infusion", "condition_indication": "Treatment of hereditary factor-VIII deficiency (Haemophilia A);Treatment of von Willebrand disease", "routes_of_administration": "Intravenous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "28/10/2014", "compliance_outcome": "Positive", "compliance_opinion_date": "22/05/2015", "compliance_procedure_number": "EMEA-C-000312-PIP01-08-M07", "contact_for_public_enquiries": "CSL Behring; Germany; E-mail: eu-cslbehring@cslbehring.com; Tel. +49 642 1395212; Fax +49 642 1394196", "first_published_date": "25/05/2012", "last_updated_date": "27/07/2015", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000312-pip01-08-m07" }, { "decision_number": "P/0297/2014", "pip_number": "EMEA-000127-PIP01-07-M03", "active_substance": "fluticasone propionate;Formoterol (fumarate)", "invented_name": "", "therapeutic_area": "Pneumology-allergology", "pharmaceutical_forms": "Pressurised inhalation;Suspension", "condition_indication": "Asthma", "routes_of_administration": "Inhalation use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "24/11/2014", "compliance_outcome": "Positive", "compliance_opinion_date": "13/02/2015", "compliance_procedure_number": "EMEA-C-000127-PIP01-07-M03", "contact_for_public_enquiries": "Mundipharma Research Ltd; United Kingdom; E-mail: paediatric@mundipharma-rd.eu; 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Portugal; E-mail: dina.c@labvitoria.pt; Tel. +351 214758300 ext. 357; Fax +351 214747070;  ", "first_published_date": "07/05/2015", "last_updated_date": "06/07/2015", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001713-pip02-14" }, { "decision_number": "P/0077/2015", "pip_number": "EMEA-001694-PIP01-14", "active_substance": "autologous bone marrow-derived cardiopoietic stem cells", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Suspension for injection", "condition_indication": "Treatment of ischemic heart disease", "routes_of_administration": "Intracardiac use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "01/04/2015", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Cardio3 BioSciences SA; Belgium; E-mail: info@c3bs.com / regulatory@c3bs.com; 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Germany; E-mail: n.burger@develco.ch, k.schmid@develco.ch; Tel. +41 614255020; Fax +41 614255029", "first_published_date": "24/03/2015", "last_updated_date": "06/07/2015", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001700-pip01-14" }, { "decision_number": "P/0051/2015", "pip_number": "EMEA-001711-PIP01-14", "active_substance": "Candesartan;amlodipine", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Capsule, hard;Tablet", "condition_indication": "Treatment of hypertension", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "06/03/2015", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Adamed Sp. z o.o.; Tel. +48227327736; E-mail: joanna.pawlak@adamed.com.pl", "first_published_date": "24/03/2015", "last_updated_date": "06/07/2015", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001711-pip01-14" }, { "decision_number": "P/0048/2015", "pip_number": "EMEA-001699-PIP01-14", "active_substance": "hydromorphone (hydrochloride);naloxone (hydrochloride)", "invented_name": "", "therapeutic_area": "Gastroentology-Hepatology", "pharmaceutical_forms": "Prolonged-release tablet", "condition_indication": "Treatment of opioid-induced constipation;Treatment of pain", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "06/03/2015", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Develco Pharma GmbH; Germany; E-mail: n.burger@develco.ch, k.schmid@develco.ch; Tel. +41 614255020; Fax +41 614255029", "first_published_date": "24/03/2015", "last_updated_date": "06/07/2015", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001699-pip01-14" }, { "decision_number": "P/0088/2015", "pip_number": "EMEA-000178-PIP01-07-M04", "active_substance": "", "invented_name": "Pumarix; Pumarix", "therapeutic_area": "Vaccines", "pharmaceutical_forms": "Emulsion and suspension for emulsion for injection", "condition_indication": "Prevention of influenza infection", "routes_of_administration": "Intramuscular use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "08/05/2015", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "GlaxoSmithKline Biologicals S.A. (Belgium); Tel. +1 438 899 8201; Email: eu.paediatric-plans@gsk.com", "first_published_date": "10/06/2009", "last_updated_date": "15/06/2015", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000178-pip01-07-m04" }, { "decision_number": "P/0085/2015", "pip_number": "EMEA-000117-PIP01-07-M07", "active_substance": "Ipilimumab", "invented_name": "Yervoy; Yervoy", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Concentrate for solution for infusion", "condition_indication": "Treatment of all conditions included in the category of malignant neoplasms (except melanoma, nervous system, haematopoietic and lymphoid tissue)", "routes_of_administration": "Intravenous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "08/05/2015", "compliance_outcome": "Positive", "compliance_opinion_date": "11/12/2015", "compliance_procedure_number": "EMEA-C-000117-PIP01-07-M07", "contact_for_public_enquiries": "Bristol-Myers Squibb Pharma EEIG E-mail: medical.information@bms.com Tel. +44 (0)1423 533610", "first_published_date": "13/07/2011", "last_updated_date": "15/06/2015", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000117-pip01-07-m07" }, { "decision_number": "P/0074/2015", "pip_number": "EMEA-001404-PIP01-12", "active_substance": "tetrabenazine (ADV6979)", "invented_name": "", "therapeutic_area": "Neurology", "pharmaceutical_forms": "Oral suspension", "condition_indication": "Treatment of dystonia", "routes_of_administration": "Oral use;Gastric use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "01/04/2015", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Advicenne Pharma ; E-mail: contact@advicenne.com; Tel. +33 4660 55420", "first_published_date": "07/05/2015", "last_updated_date": "07/05/2015", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001404-pip01-12" }, { "decision_number": "P/0072/2015", "pip_number": "EMEA-001324-PIP01-12-M01", "active_substance": "glibenclamide", "invented_name": "", "therapeutic_area": "Other", "pharmaceutical_forms": "Oral suspension", "condition_indication": "Treatment of neonatal diabetes mellitus", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "01/04/2015", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "AMMTeK; France; E-mail: a.ulmann@ammtek.eu; Tel. +33 182731319; Fax +33 140331231", "first_published_date": "07/10/2013", "last_updated_date": "06/05/2015", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001324-pip01-12-m01" }, { "decision_number": "P/0035/2015", "pip_number": "EMEA-000500-PIP01-08-M03", "active_substance": "Diphtheria toxoid;tetanus toxoid;Bordetella pertussis antigen: Pertussis toxoid;Bordetella pertussis antigen: Filamentous Haemagglutinin;Bordetella pertussis antigen: Pertactin;Inactivated Type 2 Poliovirus (MEF-1);Inactivated Type 3 Poliovirus (Saukett);Inactivated Type 1 Poliovirus (Mahoney)", "invented_name": "", "therapeutic_area": "Vaccines", "pharmaceutical_forms": "Suspension for injection;Suspension for injection in pre-filled syringe", "condition_indication": "Prevention of infectious diseases caused by Corynebacterium diphtheriae / Clostridium tetani / Bordetella pertussis / Poliovirus types 1, 2 and 3", "routes_of_administration": "Intramuscular use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "07/03/2015", "compliance_outcome": "Positive", "compliance_opinion_date": "27/05/2016", "compliance_procedure_number": "EMEA-C-000500-PIP01-08-M03", "contact_for_public_enquiries": "GSK Vaccines S.r.l.; Tel. +1 438 899 8201; Email: eu.paediatric-plans@gsk.com", "first_published_date": "30/10/2010", "last_updated_date": "25/03/2015", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000500-pip01-08-m03" }, { "decision_number": "P/0050/2015", "pip_number": "EMEA-001702-PIP01-14", "active_substance": "perindopril;amlodipine", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Tablet", "condition_indication": "Treatment of hypertension", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "06/03/2015", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Adamed Sp. z o.o.; Tel. +48227327736; E-mail: joanna.pawlak@adamed.com.pl", "first_published_date": "24/03/2015", "last_updated_date": "24/03/2015", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001702-pip01-14" }, { "decision_number": "P/0054/2015", "pip_number": "EMEA-001568-PIP03-14", "active_substance": "ceftriaxone;sulbactam", "invented_name": "", "therapeutic_area": "Infectious diseases", "pharmaceutical_forms": "Powder for solution for injection or infusion", "condition_indication": "Treatment of bacterial infections", "routes_of_administration": "Intravenous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "09/03/2015", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Venus Pharma GmbH; India; E-mail: katja.petrovic@rega.si; Tel. +91 1795 302017, +91 1795 302018; Fax +91 1795 271272", "first_published_date": "24/03/2015", "last_updated_date": "24/03/2015", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001568-pip03-14" }, { "decision_number": "P/0045/2015", "pip_number": "EMEA-001483-PIP01-13", "active_substance": "(1-methyl-2-nitro-1H-imidazole-5-yl)methyl N,N'-bis(2-bromoethyl) phosphorodiamidate [TH-302]", "invented_name": "", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Concentrate for solution for infusion", "condition_indication": "Treatment of Ewing sarcoma;Treatment of soft tissue sarcoma", "routes_of_administration": "Intravenous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "06/03/2015", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Merck KGaA; Germany; Tel. +49 6151 725200; Fax +49 6151 722000; E-mail: service@merck.de", "first_published_date": "23/03/2015", "last_updated_date": "23/03/2015", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001483-pip01-13" }, { "decision_number": "P/0008/2015", "pip_number": "EMEA-000234-PIP02-14", "active_substance": "human papillomavirus type 18 L1 protein;human papillomavirus type 16 L1 protein", "invented_name": "Cervarix; Cervarix", "therapeutic_area": "Vaccines", "pharmaceutical_forms": "Suspension for injection", "condition_indication": "Prevention of infection by human papillomavirus", "routes_of_administration": "Intramuscular use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "30/01/2015", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "GlaxoSmithKline Biologicals S.A. (Belgium); Tel. +1 438 899 8201; Email: eu.paediatric-plans@gsk.com", "first_published_date": "05/03/2015", "last_updated_date": "10/03/2015", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000234-pip02-14" }, { "decision_number": "P/0026/2015", "pip_number": "EMEA-001633-PIP01-14", "active_substance": "Candesartan cilexetil;amlodipine besilate", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Treatment of essential hypertension", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "30/01/2015", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Krka, d.d., Novo mesto; Slovenia; E-mail: tomaz.kralj@krka.biz; Tel. +386 73312055; Fax +386 73322742 ", "first_published_date": "05/03/2015", "last_updated_date": "10/03/2015", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001633-pip01-14" }, { "decision_number": "P/0322/2014", "pip_number": "EMEA-001677-PIP01-14", "active_substance": "saxagliptin;dapagliflozin", "invented_name": "", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Treatment of type II diabetes mellitus", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "19/12/2014", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "AstraZeneca AB ; Sweden ; E-mail: paediatrics@astrazeneca.com ; Tel. +46 8 5532 7709", "first_published_date": "23/02/2015", "last_updated_date": "10/03/2015", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001677-pip01-14" }, { "decision_number": "P/0028/2015", "pip_number": "EMEA-001669-PIP01-14", "active_substance": "amlodipine;perindopril erbumine", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Tablet", "condition_indication": "Treatment of hypertension;Treatment of stable coronary artery disease", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "30/01/2015", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Actavis Group PTC ehf; Iceland; Tel. +354 5503482; E-mail: hrefna.haraldsdottir@actavis.com", "first_published_date": "05/03/2015", "last_updated_date": "10/03/2015", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001669-pip01-14" }, { "decision_number": "P/0019/2015", "pip_number": "EMEA-001226-PIP01-11-M01", "active_substance": "surotomycin", "invented_name": "", "therapeutic_area": "Infectious diseases", "pharmaceutical_forms": "Tablet;Age appropriate oral solid dosage form", "condition_indication": "Treatment of clostridia infections", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "30/01/2015", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Cubist (UK) Ltd; United Kingdom; E-mail: deepak.jain@cubist.com; Tel. +1 7818601244", "first_published_date": "31/05/2013", "last_updated_date": "05/03/2015", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001226-pip01-11-m01" }, { "decision_number": "P/0005/2015", "pip_number": "EMEA-000035-PIP02-09-M02", "active_substance": "tiotropium bromide (monohydrate)", "invented_name": "", "therapeutic_area": "Pneumology-allergology", "pharmaceutical_forms": "Inhalation solution;Inhalation powder;Capsule, hard", "condition_indication": "Treatment of asthma", "routes_of_administration": "Inhalation use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "30/01/2015", "compliance_outcome": "Positive", "compliance_opinion_date": "27/05/2016", "compliance_procedure_number": "EMEA-C-000035-PIP02-09-M02", "contact_for_public_enquiries": "Boehringer Ingelheim International GmbH; Tel. +49 6132 778271; Email: Paediatrics@boehringer-ingelheim.com", "first_published_date": "23/04/2013", "last_updated_date": "05/03/2015", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000035-pip02-09-m02" }, { "decision_number": "P/0029/2015", "pip_number": "EMEA-001674-PIP01-14", "active_substance": "lutetium (177Lu) chloride", "invented_name": "", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Radiopharmaceutical precursor;Solution", "condition_indication": "Radiolabelling agent", "routes_of_administration": "Intravenous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "30/01/2015", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "ITG Isotope Technologies Garching GmbH; Germany; E-mail: regulatory@brinkerpharma.de; Tel. +49 308100980", "first_published_date": "05/03/2015", "last_updated_date": "05/03/2015", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001674-pip01-14" }, { "decision_number": "P/0004/2015", "pip_number": "EMEA-000019-PIP11-14", "active_substance": "everolimus", "invented_name": "", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Tablet;Dispersible tablet", "condition_indication": "Treatment of thoracic neuroendocrine tumour", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "30/01/2015", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Novartis Europharm Ltd; United Kingdom; E-mail: paediatric.enquiries@novartis.com; Tel. +41 613241111; Fax +41 613248001;  ", "first_published_date": "05/03/2015", "last_updated_date": "05/03/2015", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000019-pip11-14" }, { "decision_number": "P/0324/2014", "pip_number": "EMEA-001689-PIP01-14", "active_substance": "zoledronic acid monohydrate", "invented_name": "", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Concentrate for solution for infusion", "condition_indication": "Prevention of skeletal related events in patients with advanced malignancies involving bone", "routes_of_administration": "Intravenous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "19/12/2014", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Gedeon Richter Plc. ; Hungary ; E-mail: mrpRichter@richter.hu ; Tel. +36 14314040 ; Fax +36 14315415", "first_published_date": "23/02/2015", "last_updated_date": "23/02/2015", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001689-pip01-14" }, { "decision_number": "P/0339/2014", "pip_number": "EMEA-001630-PIP01-14", "active_substance": "ibandronic acid", "invented_name": "", "therapeutic_area": "Other", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Combination treatment of osteoporosis", "routes_of_administration": "Intravenous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "22/12/2014", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Gedeon Richter Plc. ; Hungary ; E-mail: mrpRichter@richter.hu ; Tel. +36 14314040 ; Fax +36 14315415", "first_published_date": "23/02/2015", "last_updated_date": "23/02/2015", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001630-pip01-14" }, { "decision_number": "P/0341/2014", "pip_number": "EMEA-001670-PIP01-14", "active_substance": "cholecalciferol;calcium carbonate", "invented_name": "", "therapeutic_area": "Other", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Combination treatment of osteoporosis", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "22/12/2014", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Gedeon Richter Plc. ; Hungary ; E-mail: mrpRichter@richter.hu ; Tel. +36 14314040 ; Fax +36 14315415", "first_published_date": "23/02/2015", "last_updated_date": "23/02/2015", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001670-pip01-14" }, { "decision_number": "P/0343/2014", "pip_number": "EMEA-001591-PIP01-14", "active_substance": "glycopyrronium bromide", "invented_name": "", "therapeutic_area": "Oto-rhino-laryngology", "pharmaceutical_forms": "Oral solution", "condition_indication": "Treatment of sialorrhoea", "routes_of_administration": "Oral use", "decision_type": "RP: decision refers to a refusal on a proposed Paediatric Investigation Plan", "decision_date": "22/12/2014", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Desitin Arzneimittel GmbH ; Germany ; E-mail: info@desitin.de ; Tel. +49 4059101525", "first_published_date": "23/02/2015", "last_updated_date": "23/02/2015", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001591-pip01-14" }, { "decision_number": "P/0321/2014", "pip_number": "EMEA-001655-PIP01-14", "active_substance": "urofollitropin", "invented_name": "", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "", "condition_indication": "Treatment of female infertility;Treatment of hypogonadotrophic hypogonadism", "routes_of_administration": "Subcutaneous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "19/12/2014", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Regiomedica GmbH ; Germany ; E-mail: info@regiomedica.de ; Tel. +49 7621166444", "first_published_date": "23/02/2015", "last_updated_date": "23/02/2015", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001655-pip01-14" }, { "decision_number": "P/0323/2014", "pip_number": "EMEA-001685-PIP01-14", "active_substance": "amlodipine;ramipril", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Capsule, hard", "condition_indication": "Treatment of hypertension", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "19/12/2014", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Helm Portugal, LDA. ; Portugal ; E-mail: i.botelheiro@helmportugal.com ; Tel. +35 1219948300 ; Fax +35 1219552475", "first_published_date": "23/02/2015", "last_updated_date": "23/02/2015", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001685-pip01-14" }, { "decision_number": "P/0325/2014", "pip_number": "EMEA-001690-PIP01-14", "active_substance": "calcium carbonate;cholecalciferol", "invented_name": "", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Prevention of skeletal related events in patients with advanced malignancies involving bone", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "19/12/2014", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Gedeon Richter Plc. ; Hungary ; E-mail: mrpRichter@richter.hu ; Tel. +36 14314040 ; Fax +36 14315415", "first_published_date": "23/02/2015", "last_updated_date": "23/02/2015", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001690-pip01-14" }, { "decision_number": "P/0315/2014", "pip_number": "EMEA-001680-PIP01-14", "active_substance": "valsartan;amlodipine besilate", "invented_name": "Exforge", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Film-coated tablet;Orodispersible tablet", "condition_indication": "Treatment of hypertension", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "05/12/2014", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Novartis Europharm LimitedE-mail: paediatric.enquiries@novartis.comTel. +41 613241111", "first_published_date": "22/01/2015", "last_updated_date": "17/02/2015", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001680-pip01-14" }, { "decision_number": "P/0307/2014", "pip_number": "EMEA-001667-PIP01-14", "active_substance": "abaloparatide", "invented_name": "", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Solution for injection;Transdermal system", "condition_indication": "Treatment of osteoporosis", "routes_of_administration": "Subcutaneous use;Transdermal use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "24/11/2014", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Triskel EU Services, Ltd (Jean-Yves le Cotonnec) ; United Kingdom ; E-mail: gwilliams@radiuspharm.com ; Tel. +1 6175514700", "first_published_date": "12/12/2014", "last_updated_date": "17/02/2015", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001667-pip01-14" }, { "decision_number": "P/0207/2014", "pip_number": "EMEA-001548-PIP01-13", "active_substance": "valaciclovir (hydrochloride)", "invented_name": "", "therapeutic_area": "Infectious diseases", "pharmaceutical_forms": "Powder for oral suspension", "condition_indication": "Treatment and prevention of Herpes simplex virus disease;Treatment and prevention of Varicella Zoster virus disease", "routes_of_administration": "Oral use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "08/08/2014", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Pharmathen S.A. ; Greece ; E-mail: mkalovidouri@pharmathen.com ; Tel. +30 2106604354", "first_published_date": "22/08/2014", "last_updated_date": "17/02/2015", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001548-pip01-13" }, { "decision_number": "P/253/2011", "pip_number": "EMEA-000150-PIP02-10", "active_substance": "(1R, 4S, 5S, 6S)-4-[[(2s)-2-amino-4-(methylthio)-1-oxobutyl]amino]-2-thiabicyclo[3.1.0]hexane-4,6-dicarboxylic acid,2,2-dioxide, monohydrate (LY2140023)", "invented_name": "", "therapeutic_area": "Psychiatry", "pharmaceutical_forms": "Coated tablet", "condition_indication": "Treatment of schizophrenia", "routes_of_administration": "Oral use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "26/10/2011", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Eli Lilly & Company Limited; E-mail: eu_paediatric@lilly.com ; Tel. +44 (0)1276 483000", "first_published_date": "29/11/2011", "last_updated_date": "16/02/2015", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000150-pip02-10" }, { "decision_number": "P/271/2010", "pip_number": "EMEA-000888-PIP01-10", "active_substance": "Betula alba;Betula pendula;Betula verrucosa", "invented_name": "", "therapeutic_area": "Pneumology-allergology", "pharmaceutical_forms": "Oromucosal solution", "condition_indication": "Treatment of allergic rhinitis;Treatment of rhino-conjuctivitis", "routes_of_administration": "Sublingual use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "03/12/2010", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Allergopharma Joachim Ganzer KG; Germany; E-mail: info@allergopharma.de; Tel. +49 40727650; Fax +49 407227713", "first_published_date": "10/01/2011", "last_updated_date": "16/02/2015", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000888-pip01-10" }, { "decision_number": "P/207/2011", "pip_number": "EMEA-000878-PIP02-11", "active_substance": "colestilan", "invented_name": "BindRen; BindRen", "therapeutic_area": "Uro-nephrology", "pharmaceutical_forms": "Granules;Film-coated tablet", "condition_indication": "Treatment of hyperphosphataemia", "routes_of_administration": "Oral use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "01/09/2011", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Mitsubishi Pharma Europe Ltd ; United Kingdom; E-mail: jvlek@m-pharma.co.uk; +44 (0)20 7065 5000; +44 (0)20 7065 5050", "first_published_date": "18/10/2011", "last_updated_date": "29/01/2015", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000878-pip02-11" }, { "decision_number": "P/0311/2014", "pip_number": "EMEA-001558-PIP02-14", "active_substance": "thiocolchicoside;diclofenac (sodium)", "invented_name": "", "therapeutic_area": "Pain", "pharmaceutical_forms": "Cutaneous patch", "condition_indication": "Treatment of musculoskeletal and connective tissue pain", "routes_of_administration": "Cutaneous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "25/11/2014", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Epifarma Srl ; Italy ; E-mail: b.trupa@epifarma.it ; Tel. +39 0973 655200 ; Fax +39 0973 655318", "first_published_date": "12/12/2014", "last_updated_date": "12/12/2014", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001558-pip02-14" }, { "decision_number": "P/0313/2014", "pip_number": "EMEA-001559-PIP01-13", "active_substance": "Pandemic live attenuated influenza virus (H5N1)", "invented_name": "", "therapeutic_area": "Vaccines", "pharmaceutical_forms": "Nasal spray;Suspension", "condition_indication": "Prevention of influenza infection", "routes_of_administration": "Nasal use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "26/11/2014", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "MedImmune Limited ; United Kingdom ; E-mail: paediatrics@medimmune.com ; Tel. +44 (0)1223 471471", "first_published_date": "12/12/2014", "last_updated_date": "12/12/2014", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001559-pip01-13" }, { "decision_number": "P/0309/2014", "pip_number": "EMEA-001672-PIP01-14", "active_substance": "varicella-zoster virus (live, attenuated)", "invented_name": "Copalia; Zostavax", "therapeutic_area": "Vaccines", "pharmaceutical_forms": "Powder and solvent for suspension for injection", "condition_indication": "", "routes_of_administration": "Subcutaneous use;Intramuscular use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "24/11/2014", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Sanofi Pasteur MSD SNC ; France ; E-mail: cbesnard@spmsd.com ; Tel. +33 437284723 ; Fax +1 2673056450 / +1 7325944950", "first_published_date": "12/12/2014", "last_updated_date": "12/12/2014", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001672-pip01-14" }, { "decision_number": "P/0308/2014", "pip_number": "EMEA-001668-PIP01-14", "active_substance": "Macrogol 3350", "invented_name": "", "therapeutic_area": "Gastroentology-Hepatology", "pharmaceutical_forms": "Oral powder", "condition_indication": "Treatment of constipation", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "24/11/2014", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Mayoly Spindler ; France ; E-mail: beatrice.raffaillac@mayoly-spindler.fr ; Tel. +1 34805536", "first_published_date": "12/12/2014", "last_updated_date": "12/12/2014", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001668-pip01-14" }, { "decision_number": "P/0306/2014", "pip_number": "EMEA-001651-PIP01-14", "active_substance": "purified adenylate cyclase recombinant protein carrying subfragments of the early protein E7 antigen from human papillomavirus strain 16 (recombinant CyaA-HPV16E7);purified adenylate cyclase recombinant protein carrying subfragments of the early protein E7 antigen from human papillomavirus strain 18 (recombinant CyaA-HPV18E7)", "invented_name": "", "therapeutic_area": "Vaccines", "pharmaceutical_forms": "Powder for solution for injection", "condition_indication": "Treatment of Human Papilloma Virus (HPV) 16 and/or 18 infection", "routes_of_administration": "Intradermal use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "24/11/2014", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Genticel S.A. ; 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USA ; E-mail: khosseini@insite.com; Tel. +510 7471264 ; Fax +510 8655700", "first_published_date": "30/09/2014", "last_updated_date": "14/11/2014", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001595-pip01-13" }, { "decision_number": "P/0211/2014", "pip_number": "EMEA-001632-PIP01-14", "active_substance": "rosuvastatin;valsartan", "invented_name": "", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Tablet", "condition_indication": "Prevention of cardiovascular events;Treatment of hypertension;Treatment of dyslipidaemia", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "22/08/2014", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Krka, d.d., Novo mesto ; Slovenia ; E-mail: helen.lukin@krka.biz ; Tel. +385 99 3110 291 ; Fax +385 1 6312 153", "first_published_date": "30/09/2014", "last_updated_date": "14/11/2014", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001632-pip01-14" }, { "decision_number": "P/0255/2014", "pip_number": "EMEA-001599-PIP01-13", "active_substance": "Ibuprofen (sodium dihydrate)", "invented_name": "", "therapeutic_area": "Other", "pharmaceutical_forms": "Solution for injection/infusion", "condition_indication": "Treatment of febrile disorders;Treatment of pain", "routes_of_administration": "Intravenous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "30/09/2014", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Proveca LimitedTel. +44 7913048665E-mail: simon@proveca.co.uk", "first_published_date": "05/11/2014", "last_updated_date": "05/11/2014", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001599-pip01-13" }, { "decision_number": "P/0240/2014", "pip_number": "EMEA-001366-PIP01-12-M02", "active_substance": "glycopyrronium bromide", "invented_name": "Sialanar", "therapeutic_area": "Neurology", "pharmaceutical_forms": "Oral liquid", "condition_indication": "Treatment of sialorrhoea", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "26/09/2014", "compliance_outcome": "Positive", "compliance_opinion_date": "14/11/2014", "compliance_procedure_number": "EMEA-C-001366-PIP01-12-M02", "contact_for_public_enquiries": "Proveca LimitedTel. +44 7913048665E-mail: simon@proveca.co.uk", "first_published_date": "13/08/2013", "last_updated_date": "09/10/2014", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001366-pip01-12-m02" }, { "decision_number": "P/0221/2014", "pip_number": "EMEA-001530-PIP01-13", "active_substance": "4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide (JNJ-54781532-AAD)", "invented_name": "", "therapeutic_area": "Immunology-Rheumatology-Transplantation", "pharmaceutical_forms": "Film-coated tablet;Age appropriate oral dosage formulation", "condition_indication": "Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, ankylosing spondyloarthritis, psoriatic arthritis and juvenile idiopathic arthritis)", "routes_of_administration": "Oral use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "03/09/2014", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Janssen Cilag International NV (Belgium); 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The Netherlands; E-mail: info@janssen.immunology.com; Tel +31 202015009; Fax: +31 713065100", "first_published_date": "03/10/2011", "last_updated_date": "29/09/2014", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000265-pip01-08-m04" }, { "decision_number": "P/0219/2014", "pip_number": "EMEA-001241-PIP02-13-M01", "active_substance": "Enalapril (maleate)", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Oral solution", "condition_indication": "Treatment of heart failure", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "03/09/2014", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Proveca LimitedTel. +44 7913048665E-mail: simon@proveca.co.uk", "first_published_date": "16/04/2014", "last_updated_date": "29/09/2014", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001241-pip02-13-m01" }, { "decision_number": "P/0208/2014", "pip_number": "EMEA-001594-PIP02-13", "active_substance": "tirasemtiv", "invented_name": "", "therapeutic_area": "Neurology", "pharmaceutical_forms": "Tablet", "condition_indication": "Treatment of amyotrophic lateral sclerosis", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "08/08/2014", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "NDA Group; United States ; E-mail: medicalaffairs@cytokinetics.com; Tel. +1  650 6243000", "first_published_date": "22/08/2014", "last_updated_date": "22/08/2014", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001594-pip02-13" }, { "decision_number": "P/0201/2014", "pip_number": "EMEA-001269-PIP02-14", "active_substance": "rosuvastatin;acetylsalicylic acid", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Capsule, hard", "condition_indication": "Treatment of cardiovascular disease", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "08/08/2014", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "EGIS Pharmaceuticals PLC ; Tel. +36 18032414; E-mail: registry@registry.hu", "first_published_date": "22/08/2014", "last_updated_date": "22/08/2014", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001269-pip02-14" }, { "decision_number": "P/0193/2014", "pip_number": "EMEA-001621-PIP01-14", "active_substance": "Pacritinib", "invented_name": "", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Capsule, hard", "condition_indication": "Treatment of post-essential thrombocythaemia myelofibrosis;Treatment of post-polycythaemia vera myelofibrosis", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "06/08/2014", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "CTI Life Sciences Ltd ; Italy ; E-mail: jbianco@ctiseattle.com ; Tel. +1 2062845774 ; Fax +1 2062846114", "first_published_date": "22/08/2014", "last_updated_date": "22/08/2014", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001621-pip01-14" }, { "decision_number": "P/0200/2014", "pip_number": "EMEA-001183-PIP02-13", "active_substance": "Human recombinant follicle-stimulating hormone (FE 999049)", "invented_name": "", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Concentrate for solution for injection", "condition_indication": "Treatment of female infertility;Treatment of hypogonadotrophic hypogonadism", "routes_of_administration": "Subcutaneous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "08/08/2014", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Ferring Pharmaceuticals A/S ; Denmark ; E-mail: dk0-disclosure@ferring.com ; Tel. +45 88338834", "first_published_date": "22/08/2014", "last_updated_date": "22/08/2014", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001183-pip02-13" }, { "decision_number": "P/0190/2014", "pip_number": "EMEA-001289-PIP01-12-M01", "active_substance": "autologous CD34+ cells transduced ex-vivo with retroviral vector (GIADAl) containing human adenosine deaminase gene from cDNA", "invented_name": "Strimvelis", "therapeutic_area": "Immunology-Rheumatology-Transplantation", "pharmaceutical_forms": "Cell suspension for infusion", "condition_indication": "Treatment of severe combined immunodeficiency due to adenosine deaminase deficiency", "routes_of_administration": "Intravenous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "06/08/2014", "compliance_outcome": "Positive", "compliance_opinion_date": "14/11/2014", "compliance_procedure_number": "EMEA-C-001289-PIP01-12-M01", "contact_for_public_enquiries": "Orchard Therapeutics (Netherlands) B.V.; regulatory@orchard-tx.com; Tel. +44 (0) 20 3808 8286", "first_published_date": "03/05/2013", "last_updated_date": "22/08/2014", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001289-pip01-12-m01" }, { "decision_number": "P/0202/2014", "pip_number": "EMEA-001292-PIP01-12-M01", "active_substance": "mifepristone", "invented_name": "", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Tablet", "condition_indication": "Treatment of hypercortisolism (Cushing's syndrome) of endogenous origin", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "08/08/2014", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Corcept Therapeutics Incorporated; United States; E-mail: srinne@corcept.com ; Tel. +1 6506888784; Fax +1 6503273218", "first_published_date": "09/08/2013", "last_updated_date": "22/08/2014", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001292-pip01-12-m01" }, { "decision_number": "P/0184/2014", "pip_number": "EMEA-000184-PIP02-14", "active_substance": "tobramycin", "invented_name": "Tobi", "therapeutic_area": "Pneumology-allergology", "pharmaceutical_forms": "Nebuliser solution", "condition_indication": "Treatment of Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis", "routes_of_administration": "Inhalation use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "06/08/2014", "compliance_outcome": "Positive", "compliance_opinion_date": "29/04/2016", "compliance_procedure_number": "EMEA-C-000184-PIP02-14", "contact_for_public_enquiries": "Mylan IRE Healthcare Limited; 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Spain; E-mail: silviamartin@ferrergrupo.com, ccasadoc@ferrergrupo.com; Tel. +34 9350 93227, +34 935093289; Fax +34 9350 93270", "first_published_date": "17/10/2011", "last_updated_date": "05/08/2014", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000981-pip01-10-m04" }, { "decision_number": "P/0172/2014", "pip_number": "EMEA-000412-PIP01-08-M01", "active_substance": "Insulin detemir", "invented_name": "Levemir; Levemir", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Treatment of type II diabetes mellitus;Treatment of type I diabetes mellitus", "routes_of_administration": "Subcutaneous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "11/07/2014", "compliance_outcome": "Positive", "compliance_opinion_date": "14/11/2014", "compliance_procedure_number": "EMEA-000412-PIP01-08-M01", "contact_for_public_enquiries": "Novo Nordisk A/S; Denmark; E-mail: drej@novonordisk.com; Tel. +45 30758086; Fax +45 44436740", "first_published_date": "10/01/2011", "last_updated_date": "05/08/2014", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000412-pip01-08-m01" }, { "decision_number": "P/0177/2014", "pip_number": "EMEA-000184-PIP01-08-M02", "active_substance": "tobramycin", "invented_name": "Tobi Podhaler; Tobi Podhaler", "therapeutic_area": "Infectious diseases", "pharmaceutical_forms": "Inhalation powder;Capsule, hard", "condition_indication": "Treatment of Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis", "routes_of_administration": "Inhalation use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "08/07/2014", "compliance_outcome": "Positive", "compliance_opinion_date": "12/09/2014", "compliance_procedure_number": "EMEA-C-000184-PIP01-08-M02", "contact_for_public_enquiries": "Mylan IRE Healthcare Limited; E-mail: info.uk@viatris.com; Tel. + 44 (0)1707853000", "first_published_date": "18/05/2009", "last_updated_date": "05/08/2014", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000184-pip01-08-m02" }, { "decision_number": "P/0164/2014", "pip_number": "EMEA-001329-PIP02-13", "active_substance": "expanded autologous bone marrow-derived osteoblastic cells", "invented_name": "", "therapeutic_area": "Other", "pharmaceutical_forms": "Suspension for injection", "condition_indication": "Treatment of non-traumatic osteonecrosis", "routes_of_administration": "Intraosseous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "25/06/2014", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Bone Therapeutics S.A.; Belgium; E-mail: preob.pip@bonetherapeutics.com; Tel. + 32 25295990; Fax +32 25295993", "first_published_date": "31/07/2014", "last_updated_date": "31/07/2014", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001329-pip02-13" }, { "decision_number": "P/0165/2014", "pip_number": "EMEA-000236-PIP04-14", "active_substance": "aflibercept", "invented_name": "Eylea; Eylea", "therapeutic_area": "Ophthalmology", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Treatment of choroidal neovascularisation secondary to pathologic myopia;Treatment of branch retinal vein occlusion", "routes_of_administration": "Solution for injection", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "27/06/2014", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Bayer Pharma AG; Tel. +49 3046 815333; E-mail: pediatrics.medical-affairs-europe@bayer.com", "first_published_date": "31/07/2014", "last_updated_date": "31/07/2014", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000236-pip04-14" }, { "decision_number": "P/0155/2014", "pip_number": "EMEA-001541-PIP01-13", "active_substance": "Freeze-dried culture of Lactobacillus casei subspecies rhamnosus Döderleini (Lcr35)", "invented_name": "", "therapeutic_area": "", "pharmaceutical_forms": "Vaginal capsule;Capsule, hard", "condition_indication": "Prevention of bacterial vaginosis;Prevention of vulvo-vaginal candidiasis", "routes_of_administration": "Vaginal use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "16/06/2014", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Probionov; France; E-mail: ml.bouyge@probionov.com; Tel. +33 4714 65462; Fax +33 4716 35398", "first_published_date": "22/07/2014", "last_updated_date": "22/07/2014", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001541-pip01-13" }, { "decision_number": "P/0156/2014", "pip_number": "EMEA-001574-PIP01-13", "active_substance": "amoxicillin", "invented_name": "", "therapeutic_area": "Gastroentology-Hepatology", "pharmaceutical_forms": "Orodispersible tablet;Film-coated tablet;Gastro-resistant tablet;Tablet", "condition_indication": "Treatment of Helicobacter spp. infections", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "18/06/2014", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Mayoly-Spindler; France; E-mail: beatrice.raffaillac@mayoly-spindler.fr; Tel. +013 4805536", "first_published_date": "22/07/2014", "last_updated_date": "22/07/2014", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001574-pip01-13" }, { "decision_number": "P/0152/2014", "pip_number": "EMEA-001576-PIP01-13", "active_substance": "(11beta,17beta)-17-hydroxy-11-[4-(methylsulfonyl)phenyl]-17-(pentafluoroethyl)estra-4,9-dien-3-one", "invented_name": "", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Treatment of leiomyoma of uterus;Treatment of endometriosis", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "13/06/2014", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Bayer Pharma AG; Germany; E-mail: pediatrics-medical-affairs-europe@bayerhealthcare.com; Tel. +49 30468 15333; Fax +49 30468 95333", "first_published_date": "22/07/2014", "last_updated_date": "22/07/2014", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001576-pip01-13" }, { "decision_number": "P/0153/2014", "pip_number": "EMEA-001597-PIP01-13", "active_substance": "lesinurad", "invented_name": "", "therapeutic_area": "Immunology-Rheumatology-Transplantation", "pharmaceutical_forms": "Tablet", "condition_indication": "Prevention of hyperuricaemia;Treatment of hyperuricaemia", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "13/06/2014", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "AstraZeneca AB - Astrazeneca European Regulatory Affairs; Sweden; E-mail: solange.rohou@astrazeneca.com; Tel. +33 609050197; Fax +46 855326904", "first_published_date": "22/07/2014", "last_updated_date": "22/07/2014", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001597-pip01-13" }, { "decision_number": "P/0154/2014", "pip_number": "EMEA-001607-PIP01-13", "active_substance": "amlodipine besilate;ramipril", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Capsule, hard", "condition_indication": "Treatment of hypertension", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "13/06/2014", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Pharmaceutical Works Polpharma SA; Poland; E-mail: michal.dembowski@polpharma.com; Tel. +48 2236 46321", "first_published_date": "22/07/2014", "last_updated_date": "22/07/2014", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001607-pip01-13" }, { "decision_number": "P/0140/2014", "pip_number": "EMEA-001608-PIP01-13", "active_substance": "Doxylamine (succinate);pyridoxine (hydrochloride)", "invented_name": "", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Gastro-resistant tablet", "condition_indication": "Treatment of nausea and vomiting in pregnancy", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "11/06/2014", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Duchesnay Inc.; Canada; E-mail: bmartin@regintel.com; Tel. +353 429376740; Fax +353 429397677", "first_published_date": "22/07/2014", "last_updated_date": "22/07/2014", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001608-pip01-13" }, { "decision_number": "P/0157/2014", "pip_number": "EMEA-001614-PIP01-13", "active_substance": "clarithromycin", "invented_name": "", "therapeutic_area": "Gastroentology-Hepatology", "pharmaceutical_forms": "Orodispersible tablet;Film-coated tablet;Gastro-resistant tablet;Tablet", "condition_indication": "Treatment of Helicobacter spp. infections", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "18/06/2014", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Mayoly-Spindler; France; E-mail: beatrice.raffaillac@mayoly-spindler.fr; Tel. +013 4805536", "first_published_date": "22/07/2014", "last_updated_date": "22/07/2014", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001614-pip01-13" }, { "decision_number": "P/0158/2014", "pip_number": "EMEA-001615-PIP01-13", "active_substance": "Metronidazole", "invented_name": "", "therapeutic_area": "Gastroentology-Hepatology", "pharmaceutical_forms": "Orodispersible tablet;Film-coated tablet;Gastro-resistant tablet;Tablet", "condition_indication": "Treatment of Helicobacter spp. infections", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "18/06/2014", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Mayoly-Spindler; France; E-mail: beatrice.raffaillac@mayoly-spindler.fr; Tel. +013 4805536", "first_published_date": "22/07/2014", "last_updated_date": "22/07/2014", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001615-pip01-13" }, { "decision_number": "P/0159/2014", "pip_number": "EMEA-001616-PIP01-13", "active_substance": "pantoprazole", "invented_name": "", "therapeutic_area": "Gastroentology-Hepatology", "pharmaceutical_forms": "Orodispersible tablet;Film-coated tablet;Gastro-resistant tablet;Tablet", "condition_indication": "Treatment of Helicobacter spp. infections", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "18/06/2014", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Mayoly-Spindler; France; E-mail: beatrice.raffaillac@mayoly-spindler.fr; Tel. +013 4805536", "first_published_date": "22/07/2014", "last_updated_date": "22/07/2014", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001616-pip01-13" }, { "decision_number": "P/0150/2014", "pip_number": "EMEA-001504-PIP01-13", "active_substance": "5-(4,6-Dimethyl-1H-benzimidazol-2-yl)-4-methyl-N-[3-(1-methyl-4-piperidinyl)propyl]-2-pyrimidinamine 2,3-dihydroxybutanedioate hydrate (1:0.5:4) (JNJ-38518168)", "invented_name": "", "therapeutic_area": "Immunology-Rheumatology-Transplantation", "pharmaceutical_forms": "Coated tablet;Age appropriate dosage form, other", "condition_indication": "Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylarthritis and juvenile idiopathic arthritis)", "routes_of_administration": "Oral use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "13/06/2014", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Janssen Cilag International NV (Belgium); Belgium; E-mail: ldobell@its.jnj.com; Tel. + 44 (0)1494 567567; Fax +44 (0)1494 658084", "first_published_date": "18/07/2014", "last_updated_date": "18/07/2014", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001504-pip01-13" }, { "decision_number": "P/0134/2014", "pip_number": "EMEA-001365-PIP01-12", "active_substance": "anamorelin hydrochloride", "invented_name": "", "therapeutic_area": "Other", "pharmaceutical_forms": "Tablet;Oral liquid", "condition_indication": "Treatment of cancer related cachexia", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "10/06/2014", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Helsinn Therapeutics (U.S.) Inc.; United States; E-mail: jfriend@helsinnthera.com; Tel. +1 9082036545; Fax +1 9082311459", "first_published_date": "18/07/2014", "last_updated_date": "18/07/2014", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001365-pip01-12" }, { "decision_number": "P/0136/2014", "pip_number": "EMEA-000457-PIP02-10-M02", "active_substance": "fibrinogen (human plasma-derived)", "invented_name": "", "therapeutic_area": "Haematology-Hemostaseology", "pharmaceutical_forms": "Powder and solvent for infusion", "condition_indication": "Treatment of congenital fibrinogen deficiency", "routes_of_administration": "Intravenous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "11/06/2014", "compliance_outcome": "Positive", "compliance_opinion_date": "16/12/2016", "compliance_procedure_number": "EMEA-C-000457-PIP02-10-M02", "contact_for_public_enquiries": "LFB Biotechnologies; France; E-mail: brossela@lfb.fr; Tel. +33 169821786; Fax +33 169827182", "first_published_date": "10/05/2011", "last_updated_date": "15/07/2014", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000457-pip02-10-m02" }, { "decision_number": "P/0129/2014", "pip_number": "EMEA-000456-PIP01-08-M02", "active_substance": "insulin degludec", "invented_name": "Tresiba; Tresiba", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Treatment of type I diabetes mellitus;Treatment of type II diabetes mellitus", "routes_of_administration": "Subcutaneous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "20/05/2014", "compliance_outcome": "Positive", "compliance_opinion_date": "23/05/2014", "compliance_procedure_number": "EMEA-C-000456-PIP01-08-M02", "contact_for_public_enquiries": "Novo Nordisk A/S; Denmark; E-mail: jamp@novonordisk.com; Tel. +45 3075 3759; Fax +45 3969 9173", "first_published_date": "18/05/2010", "last_updated_date": "25/06/2014", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000456-pip01-08-m02" }, { "decision_number": "P/0125/2014", "pip_number": "EMEA-000339-PIP02-09-M03", "active_substance": "Entecavir", "invented_name": "Baraclude; Baraclude", "therapeutic_area": "Infectious diseases", "pharmaceutical_forms": "Film-coated tablet;Oral solution", "condition_indication": "Treatment of chronic hepatitis B", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "16/05/2014", "compliance_outcome": "Positive", "compliance_opinion_date": "20/06/2014", "compliance_procedure_number": "EMEA-C-000339-PIP02-09-M03", "contact_for_public_enquiries": "Bristol-Myers Squibb Pharma EEIG; United Kingdom; E-mail: medinfo.emea@bms.com; Tel. +44 (0)189 552 3686; ax +44 (0)189 552 3788", "first_published_date": "24/01/2011", "last_updated_date": "25/06/2014", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000339-pip02-09-m03" }, { "decision_number": "P/236/2011", "pip_number": "EMEA-000328-PIP02-09", "active_substance": "vatreptacog alfa (activated)", "invented_name": "", "therapeutic_area": "Haematology-Hemostaseology", "pharmaceutical_forms": "Powder and solvent for solution for injection", "condition_indication": "Treatment of hereditary factor VIII and IX deficiency", "routes_of_administration": "Intravenous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "30/09/2011", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Novo Nordisk A/S; E-mail: paediatrics@novonordisk.com ; Tel.: +45 44448888", "first_published_date": "18/10/2011", "last_updated_date": "13/06/2014", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000328-pip02-09" }, { "decision_number": "P/0107/2013", "pip_number": "EMEA-001003-PIP01-10-M02", "active_substance": "(3aR,4S,7aR)-octahydro-4-hydroxy-4-[(3-methylphenyl)ethynyl]-1H-indole-1-carboxylic acid methyl ester", "invented_name": "", "therapeutic_area": "Neurology", "pharmaceutical_forms": "Capsule, hard;Powder for oral suspension", "condition_indication": "Treatment of fragile-X syndrome", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "30/04/2013", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Novartis Europharm Ltd; United Kingdom; E-mail: paediatric.enquiries@novartis.com; Tel. +41 613241111; Fax +41 613248001;  ", "first_published_date": "15/07/2011", "last_updated_date": "13/06/2014", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001003-pip01-10-m02" }, { "decision_number": "P/0105/2014", "pip_number": "EMEA-000019-PIP06-09-M05", "active_substance": "everolimus", "invented_name": "Afinitor; Certican; Afinitor and associated names", "therapeutic_area": "Immunology-Rheumatology-Transplantation", "pharmaceutical_forms": "Tablet;Dispersible tablet", "condition_indication": "Prevention of rejection of transplanted liver;Prevention of rejection of transplanted heart;Prevention of rejection of transplanted kidney", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "05/05/2014", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Novartis Europharm LimitedE-mail: paediatric.enquiries@novartis.comTel. +41 6132 46715", "first_published_date": "07/06/2011", "last_updated_date": "11/06/2014", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000019-pip06-09-m05" }, { "decision_number": "P/0121/2014", "pip_number": "EMEA-001578-PIP01-13", "active_substance": "amlodipine;rosuvastatin", "invented_name": "", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Prevention of cardiovascular events;Treatment of ischemic coronary artery disorders;Treatment of hypertension;Treatment of dyslipidaemia", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "07/05/2014", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Krka, d.d., Novo mesto; E-mail: dragan.priselac@krka.biz; Tel. +386 7331 9037", "first_published_date": "06/06/2014", "last_updated_date": "06/06/2014", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001578-pip01-13" }, { "decision_number": "P/0104/2014", "pip_number": "EMEA-001575-PIP01-13", "active_substance": "anastrozole;levonorgestrel", "invented_name": "", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Vaginal delivery system", "condition_indication": "Treatment of endometriosis", "routes_of_administration": "Vaginal use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "02/05/2014", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Bayer Pharma AG; Germany; E-mail: pediatrics-medical-affairs-europe@bayerhealthcare.com; Tel. +49 30468 15333; Fax +49 30468 95333", "first_published_date": "06/06/2014", "last_updated_date": "06/06/2014", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001575-pip01-13" }, { "decision_number": "P/0103/2014", "pip_number": "EMEA-001571-PIP01-13", "active_substance": "N-{2-(2,3-Difluorobenzylthio)-6-[(2R,3S)-3,4-dihydroxybut-2-yloxy]pyrimidin-4-yl}azetidine-1-sulfonamide (AZD5069)", "invented_name": "", "therapeutic_area": "Pneumology-allergology", "pharmaceutical_forms": "Tablet", "condition_indication": "Treatment of asthma", "routes_of_administration": "Oral use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "02/05/2014", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "AstraZeneca ABE-mail: alison.mcgregor@astrazeneca.comTel. +44 (0)7748 761375", "first_published_date": "06/06/2014", "last_updated_date": "06/06/2014", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001571-pip01-13" }, { "decision_number": "P/0112/2014", "pip_number": "EMEA-001516-PIP01-13", "active_substance": "Enalapril (maleate)", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Tablet for oral suspension;Orodispersible film", "condition_indication": "Treatment of hypertension", "routes_of_administration": "Oral use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "05/05/2014", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Pharmathen S.A.; Greece; E-mail: mkalovidouri@pharmathen.com; Tel. +30 2106 604354;  ", "first_published_date": "06/06/2014", "last_updated_date": "06/06/2014", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001516-pip01-13" }, { "decision_number": "P/0091/2014", "pip_number": "EMEA-000558-PIP01-09-M02", "active_substance": "human normal immunoglobulin", "invented_name": "", "therapeutic_area": "Immunology-Rheumatology-Transplantation", "pharmaceutical_forms": "Solution for infusion", "condition_indication": "Treatment of Idiopathic Thrombocytopenia Purpura (ITP);Treatment of Primary Immunodeficiency (PID)", "routes_of_administration": "Intravenous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "04/04/2014", "compliance_outcome": "Positive", "compliance_opinion_date": "23/05/2014", "compliance_procedure_number": "EMEA-C-000558-PIP01-09-M02", "contact_for_public_enquiries": "LFB Biotechnologies; France; E-mail: metenanizi@lfb.fr; Tel. +33 1698 21029; Fax +33 1837 11978", "first_published_date": "22/10/2009", "last_updated_date": "14/05/2014", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000558-pip01-09-m02" }, { "decision_number": "P/0089/2014", "pip_number": "EMEA-001586-PIP01-13", "active_substance": "atropine sulfate;dimethanesulfonate;avizafone (hydrochloride)", "invented_name": "", "therapeutic_area": "Other", "pharmaceutical_forms": "Powder and solvent for solution for injection", "condition_indication": "Treatment of organophosphorus poisoning", "routes_of_administration": "Intramuscular use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "04/04/2014", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Service de Santé des Armées; France; E-mail: isabelle.besse@santarm.fr; Tel. +33 2386 07312;  ", "first_published_date": "13/05/2014", "last_updated_date": "13/05/2014", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001586-pip01-13" }, { "decision_number": "P/0100/2014", "pip_number": "EMEA-001169-PIP02-13", "active_substance": "alirocumab", "invented_name": "", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Treatment of mixed dyslipidaemia", "routes_of_administration": "Subcutaneous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "11/04/2014", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Sanofi-Aventis Recherche & Développement; E-mail: contact-us@sanofi-aventis.com; Tel. +33 1 60 49 66 82", "first_published_date": "12/05/2014", "last_updated_date": "12/05/2014", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001169-pip02-13" }, { "decision_number": "P/0065/2014", "pip_number": "EMEA-001462-PIP01-13", "active_substance": "recombinant human growth hormone modified by fusion with two hydrophilic polypeptide chains (VRS-317)", "invented_name": "", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Treatment of growth hormone deficiency", "routes_of_administration": "Subcutaneous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "10/03/2014", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Versartis, Inc. ; United States ; E-mail: jcleland@versartis.com ; Tel. +1 6509638580 ; Fax +1 6509638598", "first_published_date": "16/04/2014", "last_updated_date": "16/04/2014", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001462-pip01-13" }, { "decision_number": "P/0067/2014", "pip_number": "EMEA-001413-PIP01-13", "active_substance": "Phleum pratense", "invented_name": "Allergovit Phleum", "therapeutic_area": "Pneumology-allergology", "pharmaceutical_forms": "Suspension for injection", "condition_indication": "Treatment of allergic rhinoconjunctivitis", "routes_of_administration": "Subcutaneous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "14/03/2014", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Allergopharma GmbH & Co. KG ; Germany ; E-mail: info@allergopharma.com; Tel. +49 4027650 ; Fax +49 407227713", "first_published_date": "16/04/2014", "last_updated_date": "16/04/2014", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001413-pip01-13" }, { "decision_number": "P/0066/2014", "pip_number": "EMEA-001560-PIP01-13", "active_substance": "ramipril;amlodipine besilate", "invented_name": "BR/AM", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Capsule, hard", "condition_indication": "Treatment of essential hypertension", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "10/03/2014", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Brunifarma Research s.r.l. ; Italy ; E-mail: info@brunifarmaresearch.com; Tel. +39 091900529 ; Fax +39 091905535", "first_published_date": "16/04/2014", "last_updated_date": "16/04/2014", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001560-pip01-13" }, { "decision_number": "P/0054/2014", "pip_number": "EMEA-001532-PIP01-13", "active_substance": "Ertugliflozin;Metformin", "invented_name": "", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Tablet", "condition_indication": "Treatment of type II diabetes mellitus", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "07/03/2014", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Merck Sharp & Dohme (Europe), Inc. ; Belgium ; E-mail: pip.information@merck.com ; Tel. +31 412663179 ; Fax +31 412662571", "first_published_date": "16/04/2014", "last_updated_date": "16/04/2014", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001532-pip01-13" }, { "decision_number": "P/0055/2014", "pip_number": "EMEA-001552-PIP01-13", "active_substance": "telmisartan;amlodipine besilate", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Tablet", "condition_indication": "Treatment of essential hypertension", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "07/03/2014", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Zentiva, k.s.; Czech Republic; blanka.zoubkova@zentiva.com; Tel. +42 0267243574", "first_published_date": "16/04/2014", "last_updated_date": "16/04/2014", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001552-pip01-13" }, { "decision_number": "P/0057/2014", "pip_number": "EMEA-001370-PIP02-13", "active_substance": "Herpes simplex 1 virus thymidine kinase and truncated low affinity nerve growth factor receptor transfected donor lymphocytes", "invented_name": "", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Cell suspension for infusion", "condition_indication": "Adjunctive treatment in haematopoietic cell transplantation", "routes_of_administration": "Intravenous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "06/03/2014", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "MolMed S.p.A. ; Italy ; E-mail: info@molmed.com ; Tel. +39 02212771 ; Fax +39 0221277220", "first_published_date": "16/04/2014", "last_updated_date": "16/04/2014", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001370-pip02-13" }, { "decision_number": "P/0056/2014", "pip_number": "EMEA-001558-PIP01-13", "active_substance": "thiocolchicoside;diclofenac (sodium)", "invented_name": "Muscoplus", "therapeutic_area": "Pain", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Treatment of musculoskeletal and connective tissue pain", "routes_of_administration": "Intramuscular use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "07/03/2014", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Epifarma Srl ; Italy ; E-mail: b.trupa@epifarma.it ; Tel. +39 0973 655200 ; Fax +39 0973 655318", "first_published_date": "16/04/2014", "last_updated_date": "16/04/2014", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001558-pip01-13" }, { "decision_number": "P/0049/2014", "pip_number": "EMEA-000986-PIP02-13", "active_substance": "ocriplasmin", "invented_name": "Jetrea; Jetrea", "therapeutic_area": "Ophthalmology", "pharmaceutical_forms": "Concentrate for solution for injection", "condition_indication": "Treatment of symptomatic focal vitreomacular adhesion", "routes_of_administration": "Intravitreal use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "07/03/2014", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "ThromboGenics NV ; Belgium ; E-mail: info@thrombogenics.com; Tel. +32 16751310", "first_published_date": "16/04/2014", "last_updated_date": "16/04/2014", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000986-pip02-13" }, { "decision_number": "P/0047/2014", "pip_number": "EMEA-001637-PIP01-13", "active_substance": "human normal immunoglobulin", "invented_name": "", "therapeutic_area": "Immunology-Rheumatology-Transplantation", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Treatment of Primary Immunodeficiency (PID)", "routes_of_administration": "Subcutaneous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "11/03/2014", "compliance_outcome": "Positive", "compliance_opinion_date": "16/01/2015", "compliance_procedure_number": "EMEA-001637-PIP01-13", "contact_for_public_enquiries": "Baxter Innovations GmbH; Austria; E-mail: europa_biosci_globalra@baxter.com; Tel. +43 1201000; Fax +43 120100 / 2475990", "first_published_date": "16/04/2014", "last_updated_date": "16/04/2014", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001637-pip01-13" }, { "decision_number": "P/0041/2014", "pip_number": "EMEA-001494-PIP01-13", "active_substance": "Fluocinolone acetonide", "invented_name": "Otoken", "therapeutic_area": "Oto-rhino-laryngology", "pharmaceutical_forms": "Ear drops, solution", "condition_indication": "Treatment of dermatitis and eczema", "routes_of_administration": "Auricular use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "05/03/2014", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Laboratorios Salvat, S.A.E-mail: regulatory@svt.com Tel. +34 933946400", "first_published_date": "16/04/2014", "last_updated_date": "16/04/2014", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001494-pip01-13" }, { "decision_number": "P/0032/2014", "pip_number": "EMEA-001534-PIP01-13", "active_substance": "Ertugliflozin;sitagliptin", "invented_name": "", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Tablet", "condition_indication": "Treatment of type II diabetes mellitus", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "03/03/2014", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Merck Sharp & Dohme (Europe), Inc.; Belgium; E-mail: pip.information@merck.com; Tel. +31 412663179; Fax +31 412662571", "first_published_date": "20/03/2014", "last_updated_date": "20/03/2014", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001534-pip01-13" }, { "decision_number": "P/0043/2014", "pip_number": "EMEA-000582-PIP01-09-M03", "active_substance": "rupatadine fumarate", "invented_name": "Rupafin and associated names", "therapeutic_area": "Pneumology-allergology", "pharmaceutical_forms": "Tablet;Granules;Oral liquid", "condition_indication": "Treatment of allergic rhinitis;Treatment of chronic idiopathic urticaria", "routes_of_administration": "Oral use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "26/02/2014", "compliance_outcome": "Positive", "compliance_opinion_date": "21/03/2014", "compliance_procedure_number": "EMEA-C-000582-PIP01-09-M03", "contact_for_public_enquiries": "J. Uriach y Compañía, S.A; Spain; E-mail: clin-izquierdo@uriach.com; Tel. +34 938630272; Fax:  +34 938646606", "first_published_date": "19/04/2010", "last_updated_date": "20/03/2014", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000582-pip01-09-m03" }, { "decision_number": "P/0013/2014", "pip_number": "EMEA-000630-PIP02-09-M05", "active_substance": "Betula alba;aluminium hydroxide adsorbed;depigmented glutaraldehyde polymerised", "invented_name": "", "therapeutic_area": "Pneumology-allergology", "pharmaceutical_forms": "Suspension for injection", "condition_indication": "Treatment of allergic rhinitis / rhino-conjunctivitis", "routes_of_administration": "Subcutaneous use", "decision_type": "RPM: decision refers to a refusal on the application for modification of an agreed PIP", "decision_date": "30/12/2022", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Leti Pharma GmbH; Germany; E-mail: paediatrics@leti.de; Tel. +49 230 2202 860; Fax +49 230 2202 8623", "first_published_date": "20/12/2010", "last_updated_date": "20/02/2014", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000630-pip02-09-m05" }, { "decision_number": "P/0027/2014", "pip_number": "EMEA-001536-PIP01-13", "active_substance": "diclofenac;Levomenthol", "invented_name": "", "therapeutic_area": "Other", "pharmaceutical_forms": "Gel", "condition_indication": "Treatment of local pain and inflammation", "routes_of_administration": "Cutaneous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "24/01/2014", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "GlaxoSmithKline Consumer Trading Services Limited; United Kingdom; E-mail: rd.gskch-paediatric-plans@gsk.com; Tel. +44 (0)19 3282 6987", "first_published_date": "20/02/2014", "last_updated_date": "20/02/2014", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001536-pip01-13" }, { "decision_number": "P/0024/2014", "pip_number": "EMEA-001537-PIP01-13", "active_substance": "Caffeine;Ibuprofen", "invented_name": "", "therapeutic_area": "Pain", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Treatment of pain", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "22/01/2014", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Boehringer Ingelheim International GmbH; Tel. +49 6132 778271; Email: Paediatrics@boehringer-ingelheim.com", "first_published_date": "20/02/2014", "last_updated_date": "20/02/2014", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001537-pip01-13" }, { "decision_number": "P/0010/2014", "pip_number": "EMEA-000406-PIP01-08-M04", "active_substance": "fosaprepitant", "invented_name": "Ivemend; Ivemend", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Powder for solution for infusion", "condition_indication": "Prevention of nausea and vomiting", "routes_of_administration": "Intravenous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "22/01/2014", "compliance_outcome": "Positive", "compliance_opinion_date": "10/10/2014", "compliance_procedure_number": "EMEA-C-000406-PIP01-08-M04", "contact_for_public_enquiries": "Merck Sharp & Dohme (Europe) Inc.Tel.: +33180464738E-mail: pip.information@merck.com", "first_published_date": "11/08/2011", "last_updated_date": "19/02/2014", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000406-pip01-08-m04" }, { "decision_number": "P/0008/2014", "pip_number": "EMEA-000144-PIP01-07-M05", "active_substance": "aprepitant", "invented_name": "Emend; Emend", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Powder for suspension;Capsule, hard", "condition_indication": "Prevention of nausea and vomiting", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "22/01/2014", "compliance_outcome": "Positive", "compliance_opinion_date": "10/10/2014", "compliance_procedure_number": "EMEA-C-000144-PIP01-07-M05", "contact_for_public_enquiries": "Merck Sharp & Dohme Ltd; United Kingdom; E-mail: pip.information@merck.com; Tel. +31 412663179; Fax +31 412662571", "first_published_date": "11/08/2011", "last_updated_date": "19/02/2014", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000144-pip01-07-m05" }, { "decision_number": "P/0009/2014", "pip_number": "EMEA-000282-PIP01-08-M02", "active_substance": "clevidipine butyrate", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Emulsion for infusion", "condition_indication": "Treatment of hypertensive disease", "routes_of_administration": "Intravenous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "22/01/2014", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "The Medicines Company UK Ltd; United Kingdom; Tel. +39 0521 2791; Fax +39 0521 774468; E-mail: info@chiesi.com", "first_published_date": "23/04/2009", "last_updated_date": "19/02/2014", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000282-pip01-08-m02" }, { "decision_number": "P/0005/2014", "pip_number": "EMEA-000056-PIP03-10-M02", "active_substance": "bevacizumab", "invented_name": "Avastin; Avastin", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Concentrate for solution for infusion", "condition_indication": "Treatment of high-grade glioma", "routes_of_administration": "Intravenous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "22/01/2014", "compliance_outcome": "Positive", "compliance_opinion_date": "13/11/2015", "compliance_procedure_number": "EMEA-C-000056-PIP03-10-M02", "contact_for_public_enquiries": "Roche Registration Ltd; United Kingdom; E-mail: info.paediatrics@roche.com; Tel. +41 616879411", "first_published_date": "08/04/2011", "last_updated_date": "19/02/2014", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000056-pip03-10-m02" }, { "decision_number": "P/0003/2014", "pip_number": "EMEA-000019-PIP02-07-M05", "active_substance": "everolimus", "invented_name": "Votubia; Votubia", "therapeutic_area": "Neurology", "pharmaceutical_forms": "Tablet;Dispersible tablet", "condition_indication": "Treatment of angiomyolipoma;Treatment of subependymal giant-cell astrocytoma", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "22/01/2014", "compliance_outcome": "Positive", "compliance_opinion_date": "29/01/2016", "compliance_procedure_number": "EMEA-C-000019-PIP02-07-M05", "contact_for_public_enquiries": "Novartis Europharm LimitedE-mail: paediatric.enquiries@novartis.comTel. +41 613241111", "first_published_date": "13/07/2011", "last_updated_date": "19/02/2014", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000019-pip02-07-m05" }, { "decision_number": "P/0004/2014", "pip_number": "EMEA-000056-PIP01-07-M02", "active_substance": "bevacizumab", "invented_name": "Avastin; Avastin", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Concentrate for solution for infusion", "condition_indication": "Treatment of non-rhabdomyosarcoma soft tissue sarcoma;Treatment of rhabdomyosarcoma", "routes_of_administration": "Intravenous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "22/01/2014", "compliance_outcome": "Positive", "compliance_opinion_date": "26/02/2016", "compliance_procedure_number": "EMEA-C-000056-PIP01-07-M02", "contact_for_public_enquiries": "Roche Registration Ltd; United Kingdom; E-mail: info.paediatrics@roche.com; Tel. +41 616879411", "first_published_date": "24/11/2008", "last_updated_date": "19/02/2014", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000056-pip01-07-m02" }, { "decision_number": "P/0320/2013", "pip_number": "EMEA-001538-PIP01-13", "active_substance": "olmesartan medoxomil;amlodipine besilate", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Treatment of essential hypertension", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "19/12/2013", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Zentiva, k.s.; Czech Republic; blanka.zoubkova@zentiva.com; Tel. +42 0267243574", "first_published_date": "05/02/2014", "last_updated_date": "05/02/2014", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001538-pip01-13" }, { "decision_number": "P/0001/2014", "pip_number": "EMEA-001442-PIP01-13", "active_substance": "raltegravir;lamivudine", "invented_name": "", "therapeutic_area": "Infectious diseases", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Treatment of human immunodeficiency virus (HIV-1) infection", "routes_of_administration": "Oral use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "13/01/2014", "compliance_outcome": "Positive", "compliance_opinion_date": "21/03/2014", "compliance_procedure_number": "EMEA-C-001442-PIP01-13", "contact_for_public_enquiries": "Merck Sharp & Dohme (Europe) Inc.Tel.: +33180464738E-mail: pip.information@merck.com", "first_published_date": "05/02/2014", "last_updated_date": "05/02/2014", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001442-pip01-13" }, { "decision_number": "P/0319/2013", "pip_number": "EMEA-001528-PIP01-13", "active_substance": "solifenacin (succinate);Mirabegron", "invented_name": "", "therapeutic_area": "Uro-nephrology", "pharmaceutical_forms": "Modified-release tablet", "condition_indication": "Treatment of myoneurogenic bladder disorders", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "19/12/2013", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Astellas Pharma Europe B.V.Tel. +31 7154 55878E-mail: contact.nl@astellas.com ", "first_published_date": "05/02/2014", "last_updated_date": "05/02/2014", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001528-pip01-13" }, { "decision_number": "P/0316/2013", "pip_number": "EMEA-001473-PIP01-13", "active_substance": "acetylsalicylic acid;omeprazole", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Modified-release tablet", "condition_indication": "Prevention of cerebrovascular embolism and thrombosis;Prevention of ischaemic coronary artery disorders", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "19/12/2013", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Pozen UK ; Limited United Kingdom ; E-mail: paediatrics@pozen.com ; Tel. +1 9199131030 ; Fax +1 9199131039", "first_published_date": "05/02/2014", "last_updated_date": "05/02/2014", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001473-pip01-13" }, { "decision_number": "P/0317/2013", "pip_number": "EMEA-001513-PIP01-13", "active_substance": "Estetrol;levonorgestrel", "invented_name": "", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Prevention of pregnancy", "routes_of_administration": "Oral use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "19/12/2013", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Estetra S.A. ; Belgium ; E-mail: llebon@uteron.com; Tel. +32 496553302 ; Fax +32 42209631", "first_published_date": "05/02/2014", "last_updated_date": "05/02/2014", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001513-pip01-13" }, { "decision_number": "P/0318/2013", "pip_number": "EMEA-001525-PIP01-13", "active_substance": "alpha-1 antitrypsin", "invented_name": "", "therapeutic_area": "Pneumology-allergology", "pharmaceutical_forms": "Nebuliser solution", "condition_indication": "Treatment of emphysema secondary to congenital deficiency of alpha-1 antitrypsin", "routes_of_administration": "Inhalation use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "19/12/2013", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Triskel EU Services Ltd; United Kingdom ; E-mail: oritp@kamada.com; Tel. +44 (0)9728 940 64 72 ; Fax +44 (0)9728 940 64 73", "first_published_date": "05/02/2014", "last_updated_date": "05/02/2014", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001525-pip01-13" }, { "decision_number": "P/0311/2013", "pip_number": "EMEA-000994-PIP01-10-M01", "active_substance": "Gadobutrol", "invented_name": "Gadovist", "therapeutic_area": "Diagnostic", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Diagnostic evaluation of tissue pathologies with contrast-enhanced magnetic resonance imaging (MRI)", "routes_of_administration": "Intravenous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "19/12/2012", "compliance_outcome": "Positive", "compliance_opinion_date": "20/06/2014", "compliance_procedure_number": "EMEA-C-000994-PIP01-10-M01", "contact_for_public_enquiries": "Bayer harma AG; pediatrics.medical-affairs-europe@bayer.com; Germany; Tel. +49 3046815333; Fax +49 3046895333", "first_published_date": "09/08/2011", "last_updated_date": "04/02/2014", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000994-pip01-10-m01" }, { "decision_number": "P/0268/2013", "pip_number": "EMEA-001173-PIP01-11-M01", "active_substance": "Lumacaftor", "invented_name": "", "therapeutic_area": "Pneumology-allergology", "pharmaceutical_forms": "Film-coated tablet;Age appropriate oral formulation", "condition_indication": "Treatment of cystic fibrosis", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "19/12/2013", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Vertex Pharmaceuticals (Europe) LimitedTel. +1 8776348789E-mail: medicalinfo@vrtx.com", "first_published_date": "09/08/2012", "last_updated_date": "04/02/2014", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001173-pip01-11-m01" }, { "decision_number": "P/0324/2013", "pip_number": "EMEA-000366-PIP01-08-M06", "active_substance": "adalimumab", "invented_name": "Humira; Humira", "therapeutic_area": "Gastroentology-Hepatology", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Treatment of psoriasis;Treatment of Crohn's disease;Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and juvenile idiopathic arthritis)", "routes_of_administration": "Subcutaneous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "19/12/2013", "compliance_outcome": "Positive", "compliance_opinion_date": "20/06/2014", "compliance_procedure_number": "EMEA-C-000366-PIP01-08-M06", "contact_for_public_enquiries": "AbbVie LtdE-mail: paediatricteam@abbvie.comTel. +44 (0)791 988 1614", "first_published_date": "04/01/2013", "last_updated_date": "04/02/2014", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000366-pip01-08-m06" }, { "decision_number": "P/0302/2013", "pip_number": "EMEA-001503-PIP01-13", "active_substance": "Lanreotide acetate", "invented_name": "", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Powder and solvent for prolonged-release suspension for injection;Solution for injection in pre-filled syringe;Powder for suspension for injection", "condition_indication": "Treatment of acromegaly;Treatment of gastrointestinal fistulae;Treatment of metastases to peritoneum;Treatment of pituitary gigantism;Treatment of pituitary neoplasms", "routes_of_administration": "Intramuscular use;Subcutaneous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "29/11/2013", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Ipsen Pharma; Email: paediatrics.plans@ipsen.com; Tel. +33 1 58 33 50 00;  ", "first_published_date": "17/01/2014", "last_updated_date": "17/01/2014", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001503-pip01-13" }, { "decision_number": "P/0285/2013", "pip_number": "EMEA-000052-PIP01-07-M03", "active_substance": "vandetanib", "invented_name": "Caprelsa; Caprelsa", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Tablet", "condition_indication": "Treatment of medullary thyroid carcinoma", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "30/11/2013", "compliance_outcome": "Positive", "compliance_opinion_date": "20/06/2014", "compliance_procedure_number": "EMEA-C-000052-PIP01-07-M03", "contact_for_public_enquiries": "AstraZeneca AB (Sweden); Tel. +46 8 5532791; E-mail: paediatrics@astrazeneca.com", "first_published_date": "07/01/2009", "last_updated_date": "06/01/2014", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000052-pip01-07-m03" }, { "decision_number": "P/0301/2013", "pip_number": "EMEA-001499-PIP01-13", "active_substance": "odanacatib;colecalciferol", "invented_name": "", "therapeutic_area": "Immunology-Rheumatology-Transplantation", "pharmaceutical_forms": "Tablet", "condition_indication": "Treatment of osteoporosis", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "29/11/2013", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Merck Sharp & Dohme (Europe) Inc.Tel.: +33180464738E-mail: pip.information@merck.com", "first_published_date": "06/01/2014", "last_updated_date": "06/01/2014", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001499-pip01-13" }, { "decision_number": "P/0303/2013", "pip_number": "EMEA-001508-PIP01-13", "active_substance": "metformin hydrochloride;rosuvastatin calcium", "invented_name": "", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Tablet", "condition_indication": "Treatment of type II diabetes mellitus concomitant with hypercholesterolaemia", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "29/11/2013", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "GlaxoSmithKline Trading Services Limited; Ireland; Email: admin@wainwrightassociates.co.uk; Tel. +44 1628530554", "first_published_date": "06/01/2014", "last_updated_date": "06/01/2014", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001508-pip01-13" }, { "decision_number": "P/0304/2013", "pip_number": "EMEA-001520-PIP01-13", "active_substance": "synthetic double-stranded siRNA oligonucleotide directed against transthyretin mRNA", "invented_name": "", "therapeutic_area": "Neurology", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Treatment of familial amyloid polyneuropathy", "routes_of_administration": "Intravenous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "29/11/2013", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Alnylam Pharmaceuticals, Inc.; United States; E-mail: snochur@alnylam.com; Tel. +1 6175518393; Fax +1 6175757339", "first_published_date": "06/01/2014", "last_updated_date": "06/01/2014", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001520-pip01-13" }, { "decision_number": "P/0299/2013", "pip_number": "EMEA-001398-PIP02-13", "active_substance": "sodium benzylpenilloate;benzylpenicilloyl octa- L-lysine", "invented_name": "", "therapeutic_area": "Diagnostic", "pharmaceutical_forms": "Powder and solvent for solution for injection", "condition_indication": "Diagnosis of beta-lactam allergy", "routes_of_administration": "Skin scarification;Intradermal use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "29/11/2013", "compliance_outcome": "Positive", "compliance_opinion_date": "12/09/2014", "compliance_procedure_number": "EMEA-C-001398-PIP02-13", "contact_for_public_enquiries": "Diater Laboratorio de Diagnóstico y Aplicaciones Terapéuticas, S.A.; Spain; E-mail: 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"15/11/2013", "last_updated_date": "15/11/2013", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001471-pip01-13" }, { "decision_number": "P/0233/2013", "pip_number": "EMEA-001479-PIP01-13", "active_substance": "Metformin;rosuvastatin", "invented_name": "", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Modified-release tablet", "condition_indication": "Treatment of type II diabetes mellitus concomitant with hypercholesterolaemia", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "23/09/2013", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Althera Laboratories LimitedEmail: regulatory.eu@altherainc.comTel.: +353 1 906 0479", "first_published_date": "15/11/2013", "last_updated_date": "15/11/2013", "pip_url": 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"https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001472-pip01-13" }, { "decision_number": "P/0230/2013", "pip_number": "EMEA-001467-PIP01-13", "active_substance": "perindopril erbumine;amlodipine besilate", "invented_name": "", "therapeutic_area": "", "pharmaceutical_forms": "Tablet", "condition_indication": "Treatment of hypertension", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "23/09/2013", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Zentiva, k.s.; Czech Republic; blanka.zoubkova@zentiva.com; Tel. +42 0267243574", "first_published_date": "15/11/2013", "last_updated_date": "15/11/2013", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001467-pip01-13" }, { "decision_number": "P/0243/2013", "pip_number": "EMEA-001394-PIP01-12", "active_substance": "Clostridium difficile toxin A human monoclonal antibody;Clostridium difficile toxin B human monoclonal antibody", "invented_name": "", "therapeutic_area": "Infectious diseases", "pharmaceutical_forms": "Concentrate for solution for infusion", "condition_indication": "Treatment of Clostridium difficile infection", "routes_of_administration": "Intravenous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "21/09/2013", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Merck Sharp & Dohme (Europe) Inc.Tel.: +33180464738E-mail: pip.information@merck.com", "first_published_date": "15/11/2013", "last_updated_date": "15/11/2013", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001394-pip01-12" }, { "decision_number": "P/0220/2013", "pip_number": "EMEA-000726-PIP01-09-M02", "active_substance": "valganciclovir", "invented_name": "Valcyte and associated names", "therapeutic_area": "Infectious diseases", "pharmaceutical_forms": "Film-coated tablet;Powder for oral solution", "condition_indication": "Prevention of infection due to cytomegalovirus in solid-organ-transplant recipients;Treatment of infection due to cytomegalovirus in immunocompromised patients", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "06/09/2013", "compliance_outcome": "Positive", "compliance_opinion_date": "11/10/2013", "compliance_procedure_number": "EMEA-C-000726-PIP01-09-M02", "contact_for_public_enquiries": "Roche Registration Limited; alexandra.kalb@roche.com; Tel. +41 61687360; Fax +41 61681560", "first_published_date": "12/05/2011", "last_updated_date": "08/10/2013", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000726-pip01-09-m02" }, { "decision_number": "P/0204/2013", "pip_number": "EMEA-000284-PIP01-08-M04", "active_substance": "grass pollen", "invented_name": "", "therapeutic_area": "Pneumology-allergology", "pharmaceutical_forms": "Suspension for injection", "condition_indication": "Treatment of acute atopic conjunctivitis;Treatment of allergic rhinitis due to pollen", "routes_of_administration": "Subcutaneous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "03/09/2013", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Allergy Therapeutics (UK) Ltd; sue.sulsh@allergytherapeutics.com; Tel. +44 (0)1903 844757; Fax +44 (0)1903 844726", "first_published_date": "03/10/2011", "last_updated_date": "08/10/2013", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000284-pip01-08-m04" }, { "decision_number": "P/0196/2013", "pip_number": "EMEA-000654-PIP01-09-M02", "active_substance": "Human-papillomavirus-type-6 L1 protein;human-papillomavirus-type-11 L1 protein;human-papillomavirus-type-16 L1 protein;human-papillomavirus-type-18 L1 protein;human-papillomavirus-type-31 L1 protein;human-papillomavirus-type-33 L1 protein;human-papillomavirus-type-45 L1 protein;human-papillomavirus-type-52 L1 protein;human-papillomavirus-type-58 L1 protein", "invented_name": "", "therapeutic_area": "Vaccines", "pharmaceutical_forms": "Suspension for injection;Suspension for injection in pre-filled syringe", "condition_indication": "Prevention of infection by human papillomavirus", "routes_of_administration": "Intramuscular use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "02/09/2013", "compliance_outcome": "Positive", 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"compliance_procedure_number": "", "contact_for_public_enquiries": "Eli Lilly & Company Limited; E-mail: eu_paediatric@lilly.com ; Tel. +44 (0)1276 483000", "first_published_date": "03/09/2013", "last_updated_date": "03/09/2013", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001237-pip01-11" }, { "decision_number": "P/0171/2013", "pip_number": "EMEA-000817-PIP02-11-M01", "active_substance": "purified antigen fractions of inactivated split virion influenza virus type A, H1N1;influenza virus type A, H3N2;influenza virus type B, Victoria lineage;influenza virus type B, Yamagata lineage", "invented_name": "Influsplit Tetra and associated names", "therapeutic_area": "Vaccines", "pharmaceutical_forms": "Suspension for injection", "condition_indication": "Prevention of influenza infection", "routes_of_administration": "Intramuscular use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "30/07/2013", "compliance_outcome": "Positive", "compliance_opinion_date": "21/04/2017", "compliance_procedure_number": "EMEA-000817-PIP02-11-M01", "contact_for_public_enquiries": "GSK Vaccines S.r.l.; Tel. +1 438 899 8201; Email: eu.paediatric-plans@gsk.com", "first_published_date": "02/09/2013", "last_updated_date": "19/01/2012", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000817-pip02-11-m01" }, { "decision_number": "P/0159/2013", "pip_number": "EMEA-001410-PIP01-12", "active_substance": "ixazomib citrate", "invented_name": "", "therapeutic_area": "Haematology-Hemostaseology", "pharmaceutical_forms": "Capsule, hard", "condition_indication": "Treatment of systemic light chain amyloidosis", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "05/07/2013", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Takeda Global Research & Development Centre (Europe) Ltd; United Kingdom; E-mail: paediatrics@tgrd.com; Tel. +44 (0)20 3116 8250", "first_published_date": "13/08/2013", "last_updated_date": "13/08/2013", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001410-pip01-12" }, { "decision_number": "P/0148/2013", "pip_number": "EMEA-001361-PIP01-12", "active_substance": "ketoprofen;omeprazole", "invented_name": "", "therapeutic_area": "Pain", "pharmaceutical_forms": "Capsule, hard;Modified release capsule", "condition_indication": "Treatment of pain", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "03/07/2013", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Conventia Healthcare LLP; United Kingdom; E-mail: kim@conventia.com ; Tel. +44 (0)1442 890903", "first_published_date": "13/08/2013", "last_updated_date": "13/08/2013", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001361-pip01-12" }, { "decision_number": "P/0149/2013", "pip_number": "EMEA-001397-PIP01-12", "active_substance": "Ibrutinib", "invented_name": "", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Capsule, hard", "condition_indication": "Treatment of mantle cell lymphoma", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "03/07/2013", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Janssen-Cilag International N.V.; E-mail: sglawe@its.jnj.com ; Tel. +49 9479218", "first_published_date": "13/08/2013", "last_updated_date": "13/08/2013", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001397-pip01-12" }, { "decision_number": "P/0150/2013", "pip_number": "EMEA-001444-PIP01-13", "active_substance": "zolpidem (tartrate)", "invented_name": "", "therapeutic_area": "Psychiatry", "pharmaceutical_forms": "Sublingual tablet", "condition_indication": "Treatment of insomnia", "routes_of_administration": "Sublingual use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "03/07/2013", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Transcept Pharmaceuticals, Inc; United States; E-mail: ssakai@transcept.com ; Tel. +1 5102153515", "first_published_date": "13/08/2013", "last_updated_date": "13/08/2013", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001444-pip01-13" }, { "decision_number": "P/0156/2013", "pip_number": "EMEA-001299-PIP01-12", "active_substance": "Betulae cortex", "invented_name": "", "therapeutic_area": "Dermatology", "pharmaceutical_forms": "Ointment", "condition_indication": "Treatment of skin injuries", "routes_of_administration": "Cutaneous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "05/07/2013", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Birken AG; Germany; E-mail: info@birken.eu ; Tel. +49 72339749; Fax +49 7233974922", "first_published_date": "09/08/2013", "last_updated_date": "09/08/2013", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001299-pip01-12" }, { "decision_number": "P/0145/2013", "pip_number": "EMEA-001305-PIP01-12", "active_substance": "cebranopadol", "invented_name": "", "therapeutic_area": "Pain", "pharmaceutical_forms": "Film-coated tablet;Granules", "condition_indication": "Treatment of chronic pain", "routes_of_administration": "Oral use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "03/07/2013", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Grünenthal GmbH; Tel. +49 2415690E-mail: pediatrics@grunenthal.com", "first_published_date": "09/08/2013", "last_updated_date": "09/08/2013", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001305-pip01-12" }, { "decision_number": "P/0151/2013", "pip_number": "EMEA-000191-PIP01-08-M05", "active_substance": "voriconazole", "invented_name": "Vfend; Vfend", "therapeutic_area": "Infectious diseases", "pharmaceutical_forms": "Film-coated tablet;Powder for oral suspension;Powder for solution for infusion", "condition_indication": "Treatment of candidaemia 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toxin type A, purified neurotoxin", "invented_name": "", "therapeutic_area": "Dermatology", "pharmaceutical_forms": "Powder for solution for injection", "condition_indication": "Treatment of skin dystrophies", "routes_of_administration": "Intramuscular use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "03/05/2013", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Janssen Biologics B.V.; The Netherlands; ssilk@its.jnj.com ; Tel. +44 (0) 1494 55 39 55; Fax +44 (0) 1494 65 80 14", "first_published_date": "24/06/2013", "last_updated_date": "24/06/2013", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001396-pip01-12" }, { "decision_number": "P/0129/2013", "pip_number": "EMEA-001405-PIP01-12", "active_substance": "metoprolol (tartrate);ivabradine hydrochloride", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Tablet", "condition_indication": "Treatment of ischaemic coronary artery disorders", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "28/05/2013", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Les Laboratoires ServierE-mail: mail.pip.enquiries@servier.comTel.: +33 155726000", "first_published_date": "24/06/2013", "last_updated_date": "24/06/2013", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001405-pip01-12" }, { "decision_number": "P/0130/2013", "pip_number": "EMEA-001408-PIP01-12", "active_substance": "valsartan;hydrochlorothiazide;rosuvastatin", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Prevention of thromboembolic events;Treatment of dyslipidaemia;Treatment of elevated cholesterol;Treatment of hypertension", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "28/05/2013", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Krka, d.d., Novo mesto; Slovenia; dragan.priselac@krka.biz ; Tel. +386 73322741; Fax +386 73322742", "first_published_date": "24/06/2013", "last_updated_date": "24/06/2013", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001408-pip01-12" }, { "decision_number": "P/0128/2013", "pip_number": "EMEA-001403-PIP01-12", "active_substance": "menotrophin", "invented_name": "", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Powder and solvent for solution for injection", "condition_indication": "Treatment of female infertility", "routes_of_administration": "Subcutaneous use;Intramuscular use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "28/05/2013", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Laboratoires Genevrier; France; amy.whyte@regulis.com ; Tel. 44 (0) 1442 890903", "first_published_date": "24/06/2013", "last_updated_date": "24/06/2013", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001403-pip01-12" }, { "decision_number": "P/0131/2013", "pip_number": "EMEA-001447-PIP01-12", "active_substance": "rosuvastatin;ezetimibe", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Capsule, hard", "condition_indication": "Treatment of elevated cholesterol", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "28/05/2013", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "EGIS Pharmaceuticals PLC; Hungary; registry@egis.hu ; Tel. +361 18032414", "first_published_date": "24/06/2013", "last_updated_date": "24/06/2013", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001447-pip01-12" }, { "decision_number": "P/0121/2013", "pip_number": "EMEA-000366-PIP04-12", "active_substance": "adalimumab", "invented_name": "Humira; Humira", "therapeutic_area": "Dermatology", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Treatment of hidradenitis suppurativa", "routes_of_administration": "Subcutaneous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "03/05/2013", "compliance_outcome": "Positive", "compliance_opinion_date": "01/04/2016", "compliance_procedure_number": "EMEA-C-000366-PIP04-12", "contact_for_public_enquiries": "AbbVie LtdE-mail: paediatricteam@abbvie.comTel. +44 (0)791 988 1614", "first_published_date": "21/06/2013", "last_updated_date": "21/06/2013", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000366-pip04-12" }, { "decision_number": "P/0090/2013", "pip_number": "EMEA-000425-PIP02-10-M04", "active_substance": "Bosentan", "invented_name": "Tracleer; Tracleer", "therapeutic_area": "Pneumology-allergology", "pharmaceutical_forms": "Film-coated tablet;Dispersible tablet", "condition_indication": "Treatment of interstitial pulmonary fibrosis;Treatment of pulmonary arterial hypertension;Treatment of systemic sclerosis", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "29/04/2013", "compliance_outcome": "Positive", "compliance_opinion_date": "21/03/2014", "compliance_procedure_number": "EMEA-C-000425-PIP02-10-M04", "contact_for_public_enquiries": "Actelion Registration LtdTel. +41 615656565E-mail: clinical-trials-disclosure@its.jnj.com", "first_published_date": "04/01/2013", "last_updated_date": "31/05/2013", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000425-pip02-10-m04" }, { "decision_number": "P/0092/2013", "pip_number": "EMEA-000822-PIP01-09-M01", "active_substance": "bucelipase alfa", "invented_name": "", "therapeutic_area": "Gastroentology-Hepatology", "pharmaceutical_forms": "Powder for oral solution", "condition_indication": "Prevention of growth retardation due to lack of bile-salt-stimulated lipase in enteral nutrition", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "29/04/2013", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Swedish Orphan Biovitrum AB; E-mail: communication@sobi.com; Country: Sweden; Tel. +46 86972000", "first_published_date": "08/04/2011", "last_updated_date": "31/05/2013", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000822-pip01-09-m01" }, { "decision_number": "P/0084/2013", "pip_number": "EMEA-000013-PIP01-07-M03", "active_substance": "recombinant L-asparaginase", "invented_name": "", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Powder for solution for injection or infusion", "condition_indication": "Treatment of acute lymphoblastic leukaemia;Treatment of lymphoblastic lymphoma", "routes_of_administration": "Intravenous use;Intramuscular use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "29/04/2013", "compliance_outcome": "Positive", "compliance_opinion_date": "14/06/2013", "compliance_procedure_number": "EMEA-C-000013-PIP01-07-M03", "contact_for_public_enquiries": "Medac Gesellschaft für klinische Spezialpräparate mbH; E-mail: j.kuehnel@medac.de; Country: Germany; Tel. +49 41038006413; Fax: +49 41038009130", "first_published_date": "06/03/2009", "last_updated_date": "31/05/2013", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000013-pip01-07-m03" }, { "decision_number": "P/0101/2013", "pip_number": "EMEA-000627-PIP01-09-M04", "active_substance": "ivabradine hydrochloride", "invented_name": "Corlentor; Corlentor", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Film-coated tablet;Solution for injection;Oral solution", "condition_indication": "Treatment of angina pectoris;Treatment of chronic heart failure;Treatment of coronary artery disease", "routes_of_administration": "Intravenous use;Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "30/04/2013", "compliance_outcome": "Positive", "compliance_opinion_date": "10/10/2014", "compliance_procedure_number": "EMEA-C-000627-PIP01-09-M04", "contact_for_public_enquiries": "Les Laboratoires ServierTel. +33 1 55 72 60 00E-mail: mail.pip.enquiries@fr.netgrs.com", "first_published_date": "12/05/2011", "last_updated_date": "31/05/2013", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000627-pip01-09-m04" }, { "decision_number": "P/0098/2013", "pip_number": "EMEA-001392-PIP01-12", "active_substance": "chlormethine", "invented_name": "", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Gel", "condition_indication": "Treatment of Cutaneous T-Cell Lymphoma", "routes_of_administration": "Cutaneous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "29/04/2013", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Actelion Registration LtdTel. +41 919851950E-mail: paediatrics-info@helsinn.com", "first_published_date": "31/05/2013", "last_updated_date": "31/05/2013", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001392-pip01-12" }, { "decision_number": "P/0111/2013", "pip_number": "EMEA-001309-PIP01-12", "active_substance": "palivizumab", "invented_name": "Synagis; Synagis", "therapeutic_area": "Neonatology-Paediatric Intensive Care", "pharmaceutical_forms": "Solution for injection;Powder and solvent for solution for injection", "condition_indication": "Prevention of lower respiratory tract disease caused by respiratory syncytial virus", "routes_of_administration": "Intramuscular use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "30/04/2013", "compliance_outcome": "Positive", "compliance_opinion_date": "09/08/2013", "compliance_procedure_number": "EMEA-C-001309-PIP01-12", "contact_for_public_enquiries": "AbbVie LtdE-mail: paediatricteam@abbvie.comTel. : +44 1628644475", "first_published_date": "31/05/2013", "last_updated_date": "31/05/2013", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001309-pip01-12" }, { "decision_number": "P/0102/2013", "pip_number": "EMEA-000628-PIP01-09-M04", "active_substance": "ivabradine hydrochloride", "invented_name": "Procoralan; Procoralan", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Film-coated tablet;Solution for injection;Oral solution", "condition_indication": "Treatment of angina pectoris;Treatment of chronic heart failure;Treatment of coronary artery disease", "routes_of_administration": "Intravenous use;Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "30/04/2013", "compliance_outcome": "Positive", "compliance_opinion_date": "10/10/2014", "compliance_procedure_number": "EMEA-C-000628-PIP01-09-M04", "contact_for_public_enquiries": "Les Laboratoires ServierTel. +33 1 55 72 60 00E-mail: mail.pip.enquiries@fr.netgrs.com", "first_published_date": "12/05/2011", "last_updated_date": "31/05/2013", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000628-pip01-09-m04" }, { "decision_number": "P/0095/2013", "pip_number": "EMEA-001167-PIP02-11-M01", "active_substance": "atomoxetine (hydrochloride)", "invented_name": "Strattera", "therapeutic_area": "Psychiatry", "pharmaceutical_forms": "Capsule, hard", "condition_indication": "Treatment of Attention Deficit Hyperactivity Disorder (ADHD)", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "29/04/2013", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Eli Lilly & Company Limited; E-mail: eu_paediatric@lilly.com ; Tel. +44 (0)1276 483000", "first_published_date": "19/01/2012", "last_updated_date": "31/05/2013", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001167-pip02-11-m01" }, { "decision_number": "P/0085/2013", "pip_number": "EMEA-000132-PIP01-07-M04", "active_substance": "voclosporin", "invented_name": "", "therapeutic_area": "Ophthalmology", "pharmaceutical_forms": "Oral liquid;Capsule, soft", "condition_indication": "Treatment of non-infectious uveitis", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "29/04/2013", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Lux Biosciences GmbH; E-mail: info@luxbio.com; Country: Germany; Tel. +49 8924213109", "first_published_date": "26/08/2010", "last_updated_date": "31/05/2013", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000132-pip01-07-m04" }, { "decision_number": "P/0113/2013", "pip_number": "EMEA-001390-PIP01-12", "active_substance": "Losartan potassium;amlodipine besilate", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Treatment of essential hypertension", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "30/04/2013", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "GlaxoSmithKline Trading Services Limited; E-mail: admin@wainwrightassociates.co.uk; Country: Ireland; Tel. +44 (0)1628 530554", "first_published_date": "31/05/2013", "last_updated_date": "31/05/2013", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001390-pip01-12" }, { "decision_number": "P/0087/2013", "pip_number": "EMEA-000205-PIP01-08-M02", "active_substance": "ceftobiprole medocaril (sodium)", "invented_name": "", "therapeutic_area": "Infectious diseases", "pharmaceutical_forms": "Powder for solution for infusion", "condition_indication": "Treatment of complicated skin and soft-tissue infections", "routes_of_administration": "Intravenous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "29/04/2013", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Basilea Pharmaceutica International Ltd.; Tel. +41 616061400; E-mail: medical.information@basilea.com", "first_published_date": "06/03/2009", "last_updated_date": "31/05/2013", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000205-pip01-08-m02" }, { "decision_number": "P/0082/2013", "pip_number": "EMEA-001288-PIP01-12", "active_substance": "1-(2R,5R)-5-ethynyl-5-(hydroxymethyl)-2,5-dihydro-2-furanyl)-5-methyl-2,4(1H,3H)-pyrimidinedione (BMS-986001)", "invented_name": "", "therapeutic_area": "Infectious diseases", "pharmaceutical_forms": "Film-coated tablet;Age appropriate oral solid dosage form", "condition_indication": "Treatment of human immunodeficiency virus (HIV-1) infection", "routes_of_administration": "Oral use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "27/03/2013", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Bristol-Myers Squibb International Corporation; E-mail: yoshida@oncolys.com; Tel. +81354721578;  ", "first_published_date": "03/05/2013", "last_updated_date": "03/05/2013", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001288-pip01-12" }, { "decision_number": "P/0080/2013", "pip_number": "EMEA-001400-PIP01-12", "active_substance": "sialic acid", "invented_name": "", "therapeutic_area": "Other", "pharmaceutical_forms": "Modified-release tablet", "condition_indication": "Treatment of distal myopathy, Nonaka type (hereditary inclusion-body myopathy)", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "27/03/2013", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Ultragenyx UK Limited c/o Regus; Tel. +1 (415) 4838148; Fax +1 (415) 4838920; E-mail: rhostutler@ultragenyx.com", "first_published_date": "03/05/2013", "last_updated_date": "03/05/2013", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001400-pip01-12" }, { "decision_number": "P/0077/2013", "pip_number": "EMEA-001385-PIP01-12", "active_substance": "bisoprolol;amlodipine", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Tablet", "condition_indication": "Treatment of ischaemic coronary artery disorders;Treatment of hypertension", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "26/03/2013", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Krka d.d. Novo Mesto; E-mail: bernarda.bevc@krka.biz; Country: Slovenia; Tel. + 386 73312730; Fax + 386 73322742", "first_published_date": "03/05/2013", "last_updated_date": "03/05/2013", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001385-pip01-12" }, { "decision_number": "P/0076/2013", "pip_number": "EMEA-001381-PIP01-12", "active_substance": "lutetium (177Lu)", "invented_name": "", "therapeutic_area": "Other", "pharmaceutical_forms": "Radiopharmaceutical precursor;Solution", "condition_indication": "Radiolabelling agent", "routes_of_administration": "Intravenous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "26/03/2013", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "I.D.B. Radiopharmacy B.V.; E-mail: je.vaessen@bfc.nl; Country: The Netherlands; Tel. + 31 402453611; Fax + 31 402374460", "first_published_date": "03/05/2013", "last_updated_date": "03/05/2013", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001381-pip01-12" }, { "decision_number": "P/0075/2013", "pip_number": "EMEA-001327-PIP01-12", "active_substance": "alendronic acid;colecalciferol", "invented_name": "", "therapeutic_area": "Immunology-Rheumatology-Transplantation", "pharmaceutical_forms": "Tablet", "condition_indication": "Treatment of osteoporosis", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "26/03/2013", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Teva Pharma B.V.; E-mail: lidija.brnic@tevapharm.com; Country: The Netherlands; Tel. +38 53722150", "first_published_date": "03/05/2013", "last_updated_date": "03/05/2013", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001327-pip01-12" }, { "decision_number": "P/0070/2013", "pip_number": "EMEA-001245-PIP01-11", "active_substance": "hexaminolevulinate", "invented_name": "Hexvix", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Vaginal ointment;Powder and solvent for intravesical solution", "condition_indication": "Diagnosis of bladder cancer;Treatment of cervical dysplasia", "routes_of_administration": "Vaginal use;Intravesical use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "26/03/2013", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Photocure ASA; E-mail: info@photocure.no; Country: Norway; Tel. + 47 22062216; Fax + 47 22062218", "first_published_date": "03/05/2013", "last_updated_date": "03/05/2013", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001245-pip01-11" }, { "decision_number": "P/0042/2013", "pip_number": "EMEA-000550-PIP02-10-M01", "active_substance": "cilengitide", "invented_name": "", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Solution for infusion", "condition_indication": "Treatment of high-grade glioma", "routes_of_administration": "Intravenous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "01/03/2013", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Merck KGaA; E-mail: service@merck.de; Country: Germany; Tel. +49 6151720", "first_published_date": "03/10/2011", "last_updated_date": "03/05/2013", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000550-pip02-10-m01" }, { "decision_number": "P/0068/2013", "pip_number": "EMEA-001100-PIP01-10", "active_substance": "anacetrapib", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Tablet;Age appropriate oral solid dosage form", "condition_indication": "Prevention of cardiovascular events in patients with hypercholesterolaemia;Treatment of hypercholesterolaemia", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "26/03/2013", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Merck Sharp & Dohme (Europe) Inc.Tel.: +33180464738E-mail: pip.information@merck.com", "first_published_date": "03/05/2013", "last_updated_date": "03/05/2013", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001100-pip01-10" }, { "decision_number": "P/0055/2013", "pip_number": "EMEA-000764-PIP02-11", "active_substance": "etoxybamide", "invented_name": "", "therapeutic_area": "Anaesthesiology", "pharmaceutical_forms": "Solution for injection/infusion", "condition_indication": "Sedation", "routes_of_administration": "Intravenous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "25/03/2013", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Dr. Franz Köhler Chemie GmbH; E-mail: info@koehler-chemie.de; Country: Germany; Tel. + 49 625110830; Fax + 49 62511083246", "first_published_date": "02/05/2013", "last_updated_date": "02/05/2013", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000764-pip02-11" }, { "decision_number": "P/0048/2013", "pip_number": "EMEA-001267-PIP01-12", "active_substance": "N-{4-chloro-2-[(1-oxido-4-pyridinyl)carbonyl]phenyl}-4-(1,1-dimethylethyl) benzenesulfonamide, sodium salt", "invented_name": "", "therapeutic_area": "Gastroentology-Hepatology", "pharmaceutical_forms": "Capsule, hard;Age appropriate dosage form, other", "condition_indication": "Treatment of Crohn's disease", "routes_of_administration": "Oral use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "01/03/2013", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Glaxo Group Limited; E-mail: eu.paediatric-plans@gsk.com; Country: United Kingdom; Tel. + +44 (0)20 8990 3650; Fax + +44 (0)20 8990 3511", "first_published_date": "30/04/2013", "last_updated_date": "30/04/2013", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001267-pip01-12" }, { "decision_number": "P/0045/2013", "pip_number": "EMEA-001033-PIP02-11", "active_substance": "enzastaurin hydrochloride", "invented_name": "", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Tablet", "condition_indication": "Treatment of diffuse large B-cell lymphoma", "routes_of_administration": "Oral use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "01/03/2013", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Eli Lilly & Company Limited; E-mail: eu_paediatric@lilly.com ; Tel. +44 (0)1276 483000", "first_published_date": "30/04/2013", "last_updated_date": "30/04/2013", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001033-pip02-11" }, { "decision_number": "P/0040/2013", "pip_number": "EMEA-001380-PIP01-12", "active_substance": "amlodipine;losartan", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Treatment of essential hypertension", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "27/02/2013", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Krka, d.d., Novo mesto; E-mail: tomaz.kralj@krka.biz; Country: Slovenia; Tel. + 386 73312055; Fax + 386 73322742", "first_published_date": "23/04/2013", "last_updated_date": "23/04/2013", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001380-pip01-12" }, { "decision_number": "P/0039/2013", "pip_number": "EMEA-001377-PIP01-12", "active_substance": "valsartan;Indapamide", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Film-coated tablet;Prolonged-release tablet", "condition_indication": "Treatment of heart failure;Treatment of acute myocardial infarction;Treatment of essential hypertension", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "27/02/2013", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Gedeon Richter Plc.; E-mail: mrprichter@richter.hu; 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E-mail: evelyne.jacqzaigrain@gmail.com; Country: France; Tel. + 33 140034099", "first_published_date": "23/04/2013", "last_updated_date": "23/04/2013", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001298-pip01-12" }, { "decision_number": "P/0034/2013", "pip_number": "EMEA-001364-PIP01-12", "active_substance": "atorvastatin calcium;amlodipine besilate", "invented_name": "", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Prevention of cardiovascular events in hypertensive patients and diabetes mellitus type II patients with multiple risk factors for cardiovascular disease;Treatment of concomitant angina and dyslipidaemia;Treatment of concomitant hypertension and dyslipidaemia", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "26/02/2013", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "HCS bvba; 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United States; E-mail: medinfoeu-ceemea@shire.com; Tel. +44 (0)2196 65520; Fax +1 7814822954", "first_published_date": "07/01/2013", "last_updated_date": "07/01/2013", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000408-pip02-12" }, { "decision_number": "P/0281/2012", "pip_number": "EMEA-001239-PIP01-11", "active_substance": "brimonidine tartrate", "invented_name": "", "therapeutic_area": "Dermatology", "pharmaceutical_forms": "Gel", "condition_indication": "Treatment of rosacea", "routes_of_administration": "Topical use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "21/11/2012", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Galderma International; France; regulatory.affairs@galderma.com; Tel. +33 493957105; Fax +33 492952101", "first_published_date": "07/01/2013", "last_updated_date": "07/01/2013", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001239-pip01-11" }, { "decision_number": "P/0271/2012", "pip_number": "EMEA-001344-PIP01-12", "active_substance": "ezetimibe;rosuvastatin", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Tablet", "condition_indication": "Treatment of hypercholesterolaemia", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "20/11/2012", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Zentiva, k.s.; Czech Republic; blanka.zoubkova@zentiva.com; Tel. +42 0267243574", "first_published_date": "04/01/2013", "last_updated_date": "04/01/2013", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001344-pip01-12" }, { "decision_number": "P/0266/2012", "pip_number": "EMEA-001234-PIP01-11", "active_substance": "(2R,3S,5R)-2-(2,5-difluorophenyl)-5-[2,6-dihydro-2-(methylsulfonyl)pyrrolo[3,4-c]pyrazol-5(4H)-yl]tetrahydro-2H-pyran-3-amine (MK-3102)", "invented_name": "", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Capsule;Capsule, hard", "condition_indication": "Treatment of type II diabetes mellitus", "routes_of_administration": "Oral use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "20/11/2012", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Merck Sharp & Dohme (Europe), Inc.; Belgium; E-mail: pip.information@merck.com; Tel. +31 412663179; Fax +31 412662571", "first_published_date": "04/01/2013", "last_updated_date": "04/01/2013", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001234-pip01-11" }, { "decision_number": "P/0270/2012", "pip_number": "EMEA-001343-PIP01-12", "active_substance": "valsartan;amlodipine besilate", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Tablet", "condition_indication": "Treatment of hypertension", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "20/11/2012", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Zentiva, k.s.; Czech Republic; blanka.zoubkova@zentiva.com; Tel. +42 0267243574", "first_published_date": "04/01/2013", "last_updated_date": "04/01/2013", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001343-pip01-12" }, { "decision_number": "P/0269/2012", "pip_number": "EMEA-001337-PIP01-12", "active_substance": "perindopril;Indapamide;amlodipine", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Tablet", "condition_indication": "Treatment of hypertension", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "20/11/2012", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Krka, d.d., Novo mesto; Slovenia; martina.crevar@krka.biz; Tel. +38 516312155; Fax +38 516312153", "first_published_date": "04/01/2013", "last_updated_date": "04/01/2013", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001337-pip01-12" }, { "decision_number": "P/0262/2012", "pip_number": "EMEA-000063-PIP01-07-M01", "active_substance": "nicotinic acid;laropiprant", "invented_name": "Tredaptive; Tredaptive", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Age appropriate oral solid dosage form;Modified-release tablet", "condition_indication": "Prevention of major vascular and major coronary events;Treatment of dyslipidaemia", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "20/11/2012", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Merck Sharp and Dohme (Europe), Inc.; Belgium; Tel. +33 180464738; E-mail: pip.information@merck.com", "first_published_date": "04/01/2013", "last_updated_date": "04/01/2013", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000063-pip01-07-m01" }, { "decision_number": "P/0252/2012", "pip_number": "EMEA-001095-PIP02-12", "active_substance": "natalizumab", "invented_name": "Tysabri; Tysabri", "therapeutic_area": "Neurology", "pharmaceutical_forms": "Concentrate for solution for infusion", "condition_indication": "Treatment of multiple sclerosis", "routes_of_administration": "Intravenous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "19/10/2012", "compliance_outcome": "Positive", "compliance_opinion_date": "16/12/2016", "compliance_procedure_number": "EMEA-C-001095-PIP02-12", "contact_for_public_enquiries": "Biogen Idec Limited E-mail: Hema.borde@biogenidec.com Tel. +44 1628 512674", "first_published_date": "27/11/2012", "last_updated_date": "27/11/2012", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001095-pip02-12" }, { "decision_number": "P/0249/2012", "pip_number": "EMEA-001322-PIP01-12", "active_substance": "Etarfolatide", "invented_name": "", "therapeutic_area": "Diagnostic", "pharmaceutical_forms": "Kit for radiopharmaceutical preparation", "condition_indication": "Diagnosis of folate-receptor status in malignant tissues", "routes_of_administration": "Intravenous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "23/10/2012", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Endocyte Europe B.V.; United States; kcarlson@endocyte.com; Phone: +1 7658070658", "first_published_date": "27/11/2012", "last_updated_date": "27/11/2012", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001322-pip01-12" }, { "decision_number": "P/0248/2012", "pip_number": "EMEA-001321-PIP01-12", "active_substance": "folic acid", "invented_name": "", "therapeutic_area": "Diagnostic", "pharmaceutical_forms": "Solution for injection;Solution for infusion", "condition_indication": "Diagnosis of folate-receptor status in malignant tissues", "routes_of_administration": "Intravenous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "23/10/2012", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Endocyte Europe B.V.; United States; kcarlson@endocyte.com; Phone: +1 7658070658", "first_published_date": "27/11/2012", "last_updated_date": "27/11/2012", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001321-pip01-12" }, { "decision_number": "P/0247/2012", "pip_number": "EMEA-001342-PIP01-12", "active_substance": "atorvastatin;ramipril;acetyl salicylic acid", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Capsule, hard", "condition_indication": "Treatment of cardiovascular disease", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "22/10/2012", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Ferrer Internacional, S.A.; E-mail: smartin@ferrer.com​; Tel. +34 9350 93227", "first_published_date": "27/11/2012", "last_updated_date": "27/11/2012", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001342-pip01-12" }, { "decision_number": "P/0246/2012", "pip_number": "EMEA-001320-PIP01-12", "active_substance": "perindopril (tosilate);amlodipine besilate", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Tablet", "condition_indication": "Treatment of hypertension", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "22/10/2012", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Teva Pharma B.V.; Croatia; lidija.brnic@pliva.com; Phone: +38 513722150", "first_published_date": "27/11/2012", "last_updated_date": "27/11/2012", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001320-pip01-12" }, { "decision_number": "P/0245/2012", "pip_number": "EMEA-001319-PIP01-12", "active_substance": "Candesartan cilexetil;amlodipine besilate", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Tablet", "condition_indication": "Treatment of hypertension", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "22/10/2012", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Zentiva, k.s.; Czech Republic; blanka.zoubkova@zentiva.com; Tel. +42 0267243574", "first_published_date": "27/11/2012", "last_updated_date": "27/11/2012", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001319-pip01-12" }, { "decision_number": "P/0244/2012", "pip_number": "EMEA-001302-PIP01-12", "active_substance": "Dexketoprofen (trometamol);tramadol hydrochloride", "invented_name": "", "therapeutic_area": "Pain", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Treatment of acute pain", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "22/10/2012", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Menarini Ricerche SpA; Italy; prijli@menarini.it; Phone: +39 0555680 633; Fax: +39 0555680689", "first_published_date": "27/11/2012", "last_updated_date": "27/11/2012", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001302-pip01-12" }, { "decision_number": "P/0242/2012", "pip_number": "EMEA-001196-PIP01-11", "active_substance": "Fostamatinib", "invented_name": "", "therapeutic_area": "Immunology-Rheumatology-Transplantation", "pharmaceutical_forms": "Tablet", "condition_indication": "Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, ankylosing spondylarthritis, psoriatic arthritis and juvenile idiopathic arthritis)", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "22/10/2012", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Astrazeneca AB (France); Tel. +33 609050197; E-mail: solange.rohou@astrazeneca.com", "first_published_date": "27/11/2012", "last_updated_date": "27/11/2012", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001196-pip01-11" }, { "decision_number": "P/0229/2012", "pip_number": "EMEA-000439-PIP02-11", "active_substance": "bitopertin", "invented_name": "", "therapeutic_area": "Psychiatry", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Treatment of schizophrenia", "routes_of_administration": "Oral use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "04/10/2012", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Roche Registration Limited; Switzerland; E-mail: info.paediatrics@roche.com; Tel. +41 616879411; Fax +41 616879233", "first_published_date": "27/11/2012", "last_updated_date": "27/11/2012", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000439-pip02-11" }, { "decision_number": "P/0224/2012", "pip_number": "EMEA-001294-PIP01-12", "active_substance": "azilsartan medoxomil;chlortalidone", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Treatment of hypertension", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "01/10/2012", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Takeda Pharma A/S; Lars.olsen@takeda.com; Tel. : +45 46771111; Fax: +45 46756560", "first_published_date": "27/11/2012", "last_updated_date": "27/11/2012", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001294-pip01-12" }, { "decision_number": "P/0223/2012", "pip_number": "EMEA-001269-PIP01-12", "active_substance": "rosuvastatin;acetylsalicylic acid", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Film-coated tablet;Gastro-resistant tablet", "condition_indication": "Treatment of cardiovascular disease", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "01/10/2012", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "EGIS Pharmaceuticals PLC; Hungary; registry@egis.hu; Phone: +36 18032414; Fax: +36 18032415", "first_published_date": "27/11/2012", "last_updated_date": "27/11/2012", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001269-pip01-12" }, { "decision_number": "P/0256/2012", "pip_number": "EMEA-000235-PIP02-10-M02", "active_substance": "aripiprazole", "invented_name": "Abilify", "therapeutic_area": "Psychiatry", "pharmaceutical_forms": "Tablet;Orodispersible tablet;Oral solution;Solution for injection", "condition_indication": "Treatment of bipolar affective disorder;Treatment of schizophrenia", "routes_of_administration": "Oral use;Intramuscular use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "26/10/2012", "compliance_outcome": "Positive", "compliance_opinion_date": "24/06/2016", "compliance_procedure_number": "EMEA-C-000235-PIP02-10-M02", "contact_for_public_enquiries": "Otsuka Pharmaceutical Europe Ltd.; E-mail: medinfo.emea@bms.com; Country: United Kingdom; Tel. +44 1895 523686; Fax +44 1895 52378", "first_published_date": "13/05/2011", "last_updated_date": "26/11/2012", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000235-pip02-10-m02" }, { "decision_number": "P/0250/2012", "pip_number": "EMEA-000510-PIP02-10-M02", "active_substance": "tazarotene", "invented_name": "", "therapeutic_area": "Dermatology", "pharmaceutical_forms": "Cream", "condition_indication": "Treatment of lamellar ichthyosis", "routes_of_administration": "Cutaneous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "24/10/2012", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Orfagen; France; E-mail: info@orfagen.com; Tel. +33 5345 06457; Fax +33 5345 03457", "first_published_date": "07/06/2011", "last_updated_date": "26/11/2012", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000510-pip02-10-m02" }, { "decision_number": "P/0234/2012", "pip_number": "EMEA-001051-PIP01-10-M03", "active_substance": "Influenza virus type A, H1N1;influenza virus type A, H3N2;influenza virus type B, Yamagata lineage;influenza virus type B, Victoria lineage", "invented_name": "", "therapeutic_area": "Vaccines", "pharmaceutical_forms": "Nasal spray", "condition_indication": "Prevention of influenza infection", "routes_of_administration": "Nasal use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "12/10/2012", "compliance_outcome": "Positive", "compliance_opinion_date": "14/06/2013", "compliance_procedure_number": "EMEA-001051-PIP01-10-M03", "contact_for_public_enquiries": "MedImmune Limited; United Kingdom; paediatrics@medimmune.com; Phone: +44 1223 471471; Fax: +44 1223 890339", "first_published_date": "30/11/2011", "last_updated_date": "26/11/2012", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001051-pip01-10-m03" }, { "decision_number": "P/0233/2012", "pip_number": "EMEA-000302-PIP01-08-M03", "active_substance": "pitavastatin (calcium)", "invented_name": "Pitavastatin and associated names", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Treatment of disorders of lipoprotein metabolism and other lipidaemias", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "05/10/2012", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Kowa Pharmaceutical Europe Company Ltd; E-mail: nhounslow@kowa.co.uk; Country: United Kingdom; Phone: +44 1189229000", "first_published_date": "21/07/2008", "last_updated_date": "26/11/2012", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000302-pip01-08-m03" }, { "decision_number": "P/0232/2012", "pip_number": "EMEA-000301-PIP01-08-M03", "active_substance": "pitavastatin (calcium)", "invented_name": "Vezepra and associated names", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Treatment of disorders of lipoprotein metabolism and other lipidaemias", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "05/10/2012", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Kowa Pharmaceutical Europe Company Ltd; E-mail: nhounslow@kowa.co.uk; Country: United Kingdom; Phone: +44 118922900", "first_published_date": "21/07/2008", "last_updated_date": "23/11/2012", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000301-pip01-08-m03" }, { "decision_number": "P/0213/2012", "pip_number": "EMEA-000404-PIP02-12", "active_substance": "Lapatinib ditosilate monohydrate", "invented_name": "Tyverb; Tyverb", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Film-coated tablet;Powder for oral suspension", "condition_indication": "Treatment of gastro oesophageal junction adenocarcinoma;Treatment of oesophageal adenocarcinoma", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "28/09/2012", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Glaxo Group Ltd; Tel. +41 613241111; E-mail: paediatric.enquiries@novartis.com", "first_published_date": "17/10/2012", "last_updated_date": "17/10/2012", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000404-pip02-12" }, { "decision_number": "P/0217/2012", "pip_number": "EMEA-001300-PIP01-12", "active_substance": "Icosapent ethyl", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Capsule, soft", "condition_indication": "Treatment of hypertriglyceridaemia", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "28/09/2012", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Amarin Pharmaceuticals Ireland Limited; United States; libette.luce@amarincorp.com ; +1 9083261233", "first_published_date": "17/10/2012", "last_updated_date": "17/10/2012", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001300-pip01-12" }, { "decision_number": "P/0201/2012", "pip_number": "EMEA-001286-PIP01-12", "active_substance": "recombinant human antibody against activin type IIB receptors", "invented_name": "", "therapeutic_area": "Neurology", "pharmaceutical_forms": "Concentrate for solution for injection", "condition_indication": "Treatment of sporadic inclusion body myositis", "routes_of_administration": "Intravenous use;Subcutaneous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "24/08/2012", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Novartis Europharm LimitedE-mail: paediatric.enquiries@novartis.comTel. +41 613241111", "first_published_date": "18/09/2012", "last_updated_date": "18/09/2012", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001286-pip01-12" }, { "decision_number": "P/0195/2012", "pip_number": "EMEA-001279-PIP01-12", "active_substance": "co-crystal of tramadol (hydrochloride);celecoxib", "invented_name": "", "therapeutic_area": "Pain", "pharmaceutical_forms": "Tablet", "condition_indication": "Treatment of pain", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "24/08/2012", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Laboratorios del Dr. Esteve S.A.; Spain; evalenti@esteve.es; +34 934466000", "first_published_date": "18/09/2012", "last_updated_date": "18/09/2012", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001279-pip01-12" }, { "decision_number": "P/0188/2012", "pip_number": "EMEA-001291-PIP01-12", "active_substance": "lisinopril (dihydrate);amlodipine besilate;rosuvastatin calcium", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Capsule, hard", "condition_indication": "Cardiovascular-event prophylaxis;Treatment of dyslipidaemia;Treatment of elevated cholesterol;Treatment of heart failure;Treatment of ischaemic coronary artery disorders;Treatment of vascular hypertensive disorders", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "21/08/2012", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Gedeon Richter Plc.; Hungary; mrprichter@richter.hu; Phone: +36 14314040; Fax: +36 14315415", "first_published_date": "18/09/2012", "last_updated_date": "18/09/2012", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001291-pip01-12" }, { "decision_number": "P/0187/2012", "pip_number": "EMEA-001277-PIP01-12", "active_substance": "[N-((2S,3R,3aS,3´R,4a´R,6S,6a´R,6b´S,7aR,12a´S,12b´S,Z)-3,6,11´,12b´-tetramethyl-2´,3a,3´,4,4´,4a´,5,5´,6,6´,6a´,6b´,7,7a,7´,8´,10´,12´,12a´,12b´-icosahydro-1´H,3Hspiro[furo[3,2-b]pyridine-2,9´-naphtho[2,1-a]azulene]-3´-yl)methanesulfonamide hydrochloride]", "invented_name": "", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Capsule, hard", "condition_indication": "Treatment of chondrosarcoma", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "21/08/2012", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Voisin Consulting; United States; irpr_info@info.com; Phone: +1 6174531336; Fax: +1 6174531001", "first_published_date": "18/09/2012", "last_updated_date": "18/09/2012", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001277-pip01-12" }, { "decision_number": "P/0186/2012", "pip_number": "EMEA-001275-PIP01-12", "active_substance": "sitagliptin;atorvastatin", "invented_name": "", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Treatment of type II diabetes mellitus concomitant with hypercholesterolaemia", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "21/08/2012", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Merck Sharp & Dohme (Europe), Inc.; Belgium; E-mail: pip.information@merck.com; Tel. +31 412663179; Fax +31 412662571", "first_published_date": "18/09/2012", "last_updated_date": "18/09/2012", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001275-pip01-12" }, { "decision_number": "P/0181/2012", "pip_number": "EMEA-001278-PIP01-12", "active_substance": "rosuvastatin;ezetimibe", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Film-coated tablet;Tablet", "condition_indication": "Treatment of hypercholesterolaemia", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "20/08/2012", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "EGIS Pharmaceuticals PLC; Country: Hungary; E-mail: registry@egis.hu; Tel. +36 1803 2414; Fax +36 18032415", "first_published_date": "17/09/2012", "last_updated_date": "17/09/2012", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001278-pip01-12" }, { "decision_number": "P/0180/2012", "pip_number": "EMEA-001274-PIP01-12", "active_substance": "autologous tumour-derived immunoglobulin idiotype coupled to keyhole limpet hemocyanin", "invented_name": "", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Treatment of mantle cell lymphoma", "routes_of_administration": "Subcutaneous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "20/08/2012", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Biovest Europe Ltd.; Country: United States; dwcalder@accentia.net; Phone: +1 8138642558; Fax: +1 8132586912", "first_published_date": "17/09/2012", "last_updated_date": "17/09/2012", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001274-pip01-12" }, { "decision_number": "P/0175/2012", "pip_number": "EMEA-001216-PIP01-12", "active_substance": "tafluprost;timolol", "invented_name": "", "therapeutic_area": "Ophthalmology", "pharmaceutical_forms": "Eye drops, solution;Solution", "condition_indication": "Treatment of ocular hypertension;Treatment of glaucoma", "routes_of_administration": "Ocular use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "27/07/2012", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Santen Oy; mail@santen.de; Finland; +49 8984807822; +49 8984807860", "first_published_date": "23/08/2012", "last_updated_date": "23/08/2012", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001216-pip01-12" }, { "decision_number": "P/0167/2012", "pip_number": "EMEA-001192-PIP01-11", "active_substance": "peginterferon lambda-1a", "invented_name": "", "therapeutic_area": "Infectious diseases", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Treatment of chronic hepatitis C", "routes_of_administration": "Subcutaneous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "26/07/2012", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Bristol-Myers Squibb International Corporation; Tel. +44 1895523740; E-mail: medical.information@bms.com", "first_published_date": "23/08/2012", "last_updated_date": "23/08/2012", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001192-pip01-11" }, { "decision_number": "P/0165/2012", "pip_number": "EMEA-001190-PIP01-11", "active_substance": "asunaprevir", "invented_name": "", "therapeutic_area": "Infectious diseases", "pharmaceutical_forms": "Capsule, soft;Chewable tablet", "condition_indication": "Treatment of chronic hepatitis C", "routes_of_administration": "Oral use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "26/08/2012", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Bristol-Myers Squibb International Corporation; Tel. +44 1895523740; E-mail: medical.information@bms.com", "first_published_date": "23/08/2012", "last_updated_date": "23/08/2012", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001190-pip01-11" }, { "decision_number": "P/0163/2012", "pip_number": "EMEA-001159-PIP02-12", "active_substance": "misoprostol", "invented_name": "", "therapeutic_area": "Other", "pharmaceutical_forms": "Vaginal delivery system", "condition_indication": "Induction of labour", "routes_of_administration": "Vaginal use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "23/07/2012", "compliance_outcome": "Positive", "compliance_opinion_date": "11/10/2012", "compliance_procedure_number": "EMEA-C-001159-PIP02-12", "contact_for_public_enquiries": "Ferring pharmaceuticals A/S; gb3-info@ferring.com ; United Kingdom; +44 1355293166; +44 1355269661", "first_published_date": "23/08/2012", "last_updated_date": "23/08/2012", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001159-pip02-12" }, { "decision_number": "P/0149/2012", "pip_number": "EMEA-001284-PIP01-12", "active_substance": "tivantinib", "invented_name": "", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Tablet", "condition_indication": "Treatment of hepatoblastoma", "routes_of_administration": "Oral use", "decision_type": "RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)", "decision_date": "24/07/2012", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Daiichi Sankyo Development Limited; kourumova@dsd-eu.com ; United Kingdom; +44 1753482813; +44 1753899107", "first_published_date": "22/08/2012", "last_updated_date": "22/08/2012", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001284-pip01-12" }, { "decision_number": "P/0141/2012", "pip_number": "EMEA-000006-PIP03-12", "active_substance": "ezetimibe;simvastatin", "invented_name": "Inegy and associated names", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Tablet", "condition_indication": "Prevention of coronary heart disease", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "23/07/2012", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Merck Sharp & Dohme Limited; E-mail: regaffairseurope@organon.com; Tel: +31 412770000", "first_published_date": "22/08/2012", "last_updated_date": "22/08/2012", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000006-pip03-12" }, { "decision_number": "P/0135/2012", "pip_number": "EMEA-000007-PIP04-12", "active_substance": "ezetimibe", "invented_name": "Ezetrol and associated names", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Tablet", "condition_indication": "Prevention of coronary heart disease", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "20/07/2012", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Merck Sharp & Dohme Limited; E-mail: regaffairseurope@organon.com; Tel: +31 412770000", "first_published_date": "22/08/2012", "last_updated_date": "22/08/2012", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000007-pip04-12" }, { "decision_number": "P/0142/2012", "pip_number": "EMEA-000414-PIP02-11", "active_substance": "Ethanol", "invented_name": "", "therapeutic_area": "Dermatology", "pharmaceutical_forms": "Gel for injection", "condition_indication": "Treatment of congenital venous malformations", "routes_of_administration": "Intralesional use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "23/07/2012", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Orphagen; info@orfagen.com; France; +33 534506458; +33 534503458", "first_published_date": "22/08/2012", "last_updated_date": "22/08/2012", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000414-pip02-11" }, { "decision_number": "P/0138/2012", "pip_number": "EMEA-001110-PIP01-10-M01", "active_substance": "human normal immunoglobulin", "invented_name": "", "therapeutic_area": "Haematology-Hemostaseology", "pharmaceutical_forms": "Solution for infusion", "condition_indication": "Treatment of chronic inflammatory demyelinating polyradiculo-neuropathy;Treatment of idiopathic thrombocytopenic purpura as a model for immunomodulation;Treatment of primary immunodeficiency (PID) as model for replacement therapy", "routes_of_administration": "Intravenous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "20/07/2012", "compliance_outcome": "Positive", "compliance_opinion_date": "11/10/2013", "compliance_procedure_number": "EMEA-C-001110-PIP01-10-M01", "contact_for_public_enquiries": "Octapharma Pharmazeutika Produktionsges.m.b.H; wolfgang.frenzel@octapharma.com; Austria; + 43 1610321201 ; + 43 1610329249", "first_published_date": "21/12/2011", "last_updated_date": "22/08/2012", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001110-pip01-10-m01" }, { "decision_number": "P/0157/2012", "pip_number": "EMEA-000556-PIP01-09-M02", "active_substance": "velaglucerase alfa", "invented_name": "", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Lyophilisate for solution for infusion", "condition_indication": "Treatment of Gaucher disease, type 2;Gaucher disease, types 1 and 3", "routes_of_administration": "Intravenous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "26/07/2012", "compliance_outcome": "Positive", "compliance_opinion_date": "29/01/2016", "compliance_procedure_number": "EMEA-C-000556-PIP01-09-M02", "contact_for_public_enquiries": "Shire Pharmaceuticals Ireland Limited; medinfouk@shire.com; United Kingdom; Phone +44 1256894000", "first_published_date": "13/05/2011", "last_updated_date": "22/08/2012", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000556-pip01-09-m02" }, { "decision_number": "P/0161/2012", "pip_number": "EMEA-000036-PIP01-07-M06", "active_substance": "13-valent pneumococcal polysaccharide conjugate vaccine: pneumococcal polysaccharide serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F; diphtheria CRM197 conjugate", "invented_name": "Prevenar 13; Prevenar 13", "therapeutic_area": "Vaccines", "pharmaceutical_forms": "Suspension for injection", "condition_indication": "Disease caused by Streptococcus pneumoniae", "routes_of_administration": "Intramuscular use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "05/04/2011", "compliance_outcome": "Positive", "compliance_opinion_date": "10/10/2014", "compliance_procedure_number": "EMEA-C-000036-PIP01-07-M06", "contact_for_public_enquiries": "Pfizer Limited; Tel. + 44 1304646607; E-mail: pip_enquiries@pfizer.com", "first_published_date": "10/05/2011", "last_updated_date": "21/08/2012", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000036-pip01-07-m06" }, { "decision_number": "P/0129/2012", "pip_number": "EMEA-001144-PIP01-11", "active_substance": "ulimorelin", "invented_name": "", "therapeutic_area": "Gastroentology-Hepatology", "pharmaceutical_forms": "Concentrate for solution for infusion", "condition_indication": "Prevention of post-operative ileus", "routes_of_administration": "Intravenous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "04/07/2012", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Norgine Ltd; United Kingdom; enquiries@norgine.com ; +44 1895 826600", "first_published_date": "09/08/2012", "last_updated_date": "09/08/2012", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001144-pip01-11" }, { "decision_number": "P/0124/2012", "pip_number": "EMEA-000724-PIP02-11", "active_substance": "alisporivir", "invented_name": "", "therapeutic_area": "Infectious diseases", "pharmaceutical_forms": "Capsule, soft", "condition_indication": "Treatment of chronic hepatitis C", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "04/07/2012", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Debiopharm International SA; E-mail: regulatory.affairs@debiopharm.com; Tel. +41 2131 10111", "first_published_date": "09/08/2012", "last_updated_date": "09/08/2012", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000724-pip02-11" }, { "decision_number": "P/0119/2012", "pip_number": "EMEA-001145-PIP01-10", "active_substance": "azithromycin (monohydrate)", "invented_name": "", "therapeutic_area": "Infectious diseases", "pharmaceutical_forms": "Gel", "condition_indication": "Prevention of borrelial infections", "routes_of_administration": "Cutaneous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "02/07/2012", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Ixodes AG, Zürih; Switzerland; ixodesag@bluewin.ch ; +41 432680565; +41 432680864", "first_published_date": "09/08/2012", "last_updated_date": "09/08/2012", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001145-pip01-10" }, { "decision_number": "P/0105/2012", "pip_number": "EMEA-000035-PIP01-07-M05", "active_substance": "tiotropium bromide (monohydrate)", "invented_name": "Spiriva Respimat and associated names", "therapeutic_area": "Pneumology-allergology", "pharmaceutical_forms": "Solution for inhalation via the Respimat inhaler", "condition_indication": "Treatment of cystic fibrosis", "routes_of_administration": "Inhalation use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "04/06/2012", "compliance_outcome": "Positive", "compliance_opinion_date": "21/08/2012", "compliance_procedure_number": "", "contact_for_public_enquiries": "Boehringer Ingelheim International GmbH; Tel. +49 6132 778271; Email: Paediatrics@boehringer-ingelheim.com", "first_published_date": "24/11/2010", "last_updated_date": "23/07/2012", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000035-pip01-07-m05" }, { "decision_number": "P/0110/2012", "pip_number": "EMEA-001065-PIP01-10", "active_substance": "Bivalirudin", "invented_name": "Angiox; Angiox", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Powder for concentrate for solution for infusion", "condition_indication": "Treatment of atherosclerosis;Treatment of thrombosis", "routes_of_administration": "Intravenous use", "decision_type": "RP: decision refers to a refusal on a proposed Paediatric Investigation Plan", "decision_date": "18/06/2012", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "The Medicines Company UK Limited; United Kingdom; camille.debray@themedco.com ; +44 1235 448500; +44 1235 835561", "first_published_date": "19/07/2012", "last_updated_date": "19/07/2012", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001065-pip01-10" }, { "decision_number": "P/0104/2012", "pip_number": "EMEA-001266-PIP01-12", "active_substance": "Masitinib mesilate", "invented_name": "", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Treatment of gastro-intestinal stromal tumours", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "01/06/2012", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "AB Science; France; a.moussy@ab-science.com ; +33 147200014; +33 147202411", "first_published_date": "19/07/2012", "last_updated_date": "19/07/2012", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001266-pip01-12" }, { "decision_number": "P/0114/2012", "pip_number": "EMEA-001247-PIP01-11", "active_substance": "valsartan;amlodipine besilate", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Tablet", "condition_indication": "Treatment of essential hypertension", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "29/06/2012", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Synthon B.V.; Germany; avril.mankel@ndareg.com ; +49 89 35854009; +49 89 35854010", "first_published_date": "19/07/2012", "last_updated_date": "19/07/2012", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001247-pip01-11" }, { "decision_number": "P/0103/2012", "pip_number": "EMEA-001232-PIP01-11", "active_substance": "glimepiride;atorvastatin calcium", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Tablet", "condition_indication": "Treatment of hyperlipidaemia;Treatment of type II diabetes mellitus", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "30/05/2012", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "GlaxoSmithKline Trading Services Limited; United Kingdom; admin@wainwrightassociates.co.uk; +44 1628530554", "first_published_date": "25/06/2012", "last_updated_date": "25/06/2012", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001232-pip01-11" }, { "decision_number": "P/0089/2012", "pip_number": "EMEA-000917-PIP02-11", "active_substance": "bimatoprost", "invented_name": "Lumigan; Lumigan", "therapeutic_area": "Dermatology", "pharmaceutical_forms": "Cutaneous solution", "condition_indication": "Treatment of androgenic alopecia", "routes_of_administration": "Cutaneous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "29/05/2012", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Allergan Pharmaceuticals International Limited; E-mail: ml-eu_reg_affairs@allergan.com; Tel. +44 (0)1628 4944444", "first_published_date": "25/06/2012", "last_updated_date": "25/06/2012", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000917-pip02-11" }, { "decision_number": "P/0092/2012", "pip_number": "EMEA-001252-PIP01-11", "active_substance": "nifedipine;Candesartan cilexetil", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Coated tablet", "condition_indication": "Treatment of essential hypertension", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "29/05/2012", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Bayer Pharma AG; Germany; pediatrics.medical-affairs-europe@bayerhealthcare.com ; +49 3046815333; +49 3046895333", "first_published_date": "25/06/2012", "last_updated_date": "25/06/2012", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001252-pip01-11" }, { "decision_number": "P/0094/2012", "pip_number": "EMEA-000266-PIP01-08-M01", "active_substance": "nalfurafine hydrochloride", "invented_name": "", "therapeutic_area": "Dermatology", "pharmaceutical_forms": "Concentrate for solution for infusion", "condition_indication": "Severe uraemic pruritus", "routes_of_administration": "Intravenous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "30/05/2012", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Toray International U.K. Limited; E-mail: nalfurafine_pip@toray-intl.co.uk; Country: United Kingdom; Phone: +44 2076637760; Fax: +44 2076637770", "first_published_date": "24/11/2008", "last_updated_date": "22/06/2012", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000266-pip01-08-m01" }, { "decision_number": "P/0079/2012", "pip_number": "Human normal immunoglobulin", "active_substance": "human normal immunoglobulin", "invented_name": "Gammagen", "therapeutic_area": "Dermatology", "pharmaceutical_forms": "Solution for infusion", "condition_indication": "Treatment of dermatopolymyositis", "routes_of_administration": "Intravenous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "27/04/2012", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Orfagen; E-mail: info@orfagen.com; Country: France; Phone: + 33 5354506457; Fax: +33 534503457", "first_published_date": "25/05/2012", "last_updated_date": "25/05/2012", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/human-normal-immunoglobulin-0" }, { "decision_number": "P/0071/2012", "pip_number": "EMEA-000015-PIP01-07-M04", "active_substance": "Doripenem monohydrate", "invented_name": "Doribax; Doribax", "therapeutic_area": "Infectious diseases", "pharmaceutical_forms": "Intravenous use", "condition_indication": "Treatment of bacterial infections", "routes_of_administration": "Intravenous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "21/04/2012", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Shionogi Limited; E-mail: joe.gaugas@shionogi.co.uk; Tel. +44 (0)20 3609 8660", "first_published_date": "24/05/2012", "last_updated_date": "24/05/2012", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000015-pip01-07-m04" }, { "decision_number": "P/0077/2012", "pip_number": "EMEA-001257-PIP01-11", "active_substance": "clopidogrel hydrogen sulfate;acetylsalicylic acid", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Prevention of arterial thromboembolism", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "25/04/2012", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Sandoz BV; The Netherlands; Phone: +31 365241700; caroline.kleinjan@sandoz.com", "first_published_date": "24/05/2012", "last_updated_date": "24/05/2012", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001257-pip01-11" }, { "decision_number": "P/0061/2012", "pip_number": "EMEA-000007-PIP01-07-M02", "active_substance": "ezetimibe", "invented_name": "Ezetrol and associated names", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Tablet", "condition_indication": "Treatment of hypercholesterolaemia;Treatment of sitosterolaemia", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "28/03/2012", "compliance_outcome": "Positive", "compliance_opinion_date": "17/01/2013", "compliance_procedure_number": "EMEA-C-000007-PIP01-07-M02", "contact_for_public_enquiries": "Merck Sharp & Dohme (Europe) Inc.Tel.: +33180464738E-mail: pip.information@merck.com", "first_published_date": "20/04/2012", "last_updated_date": "20/04/2012", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000007-pip01-07-m02" }, { "decision_number": "P/0066/2012", "pip_number": "EMEA-001212-PIP01-11", "active_substance": "anakinra", "invented_name": "Kineret; Kineret", "therapeutic_area": "Immunology-Rheumatology-Transplantation", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, psoriatic arthritis, ankylosing;Treatment of cryopyrin-associated periodic syndromes (CAPS)", "routes_of_administration": "Subcutaneous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "28/03/2012", "compliance_outcome": "Positive", "compliance_opinion_date": "12/12/2014", "compliance_procedure_number": "EMEA-C-001212-PIP01-11", "contact_for_public_enquiries": "Swedish Orphan Biovitrum AB; christina.rickhammar@sobi.com; Country: Sweden; Phone: +46 86972000", "first_published_date": "19/04/2012", "last_updated_date": "19/04/2012", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001212-pip01-11" }, { "decision_number": "-", "pip_number": "EMEA-001218-PIP01-11", "active_substance": "Deoxycholic acid", "invented_name": "", "therapeutic_area": "Dermatology", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Treatment of localised fat deposits", "routes_of_administration": "Subcutaneous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "23/03/2012", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Kythera Biopharmaceuticals (Europe) Limited; United Kingdom; Email: dstroehmann@kytherabiopharma.com ; Tel. +1 818 587 4521; Fax +1 818 587 4591", "first_published_date": "19/04/2012", "last_updated_date": "19/04/2012", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001218-pip01-11" }, { "decision_number": "P/0052/2012", "pip_number": "EMEA-000488-PIP02-11", "active_substance": "rubidium (82Rb) chloride", "invented_name": "", "therapeutic_area": "Diagnostic", "pharmaceutical_forms": "Radionuclide generator", "condition_indication": "Visualisation of myocardial perfusion for diagnostic purposes", "routes_of_administration": "Intravenous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "23/03/2012", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Advanced Accelerator Applications; Email: infomed@adacap.com    ; Tel. +33 (0)450993070", "first_published_date": "19/04/2012", "last_updated_date": "19/04/2012", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000488-pip02-11" }, { "decision_number": "P/0043/2012", "pip_number": "EMEA-001121-PIP01-10", "active_substance": "Elacytarabine", "invented_name": "", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Dispersion for infusion", "condition_indication": "Treatment of acute myeloid leukaemia", "routes_of_administration": "Intravenous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "28/02/2012", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Clavis Pharma ASA ; Norway ; mail@clavispharma.com ; +47 24110850 ; +47 24110951", "first_published_date": "26/03/2012", "last_updated_date": "26/03/2012", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001121-pip01-10" }, { "decision_number": "P/0034/2012", "pip_number": "EMEA-000394-PIP01-08-M01", "active_substance": "purified tetanus toxoid;Inactivated Type 1 Poliovirus (Mahoney);Inactivated Type 2 Poliovirus (MEF-1);Inactivated Type 3 Poliovirus (Saukett);polyribosylribitol phosphate (PRP) from Haemophilus influenzae type b as prp-ompc;hepatitis B surface antigen recombinant;purified filamentous haemagglutinin;purified pertussis toxoid;purified fimbriae types 2 and 3;purified pertactin;purified diphtheria toxoid", "invented_name": "", "therapeutic_area": "Vaccines", "pharmaceutical_forms": "Suspension for injection;Suspension for injection in pre-filled syringe", "condition_indication": "Active immunisation against infectious diseases caused by Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis and poliovirus types 1, 2 and 3, against invasive disease caused by...", "routes_of_administration": "Intramuscular route", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "03/02/2012", "compliance_outcome": "Positive", "compliance_opinion_date": "10/10/2014", "compliance_procedure_number": "EMEA-C-000394-PIP01-08-M01", "contact_for_public_enquiries": "Sanofi Pasteur MSD SNC; E-mail: piplan@spmsd.com; Country: France; Phone: + 33 437284000", "first_published_date": "22/10/2009", "last_updated_date": "15/03/2012", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000394-pip01-08-m01" }, { "decision_number": "P/0022/2012", "pip_number": "EMEA-000736-PIP01-09", "active_substance": "culture expanded autologous chondrocytes", "invented_name": "", "therapeutic_area": "Other", "pharmaceutical_forms": "Implant", "condition_indication": "Treatment of cartilage disorders", "routes_of_administration": "Implant use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "27/01/2012", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Fidia Advanced Biopolymers S.r.l.; info@fidiapharma.it; Italy; +39 0498232111", "first_published_date": "24/02/2012", "last_updated_date": "24/02/2012", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000736-pip01-09" }, { "decision_number": "P/0018/2012", "pip_number": "EMEA-001204-PIP01-11", "active_substance": "ezetimibe;atorvastatin calcium", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Treatment of hypercholesterolaemia;Treatment of mixed hyperlipidaemia", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "25/01/2012", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Merck Sharp & Dohme (Europe) Inc.Tel.: +33180464738E-mail: pip.information@merck.com", "first_published_date": "24/02/2012", "last_updated_date": "24/02/2012", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001204-pip01-11" }, { "decision_number": "P/0026/2012", "pip_number": "EMEA-001223-PIP01-11", "active_substance": "Diltiazem (hydrochloride)", "invented_name": "", "therapeutic_area": "Gastroentology-Hepatology", "pharmaceutical_forms": "Cream", "condition_indication": "Treatment of chronic anal fissure", "routes_of_administration": "Cutaneous use;Epilesional use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "27/01/2012", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "S.L.A. Pharma (UK) Limited; United Kingdom; info@slapharma.com; +44 1923 681001; +44 1923 681221", "first_published_date": "24/02/2012", "last_updated_date": "24/02/2012", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001223-pip01-11" }, { "decision_number": "P/0021/2012", "pip_number": "EMEA-000530-PIP02-11", "active_substance": "cyclophosphamide", "invented_name": "", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Soluble tablet", "condition_indication": "Treatment of malignant diseases", "routes_of_administration": "Oral use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "27/01/2012", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Keocyt SAS; catherine.lallier@keocyt.com; France; +33 1423107; +33 142312379", "first_published_date": "24/02/2012", "last_updated_date": "24/02/2012", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000530-pip02-11" }, { "decision_number": "P/0014/2012", "pip_number": "EMEA-001198-PIP01-11", "active_substance": "netupitant;palonosetron", "invented_name": "", "therapeutic_area": "Other", "pharmaceutical_forms": "Capsule, hard", "condition_indication": "Prevention of chemotherapy-induced nausea and vomiting", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "24/01/2012", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Helsinn Birex Pharmaceuticals Limited; 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info1@unither.com; United Kingdom; +44 1932573800; +44 1932571110", "first_published_date": "24/02/2012", "last_updated_date": "24/02/2012", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001165-pip01-11" }, { "decision_number": "P/0028/2012", "pip_number": "EMEA-000463-PIP01-08-M03", "active_substance": "imatinib mesilate", "invented_name": "Glivec; Glivec", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Capsule, hard;Film-coated tablet", "condition_indication": "Dermatofibrosarcoma protuberans;Hypereosinophilic syndrome and/or chronic eosinophilic leukaemia with FIP1L1-platelet-derived growth factor receptor alpha gene re-arrangement;Kit (CD 117)-positive gastrointestinal stromal tumours;Myelodysplastic / myeloproliferative diseases associated with platelet-derived growth factor receptor gene re-arrangements;Philadelphia chromosome (BCR-ABL translocation)-positive acute lymphoblastic leukaemia;Philadelphia chromosome (BCR-ABL translocation)-positive chronic myeloid leukaemia", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "28/01/2012", "compliance_outcome": "Positive", "compliance_opinion_date": "09/03/2012", "compliance_procedure_number": "EMEA-C-000463-PIP01-08-M03", "contact_for_public_enquiries": "Novartis Europharm Limited; paediatric.enquiries@novartis.com; Country: Switzerland; Phone: +41 61 324 6715; Fax: +41 61 324 2224", "first_published_date": "14/07/2011", "last_updated_date": "23/02/2012", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000463-pip01-08-m03" }, { "decision_number": "P/0029/2012", "pip_number": "EMEA-000562-PIP01-09-M01", "active_substance": "semuloparin sodium", "invented_name": "", "therapeutic_area": "Haematology-Hemostaseology", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Thromboembolic events", "routes_of_administration": "Subcutaneous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "30/01/2012", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Sanofi-aventis Recherche & Développement; France; frederique.maneval@sanofi-aventis.com; +33 169495011", "first_published_date": "18/05/2010", "last_updated_date": "23/02/2012", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000562-pip01-09-m01" }, { "decision_number": "P/304/2011", "pip_number": "EMEA-001042-PIP02-11", "active_substance": "recombinant human granulocyte colony stimulating factor coupled with recombinant human albumin fusion protein", "invented_name": "", "therapeutic_area": "Haematology-Hemostaseology", "pharmaceutical_forms": "Powder for solution for injection", "condition_indication": "Treatment of chemotherapy-induced neutropenia;Prevention of chemotherapy-induced febrile neutropenia", "routes_of_administration": "Subcutaneous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "20/12/2011", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Teva Pharma B.V.; E-mail: info@ratiopharm.de; Tel. : +49 73140202; Fax: +49 7314027832", "first_published_date": "19/01/2012", "last_updated_date": "19/01/2012", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001042-pip02-11" }, { "decision_number": "P/308/2011", "pip_number": "EMEA-001134-PIP01-11", "active_substance": "chimeric monoclonal anti-Shiga toxin antibodies cαStx1 and cαStx2", "invented_name": "", "therapeutic_area": "Infectious diseases", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Prevention of Shiga toxin-mediated complications", "routes_of_administration": "Intravenous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "20/12/2011", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "LFB Biotechnologies ; France ; roussariec@lfb.fr; +33 169828842 ; +33 169827182", "first_published_date": "19/01/2012", "last_updated_date": "19/01/2012", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001134-pip01-11" }, { "decision_number": "P/310/2011", "pip_number": "EMEA-001193-PIP01-11", "active_substance": "insulin degludec;liraglutide", "invented_name": "", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Treatment of type II diabetes mellitus", "routes_of_administration": "Subcutaneous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "21/12/2011", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Novo Nordisk A/S ; Denmark ; mbse@novonordisk.com ; +45 30796941 ; +45 39699173", "first_published_date": "19/01/2012", "last_updated_date": "19/01/2012", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001193-pip01-11" }, { "decision_number": "P/313/2011", "pip_number": "EMEA-001075-PIP01-10", "active_substance": "anti-sclerostin human monoclonal antibody (AMG785)", "invented_name": "", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Treatment of fractures and fracture associated complications", "routes_of_administration": "Subcutaneous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "21/12/2011", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Amgen Europe B.V ; United Kingdom ; pipenquiry@amgen.com ; + 44 1223420305 ; + 44 1223426814", "first_published_date": "19/01/2012", "last_updated_date": "19/01/2012", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001075-pip01-10" }, { "decision_number": "P/302/2011", "pip_number": "EMEA-000770-PIP02-11", "active_substance": "esketamine hydrochloride", "invented_name": "", "therapeutic_area": "Oto-rhino-laryngology", "pharmaceutical_forms": "Gel for injection", "condition_indication": "Treatment of acute inner ear tinnitus", "routes_of_administration": "Intratympanic use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "20/12/2011", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Auris Medical Limited ; Ireland ; ear@aurismedical.com ; +353 766154675 ; +353 16853040", "first_published_date": "19/01/2012", "last_updated_date": "19/01/2012", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000770-pip02-11" }, { "decision_number": "P/290/2011", "pip_number": "EMEA-000389-PIP01-08-M01", "active_substance": "N-[4-(3-amino-1H-indazol-4 yl)phenyl]-N1-(2-fluoro-5-methylphenyl) urea (ABT-869)", "invented_name": "", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Liquid formulation;Age appropriate oral formulation", "condition_indication": "Treatment of solid malignant tumours", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "02/12/2011", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "AbbVie LtdE-mail: paediatricteam@abbvie.comTel. : +44 1628644475", "first_published_date": "16/09/2009", "last_updated_date": "18/01/2012", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000389-pip01-08-m01" }, { "decision_number": "P/285/2011", "pip_number": "EMEA-001120-PIP01-10", "active_substance": "Budesonide", "invented_name": "Budiair and associated names", "therapeutic_area": "Neonatology-Paediatric Intensive Care", "pharmaceutical_forms": "Pressurised inhalation (solution)", "condition_indication": "Prevention of bronchopulmonary dysplasia", "routes_of_administration": "Inhalation use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "30/11/2011", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Neurosis Consortium ; dirk.bassler@med.uni-tuebingen.de; German; +49 7071 29 80898 ; +49 7071 29 4471", "first_published_date": "21/12/2011", "last_updated_date": "21/12/2011", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001120-pip01-10" }, { "decision_number": "P/281/2011", "pip_number": "EMEA-001117-PIP01-10", "active_substance": "Icosapent", "invented_name": "", "therapeutic_area": "Gastroentology-Hepatology", "pharmaceutical_forms": "Gastro-resistant capsule;Capsule, soft", "condition_indication": "Treatment of Familial Adenomatous Polyposis", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "28/11/2011", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "S.L.A. Pharma (UK) Limited ; info@slapharma.com ; United Kingdom; +44 1923681001 ; +44 1923681 221", "first_published_date": "21/12/2011", "last_updated_date": "21/12/2011", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001117-pip01-10" }, { "decision_number": "P/269/2011", "pip_number": "EMEA-000800-PIP01-09-M01", "active_substance": "ombrabulin", "invented_name": "", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Concentrate for solution for infusion", "condition_indication": "Treatment of non-rhabdomyosarcoma soft tissue sarcoma;Treatment of rhabdomyosarcoma", "routes_of_administration": "Intravenous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "28/10/2011", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Sanofi-aventis recherche & developpement; France; E-mail: sylvie.gabriel@sanofi-aventis.com; Tel. +33 1537 74152; Fax +33 1537 74133", "first_published_date": "14/07/2011", "last_updated_date": "30/11/2011", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000800-pip01-09-m01" }, { "decision_number": "P/271/2011", "pip_number": "EMEA-001182-PIP01-11", "active_substance": "(2S,3R,4R,5S,6R)-2-(4-chloro-3-{3-[(S)-(tetrahydrofuran-3-yl)oxy]-benzyl}-phenyl)-6-hydroxymethyltetrahydro-pyran-3,4,5-triol;Metformin", "invented_name": "", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Treatment of type II diabetes mellitus", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "28/10/2011", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Boehringer Ingelheim International GmbH; Tel. +49 6132 778271; Email: Paediatrics@boehringer-ingelheim.com", "first_published_date": "29/11/2011", "last_updated_date": "29/11/2011", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001182-pip01-11" }, { "decision_number": "P/270/2011", "pip_number": "EMEA-001163-PIP01-11", "active_substance": "clopidogrel (bisulfate);acetylsalicylic acid", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Tablet", "condition_indication": "Prevention of cardiovascular disease", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "28/10/2011", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "TEVA Pharma B.V.; Croatia; lidija.brnic@tevapharm.com ; +38 53722150", "first_published_date": "29/11/2011", "last_updated_date": "29/11/2011", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001163-pip01-11" }, { "decision_number": "P/262/2011", "pip_number": "EMEA-000026-PIP02-11", "active_substance": "temsirolimus", "invented_name": "Torisel; Torisel", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Concentrate and diluent for solution for infusion", "condition_indication": "Treatment of mantle cell lymphoma", "routes_of_administration": "Intravenous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "28/10/2011", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Pfizer Limited; Tel. + 44 1304646607; E-mail: pip_enquiries@pfizer.com", "first_published_date": "29/11/2011", "last_updated_date": "29/11/2011", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000026-pip02-11" }, { "decision_number": "P/260/2011", "pip_number": "EMEA-001069-PIP01-10", "active_substance": "secretin", "invented_name": "", "therapeutic_area": "", "pharmaceutical_forms": "Powder for solution for injection", "condition_indication": "Diagnosis of pancreatic diseases", "routes_of_administration": "Intravenous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "28/10/2011", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Repligen Europe Limited; USA; kjauregui@repligen.com; +1 7814191821", "first_published_date": "29/11/2011", "last_updated_date": "29/11/2011", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001069-pip01-10" }, { "decision_number": "P/259/2011", "pip_number": "EMEA-001172-PIP01-11", "active_substance": "brinzolamide;brimonidine tartrate", "invented_name": "", "therapeutic_area": "Ophthalmology", "pharmaceutical_forms": "Eye drops, solution;Suspension", "condition_indication": "Treatment of glaucoma", "routes_of_administration": "Ocular use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "26/10/2011", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Alcon Laboratories (UK) Ltd.; Doug.MacHatton@AlconLabs.com; United States; Phone: +1 8175518974; Fax: +1 8176154607", "first_published_date": "29/11/2011", "last_updated_date": "29/11/2011", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001172-pip01-11" }, { "decision_number": "P/258/2011", "pip_number": "EMEA-001170-PIP01-11", "active_substance": "4-[[9-[(3S)-tetrahydro-3-furanyl]-8-[(2,4,6-trifluorophenyl)amino]-9H-purin-2-yl]amino]-transcyclohexanol (CC-930)", "invented_name": "", "therapeutic_area": "Pneumology-allergology", "pharmaceutical_forms": "Capsule, hard", "condition_indication": "Treatment of idiopathic pulmonary fibrosis", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "26/10/2011", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Celgene Europe LimitedTel.  +41 327298500E-mail: medinfo.intl@celgene.com", "first_published_date": "29/11/2011", "last_updated_date": "29/11/2011", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001170-pip01-11" }, { "decision_number": "P/254/2011", "pip_number": "EMEA-000287-PIP02-10", "active_substance": "pancreas powder", "invented_name": "", "therapeutic_area": "Neurology", "pharmaceutical_forms": "Gastro-resistant capsule;Capsule, hard", "condition_indication": "Treatment of exocrine pancreatic insufficiency", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "26/11/2011", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Eurand Pharmaceuticals Limited; Italy; pamela.ventura@eurand.com; +39 0295428347; +39 0295745018", "first_published_date": "29/11/2011", "last_updated_date": "29/11/2011", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000287-pip02-10" }, { "decision_number": "P/247/2011", "pip_number": "EMEA-001184-PIP01-11", "active_substance": "(2S,3R,4R,5S,6R)-2-(4-chloro-3-{3-[(S)-(tetrahydrofuran-3-yl)oxy]-benzyl}-phenyl)-6-hydroxymethyltetrahydro-pyran-3,4,5-triol;linagliptin", "invented_name": "", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Treatment of type II diabetes mellitus", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "21/10/2011", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Boehringer Ingelheim International GmbH; Tel. +49 6132 778271; Email: Paediatrics@boehringer-ingelheim.com", "first_published_date": "28/11/2011", "last_updated_date": "28/11/2011", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001184-pip01-11" }, { "decision_number": "P/22/2010", "pip_number": "EMEA-000637-PIP01-09-M01", "active_substance": "Lanthanum carbonate hydrate", "invented_name": "Fosrenol and associated name Foznol", "therapeutic_area": "Uro-nephrology", "pharmaceutical_forms": "Chewable tablet;Granules", "condition_indication": "Hyperphosphataemia", "routes_of_administration": "Oral use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "28/11/2011", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Shire Pharmaceutical Contracts Ltd; United Kingdom; Tel. +44 (0)1423 850717; E-mail: medinfoemea@shire.com ", "first_published_date": "28/11/2011", "last_updated_date": "28/11/2011", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000637-pip01-09-m01" }, { "decision_number": "P/240/2011", "pip_number": "EMEA-001148-PIP01-11", "active_substance": "Dextromethorphan (hydrobromide);quinidine sulfate", "invented_name": "", "therapeutic_area": "Neurology", "pharmaceutical_forms": "Capsule, hard", "condition_indication": "Treatment of pseudobulbar affect (uncontrollable laughing and/or crying)", "routes_of_administration": "Oral use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "30/09/2011", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Avanir Pharmaceuticals, Incorporated; E-mail: arosenthal@avanir.com; Tel.: +1 9493896748", "first_published_date": "18/10/2011", "last_updated_date": "18/10/2011", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001148-pip01-11" }, { "decision_number": "P/230/2011", "pip_number": "EMEA-001109-PIP01-10", "active_substance": "progesterone", "invented_name": "", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Vaginal delivery system", "condition_indication": "Treatment of female infertility", "routes_of_administration": "Vaginal use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "28/09/2011", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Teva Pharmaceuticals Europe B.V.; Country: Croatia; E-mail: ana.lebo@pliva.com, lidija.brnic@pliva.com; Phone: +385 13722875, +385 13722150; Fax: +385 13723157", "first_published_date": "18/10/2011", "last_updated_date": "18/10/2011", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001109-pip01-10" }, { "decision_number": "P/226/2011", "pip_number": "EMEA-001154-PIP01-11", "active_substance": "antithrombin alfa", "invented_name": "ATryn; ATryn", "therapeutic_area": "Haematology-Hemostaseology", "pharmaceutical_forms": "Powder for solution for infusion", "condition_indication": "Treatment of antithrombin deficiency", "routes_of_administration": "Intravenous use", "decision_type": "RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)", "decision_date": "27/09/2011", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "GTC Biotherapeutics UK Limited; E-mail: Dick.Scotland@gtc-bio.com; Tel.: +1 5083705164", "first_published_date": "18/10/2011", "last_updated_date": "18/10/2011", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001154-pip01-11" }, { "decision_number": "P/221/2011", "pip_number": "EMEA-001151-PIP01-11", "active_substance": "dapagliflozin;metformin hydrochloride", "invented_name": "", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Treatment of type II diabetes mellitus", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "26/09/2011", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Bristol-Myers Squibb / AstraZeneca EEIG; Email: medical.information@bms.com; Tel.: +44 1895523740", "first_published_date": "18/10/2011", "last_updated_date": "18/10/2011", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001151-pip01-11" }, { "decision_number": "P/217/2011", "pip_number": "EMEA-000993-PIP01-10", "active_substance": "prednicarbate;octenidine dihydrochloride", "invented_name": "", "therapeutic_area": "Dermatology", "pharmaceutical_forms": "Cream", "condition_indication": "Treatment of atopic dermatitis;Treatment of dermatomycosis", "routes_of_administration": "Cutaneous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "16/09/2011", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Almirall Hermal GmbH; Country: Germany; E-mail: info@almirall.de; Phone: +49 40727040; Fax: +49 407229296", "first_published_date": "18/10/2011", "last_updated_date": "18/10/2011", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000993-pip01-10" }, { "decision_number": "P/241/2011", "pip_number": "Etanercept", "active_substance": "etanercept", "invented_name": "Enbrel; Enbrel", "therapeutic_area": "Dermatology", "pharmaceutical_forms": "Powder and solvent for solution for injection;Powder for solution for injection;Solution for injection;Powder and solvent for solution for injection", "condition_indication": "Juvenile idiopathic arthritis;Plaque psoriasis", "routes_of_administration": "Subcutaneous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "29/09/2011", "compliance_outcome": "Positive", "compliance_opinion_date": "13/12/2011", "compliance_procedure_number": "EMEA-C-000299-PIP01-08-M03", "contact_for_public_enquiries": "Wyeth Europa Limited; julian.britton@pfizer.com; United Kingdom; Phone: +44 1628692245", "first_published_date": "17/10/2011", "last_updated_date": "17/10/2011", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/etanercept" }, { "decision_number": "P228/2011", "pip_number": "EMEA-000725-PIP01-09-M03", "active_substance": "split influenza virus, inactivated, containing antigen: A/California/7/2009 (H1N1)v like strain (X-179A)", "invented_name": "Pandemrix; Pandemrix", "therapeutic_area": "Vaccines", "pharmaceutical_forms": "Suspension and emulsion for injection", "condition_indication": "Influenza", "routes_of_administration": "Intramuscular use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "29/09/2011", "compliance_outcome": "Positive", "compliance_opinion_date": "12/12/2014", "compliance_procedure_number": "EMEA-000725-PIP01-09-M03", "contact_for_public_enquiries": "GlaxoSmithKline Biologicals S.A. (Belgium); Tel. +1 438 899 8201; Email: eu.paediatric-plans@gsk.com", "first_published_date": "17/10/2011", "last_updated_date": "17/10/2011", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000725-pip01-09-m03" }, { "decision_number": "P/215/2011", "pip_number": "EMEA-000670-PIP01-09-M02", "active_substance": "split influenza virus, inactivated containing antigen equivalent to A/California/7/2009 (H1N1)-like strain (A/California/7/2009 (NYMC X-179A)), non-adjuvanted", "invented_name": "Panenza", "therapeutic_area": "Vaccines", "pharmaceutical_forms": "Suspension for injection", "condition_indication": "Influenza", "routes_of_administration": "Intramuscular use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "09/09/2011", "compliance_outcome": "Positive", "compliance_opinion_date": "13/09/2013", "compliance_procedure_number": "EMEA-C-000670-PIP01-09-M02", "contact_for_public_enquiries": "Sanofi Pasteur SA; E-mail: Piplan@sanofipasteur.com; Country: France; Phone: +33 437375038", "first_published_date": "17/10/2011", "last_updated_date": "17/10/2011", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000670-pip01-09-m02" }, { "decision_number": "P/206/2011", "pip_number": "Cholic acid", "active_substance": "cholic acid", "invented_name": "", "therapeutic_area": "Gastroentology-Hepatology", "pharmaceutical_forms": "Capsule, hard;Age appropriate oral formulation", "condition_indication": "Treatment of other inborn errors of bile acid synthesis;Treatment of oxysterol 7a-hydrolylase deficiency and defective amida", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "31/08/2011", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "FGK Representative Service GmbH; E-mail: info@nymox.com; Tel. +1 8009369669", "first_published_date": "03/10/2011", "last_updated_date": "03/10/2011", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/cholic-acid" }, { "decision_number": "P/198/2011", "pip_number": "EMEA-000305-PIP01-08-M02", "active_substance": "ulipristal acetate", "invented_name": "ellaOne; ellaOne", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Tablet", "condition_indication": "Contraception", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "30/08/2011", "compliance_outcome": "Positive", "compliance_opinion_date": "08/11/2013", "compliance_procedure_number": "EMEA-C-000305-PIP01-08-M02", "contact_for_public_enquiries": "Laboratoire HRA Pharma; regulatory@hra-pharma.com; France; Phone: +33 140331130; Fax: +33 142771060", "first_published_date": "03/10/2011", "last_updated_date": "03/10/2011", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000305-pip01-08-m02" }, { "decision_number": "P/177/2011", "pip_number": "EMEA-000700-PIP02-10", "active_substance": "vildagliptin", "invented_name": "Galvus; Galvus", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Tablet", "condition_indication": "Treatment of type II diabetes mellitus", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "26/08/2011", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Novartis Europharm LimitedE-mail: paediatric.enquiries@novartis.comTel. +41 613241111", "first_published_date": "03/10/2011", "last_updated_date": "03/10/2011", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000700-pip02-10" }, { "decision_number": "P/195/2011", "pip_number": "Human normal immunoglobulin", "active_substance": "human normal immunoglobulin", "invented_name": "", "therapeutic_area": "Immunology-Rheumatology-Transplantation", "pharmaceutical_forms": "Solution for infusion", "condition_indication": "Idiopathic thrombocytopenic purpura (ITP);Neonatal haemolytic disease (ABO - Rh-incompatability);Primary immunodeficiency (PID)", "routes_of_administration": "Intravenous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "29/07/2011", "compliance_outcome": "Positive", "compliance_opinion_date": "15/10/2012", "compliance_procedure_number": "EMEA-C-000167-PIP01-07-M02", "contact_for_public_enquiries": "LFB Biotechnologies; micardt@lfb.fr; France; Phone: +33 169828842; Fax: +33 169827182", "first_published_date": "15/09/2011", "last_updated_date": "15/09/2011", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/human-normal-immunoglobulin" }, { "decision_number": "P/190/2011", "pip_number": "EMEA-001138-PIP02-11", "active_substance": "valsartan;amlodipine besilate", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Prevention of acute myocardial infarction;Prevention of atherosclerotic heart disease;Prevention of stroke;Treatment of essential hypertension;Treatment of heart failure;Treatment of Prinzmetal's angina", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "02/08/2011", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Gedeon Richter Plc.; mrpRichter@richter.hu; Hungary; Phone +36 1 431 4040; Fax +36 1 431 5415", "first_published_date": "13/09/2011", "last_updated_date": "13/09/2011", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001138-pip02-11" }, { "decision_number": "P/189/2011", "pip_number": "EMEA-001135-PIP01-11", "active_substance": "teriparatide", "invented_name": "Forsteo; Forsteo", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Solution for injection in pre-filled pen;Transdermal system", "condition_indication": "Treatment of fractures;Treatment of osteoporosis", "routes_of_administration": "Subcutaneous use;Transdermal use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "02/08/2011", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Eli Lilly & Company Limited; E-mail: eu_paediatric@lilly.com ; Tel. +44 (0)1276 483000", "first_published_date": "13/09/2011", "last_updated_date": "13/09/2011", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001135-pip01-11" }, { "decision_number": "P/188/2011", "pip_number": "EMEA-001131-PIP01-11", "active_substance": "colecalciferol;strontium ranelate", "invented_name": "", "therapeutic_area": "Immunology-Rheumatology-Transplantation", "pharmaceutical_forms": "Granules for oral suspension", "condition_indication": "Treatment of osteoporosis", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "02/08/2011", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Les Laboratoires ServierTel. +33 1 55 72 60 00E-mail: mail.pip.enquiries@fr.netgrs.com", "first_published_date": "13/09/2011", "last_updated_date": "13/09/2011", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001131-pip01-11" }, { "decision_number": "P/193/2011", "pip_number": "EMEA-001090-PIP01-11", "active_substance": "Florbetaben", "invented_name": "", "therapeutic_area": "Diagnostic", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Diagnosis of Alzheimer's disease", "routes_of_administration": "Intravenous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "03/08/2011", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Bayer Schering Pharma AG; ulrike.bodesheim@bayer.com; Germany; Phone +49 3046818208", "first_published_date": "13/09/2011", "last_updated_date": "13/09/2011", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001090-pip01-11" }, { "decision_number": "P/186/2011", "pip_number": "EMEA-000236-PIP03-11", "active_substance": "aflibercept", "invented_name": "Eylea", "therapeutic_area": "Ophthalmology", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Treatment of central retinal vein occlusion", "routes_of_administration": "Intravitreal use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "02/08/2011", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Bayer Schering Pharma AG; pediatrics.medical-affairs-europe@bayerhealthcare.com; Germany; Phone: +49 3046815333; Fax: +49 3046895333", "first_published_date": "13/09/2011", "last_updated_date": "13/09/2011", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000236-pip03-11" }, { "decision_number": "P/194/2011", "pip_number": "EMEA-000092-PIP02-11", "active_substance": "recombinant salmon calcitonin", "invented_name": "", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Tablet", "condition_indication": "Treatment of bone metabolism disorders", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "03/08/2011", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Novartis Europharm LimitedE-mail: paediatric.enquiries@novartis.comTel. +41 613241111", "first_published_date": "13/09/2011", "last_updated_date": "13/09/2011", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000092-pip02-11" }, { "decision_number": "P/135/2011", "pip_number": "EMEA-000478-PIP01-08-M01", "active_substance": "Benzamide, 4-[4-[[2-(4-chlorophenyl)-5,5-dimethyl-1-cyclohexen-1-yl]methyl]-1-piperazinyl]-N-[[4-[[(1R)-3-(4-morpholinyl)-1-[(phenylthio)methyl] propyl]amino]-3-[(trifluoromethyl)sulfonyl]phenyl] sulfonyl] (ABT-263)", "invented_name": "", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Powder for solution;Capsule;Capsule, soft;Liquid formulation", "condition_indication": "Treatment of acute lymphoblastic leukaemia;Treatment of non-Hodgkin lymphoma", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "11/06/2011", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "", "first_published_date": "12/08/2011", "last_updated_date": "12/08/2011", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000478-pip01-08-m01" }, { "decision_number": "P/154/2011", "pip_number": "EMEA-000014-PIP01-07-M06", "active_substance": "paliperidone;paliperidone palmitate", "invented_name": "Invega; Invega", "therapeutic_area": "Psychiatry", "pharmaceutical_forms": "Prolonged-release tablet;Suspension for injection", "condition_indication": "Schizoaffective disorder;Schizophrenia", "routes_of_administration": "Oral use;Intramuscular use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "05/07/2011", "compliance_outcome": "Positive", "compliance_opinion_date": "14/02/2013", "compliance_procedure_number": "EMEA-C-000014-PIP01-07-M06", "contact_for_public_enquiries": "Janssen-Cilag International NV; bbyl@gcpbe.jnj.com; Belgium; Phone: +32 14607172; Fax: +32 473839426", "first_published_date": "10/08/2011", "last_updated_date": "10/08/2011", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000014-pip01-07-m06" }, { "decision_number": "P/167/2011", "pip_number": "EMEA-001034-PIP01-10", "active_substance": "risperidone", "invented_name": "Risperdal and associated names", "therapeutic_area": "Psychiatry", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Treatment of conduct disorder", "routes_of_administration": "Oral use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "06/07/2011", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Wockhardt UK Ltd; gordon.urquhart@wockhardt.co.uk; United Kingdom; Phone: +44 1961773934", "first_published_date": "09/08/2011", "last_updated_date": "09/08/2011", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001034-pip01-10" }, { "decision_number": "P/165/2011", "pip_number": "EMEA-001128-PIP01-10", "active_substance": "alogliptin benzoate;metformin hydrochloride", "invented_name": "", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Treatment of type II diabetes mellitus", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "04/07/2011", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Takeda Global Research and Development Centre (Europe) Ltd; paediatrics@tgrd.com; United Kingdom; Phone: +44 2031168237; Fax: +44 2031168250", "first_published_date": "09/08/2011", "last_updated_date": "09/08/2011", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001128-pip01-10" }, { "decision_number": "P/166/2011", "pip_number": "EMEA-001007-PIP01-10", "active_substance": "ciclosporin", "invented_name": "", "therapeutic_area": "Ophthalmology", "pharmaceutical_forms": "Eye drops, solution;Solution", "condition_indication": "Treatment of atopic keratoconjunctivitis", "routes_of_administration": "Ocular use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "06/07/2011", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Allergan Pharmaceuticals International Limited; E-mail: ml-eu_reg_affairs@allergan.com; Tel. +44 (0)1628 4944444", "first_published_date": "09/08/2011", "last_updated_date": "09/08/2011", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001007-pip01-10" }, { "decision_number": "P/174/2011", "pip_number": "EMEA-001118-PIP01-10", "active_substance": "acetylsalicylic acid;Pravastatin sodium", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Capsule, hard", "condition_indication": "Treatment of cardiovascular disease", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "08/07/2011", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "TEVA Pharma B.V.; Lidija.Brnic@tevapharm.com; Croatia; Phone: +385 3722150", "first_published_date": "09/08/2011", "last_updated_date": "09/08/2011", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001118-pip01-10" }, { "decision_number": "P/187/2011", "pip_number": "EMEA-001141-PIP01-11", "active_substance": "perindopril erbumine;amlodipine besilate", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Tablet", "condition_indication": "Treatment of hypertension", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "29/07/2011", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "KBM Pharma OÜ; tiina.must@kbmpharma.eu; Estonia; Phone: +372 7338080; Fax: +372 7338081", "first_published_date": "09/08/2011", "last_updated_date": "09/08/2011", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001141-pip01-11" }, { "decision_number": "P/150/2011", "pip_number": "EMEA-001137-PIP01-11", "active_substance": "progesterone", "invented_name": "", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Solution for injection;Powder for solution for injection", "condition_indication": "Treatment of female infertility;Prevention of recurrent spontaneous abortion", "routes_of_administration": "Subcutaneous use;Intramuscular use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "10/06/2011", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "IBSA Farmaceutici Italia Srl; Julie.cook@regulis.com; United Kingdom; +44 1442890909; +44 1442890903", "first_published_date": "14/07/2011", "last_updated_date": "14/07/2011", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001137-pip01-11" }, { "decision_number": "P/133/2011", "pip_number": "EMEA-001102-PIP01-10", "active_substance": "gallium (68Ga) chloride;germanium (68Ge) chloride", "invented_name": "", "therapeutic_area": "Other", "pharmaceutical_forms": "Radionuclide generator", "condition_indication": "Radiolabelling agent", "routes_of_administration": "Other use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "08/06/2011", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Eckert & Ziegler Radiopharma GmbH; regaffairs.radiopharma@ezag.de; Germany; +49 30941084282; +49 30941084160", "first_published_date": "14/07/2011", "last_updated_date": "14/07/2011", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001102-pip01-10" }, { "decision_number": "P/138/2011", "pip_number": "EMEA-001111-PIP01-10", "active_substance": "canagliflozin;Metformin", "invented_name": "", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Tablet", "condition_indication": "Treatment of type II diabetes mellitus", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "10/06/2011", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Janssen-Cilag International; E-mail: lpeeter8@its.jnj.com; Tel. +32 14 603 876;  ", "first_published_date": "14/07/2011", "last_updated_date": "14/07/2011", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001111-pip01-10" }, { "decision_number": "P/139/2011", "pip_number": "EMEA-000928-PIP01-10-M01", "active_substance": "mipomersen sodium", "invented_name": "", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Treatment of heterozygous and homozygous familial hypercholesterolaemia", "routes_of_administration": "Subcutaneous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "01/06/2011", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Genzyme Europe B.V.; Tel. +31 (0) 20 245 3917; E-mail: EUmedinfo@genzyme.com;  ", "first_published_date": "13/07/2011", "last_updated_date": "13/07/2011", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000928-pip01-10-m01" }, { "decision_number": "P/149/2011", "pip_number": "EMEA000967-PIP01-10-M01", "active_substance": "rotavirus serotype G1;rotavirus serotype G2;rotavirus serotype G3;rotavirus serotype G4;rotavirus serotype P1A[8]", "invented_name": "RotaTeq; RotaTeq", "therapeutic_area": "Vaccines", "pharmaceutical_forms": "Oral solution", "condition_indication": "Prevention of rotaviral enteritis", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "09/06/2011", "compliance_outcome": "Positive", "compliance_opinion_date": "21/07/2011", "compliance_procedure_number": "EMEA-C-000967-PIP01-10-M01", "contact_for_public_enquiries": "Sanofi Pasteur MSD SNC; piplan@spmsd.com; France; Phone: +33 437284000", "first_published_date": "13/07/2011", "last_updated_date": "13/07/2011", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea000967-pip01-10-m01" }, { "decision_number": "P/116/2011", "pip_number": "EMEA-000194-PIP03-10", "active_substance": "perflubutane", "invented_name": "", "therapeutic_area": "Diagnostic", "pharmaceutical_forms": "Powder for suspension for injection", "condition_indication": "Visualisation of myocardial perfusion for diagnostic purposes", "routes_of_administration": "Intravenous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "18/05/2011", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Granzer Regulatory Consulting & Services; office@granzer.biz; Germany; Phone +49 8978068980; Fax +49 89780689815", "first_published_date": "09/06/2011", "last_updated_date": "09/06/2011", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000194-pip03-10" }, { "decision_number": "P/118/2011", "pip_number": "EMEA-001004-PIP01-10", "active_substance": "autologous oral mucosal epithelial cells", "invented_name": "", "therapeutic_area": "Ophthalmology", "pharmaceutical_forms": "Living tissue equivalent", "condition_indication": "Treatment of limbal stem cell deficiency", "routes_of_administration": "Ocular use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "23/05/2011", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "CellSeed Europe S.A.R.L.; aokamoto@cellseed.com; Japan; Phone +81 3 5286 6231; Fax +81 3 5286 6233", "first_published_date": "09/06/2011", "last_updated_date": "09/06/2011", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001004-pip01-10" }, { "decision_number": "P/77/2011", "pip_number": "EMEA-000988-PIP01-10", "active_substance": "ciclosporin", "invented_name": "", "therapeutic_area": "Immunology-Rheumatology-Transplantation", "pharmaceutical_forms": "Nebuliser solution", "condition_indication": "Prevention of rejection following lung transplantation", "routes_of_administration": "Inhalation use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "05/04/2011", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "APT Pharmaceuticals Limited; info@aptbio.com; United States; Phone +1 6509311666; Fax +1 6509311667", "first_published_date": "13/05/2011", "last_updated_date": "13/05/2011", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000988-pip01-10" }, { "decision_number": "P/98/2011", "pip_number": "EMEA-001080-PIP01-10", "active_substance": "Delafloxacin", "invented_name": "", "therapeutic_area": "Infectious diseases", "pharmaceutical_forms": "Powder for solution for infusion", "condition_indication": "Treatment of local infections of skin and subcutaneous tissues", "routes_of_administration": "Intravenous use;Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "08/04/2011", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Rib-X Therapeutics Ltd; Tel: +39 055 5680 633; E-mail: prijli@menarini.it", "first_published_date": "12/05/2011", "last_updated_date": "12/05/2011", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001080-pip01-10" }, { "decision_number": "P/95/2011", "pip_number": "EMEA-000006-PIP02-10", "active_substance": "ezetimibe;simvastatin", "invented_name": "Inegy and associated names", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Tablet", "condition_indication": "Prevention of cardiovascular events in chronic kidney disease", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "04/04/2011", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Merck Sharp & Dohme Limited; E-mail: regaffairseurope@organon.com; Tel: +31 412770000", "first_published_date": "12/05/2011", "last_updated_date": "12/05/2011", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000006-pip02-10" }, { "decision_number": "P/85/2011", "pip_number": "EMEA-000463-PIP02-10", "active_substance": "imatinib mesilate", "invented_name": "Glivec", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Film-coated tablet;Capsule, hard;Age appropriate oral solid dosage form", "condition_indication": "Treatment of pulmonary arterial hypertension", "routes_of_administration": "Oral use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "08/04/2011", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Novartis Europharm LimitedE-mail: paediatric.enquiries@novartis.comTel. +41 613241111", "first_published_date": "12/05/2011", "last_updated_date": "12/05/2011", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000463-pip02-10" }, { "decision_number": "P/82/2011", "pip_number": "EMEA-000990-PIP02-10", "active_substance": "azelastine (hydrochloride);fluticasone propionate", "invented_name": "", "therapeutic_area": "Pneumology-allergology", "pharmaceutical_forms": "Nasal spray;Suspension", "condition_indication": "Treatment of allergic rhinitis;Treatment of rhino-conjuctivitis", "routes_of_administration": "Nasal use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "06/04/2011", "compliance_outcome": "Positive", "compliance_opinion_date": "24/06/2011", "compliance_procedure_number": "EMEA-C-000990-PIP02-10", "contact_for_public_enquiries": "MEDA Pharma GmbH & Co. KG; info@medapharma.de; Germany; Phone +49 617288801; Fax +49 61728881112", "first_published_date": "12/05/2011", "last_updated_date": "12/05/2011", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000990-pip02-10" }, { "decision_number": "P/83/2011", "pip_number": "EMEA-001066-PIP01-10", "active_substance": "aciclovir", "invented_name": "", "therapeutic_area": "Infectious diseases", "pharmaceutical_forms": "Muco-adhesive buccal tablet", "condition_indication": "Prevention of recurrences of herpes simplex labialis;Treatment of recurrent herpes simplex labialis", "routes_of_administration": "Gingival use", "decision_type": "RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)", "decision_date": "06/04/2011", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Onxeo; France; E-mail: a.dembri@onxeo.com; Tel. +33 1455 86000; Fax +33 1455 80881", "first_published_date": "12/05/2011", "last_updated_date": "12/05/2011", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001066-pip01-10" }, { "decision_number": "P/93/2011", "pip_number": "EMEA-000032-PIP01-07-M04", "active_substance": "Meningococcal group A oligosaccharide conjugated to Corynebacterium diphteriae CRM197 protein (MenA-CRM) Meningococcal group C oligosaccharide conjugated to Corynebacterium diphteriae CRM197 protein (MenC-CRM) Meningococcal group W-135 oligosaccharide conjugated to Corynebacterium diphteriae CRM197 protein (MenW-CRM) Meningococcal group Y oligosaccharide conjugated to Corynebacterium diphteriae CRM197 protein (MenY-CRM)", "invented_name": "Menveo; Menveo", "therapeutic_area": "Vaccines", "pharmaceutical_forms": "Powder and solvent for solution for injection", "condition_indication": "Meningococcal meningitis", "routes_of_administration": "Intramuscular use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "01/04/2011", "compliance_outcome": "Positive", "compliance_opinion_date": "25/05/2011", "compliance_procedure_number": "EMEA-C-000032-PIP01-07-M04", "contact_for_public_enquiries": "GSK Vaccines S.r.l.; Tel. +1 438 899 8201; Email: eu.paediatric-plans@gsk.com", "first_published_date": "12/05/2011", "last_updated_date": "12/05/2011", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000032-pip01-07-m04" }, { "decision_number": "P/113/2011", "pip_number": "EMEA-001084-PIP02-11", "active_substance": "rivastigmine", "invented_name": "Exelon; Prometax", "therapeutic_area": "Neurology", "pharmaceutical_forms": "Capsule, hard;Oral solution;Transdermal patch", "condition_indication": "Treatment of dementia", "routes_of_administration": "Oral use;Transdermal use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "27/04/2011", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Novartis Europharm LimitedE-mail: paediatric.enquiries@novartis.comTel. +41 613241111", "first_published_date": "12/05/2011", "last_updated_date": "12/05/2011", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001084-pip02-11" }, { "decision_number": "P/94/2011", "pip_number": "EMEA-001085-PIP01-10", "active_substance": "atorvastatin calcium;amlodipine besilate", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Prevention of cardiovascular events in hypertensive patients and diabetes mellitus type II patients with multiple risk factors for cardiovascular disease;Treatment of concomitant angina and dyslipidemia;Treatment of concomitant hypertension and dyslipidemia", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "04/04/2011", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Miklich Laboratorios, S.L.; borut@miklich.eu; Spain; Phone +34 9520+8822; Fax +34 952067709", "first_published_date": "12/05/2011", "last_updated_date": "12/05/2011", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001085-pip01-10" }, { "decision_number": "P/79/2011", "pip_number": "EMEA-000558-PIP02-10", "active_substance": "human normal immunoglobulin", "invented_name": "", "therapeutic_area": "Immunology-Rheumatology-Transplantation", "pharmaceutical_forms": "Solution for infusion", "condition_indication": "Treatment of multifocal motor neuropathy (MMN)", "routes_of_administration": "Intravenous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "06/04/2011", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "LFB Biotechnologies; micardt@lfb.fr; France; Phone +33 169821749; Fax +33 169827182", "first_published_date": "12/05/2011", "last_updated_date": "12/05/2011", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000558-pip02-10" }, { "decision_number": "P/70/2011", "pip_number": "EMEA-000823-PIP02-10", "active_substance": "amlodipine besilate;perindopril tert-butylamine", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Tablet", "condition_indication": "Prevention of heart failure;Prevention of stroke;Treatment of acute myocardial infarction;Treatment of atherosclerotic heart disease;Treatment of heart failure;Treatment of Prinzmetal's angina", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "04/04/2011", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Gedeon Richter Plc.; mrpRichter@richter.hu; Hungary; Tel. +36 14314040; Fax. +36 14315415", "first_published_date": "10/05/2011", "last_updated_date": "10/05/2011", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000823-pip02-10" }, { "decision_number": "P/72/2011", "pip_number": "EMEA-001028-PIP01-10", "active_substance": "flutemetamol (18F)", "invented_name": "", "therapeutic_area": "Diagnostic", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Diagnosis of Alzheimer's disease", "routes_of_administration": "Intravenous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "04/04/2011", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "GE Healthcare Inc.; Tel. +44 1494543483; E-mail: Gabriel.Brooks@ge.com", "first_published_date": "10/05/2011", "last_updated_date": "10/05/2011", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001028-pip01-10" }, { "decision_number": "P/71/2011", "pip_number": "EMEA-000995-PIP01-10", "active_substance": "iloperidone", "invented_name": "", "therapeutic_area": "Psychiatry", "pharmaceutical_forms": "Suspension for injection;Tablet", "condition_indication": "Treatment of schizophrenia", "routes_of_administration": "Intramuscular use;Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "04/04/2011", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Vanda Pharmaceuticals Ltd; United States; E-mail: gunther.birznieks@vandapharma.com; Tel. +1 202 7343416; Fax +1 202 2961450", "first_published_date": "10/05/2011", "last_updated_date": "10/05/2011", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000995-pip01-10" }, { "decision_number": "P/266/2010", "pip_number": "EMEA-000926-PIP01-10", "active_substance": "Dermatophagoides pteronyssinus;Dermatophagoides farinae", "invented_name": "", "therapeutic_area": "Pneumology-allergology", "pharmaceutical_forms": "Oromucosal solution", "condition_indication": "Treatment of allergic rhinitis / rhino-conjunctivitis", "routes_of_administration": "Sublingual use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "26/11/2010", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "LETI Pharma GmbH; paediatrics@leti.de; Germany; Phone: +49 2302202860; Fax: +49 23022028620", "first_published_date": "05/05/2011", "last_updated_date": "05/05/2011", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000926-pip01-10" }, { "decision_number": "P/81/2010", "pip_number": "EMEA-000665-PIP01-09", "active_substance": "taspoglutide", "invented_name": "", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Treatment of type II diabetes mellitus", "routes_of_administration": "Subcutaneous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "07/05/2010", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Ipsen Pharma; E-mail: paediatrics.plans@ispen.com; Tel. +33 1 5833 5000", "first_published_date": "27/07/2010", "last_updated_date": "20/04/2011", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000665-pip01-09" }, { "decision_number": "P/80/2010", "pip_number": "EMEA-000649-PIP01-09", "active_substance": "taspoglutide", "invented_name": "", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Treatment of type II diabetes mellitus", "routes_of_administration": "Subcutaneous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "07/05/2010", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Ipsen Pharma; E-mail: paediatrics.plans@ispen.com; Tel. +33 1 5833 5000", "first_published_date": "27/07/2010", "last_updated_date": "20/04/2011", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000649-pip01-09" }, { "decision_number": "P/67/2011", "pip_number": "EMEA-000156-PIP01-07-M02", "active_substance": "antigen of pre-pandemic strain A/Vietnam/1203/2004 propagated in Vero cells", "invented_name": "", "therapeutic_area": "Vaccines", "pharmaceutical_forms": "Suspension for injection", "condition_indication": "Influenza infection caused by an influenza strain contained in the vaccine or related to a strain contained in the vaccine", "routes_of_administration": "Intramuscular injection", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "11/03/2011", "compliance_outcome": "Positive", "compliance_opinion_date": "17/01/2013", "compliance_procedure_number": "EMEA-C-000156-PIP01-07-M02", "contact_for_public_enquiries": "Baxter Innovations GmbH; E-mail: johannes_braun@baxter.com; Tel.: +43 1201002542", "first_published_date": "26/08/2010", "last_updated_date": "08/04/2011", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000156-pip01-07-m02" }, { "decision_number": "P/61/2011", "pip_number": "EMEA-001055-PIP01-10", "active_substance": "human papilloma virus type 16 E6 071-095;human papilloma virus type 16 E7 064-098;human papilloma virus type 16 E6 055-080;human papilloma virus type 16 E6 001-032;human papilloma virus type 16 E6 091-122", "invented_name": "", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Powder for suspension for injection", "condition_indication": "Treatment of vulvar intraepithelial neoplasia", "routes_of_administration": "Subcutaneous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "04/03/2011", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "ISA Therapeutics BV; info@isa-pharma.com; The Netherlands; +31 713322310", "first_published_date": "08/04/2011", "last_updated_date": "08/04/2011", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001055-pip01-10" }, { "decision_number": "P/50/2011", "pip_number": "EMEA-000371-PIP02-09", "active_substance": "lenalidomide", "invented_name": "Revlimid; Revlimid", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Capsule, hard", "condition_indication": "Treatment of diffuse large B-cell lymphoma", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "04/03/2011", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Celgene Europe LimitedTel.  +41 327298500E-mail: medinfo.intl@celgene.com", "first_published_date": "08/04/2011", "last_updated_date": "08/04/2011", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000371-pip02-09" }, { "decision_number": "P/60/2011", "pip_number": "EMEA-001026-PIP01-10", "active_substance": "testosterone", "invented_name": "", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Cutaneous solution", "condition_indication": "Treatment of male hypogonadism", "routes_of_administration": "Cutaneous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "04/03/2011", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "", "first_published_date": "08/04/2011", "last_updated_date": "08/04/2011", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001026-pip01-10" }, { "decision_number": "P/65/2011", "pip_number": "EMEA-001084-PIP01-10", "active_substance": "rivastigmine", "invented_name": "Exelon; Exelon", "therapeutic_area": "Neurology", "pharmaceutical_forms": "Transdermal patch", "condition_indication": "Treatment of dementia", "routes_of_administration": "Transdermal use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "11/03/2011", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Novartis Europharm LimitedE-mail: paediatric.enquiries@novartis.comTel. +41 613241111", "first_published_date": "08/04/2011", "last_updated_date": "08/04/2011", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001084-pip01-10" }, { "decision_number": "P/44/2011", "pip_number": "Telcagepant", "active_substance": "telcagepant", "invented_name": "", "therapeutic_area": "Pain", "pharmaceutical_forms": "Film-coated tablet;Age appropriate dosage form, other", "condition_indication": "Migraine with or without aura", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "03/03/2011", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Merck Sharp & Dohme (Europe) Inc.Tel.: +33180464738E-mail: pip.information@merck.com", "first_published_date": "10/06/2009", "last_updated_date": "05/04/2011", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/telcagepant" }, { "decision_number": "P/46/2011", "pip_number": "EMEA-001060-PIP01-10", "active_substance": "(E)-4-(2-(6-(2-(2-(2-[18F]fluoroethoxy)ethoxy)ethoxy)pyridin-3-yl)vinyl)-N-methylbenzenamine", "invented_name": "", "therapeutic_area": "Diagnostic", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Diagnosis of Alzheimer's disease", "routes_of_administration": "Intravenous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "03/03/2011", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Eli Lilly & Company Limited; E-mail: eu_paediatric@lilly.com ; Tel. +44 (0)1276 483000", "first_published_date": "05/04/2011", "last_updated_date": "05/04/2011", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001060-pip01-10" }, { "decision_number": "P/45/2011", "pip_number": "EMEA-000719-PIP02-10", "active_substance": "atorvastatin (L-lysine salt);amlodipine besilate", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Prevention of atherosclerotic heart disease", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "03/03/2011", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Gedeon Richter Plc.; mrpRichter@richter.hu; Hungary; +36 14314040; +36 14315415", "first_published_date": "05/04/2011", "last_updated_date": "05/04/2011", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000719-pip02-10" }, { "decision_number": "P/40/2011", "pip_number": "EMEA-001023-PIP01-10", "active_substance": "romidepsin", "invented_name": "", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Treatment of peripheral T-cell lymphoma (nodal, other extranodal and leukaemic/disseminated)", "routes_of_administration": "Intravenous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "03/02/2011", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Celgene Europe B.V.; Tel. +41 327298500; E-mail: medinfo.emea@celgene.com", "first_published_date": "08/03/2011", "last_updated_date": "08/03/2011", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001023-pip01-10" }, { "decision_number": "P/25/2011", "pip_number": "EMEA-000552-PIP01-09-M01", "active_substance": "briakinumab", "invented_name": "", "therapeutic_area": "Dermatology", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Psoriasis vulgaris", "routes_of_administration": "Subcutaneous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "26/01/2011", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "AbbVie LtdE-mail: paediatricteam@abbvie.comTel. +44 (0)1628 408248", "first_published_date": "24/02/2011", "last_updated_date": "24/02/2011", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000552-pip01-09-m01" }, { "decision_number": "P/36/2011", "pip_number": "EMEA-001042-PIP01-10", "active_substance": "recombinant human granulocyte colony stimulating factor;recombinant human albumin fusion protein", "invented_name": "", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Prevention of chemotherapy induced neutropenia", "routes_of_administration": "Subcutaneous use", "decision_type": "RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)", "decision_date": "28/01/2011", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Teva Pharmaceuticals Europe B.V; info@ratiopharm.de; Germany; Phone: +49 73140202; Fax: +49 7314027832", "first_published_date": "24/02/2011", "last_updated_date": "24/02/2011", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001042-pip01-10" }, { "decision_number": "P/16/2011", "pip_number": "EMEA-000913-PIP01-10", "active_substance": "nepafenac", "invented_name": "Nevanac; Nevanac", "therapeutic_area": "Ophthalmology", "pharmaceutical_forms": "Eye drops, solution;Suspension", "condition_indication": "Prevention of post operative pain and inflammation associated with cataract surgery", "routes_of_administration": "Ocular use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "21/01/2011", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Alcon Laboratories (UK) Ltd.; Doug.MacHatton@AlconLabs.com; United States; Phone: +1 8175518974; Fax: +1 8176154607", "first_published_date": "24/02/2011", "last_updated_date": "24/02/2011", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000913-pip01-10" }, { "decision_number": "P/17/2011", "pip_number": "EMEA-001048-PIP01-10", "active_substance": "perindopril arginine;Indapamide;amlodipine besilate", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Tablet", "condition_indication": "Treatment of arterial hypertension", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "21/01/2011", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Les Laboratoires ServierTel. +33 1 55 72 60 00E-mail: mail.pip.enquiries@fr.netgrs.com", "first_published_date": "24/02/2011", "last_updated_date": "24/02/2011", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001048-pip01-10" }, { "decision_number": "P/23/2011", "pip_number": "EMEA-001029-PIP01-10", "active_substance": "tesamorelin", "invented_name": "", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Lyophilisate for solution for injection", "condition_indication": "Treatment of HIV-associated lipodystrophy", "routes_of_administration": "Subcutaneous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "23/01/2011", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Theratechnologies Inc; communications@theratech.com; Canada; Phone: +1 5143367800", "first_published_date": "24/02/2011", "last_updated_date": "24/02/2011", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001029-pip01-10" }, { "decision_number": "P/27/2011", "pip_number": "EMEA-000084-PIP02-10", "active_substance": 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rhinitis;Treatment of rhino-conjuctivitis", "routes_of_administration": "Subcutaneous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "26/11/2010", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "LETI Pharma GmbH; paediatrics@leti.de; Germany; Phone: +49 2302202860; Fax: +49 23022028620", "first_published_date": "21/12/2010", "last_updated_date": "21/12/2010", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000840-pip01-10" }, { "decision_number": "P/235/2010", "pip_number": "EMEA-000189-PIP01-08-M01", "active_substance": "eptacog alfa pegol (activated)", "invented_name": "", "therapeutic_area": "Haematology-Hemostaseology", "pharmaceutical_forms": "Powder for solution for injection", "condition_indication": "Hereditary factor VIII and factor IX deficiency", "routes_of_administration": "Subcutaneous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "26/11/2010", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Novo Nordisk A/S; E-mail: paediatrics@novonordisk.com; Tel: +45 44448888;  ", "first_published_date": "21/12/2010", "last_updated_date": "21/12/2010", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000189-pip01-08-m01" }, { "decision_number": "P/263/2010", "pip_number": "EMEA-000923-PIP01-10", "active_substance": "mixture of Phleum pratense, Dactylis glomerata, Festuca elatior, Lolium perenne and Poa pratensis (Grasses-Mix) and Secale cereale (75/25) allergen extracts", "invented_name": "", "therapeutic_area": "Pneumology-allergology", "pharmaceutical_forms": "Oromucosal solution", "condition_indication": "Treatment of allergic rhinitis;Treatment of 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"routes_of_administration": "Sublingual use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "26/11/2010", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "LETI Pharma GmbH; paediatrics@leti.de; Germany; Phone: +49 2302202860; Fax: +49 23022028620", "first_published_date": "21/12/2010", "last_updated_date": "21/12/2010", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000925-pip01-10" }, { "decision_number": "P/262/2010", "pip_number": "EMEA-000922-PIP01-10", "active_substance": "mixture of Phleum pratense, Dactylis glomerata, Festuca elatior, Lolium perenne and Poa pratensis (Grasses-Mix) and Secale cereale (50/50) allergen extracts", "invented_name": "", "therapeutic_area": "Pneumology-allergology", "pharmaceutical_forms": "Oromucosal solution", "condition_indication": "Treatment of allergic rhinitis;Treatment of rhino-conjuctivitis", "routes_of_administration": "Sublingual use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "26/11/2010", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "LETI Pharma GmbH; paediatrics@leti.de; Germany; Phone: +49 2302202860; Fax: +49 23022028620", "first_published_date": "21/12/2010", "last_updated_date": "21/12/2010", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000922-pip01-10" }, { "decision_number": "P/258/2010", "pip_number": "EMEA-000918-PIP01-10", "active_substance": "birch, hazel and alder allergen extracts", "invented_name": "", "therapeutic_area": "Pneumology-allergology", "pharmaceutical_forms": "Oromucosal solution", "condition_indication": "Treatment of allergic rhinitis;Treatment of rhino-conjuctivitis", "routes_of_administration": "Sublingual use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "26/11/2010", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "LETI Pharma GmbH; paediatrics@leti.de; Germany; Phone: +49 2302202860; Fax: +49 23022028620", "first_published_date": "21/12/2010", "last_updated_date": "21/12/2010", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000918-pip01-10" }, { "decision_number": "P/247/2010", "pip_number": "EMEA-000791-PIP01-09", "active_substance": "aluminium hydroxide adsorbed, depigmented glutaraldehyde polymerised, allergic extract of equal amounts of Phleum pratense, Dactylis glomerata, Festuca elatior, Lolium perenne and Poa pratensis pollen (Grasses-Mix) and Secale cereale (Cultivated Rye) pollen (75/25)", "invented_name": "", "therapeutic_area": "Pneumology-allergology", "pharmaceutical_forms": "Suspension for injection", "condition_indication": "Treatment of allergic rhinitis;Treatment of rhino-conjuctivitis", "routes_of_administration": "Subcutaneous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "26/11/2010", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "LETI Pharma GmbH; paediatrics@leti.de; Germany; Phone: +49 2302202860; Fax: +49 23022028620", "first_published_date": "21/12/2010", "last_updated_date": "21/12/2010", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000791-pip01-09" }, { "decision_number": "P/246/2010", "pip_number": "EMEA-000790-PIP01-09", "active_substance": "aluminium hydroxide adsorbed, depigmented glutaraldehyde polymerised, allergic extract of Phleum pratense, Dactylis glomerata, Festuca elatior, Lolium perenne and Poa pratensis pollen (grasses-mix) and birch pollen (50/50)", "invented_name": "", "therapeutic_area": "Pneumology-allergology", "pharmaceutical_forms": "Suspension for injection", "condition_indication": "Treatment of allergic rhinitis;Treatment of rhino-conjuctivitis", "routes_of_administration": "Subcutaneous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "26/11/2010", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "LETI Pharma GmbH; paediatrics@leti.de; Germany; Phone: +49 2302202860; Fax: +49 23022028620", "first_published_date": "21/12/2010", "last_updated_date": "21/12/2010", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000790-pip01-09" }, { "decision_number": "P/255/2010", "pip_number": "EMEA-000839-PIP01-10", "active_substance": "aluminium hydroxide adsorbed, depigmented glutaraldehyde polymerised, allergen extract of Phleum pratense pollen", "invented_name": "", "therapeutic_area": "Pneumology-allergology", "pharmaceutical_forms": "Suspension for injection", "condition_indication": "Treatment of allergic rhinitis;Treatment of rhino-conjuctivitis", "routes_of_administration": "Subcutaneous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "26/11/2010", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "LETI Pharma GmbH; paediatrics@leti.de; Germany; Phone: +49 2302202860; Fax: +49 23022028620", "first_published_date": "21/12/2010", "last_updated_date": "21/12/2010", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000839-pip01-10" }, { "decision_number": "P/230/2010", "pip_number": "EMEA-000288-PIP01-08-M02", "active_substance": "moxifloxacin hydrochloride", "invented_name": "Avalox and associated names; Octegra and associated names; Actimax and associated names; Actira and associated names", "therapeutic_area": "Infectious diseases", "pharmaceutical_forms": "Film-coated tablet;Solution for infusion;Granules and solvent for oral suspension", "condition_indication": "Acute Exacerbation of Chronic Bronchitis;Community Acquired Pneumonia;Complicated Intra-Abdominal Infection;Complicated Skin and Skin Structure Infections;Pelvic Inflammatory Disease;Treatment of acute bacterial sinusitis", "routes_of_administration": "Oral use;Intravenous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "24/11/2010", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Bayer Schering Pharma AG; pediatrics.medical-affairs-europe@bayerhealthcare.com; Germany; Phone: +49 3046815333; Fax: +49 3046895333", "first_published_date": "21/12/2010", "last_updated_date": "21/12/2010", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000288-pip01-08-m02" }, { "decision_number": "P/229/2010", "pip_number": "Rosuvastatin (calcium)", "active_substance": "rosuvastatin calcium", "invented_name": "Crestor and associated names", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Homozygous Familial Hypercholesterolaemia;Prevention of cardiovascular events;Primary combined (mixed) dyslipidaemia;Primary hypercholesterolaemia", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "24/11/2010", "compliance_outcome": "Positive", "compliance_opinion_date": "11/10/2013", "compliance_procedure_number": "EMEA-C-000022-PIP01-07-M04", "contact_for_public_enquiries": "AstraZeneca ABE-mail: paediatrics@astrazeneca.comTel. +44 20 7304 5345", "first_published_date": "21/12/2010", "last_updated_date": "07/12/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/rosuvastatin-calcium" }, { "decision_number": "P/231/2010", "pip_number": "EMEA-000712-PIP01-09", "active_substance": "Fentanyl citrate", "invented_name": "", "therapeutic_area": "Neonatology-Paediatric Intensive Care", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Treatment of acute pain;Prevention of acute pain", "routes_of_administration": "Intravenous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "23/11/2010", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "EPMC Pharma SPRL; Hugo.Lagercrantz@ki.se; Sweden; Phone: + 46 8709845273; Fax: + 46 8709845273", "first_published_date": "20/12/2010", "last_updated_date": "20/12/2010", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000712-pip01-09" }, { "decision_number": "P/232/2010", "pip_number": "EMEA-000764-PIP01-09", "active_substance": "4-Hydroxy-n-(2-hydroxyethyl)-butyramide", "invented_name": "", "therapeutic_area": "Anaesthesiology", "pharmaceutical_forms": "Solution for injection;Solution for infusion", "condition_indication": "Sedation", "routes_of_administration": "Intravenous use", "decision_type": "RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)", "decision_date": "23/11/2010", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Dr. Franz Köhler Chemie GmbH; info@koehler-chemie.de; Germany; Phone: +49 625110830; Fax: +49 62511083246", "first_published_date": "20/12/2010", "last_updated_date": "20/12/2010", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000764-pip01-09" }, { "decision_number": "P/244/2010", "pip_number": "EMEA-000742-PIP01-09", "active_substance": "recombinant Bet v1 folding variant (rBet v1-FV)", "invented_name": "", "therapeutic_area": "Pneumology-allergology", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Treatment of allergic rhinitis;Treatment of rhino-conjuctivitis", "routes_of_administration": "Subcutaneous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "26/11/2010", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Allergopharma J. Ganzer KG; info@allergopharma.de; Germany; Phone: +49 40727650; Fax: +49 407227713", "first_published_date": "20/12/2010", "last_updated_date": "20/12/2010", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000742-pip01-09" }, { "decision_number": "P/237/2010", "pip_number": "EMEA-000380-PIP04-10", "active_substance": "recombinant human monoclonal antibody to human interleukin 17A (AIN457)", "invented_name": "", "therapeutic_area": "Ophthalmology", "pharmaceutical_forms": "Powder for solution for injection", "condition_indication": "Treatment of chronic non-infectious uveitis", "routes_of_administration": "Subcutaneous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "26/11/2010", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Novartis Europharm LimitedE-mail: paediatric.enquiries@novartis.comTel. +41 613241111", "first_published_date": "20/12/2010", "last_updated_date": "20/12/2010", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000380-pip04-10" }, { "decision_number": "P/239/2010", "pip_number": "Infliximab", "active_substance": "infliximab", "invented_name": "Remicade; Remicade", "therapeutic_area": "Gastroentology-Hepatology", "pharmaceutical_forms": "Powder for concentrate for solution for infusion", "condition_indication": "Ankylosing spondylitis;Juvenile idiopathic arthritis;Psoriatic arthritis;Rheumatoid arthritis;Treatment of Crohn's disease;Treatment of psoriasis;Treatment of ulcerative colitis", "routes_of_administration": "Intravenous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "05/11/2010", "compliance_outcome": "Positive", "compliance_opinion_date": "16/09/2011", "compliance_procedure_number": "EMEA-C-000549-PIP01-09-M01", "contact_for_public_enquiries": "Centocor B.V.; info@remicade.eu; The Netherlands; Phone: +31 202015009; Fax: +-*31 713065101", "first_published_date": "20/12/2010", "last_updated_date": "20/12/2010", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/infliximab" }, { "decision_number": "P/245/2010", "pip_number": "EMEA-000789-PIP01-09", "active_substance": "aluminium hydroxide adsorbed, depigmented glutaraldehyde polymerised, allergic extract of Phleum pratense, Dactylis glomerata, Festuca elatior, Lolium perenne and poa pratensis pollen (grasses-mix) and birch, alder and hazel pollen (tree-mix) (50/50)", "invented_name": "", "therapeutic_area": "Pneumology-allergology", "pharmaceutical_forms": "Suspension for injection", "condition_indication": "Treatment of rhino-conjuctivitis;Treatment of allergic rhinitis", "routes_of_administration": "Subcutaneous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "26/11/2010", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "LETI Pharma GmbH; paediatrics@leti.de; Germany; Phone: +49 2302202860; Fax: +49 23022028620", "first_published_date": "20/12/2010", "last_updated_date": "20/12/2010", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000789-pip01-09" }, { "decision_number": "P/233/2010", "pip_number": "EMEA-000049-PIP01-07-M03", "active_substance": "clopidogrel", "invented_name": "Plavix; Plavix", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Oral formulation;Film-coated tablet", "condition_indication": "Prevention of thromboembolic events", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "26/11/2010", "compliance_outcome": "Positive", "compliance_opinion_date": "10/12/2010", "compliance_procedure_number": "EMEA-C-000049-PIP01-07-M03", "contact_for_public_enquiries": "Sanofi Pharma Bristol-Myers Squibb SNC; sylvie.gabriel@sanofi-aventis.com; France; Phone: +33 153774152; Fax: +33 153774133", "first_published_date": "20/12/2010", "last_updated_date": "20/12/2010", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000049-pip01-07-m03" }, { "decision_number": "P/197/2010", "pip_number": "EMEA-000991-PIP01-10", "active_substance": "lidocaine hydrochloride;phenylephrine hydrochloride;tropicamide", "invented_name": "", "therapeutic_area": "Ophthalmology", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Prevention of pain during cataract surgery", "routes_of_administration": "Intraocular use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "26/10/2010", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Laboratoires Théa; E-mail: s.momege@laboratoires-thea.fr; Tel. +33 473981436;  ", "first_published_date": "25/11/2010", "last_updated_date": "25/11/2010", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000991-pip01-10" }, { "decision_number": "P/212/2010", "pip_number": "EMEA-000608-PIP01-09", "active_substance": "Pagibaximab", "invented_name": "", "therapeutic_area": "Neonatology-Paediatric Intensive Care", "pharmaceutical_forms": "Solution for infusion", "condition_indication": "Prevention of bacterial sepsis", "routes_of_administration": "Intravenous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "29/10/2010", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Biosynexus, Incorporated; Veronika.Alt@eraconsulting.com; Germany; Phone:+49 5161989011; Fax: +49 5161989018", "first_published_date": "25/11/2010", "last_updated_date": "25/11/2010", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000608-pip01-09" }, { "decision_number": "P/223/2010", "pip_number": "EMEA-000826-PIP01-09", "active_substance": "phentermine;topiramate", "invented_name": "", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Capsule, hard", "condition_indication": "Treatment of obesity", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "29/10/2010", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Vivus BV; Tam@vivus.com; United States; Phone: + 1 6509345200", "first_published_date": "25/11/2010", "last_updated_date": "25/11/2010", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000826-pip01-09" }, { "decision_number": "P/215/2010", "pip_number": "EMEA-000758-PIP01-09", "active_substance": "derivative of 4,4'-(1-methylene)-bisbenzonitrile", "invented_name": "", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Tablet", "condition_indication": "Treatment of endometriosis", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "29/10/2010", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Novartis Europharm LimitedE-mail: paediatric.enquiries@novartis.comTel. +41 613241111", "first_published_date": "25/11/2010", "last_updated_date": "25/11/2010", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000758-pip01-09" }, { "decision_number": "P/206/2010", "pip_number": "EMEA-000894-PIP01-10", "active_substance": "Ingenol mebutate", "invented_name": "", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Gel", "condition_indication": "Treatment of actinic keratosis;Treatment of squamous cell carcinoma", "routes_of_administration": "Cutaneous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "27/10/2010", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "LEO Pharma A/S; paediatrics@leo-pharma.com; Denmark; Phone: +45 44945888; Fax: +45 72263321", "first_published_date": "25/11/2010", "last_updated_date": "25/11/2010", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000894-pip01-10" }, { "decision_number": "P/218/2010", "pip_number": "EMEA-000810-PIP01-09", "active_substance": "grass pollen;rye pollen;birch pollen", "invented_name": "", "therapeutic_area": "Pneumology-allergology", "pharmaceutical_forms": "Suspension for injection", "condition_indication": "Treatment of allergic rhinitis / rhino-conjunctivitis", "routes_of_administration": "Subcutaneous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "29/10/2010", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Allergy Therapeutics (UK) Ltd; Tel. +44(0)1903 844 700; E-mail: infoservices@allergytherapeutics.com", "first_published_date": "25/11/2010", "last_updated_date": "25/11/2010", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000810-pip01-09" }, { "decision_number": "P/225/2010", "pip_number": "EMEA-001006-PIP01-10", "active_substance": "1H-Indole-6-carboxylic acid, 2,3-dihydro-3-[[[4-[methyl[(4-methyl-1-piperazinyl)acetyl]amino]phenyl]amino]phenylmethylene]-2-oxo-, methyl ester, (3Z)-, monoethanesulfonate", "invented_name": "", "therapeutic_area": "Pneumology-allergology", "pharmaceutical_forms": "Capsule, soft", "condition_indication": "Treatment of idiopathic pulmonary fibrosis", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "29/10/2010", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Boehringer Ingelheim International GmbH; 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p.panichelli@sparklepet.it; Italy; +39 0733229739; +39 0733560352", "first_published_date": "29/10/2010", "last_updated_date": "29/10/2010", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001002-pip01-10" }, { "decision_number": "P/155/2010", "pip_number": "EMEA-000998-PIP01-10", "active_substance": "bazedoxifene;conjugated estrogens", "invented_name": "", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Postmenopausal osteoporosis", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "03/09/2010", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Pfizer Ltd; United Kingdom; E-mail: kulminder.nowacki@pfizer.com; Tel. +44 (0)1628 692253; Fax +44 (0)1628 692283", "first_published_date": "29/10/2010", "last_updated_date": "29/10/2010", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000998-pip01-10" }, { "decision_number": "P/184/2010", "pip_number": "EMEA-000632-PIP01-09", "active_substance": "Influenza virus surface antigens (haemagglutinin and neuraminidase), inactivated, trivalent", "invented_name": "", "therapeutic_area": "Vaccines", "pharmaceutical_forms": "Suspension for injection in pre-filled syringe", "condition_indication": "Prevention of influenza", "routes_of_administration": "Intramuscular use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "24/09/2010", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Abbott Biologicals B.V.Email: Filip.Goossens@abbott.comTel.: +32 477777148", "first_published_date": "29/10/2010", "last_updated_date": "29/10/2010", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000632-pip01-09" }, { "decision_number": "P/168/2010", "pip_number": "EMEA-000915-PIP01-10", "active_substance": "lixisenatide;insulin glargine", "invented_name": "", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Treatment of type II diabetes mellitus", "routes_of_administration": "Subcutaneous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "03/09/2010", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Sanofi-aventis R&D; sylvie.gabriel@sanofi-aventis.com; France; +33 153774152; +33 153774133", "first_published_date": "29/10/2010", "last_updated_date": "29/10/2010", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000915-pip01-10" }, { "decision_number": "P/181/2010", "pip_number": "EMEA-000464-PIP02-10", "active_substance": "pasireotide", "invented_name": "", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Solution for injection;Powder and solvent for suspension for injection", "condition_indication": "Treatment of acromegaly and pituitary gigantism", "routes_of_administration": "Subcutaneous use;Intramuscular use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "24/09/2010", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Novartis Europharm LimitedE-mail: paediatric.enquiries@novartis.comTel. +41 613241111", "first_published_date": "29/10/2010", "last_updated_date": "29/10/2010", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000464-pip02-10" }, { "decision_number": "P/148/2010", "pip_number": "EMEA-000687-PIP01-09-M02", "active_substance": "Pandemic influenza vaccine (H1N1) (split virion, inactivated, adjuvanted), containing antigen equivalent to Influenza A/California/7/2009", "invented_name": "Arepanrix; 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(UK); E-mail: eu.paediatric-plans@gsk.com; Tel.: +1 438 899 8201", "first_published_date": "07/10/2010", "last_updated_date": "07/10/2010", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000687-pip01-09-m02" }, { "decision_number": "P/160/2010", "pip_number": "EMEA-000892-PIP01-10", "active_substance": "clindamycin phosphate;tretinoin", "invented_name": "", "therapeutic_area": "Dermatology", "pharmaceutical_forms": "Gel", "condition_indication": "Treatment of acne vulgaris", "routes_of_administration": "Cutaneous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "27/08/2010", "compliance_outcome": "Positive", "compliance_opinion_date": "10/12/2010", "compliance_procedure_number": "EMEA-C-000892-PIP01-10", "contact_for_public_enquiries": "MEDA Pharma GmbH & Co. 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E-mail: sendi.kersnic@krka.biz; Tel. +386 1475 1159;  ", "first_published_date": "06/10/2010", "last_updated_date": "06/10/2010", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000983-pip01-10" }, { "decision_number": "P/138/2010", "pip_number": "Darunavir", "active_substance": "darunavir", "invented_name": "Prezista; Prezista", "therapeutic_area": "Infectious diseases", "pharmaceutical_forms": "Film-coated tablet;Oral suspension", "condition_indication": "Treatment of human immunodeficiency virus (HIV-1) infection", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "31/07/2010", "compliance_outcome": "Positive", "compliance_opinion_date": "13/12/2011", "compliance_procedure_number": "EMEA-C-000038-PIP01-07-M03", "contact_for_public_enquiries": "Janssen-Cilag International NV; E-mail: info@its.jnj.com; Country: Belgium; Phone: +32 15293100; Fax: +32 15286347", "first_published_date": "27/08/2010", "last_updated_date": "27/08/2010", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/darunavir" }, { "decision_number": "P/135/2010", "pip_number": "EMEA-000829-PIP01-09", "active_substance": "levonorgestrel;ethinylestradiol", "invented_name": "", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Contraception", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "28/07/2010", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Teva Pharma B.V.; 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KG; E-mail: pip.seq@seqirus.com; Phone: +39 0577 243046;  ", "first_published_date": "26/08/2010", "last_updated_date": "26/08/2010", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000663-pip01-09-m03" }, { "decision_number": "P/134/2010", "pip_number": "EMEA-000823-PIP01-10", "active_substance": "amlodipine besilate;perindopril tert-butylamine", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Tablet", "condition_indication": "Treatment of hypertension", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "28/07/2010", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Gedeon Richter Plc.; E-mail: mrpRichter@richter.hu; Country: Hungary; Phone: +36 14314040; Fax: +36 14315415", "first_published_date": "26/08/2010", "last_updated_date": "26/08/2010", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000823-pip01-10" }, { "decision_number": "P/147/2010", "pip_number": "EMEA-000884-PIP01-10", "active_substance": "tafamidis meglumine", "invented_name": "", "therapeutic_area": "Neurology", "pharmaceutical_forms": "Capsule, soft", "condition_indication": "Neuropathic heredofamilial amyloidosis", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "30/07/2010", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "FoldRx Pharmaceuticals; E-mail: PIP_enquiries@pfizer.com; United States; Phone: +44 1304 646607; Fax: +44 1304 653601", "first_published_date": "26/08/2010", "last_updated_date": "26/08/2010", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000884-pip01-10" }, { "decision_number": "P/136/2010", "pip_number": "EMEA-000887-PIP01-10", "active_substance": "amlodipine;ramipril", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Capsule, hard", "condition_indication": "Treatment of hypertension", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "28/07/2010", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "EGIS Pharmaceuticals PLC; E-mail: registry@egis.hu; Country: Hungary; Phone: +36 14692414; Fax: +36 14692415", "first_published_date": "26/08/2010", "last_updated_date": "26/08/2010", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000887-pip01-10" }, { "decision_number": "P/129/2010", "pip_number": "EMEA-000641-PIP01-09", "active_substance": "4-0-(ß-D-galactopiranosyl)-D-xylopyranose", "invented_name": "", "therapeutic_area": "Diagnostic", "pharmaceutical_forms": "Powder for oral solution", "condition_indication": "Diagnosis of intestinal lactase deficiency", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "28/07/2010", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Lactest SL; E-mail: jlmartin@lactest.com; Country: Spain; Phone: +34911467897; Fax: +34 915938262", "first_published_date": "26/08/2010", "last_updated_date": "26/08/2010", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000641-pip01-09" }, { "decision_number": "P/139/2010", "pip_number": "EMEA-000198-PIP04-10", "active_substance": "dexamethasone", "invented_name": "", "therapeutic_area": "Ophthalmology", "pharmaceutical_forms": "Intravitreal implant in applicator", "condition_indication": "Treatment of diabetic macular oedema", "routes_of_administration": "Intravitreal use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "30/07/2010", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Allergan Pharmaceuticals International Limited; E-mail: ml-eu_reg_affairs@allergan.com; Tel. +44 (0)1628 4944444", "first_published_date": "26/08/2010", "last_updated_date": "26/08/2010", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000198-pip04-10" }, { "decision_number": "P/125/2010", "pip_number": "Lidocaine/tetracaine", "active_substance": "lidocaine;tetracaine", "invented_name": "", "therapeutic_area": "Anaesthesiology", "pharmaceutical_forms": "Cream", "condition_indication": "Local anaesthesia", "routes_of_administration": "Cutaneous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "28/07/2010", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "ZARS Pharma; 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E-mail: paediatrics.plans@ipsen.com; Tel. +33 58335820", "first_published_date": "29/07/2010", "last_updated_date": "29/07/2010", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000816-pip01-09" }, { "decision_number": "P/117/2010", "pip_number": "EMEA-000820-PIP01-09", "active_substance": "omeprazole;diclofenac (sodium)", "invented_name": "", "therapeutic_area": "Immunology-Rheumatology-Transplantation", "pharmaceutical_forms": "Modified release capsule", "condition_indication": "Ankylosing spondylitis;Osteoarthritis;Rheumatoid arthritis", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "07/07/2010", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Temmler Werke GmbH; E-mail: avril.mankel@ndareg.com; Tel.: +49 8935854000", "first_published_date": "29/07/2010", "last_updated_date": "29/07/2010", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000820-pip01-09" }, { "decision_number": "P/118/2010", "pip_number": "EMEA-000833-PIP01-10", "active_substance": "chimeric antibody to mesothelin (MORAB-009)", "invented_name": "", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Solution for infusion", "condition_indication": "Treatment of mesothelioma", "routes_of_administration": "Intravenous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "07/07/2010", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Eisai Ltd; E-mail: angela_miller@eisai.net; Country: United Kingdom; Phone: +44 8456765089", "first_published_date": "29/07/2010", "last_updated_date": "29/07/2010", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000833-pip01-10" }, { "decision_number": "P/111/2010", "pip_number": "EMEA-000763-PIP01-09", "active_substance": "tulobuterol", "invented_name": "", "therapeutic_area": "Pneumology-allergology", "pharmaceutical_forms": "Transdermal patch", "condition_indication": "Asthma;Episodic wheeze", "routes_of_administration": "Transdermal use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "06/07/2010", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "CSI GmbH; E-mail: CSI.GmbH.cs@gmail.com; Tel.: +1 4083706150", "first_published_date": "29/07/2010", "last_updated_date": "29/07/2010", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000763-pip01-09" }, { "decision_number": "P/61/2010", "pip_number": "EMEA-000250-PIP01-08-M02", "active_substance": "nomegestrol acetate;17 beta-estradiol", "invented_name": "", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Contraception", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "09/03/2010", "compliance_outcome": "Positive", "compliance_opinion_date": "21/05/2010", "compliance_procedure_number": "EMEA-C-000250-PIP01-08-M02", "contact_for_public_enquiries": "N.V. Organon; Tel. +33 180 464 738; E-mail: pip.information@merck.com", "first_published_date": "28/07/2010", "last_updated_date": "28/07/2010", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000250-pip01-08-m02" }, { "decision_number": "P/70/2010", "pip_number": "Diamorphine hydrochloride", "active_substance": "diamorphine hydrochloride", "invented_name": "", "therapeutic_area": "Other", "pharmaceutical_forms": "Powder for solution for injection", "condition_indication": "Dependence to intravenous heroin use", "routes_of_administration": "Intravenous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "04/05/2010", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Genus Pharmaceuticals Limited; E-mail: katyg@genuspharma.com; Country: United Kingdom; Phone: +44 1635568405", "first_published_date": "28/07/2010", "last_updated_date": "28/07/2010", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/diamorphine-hydrochloride" }, { "decision_number": "P/68/2010", "pip_number": "EMEA-000781-PIP01-09", "active_substance": "sorafenib tosilate", "invented_name": "Nexavar; Nexavar", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Differentiated thyroid cancer", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "04/05/2010", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Bayer Schering Pharma AG; E-mail: pediatrics.medical-affairs-europe@bayerhealthcare.com; Country: Germany; Phone: +49 3046815333; Fax: +49 3046815333", "first_published_date": "28/07/2010", "last_updated_date": "28/07/2010", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000781-pip01-09" }, { "decision_number": "P/67/2010", "pip_number": "Diamorphine", "active_substance": "Diamorphine", "invented_name": "", "therapeutic_area": "Other", "pharmaceutical_forms": "Powder for solution for injection", "condition_indication": "Treatment-resistant heroin dependence", "routes_of_administration": "Intravenous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "04/05/2010", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Azanta A/S; E-mail: cm@azanta.com; Country: Denmark; Phone: +45 33267477", "first_published_date": "28/07/2010", "last_updated_date": "28/07/2010", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/diamorphine" }, { "decision_number": "P/69/2010", "pip_number": "Forodesine hydrochloride", "active_substance": "forodesine hydrochloride", "invented_name": "", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Capsule, hard", "condition_indication": "Treatment of Cutaneous T-Cell Lymphoma", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "04/05/2010", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Mundipharma Research Ltd; E-mail: paediatric@mundipharma-rd.eu; Country: United Kingdom; Phone: +44 1223424900; Fax: +44 1223426054", "first_published_date": "28/07/2010", "last_updated_date": "28/07/2010", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/forodesine-hydrochloride" }, { "decision_number": "P/65/2010", "pip_number": "Octocog alfa", "active_substance": "octocog alfa", "invented_name": "Advate; Advate", "therapeutic_area": "Haematology-Hemostaseology", "pharmaceutical_forms": "Powder and solvent for solution for injection", "condition_indication": "Haemophilia A (congenital Factor VIII deficiency)", "routes_of_administration": "Intravenous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "04/05/2010", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Baxter AG; E-mail: juliana_brankova@baxter.com; Country: Austria; Phone: +43 1201002548; Fax: + 43 120100727", "first_published_date": "28/07/2010", "last_updated_date": "28/07/2010", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/octocog-alfa" }, { "decision_number": "P/66/2010", "pip_number": "Avotermin", "active_substance": "avotermin", "invented_name": "", "therapeutic_area": "Dermatology", "pharmaceutical_forms": "Powder for solution for injection", "condition_indication": "Scar conditions and fibrosis of the skin;Hypertrophic disorders of skin and keloid scars", "routes_of_administration": "Intradermal use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "04/05/2010", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Renovo Ltd; E-mail: David.Fairlamb@renovo.com; Country: United Kingdom; Phone: +44 1612767132; Fax: +44 1612767200", "first_published_date": "28/07/2010", "last_updated_date": "28/07/2010", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/avotermin" }, { "decision_number": "P/64/2010", "pip_number": "EMEA-000100-PIP01-07-M01", "active_substance": "Iron, aqua carbonate hydroxy oxo starch sucrose complex", "invented_name": "", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Powder for oral suspension", "condition_indication": "Hyperphosphataemia in chronic kidney disease", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "03/05/2010", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Novartis Europharm LimitedE-mail: paediatric.enquiries@novartis.comTel. +41 613241111", "first_published_date": "28/07/2010", "last_updated_date": "28/07/2010", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000100-pip01-07-m01" }, { "decision_number": "P/86/2010", "pip_number": "EMEA-000477-PIP01-08", "active_substance": "cediranib maleate", "invented_name": "", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Tablet", "condition_indication": "Treatment of high-grade glioma", "routes_of_administration": "Oral use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "01/06/2010", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "AstraZeneca AB (UK); Tel. +44 2037496236; E-mail: paediatrics@astrazeneca.com", "first_published_date": "27/07/2010", "last_updated_date": "27/07/2010", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000477-pip01-08" }, { "decision_number": "P/78/2010", "pip_number": "EMEA-000351-PIP01-08", "active_substance": "mometasone furoate", "invented_name": "Nasonex and associated names", "therapeutic_area": "Oto-rhino-laryngology", "pharmaceutical_forms": "Nasal spray;Suspension", "condition_indication": "Seasonal and perennial allergic rhinitis", "routes_of_administration": "Nasal use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "07/05/2010", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Schering-Plough Research Institute, a division of Schering Corporation; E-mail: regaffairseurope@organon.com; Tel: +31 412770000", "first_published_date": "27/07/2010", "last_updated_date": "27/07/2010", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000351-pip01-08" }, { "decision_number": "P/82/2010", "pip_number": "EMEA-000805-PIP01-09", "active_substance": "vorinostat", "invented_name": "", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Capsule, hard", "condition_indication": "Malignant pleural mesothelioma;Treatment of Cutaneous T-Cell Lymphoma", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "30/04/2010", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Merck Sharp & Dohme Ltd; Belgium; E-mail: pip.information@merck.com; Tel. +31 412663179; Fax +31 412662571", "first_published_date": "27/07/2010", "last_updated_date": "27/07/2010", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000805-pip01-09" }, { "decision_number": "P/91/2010", "pip_number": "EMEA-000801-PIP01-09", "active_substance": "Fluocinolone acetonide", "invented_name": "", "therapeutic_area": "Ophthalmology", "pharmaceutical_forms": "Intravitreal implant in applicator", "condition_indication": "Treatment of diabetic macular oedema", "routes_of_administration": "Intravitreal use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "01/06/2010", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Campharm Ltd.; E-mail: craig.mccarthy@campharm.eu; Country: France; Phone: +33 494508996; Fax: +33 494506824", "first_published_date": "26/07/2010", "last_updated_date": "26/07/2010", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000801-pip01-09" }, { "decision_number": "P/90/2010", "pip_number": "EMEA-000585-PIP01-09", "active_substance": "bisoctrizole;titanium dioxide", "invented_name": "", "therapeutic_area": "Dermatology", "pharmaceutical_forms": "Cream", "condition_indication": "Treatment of solar urticaria", "routes_of_administration": "Cutaneous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "01/06/2010", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Orfagen; E-mail: info@orfagen.com; Country: France; Phone: +33 562247683; Fax: +33 562247686", "first_published_date": "26/07/2010", "last_updated_date": "26/07/2010", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000585-pip01-09" }, { "decision_number": "P/93/2010", "pip_number": "EMEA-000165-PIP02-09", "active_substance": "sitagliptin phosphate monohydrate;metformin hydrochloride", "invented_name": "Janumet and associated names", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Film-coated tablet;Modified-release tablet", "condition_indication": "Treatment of type II diabetes mellitus", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "02/06/2010", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Merck Sharp & Dohme (Europe), Inc.; Belgium; E-mail: pip.information@merck.com; Tel. +31 412663179; Fax +31 412662571", "first_published_date": "26/07/2010", "last_updated_date": "26/07/2010", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000165-pip02-09" }, { "decision_number": "P/75/2010", "pip_number": "Levonorgestrel", "active_substance": "levonorgestrel", "invented_name": "", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Intrauterine delivery system", "condition_indication": "Contraception", "routes_of_administration": "Intrauterine use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "05/05/2010", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Bayer Schering Pharma AG; E-mail: pediatrics.medical-affairs-europe@bayerhealthcare.com; Country: Germany; Phone: +49 3046815333; Fax: +49 3046895333", "first_published_date": "22/07/2010", "last_updated_date": "22/07/2010", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/levonorgestrel" }, { "decision_number": "P/59/2010", "pip_number": "Esomeprazole magnesium/acetylsalisylic acid", "active_substance": "esomeprazole magnesium;acetylsalicylic acid", "invented_name": "", "therapeutic_area": "Gastroentology-Hepatology", "pharmaceutical_forms": "Capsule", "condition_indication": "Duodenal ulcer;Gastric ulcer", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "23/03/2010", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "AstraZeneca AB (Sweden); Tel. +46 8 5532791; E-mail: paediatrics@astrazeneca.com", "first_published_date": "18/05/2010", "last_updated_date": "18/05/2010", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/esomeprazole-magnesium-acetylsalisylic-acid" }, { "decision_number": "P/47/2010", "pip_number": "Budesonide / salmeterol xinafoate", "active_substance": "Budesonide;salmeterol xinafoate", "invented_name": "", "therapeutic_area": "Pneumology-allergology", "pharmaceutical_forms": "Inhalation powder;Capsule, hard", "condition_indication": "Asthma", "routes_of_administration": "Inhalation use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "31/03/2010", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Laboratoires SMB s.a.; E-mail: regulatory@smb.be; Country: Belgium; Phone: +32 24114828", "first_published_date": "18/05/2010", "last_updated_date": "18/05/2010", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/budesonide-salmeterol-xinafoate" }, { "decision_number": "P/41/2010", "pip_number": "Tartaric acid", "active_substance": "tartaric acid", "invented_name": "", "therapeutic_area": "Uro-nephrology", "pharmaceutical_forms": "Nebuliser solution", "condition_indication": "Stress incontinence, female", "routes_of_administration": "Inhalation use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "31/03/2010", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Pneumoflex E.U. Limited; E-mail: info@interfaceconsultancy.com; Country: United Kingdom; Phone: +44 1377288420; Fax: +44 1377288420", "first_published_date": "18/05/2010", "last_updated_date": "18/05/2010", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/tartaric-acid" }, { "decision_number": "P/57/2010", "pip_number": "Taliglucerase alfa", "active_substance": "taliglucerase alfa", "invented_name": "", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Powder for solution for infusion", "condition_indication": "Gaucher Disease, acute neuronopathic;Gaucher Disease (except acute neuronopathic)", "routes_of_administration": "Intravenous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "09/04/2010", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Protalix B.V.; einata@protalix.com; Israel; Phone: +972 9028100 / ext.137; Fax: +972 9889489", "first_published_date": "18/05/2010", "last_updated_date": "18/05/2010", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/taliglucerase-alfa" }, { "decision_number": "P/23/2010", "pip_number": "Strontium ranelate", "active_substance": "strontium ranelate", "invented_name": "Protelos; Protelos", "therapeutic_area": "Immunology-Rheumatology-Transplantation", "pharmaceutical_forms": "Granules for oral suspension", "condition_indication": "Osteoporosis", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "02/03/2010", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Les Laboratoires ServierE-mail: mail.pip.enquiries@servier.comTel.: +33 155726000", "first_published_date": "19/04/2010", "last_updated_date": "19/04/2010", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/strontium-ranelate" }, { "decision_number": "P/24/2010", "pip_number": "Strontium ranelate", "active_substance": "strontium ranelate", "invented_name": "Osseor; Osseor", "therapeutic_area": "Immunology-Rheumatology-Transplantation", "pharmaceutical_forms": "Granules for oral suspension", "condition_indication": "Osteoporosis", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "02/03/2010", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Les Laboratoires ServierE-mail: mail.pip.enquiries@servier.comTel.: +33 155726000", "first_published_date": "19/04/2010", "last_updated_date": "19/04/2010", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/strontium-ranelate-0" }, { "decision_number": "P/27/2010", "pip_number": "Pramipexole dihydrochloride monohydrate", "active_substance": "pramipexole dihydrochloride monohydrate", "invented_name": "Sifrol; Sifrol", "therapeutic_area": "Neurology", "pharmaceutical_forms": "Immediate release tablet", "condition_indication": "Combined vocal and multiple motor tic disorder (de la Tourette);Restless Legs Syndrome", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "05/03/2010", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "", "first_published_date": "19/04/2010", "last_updated_date": "19/04/2010", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/pramipexole-dihydrochloride-monohydrate-0" }, { "decision_number": "P/26/2010", "pip_number": "EMEA-000391-PIP01-08-M01", "active_substance": "nevirapine", "invented_name": "Viramune; Viramune", "therapeutic_area": "Infectious diseases", "pharmaceutical_forms": "Prolonged-release tablet;Tablet;Oral suspension", "condition_indication": "Treatment of human immunodeficiency virus (HIV-1) infection", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "03/03/2010", "compliance_outcome": "Positive", "compliance_opinion_date": "06/08/2010", "compliance_procedure_number": "EMEA-C-000391-PIP01-08-M01", "contact_for_public_enquiries": "", "first_published_date": "19/04/2010", "last_updated_date": "19/04/2010", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000391-pip01-08-m01" }, { "decision_number": "P/6/2010", "pip_number": "EMEA-000744-PIP01-09", "active_substance": "valsartan;hydrochlorothiazide;amlodipine besilate", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Treatment of hypertension", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "25/01/2010", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Novartis Europharm Ltd.; E-mail: paediatric.enquiries@novartis.com; Country: Switzerland; Phone: +41 61 324 1111; Fax: +41 61 324 8001", "first_published_date": "25/02/2010", "last_updated_date": "25/02/2010", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000744-pip01-09" }, { "decision_number": "P/4/2010", "pip_number": "EMEA-000714-PIP01-09", "active_substance": "Larvae of Lucilia sericata", "invented_name": "", "therapeutic_area": "Other", "pharmaceutical_forms": "Larvae enclosed in a mesh bag with foam pieces", "condition_indication": "Sloughy and necrotic venous and mixed venous/arterial leg ulcers", "routes_of_administration": "Epilesional use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "25/01/2010", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "ZooBiotic Limited; E-mail: enquiries@zoobiotic.co.uk; Country: United Kingdom; Phone: +44 8452301810; Fax: +44 1656668047", "first_published_date": "25/02/2010", "last_updated_date": "25/02/2010", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000714-pip01-09" }, { "decision_number": "P/9/2010", "pip_number": "EMEA-000551-PIP01-09", "active_substance": "givinostat", "invented_name": "", "therapeutic_area": "Immunology-Rheumatology-Transplantation", "pharmaceutical_forms": "Oral suspension", "condition_indication": "Juvenile idiopathic arthritis", "routes_of_administration": "Oral use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "29/01/2010", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Italfarmaco SpA; E-mail: c.durzo@italfarmaco.com; Country: Italy; Phone: +39 0264432584; Fax: +39 0264433554", "first_published_date": "25/02/2010", "last_updated_date": "25/02/2010", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000551-pip01-09" }, { "decision_number": "P/266/2009", "pip_number": "EMEA-000552-PIP01-0", "active_substance": "recombinant human monoclonal antibody to the p40 subunit of human interleukin-12 and human interleukin-23 of the IgG1-class (ABT-874)", "invented_name": "", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Psoriasis vulgaris", "routes_of_administration": "Subcutaneous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "23/12/2009", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Abbott Laboratories Ltd; E-mail: pediatric_oncology_immunology@abbott.com; Country: United Kingdom; Phone: +44 1628644475; Fax: +44 1628644330", "first_published_date": "25/02/2010", "last_updated_date": "25/02/2010", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000552-pip01-0" }, { "decision_number": "P/3/2010", "pip_number": "EMA-000699-PIP01-09", "active_substance": "linagliptin;metformin", "invented_name": "", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Treatment of type II diabetes mellitus", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "25/01/2010", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "", "first_published_date": "25/02/2010", "last_updated_date": "25/02/2010", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/ema-000699-pip01-09" }, { "decision_number": "P/5/2010", "pip_number": "EMEA-000719-PIP01-09", "active_substance": "atorvastatin (L-lysine salt);amlodipine besilate", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Hypertension with dyslipidemia", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "25/01/2010", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Gedeon Richter Plc.; E-mail: mrpRichter@richter.hu; Country: Hungary; Phone: +36 14314040; Fax: +36 14315415", "first_published_date": "25/02/2010", "last_updated_date": "25/02/2010", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000719-pip01-09" }, { "decision_number": "P/241/2009", "pip_number": "Fluorouracil / salicylic acid", "active_substance": "Fluorouracil;salicylic acid", "invented_name": "", "therapeutic_area": "Dermatology", "pharmaceutical_forms": "Solution", "condition_indication": "Treatment of actinic keratosis", "routes_of_administration": "Cutaneous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "01/12/2009", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Almirall Hermal GmbH; E-mail: info@alimirall.de; Country: Germany; Phone: +49 40727040; Fax: +49 407229296", "first_published_date": "25/01/2010", "last_updated_date": "25/01/2010", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/fluorouracil-salicylic-acid" }, { "decision_number": "P/261/2009", "pip_number": "Tramadol hydrochloride, Paracetamol", "active_substance": "tramadol hydrochloride;paracetamol", "invented_name": "", "therapeutic_area": "Pain", "pharmaceutical_forms": "Prolonged-release tablet", "condition_indication": "Pain", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "23/12/2009", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Labopharm Europe Limited; E-mail: info@labopharm.com; Country: Ireland; Phone: +353 18540140; Fax: +353 18540144", "first_published_date": "25/01/2010", "last_updated_date": "25/01/2010", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/tramadol-hydrochloride-paracetamol" }, { "decision_number": "P/251/2009", "pip_number": "Amlodipine besilate / bisoprolol fumarate", "active_substance": "amlodipine besilate;Bisoprolol fumarate", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Tablet", "condition_indication": "Chronic stable angina pectoris;Treatment of hypertension", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "18/12/2009", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "EGIS Pharmaceuticals PLC; E-mail: regulatory@egis.hu; Country:  Hungary; Phone: +36 14692414; Fax: +36 14692415", "first_published_date": "25/01/2010", "last_updated_date": "25/01/2010", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/amlodipine-besilate-bisoprolol-fumarate" }, { "decision_number": "P/260/2009", "pip_number": "Tramadol hydrochloride, Paracetamol", "active_substance": "tramadol hydrochloride;paracetamol", "invented_name": "", "therapeutic_area": "Pain", "pharmaceutical_forms": "Prolonged-release tablet", "condition_indication": "Pain", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "23/12/2009", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Labopharm Europe Limited; E-mail: info@labopharm.com; Country: Ireland; Phone: +353 18540140; Fax: +353 18540144", "first_published_date": "25/01/2010", "last_updated_date": "25/01/2010", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/tramadol-hydrochloride-paracetamol-0" }, { "decision_number": "P/258/2009", "pip_number": "Fentanyl citrate", "active_substance": "Fentanyl citrate", "invented_name": "", "therapeutic_area": "Pain", "pharmaceutical_forms": "Nasal spray;Solution", "condition_indication": "Acute pain", "routes_of_administration": "Nasal use", "decision_type": "RP: decision refers to a refusal on a proposed Paediatric Investigation Plan", "decision_date": "23/12/2009", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Nycomed Danmark ApS; E-mail: corporatecommunications@nycomed.com; Country: Switzerland; Phone: +41 445551510", "first_published_date": "25/01/2010", "last_updated_date": "25/01/2010", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/fentanyl-citrate" }, { "decision_number": "P/240/2009", "pip_number": "Saxagliptin / metformin", "active_substance": "saxagliptin;Metformin", "invented_name": "", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Treatment of type II diabetes mellitus", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "01/12/2009", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Bristol-Myers Squibb / AstraZeneca EEIG; Email: medical.information@bms.com; Tel.: +44 1895523740", "first_published_date": "25/01/2010", "last_updated_date": "25/01/2010", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/saxagliptin-metformin" }, { "decision_number": "P/259/2009", "pip_number": "EMEA-000564-PIP01-09", "active_substance": "paracetamol;Ibuprofen", "invented_name": "", "therapeutic_area": "Pain", "pharmaceutical_forms": "Film-coated tablet;Suspension", "condition_indication": "Acute pain", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "23/12/2009", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Vale Pharmaceuticals Limited; E-mail: majella.ryan@ivowen.com; Country: Ireland; Phone: +353 526180664; Fax: +353 526180665", "first_published_date": "25/01/2010", "last_updated_date": "25/01/2010", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000564-pip01-09" }, { "decision_number": "P/255/2009", "pip_number": "Allogeneic ex vivo expanded umbilical cord blood cells", "active_substance": "allogeneic ex vivo expanded umbilical cord blood cells", "invented_name": "", "therapeutic_area": "Haematology-Hemostaseology", "pharmaceutical_forms": "Solution for infusion", "condition_indication": "Treatment of acute lymphoblastic leukaemia;Treatment of acute myeloid leukaemia;Treatment of chronic myeloid leukaemia (CML);Treatment of Hodgkin lymphoma;Treatment of myelodysplastic syndromes;Treatment of non-Hodgkin lymphoma", "routes_of_administration": "Intravenous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "22/12/2009", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Teva Pharma GmbH; E-mail: Ekkehard.Baader@TEVA.DE; Country: Germany; Phone: +49 61059767617; Fax: +49 61059767660", "first_published_date": "25/01/2010", "last_updated_date": "25/01/2010", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/allogeneic-ex-vivo-expanded-umbilical-cord-blood-cells" }, { "decision_number": "P/264/2009", "pip_number": "EMEA-000492-PIP01-08-M01", "active_substance": "moxifloxacin hydrochloride", "invented_name": "Actimax and associated names", "therapeutic_area": "Infectious diseases", "pharmaceutical_forms": "Film-coated tablet;Solution for infusion;Granules and solvent for oral suspension", "condition_indication": "Acute Exacerbation of Chronic Bronchitis;Community Acquired Pneumonia;Complicated Intra-Abdominal Infection;Complicated Skin and Skin Structure Infections;Pelvic Inflammatory Disease;Treatment of acute bacterial sinusitis", "routes_of_administration": "Oral use;Intravenous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "23/12/2009", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Bayer Schering Pharma AG; E-mail: steven.kowalsky@bayer.com; Country: United States; Phone: +1 9734872107", "first_published_date": "25/01/2010", "last_updated_date": "25/01/2010", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000492-pip01-08-m01" }, { "decision_number": "P/256/09", "pip_number": "EMEA-000612-PIP01-09", "active_substance": "nitric oxide", "invented_name": "INOmax; INOmax", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Inhalation gas", "condition_indication": "Other pulmonary heart disease;Persistent Pulmonary Hypertension", "routes_of_administration": "Endotracheopulmonary use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "22/12/2009", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "INO Therapeutics AB; E-mail: Cecilia.dahlgren@linde-gas.com; Country: Sweden; Phone: +46 702500055; Fax: +46 87655287", "first_published_date": "25/01/2010", "last_updated_date": "25/01/2010", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000612-pip01-09" }, { "decision_number": "P/242/2009", "pip_number": "EMEA-000281-PIP01-08-M02", "active_substance": "recombinant human monoclonal antibody of the IgG1 class to insulin-like growth factor-1 receptor (RO4858696)", "invented_name": "", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Powder for concentrate for solution for infusion", "condition_indication": "Ewing sarcoma family of tumours (including Ewing sarcoma of bone, peripheral primitive neuroectodermal tumour, extraskeletal Ewing sarcoma, and Askin tumour)", "routes_of_administration": "Intravenous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "02/12/2009", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Roche Registration Limited; E-mail: info.paediatrics@roche.com; Tel.: +41 616879411", "first_published_date": "25/01/2010", "last_updated_date": "25/01/2010", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000281-pip01-08-m02" }, { "decision_number": "P/265/2009", "pip_number": "EMEA-000493-PIP01-08-M01", "active_substance": "moxifloxacin hydrochloride", "invented_name": "Actira and associated names", "therapeutic_area": "Infectious diseases", "pharmaceutical_forms": "Film-coated tablet;Solution for infusion;Granules and solvent for oral suspension", "condition_indication": "Acute Exacerbation of Chronic Bronchitis;Community Acquired Pneumonia;Complicated Intra-Abdominal Infection;Complicated Skin and Skin Structure Infections;Pelvic Inflammatory Disease;Treatment of acute bacterial sinusitis", "routes_of_administration": "Oral use;Intravenous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "23/12/2009", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Bayer Schering Pharma AG; E-mail: steven.kowalsky@bayer.com; Country: United States; Phone: +1 9734872107", "first_published_date": "25/01/2010", "last_updated_date": "25/01/2010", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000493-pip01-08-m01" }, { "decision_number": "P/263/2009", "pip_number": "EMEA-000491-PIP01-08-M01", "active_substance": "moxifloxacin hydrochloride", "invented_name": "Octegra and associated names", "therapeutic_area": "Infectious diseases", "pharmaceutical_forms": "Film-coated tablet;Solution for infusion;Granules and solvent for oral suspension", "condition_indication": "Acute Exacerbation of Chronic Bronchitis;Community Acquired Pneumonia;Complicated Intra-Abdominal Infection;Complicated Skin and Skin Structure Infections;Pelvic Inflammatory Disease;Treatment of acute bacterial sinusitis", "routes_of_administration": "Oral use;Intravenous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "23/12/2009", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Bayer Schering Pharma AG; E-mail: steven.kowalsky@bayer.com; Country: United States; Phone: +1 9734872107", "first_published_date": "25/01/2010", "last_updated_date": "25/01/2010", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000491-pip01-08-m01" }, { "decision_number": "P/236/2009", "pip_number": "EMEA-000656-PIP01-09", "active_substance": "aliskiren hemifumarate;amlodipine besilate;hydrochlorothiazide", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Essential hypertension", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "27/11/2009", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Novartis Europharm Ltd.; E-mail: paediatric.enquiries@novartis.com; Country: Switzerland; Phone: +41 61 324 1111; Fax: +41 61 324 8001", "first_published_date": "23/12/2009", "last_updated_date": "23/12/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000656-pip01-09" }, { "decision_number": "P/235/2009", "pip_number": "EMEA-000631-PIP01-09", "active_substance": "simvastatin;ramipril;acetyl salicylic acid", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Capsule, hard", "condition_indication": "Prevention of Ischaemic Heart Disease", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "27/11/2009", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Ferrer Internacional, S.A; E-mail: jrandreu@ferrergrupo.com / silviamartin@ferrergrupo.com; Phone: +34 936003801 / +34 935093227", "first_published_date": "23/12/2009", "last_updated_date": "23/12/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000631-pip01-09" }, { "decision_number": "P/220/2009", "pip_number": "Latanoprost", "active_substance": "Latanoprost", "invented_name": "Xalatan", "therapeutic_area": "Ophthalmology", "pharmaceutical_forms": "Eye drops, solution", "condition_indication": "Treatment of glaucoma", "routes_of_administration": "Ocular use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "03/11/2009", "compliance_outcome": "Positive", "compliance_opinion_date": "19/03/2010", "compliance_procedure_number": "EMEA-C-000011-PIP01-07-M03", "contact_for_public_enquiries": "Pfizer Global Research & Development; E-mail: PIP_Enquiries@pfizer.com; Country: United Kingdom; Phone: +44 13046446607; Fax: +44 1304646607 ", "first_published_date": "23/12/2009", "last_updated_date": "23/12/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/latanoprost" }, { "decision_number": "P/221/2009", "pip_number": "Soluble yeast beta-1,3/1,6-glucan", "active_substance": "soluble yeast beta-1,3/1,6-glucan", "invented_name": "", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Cutaneous solution", "condition_indication": "Treatment of diabetic foot ulcer", "routes_of_administration": "Cutaneous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "03/11/2009", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Biotec Pharmacon ASA; E-mail: info@biotec.no; Country: Norway; Phone: +47 77648900; Fax: +4777648901", "first_published_date": "23/12/2009", "last_updated_date": "23/12/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/soluble-yeast-beta-13-16-glucan" }, { "decision_number": "P/228/2009", "pip_number": "Olmesartan medoxomil / amlodipine besilate / hydrochlorothiazide", "active_substance": "olmesartan medoxomil;amlodipine besilate;hydrochlorothiazide", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Essential hypertension", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "04/11/2009", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Daiichi Sankyo Europe GmbH; E-mail: service@daiichi-sankyo.eu; Country: Germany; Phone: +49 8978080; Fax: +49 897808267", "first_published_date": "23/12/2009", "last_updated_date": "23/12/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/olmesartan-medoxomil-amlodipine-besilate-hydrochlorothiazide" }, { "decision_number": "P/226/2009", "pip_number": "Olmesartan medoxomil / amlodipine besilate / hydrochlorothiazide", "active_substance": "olmesartan medoxomil;amlodipine besilate;hydrochlorothiazide", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Essential hypertension", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "04/11/2009", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Daiichi Sankyo Europe GmbH; E-mail: service@daiichi-sankyo.eu; Country: Germany; Phone: +49 8978080; Fax: +49 897808267", "first_published_date": "23/12/2009", "last_updated_date": "23/12/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/olmesartan-medoxomil-amlodipine-besilate-hydrochlorothiazide-0" }, { "decision_number": "P/230/2009", "pip_number": "EMEA-000658-PIP01-08", "active_substance": "nomegestrol acetate;17 beta-estradiol", "invented_name": "", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Contraception", "routes_of_administration": "Oral use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "13/11/2009", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "NV Organon (part of Schering Plough); Tel.+ 33 180 464 738; E-mail: pip.information@merck.com", "first_published_date": "23/12/2009", "last_updated_date": "23/12/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000658-pip01-08" }, { "decision_number": "P/227/2009", "pip_number": "Olmesartan medoxomil / amlodipine besilate / hydrochlorothiazide", "active_substance": "olmesartan medoxomil;amlodipine besilate;hydrochlorothiazide", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Essential hypertension", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "04/11/2009", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Daiichi Sankyo Europe GmbH; E-mail: service@daiichi-sankyo.eu; Country: Germany; Phone: +49 8978080; Fax: +49 897808267", "first_published_date": "23/12/2009", "last_updated_date": "23/12/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/olmesartan-medoxomil-amlodipine-besilate-hydrochlorothiazide-1" }, { "decision_number": "P/201/2009", "pip_number": "Ibuprofen / Famotidine", "active_substance": "Ibuprofen;Famotidine", "invented_name": "", "therapeutic_area": "Pain", "pharmaceutical_forms": "Tablet", "condition_indication": "Chronic pain due to arthropathies", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "09/10/2009", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Horizon Therapeutics Inc.; E-mail: twalbert@horizontherapeutics.com; Tel.: +1 2243833000", "first_published_date": "07/12/2009", "last_updated_date": "07/12/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/ibuprofen-famotidine" }, { "decision_number": "P/183/2009", "pip_number": "EMEA-000527-PIP01-08", "active_substance": "ranibizumab", "invented_name": "Lucentis; Lucentis", "therapeutic_area": "Ophthalmology", "pharmaceutical_forms": "Solution for injection in a vial;Solution for injection in pre-filled syringe", "condition_indication": "Visual impairment due to diabetic macular edema;Visual impairment due to macular edema associated with branch retinal vein occlusion;Visual impairment due to macular edema associated with central retinal vein occlusion", "routes_of_administration": "Intravitreal use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "07/09/2009", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Novartis Europharm LimitedE-mail: paediatric.enquiries@novartis.comTel. +41 613241111", "first_published_date": "07/12/2009", "last_updated_date": "07/12/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000527-pip01-08" }, { "decision_number": "P/190/2009", "pip_number": "Clopidogrel", "active_substance": "clopidogrel", "invented_name": "Clopidogrel BMS; Clopidogrel BMS", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Age appropriate oral formulation;Film-coated tablet", "condition_indication": "Thromboembolic events", "routes_of_administration": "Oral use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "22/09/2009", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Bristol-Myers Squibb Pharma EEIG; E-mail: sylvie.gabriel@sanofi-aventis.com; Country: France; Phone: +33 153774152; Fax: +33 153774133", "first_published_date": "07/12/2009", "last_updated_date": "07/12/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/clopidogrel-1" }, { "decision_number": "P/215/2009", "pip_number": "Ulipristal acetate", "active_substance": "ulipristal acetate", "invented_name": "", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Tablet", "condition_indication": "Leiomyoma of uterus", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "30/10/2009", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "PregLem SA; E-mail: info@preglem.com; Country: Switzerland; Phone: +41 228840340; Fax: +41 228840349", "first_published_date": "07/12/2009", "last_updated_date": "07/12/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/ulipristal-acetate" }, { "decision_number": "P/217/2009", "pip_number": "Chloroprocaine hydrochloride", "active_substance": "chloroprocaine hydrochloride", "invented_name": "", "therapeutic_area": "Anaesthesiology", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Intrathecal anaesthesia", "routes_of_administration": "Intrathecal use", "decision_type": "RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)", "decision_date": "30/10/2009", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Sintetica Italia S.r.l; E-mail: italia@sintetica.com; Country: Switzerland; Phone: +41 916404250; Fax: +41 916468561", "first_published_date": "07/12/2009", "last_updated_date": "07/12/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/chloroprocaine-hydrochloride" }, { "decision_number": "P/208/2009", "pip_number": "Skimmed cow's milk powder", "active_substance": "skimmed cow's milk powder", "invented_name": "Diallertest", "therapeutic_area": "Other", "pharmaceutical_forms": "Cutaneous patch", "condition_indication": "Cow's milk allergy", "routes_of_administration": "Cutaneous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "30/10/2009", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "DBV Technologies; E-mail: isabelle.pascal@dbv-technologies.com / laurent.martin@dbv-technologies.com; Country: France; Phone: +33 155427895; Fax: +33 143261083", "first_published_date": "07/12/2009", "last_updated_date": "07/12/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/skimmed-cows-milk-powder" }, { "decision_number": "P/177/2009", "pip_number": "EMEA-000315-PIP01-08", "active_substance": "6,7-dihydro-5H-pyrrolo[1,2-c] imidazol-5-yl) - (benzo derivative)", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Treatment of hypertension", "routes_of_administration": "Oral use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "07/09/2009", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Recordati Rare Diseases; Tel. +33 1 47 73 64 58; E-mail: RRDinfo@recordati.com", "first_published_date": "07/12/2009", "last_updated_date": "07/12/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000315-pip01-08" }, { "decision_number": "P/203/2009", "pip_number": "EMEA-000565-PIP01-09", "active_substance": "Dirucotide acetate", "invented_name": "", "therapeutic_area": "Neurology", "pharmaceutical_forms": "Lyophilisate for solution for injection", "condition_indication": "Secondary progressive multiple sclerosis", "routes_of_administration": "Intravenous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "15/10/2009", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Eli Lilly & Company Limited; E-mail: eu_paediatric@lilly.com ; Tel. +44 (0)1276 483000", "first_published_date": "07/12/2009", "last_updated_date": "07/12/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000565-pip01-09" }, { "decision_number": "P/189/2009", "pip_number": "Clopidogrel", "active_substance": "clopidogrel", "invented_name": "Clopidogrel Zentiva (previously Clopidogrel Winthrop); 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E-mail: regaffairseurope@organon.com; Tel: +31 412770000", "first_published_date": "07/12/2009", "last_updated_date": "07/12/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000012-pip01-07-m01" }, { "decision_number": "P/218/2009", "pip_number": "Aluminium hydroxide adsorbed, depigmented glutaraldehyde polymerized, allergenic extract of birch, alder and hazel pollen", "active_substance": "aluminium hydroxide adsorbed;depigmented glutaraldehyde polymerised;birch pollen;alder pollen;hazel pollen", "invented_name": "", "therapeutic_area": "Pneumology-allergology", "pharmaceutical_forms": "Suspension for injection (multidose vial)", "condition_indication": "Treatment of allergic rhinitis;Treatment of allergic rhinoconjunctivitis due to pollen", "routes_of_administration": "Subcutaneous use", "decision_type": "RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)", "decision_date": "30/10/2009", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "LETI Pharma GmbH; E-mail: renner@leti.de; Country: Germany; Phone: +49 2302202860; Fax: +49 23022028620", "first_published_date": "07/12/2009", "last_updated_date": "07/12/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/aluminium-hydroxide-adsorbed-depigmented-glutaraldehyde-polymerized-allergenic-extract-birch-alder-hazel-pollen" }, { "decision_number": "P/209/2009", "pip_number": "EMEA-000331-PIP01-08-M01", "active_substance": "esomeprazole magnesium trihydrate;esomeprazole sodium", "invented_name": "Nexium Control; Nexium and associated names", "therapeutic_area": "Gastroentology-Hepatology", "pharmaceutical_forms": "Gastro-resistant tablet;Gastro-resistant granules for oral suspension;Powder for solution for injection or infusion", "condition_indication": "Duodenal ulcer;Gastric ulcer;Gastro-oesophageal reflux disease;Peptic ulcer, site unspecified;Zollinger-Ellison syndrome", "routes_of_administration": "Intravenous use;Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "30/10/2009", "compliance_outcome": "Positive", "compliance_opinion_date": "16/07/2010", "compliance_procedure_number": "EMEA-C-000331-PIP01-08-M01", "contact_for_public_enquiries": "AstraZeneca AB (Sweden); Tel. +46 8 5532791; E-mail: paediatrics@astrazeneca.com", "first_published_date": "07/12/2009", "last_updated_date": "07/12/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000331-pip01-08-m01" }, { "decision_number": "P/191/2009", "pip_number": "Alanine, arginine, aspartic acid, cysteine/cystine, glutamic acid, glycine, histidine, isoleucine, leucine, lysine monohydrate, methionine, ornithine hydrochloride, phenylalanine, proline, serine, taurine, threonine, tryptophan, tyrosine, valine; sod...", "active_substance": "alanine;arginine;aspartic acid;cysteine;cystine;glutamic acid;glycine;histidine;isoleucine;leucine;lysine monohydrate;methionine;ornithine hydrochloride;phenylalanine;proline;serine;taurine;threonine;tryptophan;tyrosine;valine;sodium chloride;potassium acetate;magnesium acetate tetrahydrate;calcium chloride;sodium glycerophosphate;glucose;soya bean oil;olive oil", "invented_name": "", "therapeutic_area": "Nutrition", "pharmaceutical_forms": "Solution for infusion", "condition_indication": "Parenteral nutrition", "routes_of_administration": "Intravenous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "02/10/2009", "compliance_outcome": "Positive", "compliance_opinion_date": "16/10/2009", "compliance_procedure_number": "EMEA-C-000112-PIP01-07-M01", "contact_for_public_enquiries": "Baxter World Trade SPRL; E-mail: jacek_bedkowski@baxter.com; Country: Belgium; Phone: +32 26501850; Fax: +32 26501679", "first_published_date": "07/12/2009", "last_updated_date": "07/12/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/alanine-arginine-aspartic-acid-cysteine-cystine-glutamic-acid-glycine-histidine-isoleucine-leucine-lysine-monohydrate-methionine-ornithine-hydrochloride-phenylalanine-proline-serine-taurine-threonine" }, { "decision_number": "P/214/2009", "pip_number": "EMEA-000487-PIP01-08", "active_substance": "bromocriptine (mesilate)", "invented_name": "", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Tablet", "condition_indication": "Treatment of type II diabetes mellitus", "routes_of_administration": "Oral use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "30/10/2009", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "VeroScience EU Ltd; E-mail: Paeds-Enquiries@veroscience.com; Country: United States; Phone: +1 5085320832; Fax: +1 4018160524", "first_published_date": "07/12/2009", "last_updated_date": "07/12/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000487-pip01-08" }, { "decision_number": "P/216/2009", "pip_number": "Aluminium hydroxide adsorbed, depigmented glutaraldehyde polymerized allergic extract of birch pollen", "active_substance": "aluminium hydroxide adsorbed;depigmented glutaraldehyde polymerised;birch pollen", "invented_name": "", "therapeutic_area": "Pneumology-allergology", "pharmaceutical_forms": "Suspension for injection (multidose vial)", "condition_indication": "Treatment of allergic rhinitis;Treatment of allergic rhinoconjunctivitis due to pollen", "routes_of_administration": "Subcutaneous use", "decision_type": "RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)", "decision_date": "30/10/2009", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "LETI Pharma GmbH; E-mail: renner@leti.de; Country: Germany; Phone: +49 2302202860; Fax: +49 23022028620", "first_published_date": "07/12/2009", "last_updated_date": "07/12/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/aluminium-hydroxide-adsorbed-depigmented-glutaraldehyde-polymerized-allergic-extract-birch-pollen" }, { "decision_number": "P/195/2009", "pip_number": "EMEA-000611-PIP01-09", "active_substance": "pegaptanib sodium", "invented_name": "Macugen; Macugen", "therapeutic_area": "Ophthalmology", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Diabetic retinopathy", "routes_of_administration": "Intravitreal use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "07/10/2009", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Pfizer Global Research & Development; E-mail: PIP_Enquiries@pfizer.com; Country: United Kingdom; Phone: +44 13046446607; Fax: +44 1304646607 ", "first_published_date": "07/12/2009", "last_updated_date": "07/12/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000611-pip01-09" }, { "decision_number": "P/204/2009", "pip_number": "EMEA-000436-PIP01-08", "active_substance": "mannitol", "invented_name": "", "therapeutic_area": "Pneumology-allergology", "pharmaceutical_forms": "Inhalation powder;Capsule, hard", "condition_indication": "Cystic fibrosis with pulmonary disease", "routes_of_administration": "Inhalation use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "21/10/2009", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Pharmaxis Pharmaceuticals Limited; E-mail: med.info@pharmaxis.com.au; Tel.: +61 294547257", "first_published_date": "07/12/2009", "last_updated_date": "07/12/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000436-pip01-08" }, { "decision_number": "P/161/2009", "pip_number": "Testosterone", "active_substance": "testosterone", "invented_name": "", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Transdermal patch", "condition_indication": "Treatment of hypoactive sexual desire disorder", "routes_of_administration": "Transdermal use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "11/08/2009", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Procter & Gamble Pharmaceuticals UK Ltd; E-mail: Medinfo.im@pg.com; Country: Germany; Phone: +49 1726583443; Fax: +49 6196891378", "first_published_date": "22/10/2009", "last_updated_date": "22/10/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/testosterone" }, { "decision_number": "P/169/2009", "pip_number": "Sitagliptin phosphate monohydrate / simvastatin", "active_substance": "sitagliptin phosphate monohydrate;simvastatin", "invented_name": "", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "28/08/2009", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Merck Sharp & Dohme (Europe), Inc.; Belgium; E-mail: pip.information@merck.com; Tel. +31 412663179; Fax +31 412662571", "first_published_date": "22/10/2009", "last_updated_date": "22/10/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/sitagliptin-phosphate-monohydrate-simvastatin" }, { "decision_number": "P/170/2009", "pip_number": "Simvastatin / sitagliptin phosphate monohydrate", "active_substance": "simvastatin;sitagliptin phosphate monohydrate", "invented_name": "", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "28/08/2009", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Merck Sharp & Dohme (Europe), Inc.; Belgium; E-mail: pip.information@merck.com; Tel. +31 412663179; Fax +31 412662571", "first_published_date": "22/10/2009", "last_updated_date": "22/10/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/simvastatin-sitagliptin-phosphate-monohydrate" }, { "decision_number": "P/171/2009", "pip_number": "Sitagliptin phosphate monohydrate / simvastatin", "active_substance": "sitagliptin phosphate monohydrate;simvastatin", "invented_name": "", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "28/08/2009", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Merck Sharp & Dohme (Europe), Inc.; Belgium; E-mail: pip.information@merck.com; Tel. +31 412663179; Fax +31 412662571", "first_published_date": "22/10/2009", "last_updated_date": "22/10/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/sitagliptin-phosphate-monohydrate-simvastatin-0" }, { "decision_number": "P/163/2009", "pip_number": "EMEA-000557-PIP01-09", "active_substance": "patupilone", "invented_name": "", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Concentrate for solution for infusion", "condition_indication": "Malignant neoplasm of other and unspecified genital organs - Fallopian tube (oviduct, uterine tube);Malignant neoplasm of the retroperitoneum and peritoneum - Peritoneum, unspecified", "routes_of_administration": "Intravenous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "12/08/2009", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Novartis Europharm LimitedE-mail: paediatric.enquiries@novartis.comTel. +41 613241111", "first_published_date": "22/10/2009", "last_updated_date": "22/10/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000557-pip01-09" }, { "decision_number": "W/185/2009", "pip_number": "Tramadol / paracetamol", "active_substance": "tramadol;paracetamol", "invented_name": "", "therapeutic_area": "Pain", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Moderate to severe pain", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "07/09/2009", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "TEVA Pharma B.V.; E-mail: sandy.eisen@tevauk.com; Country: United Kingdom; Phone: +44 7921495663", "first_published_date": "22/10/2009", "last_updated_date": "22/10/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/tramadol-paracetamol" }, { "decision_number": "P/157/2009", "pip_number": "EMEA-000521-PIP01-08", "active_substance": "5-aminolevulinic acid hydrochloride", "invented_name": "", "therapeutic_area": "Dermatology", "pharmaceutical_forms": "Gel", "condition_indication": "Treatment of actinic keratosis", "routes_of_administration": "Cutaneous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "11/08/2009", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Biofrontera Bioscience GmbHE-mail: r.gahlmann@biofrontera.comPhone: +49 214876320", "first_published_date": "22/10/2009", "last_updated_date": "22/10/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000521-pip01-08" }, { "decision_number": "P/181/2009", "pip_number": "EMEA-000513-PIP01-08", "active_substance": "paracetamol;opium", "invented_name": "", "therapeutic_area": "Pain", "pharmaceutical_forms": "Capsule, hard", "condition_indication": "Pain", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "07/09/2009", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Solvay Pharma; E-mail: jean-pascal.yaher@solvay.com; Country: France; Phone: +33 146258513; Fax: +33 146258626", "first_published_date": "22/10/2009", "last_updated_date": "22/10/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000513-pip01-08" }, { "decision_number": "P/158/2009", "pip_number": "Desvenlafaxine succinate monohydrate", "active_substance": "Desvenlafaxine succinate monohydrate", "invented_name": "", "therapeutic_area": "Psychiatry", "pharmaceutical_forms": "Prolonged-release tablet", "condition_indication": "Treatment of major depressive disorder", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "11/08/2009", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Laboratorios Almirall S.A.; E-mail: fernando.ferrer@almirall.es; Country: Spain; Phone: +34 932913667; Fax: +34 932912813", "first_published_date": "22/10/2009", "last_updated_date": "22/10/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/desvenlafaxine-succinate-monohydrate" }, { "decision_number": "P/166/2009", "pip_number": "Live bacterium B. thetaiotaomicron", "active_substance": "Live bacterium B. thetaiotaomicron", "invented_name": "", "therapeutic_area": "Gastroentology-Hepatology", "pharmaceutical_forms": "Live Bacteria in an Enteric Coated Capsule", "condition_indication": "Treatment of Crohn's disease", "routes_of_administration": "Oral use", "decision_type": "RP: decision refers to a refusal on a proposed Paediatric Investigation Plan", "decision_date": "21/08/2009", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "4D Pharma Research LtdE-mail: katrina.lawrie@4dpharmaplc.comTel. +44 (0)1224 437369", "first_published_date": "22/10/2009", "last_updated_date": "22/10/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/live-bacterium-b-thetaiotaomicron" }, { "decision_number": "P/160/2009", "pip_number": "EMEA-000571-PIP01-09", "active_substance": "testosterone", "invented_name": "", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Transdermal patch", "condition_indication": "Treatment of hypoactive sexual desire disorder", "routes_of_administration": "Transdermal use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "11/08/2009", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Procter & Gamble Pharmaceuticals UK Ltd; E-mail: Medinfo.im@pg.com; Country: Germany; Phone: +49 1726583443; Fax: +49 6196891378", "first_published_date": "22/10/2009", "last_updated_date": "22/10/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000571-pip01-09" }, { "decision_number": "P/155/2009", "pip_number": "EMEA-000395-PIP01-08", "active_substance": "Midazolam Hydrochloride", "invented_name": "Buccolam", "therapeutic_area": "Neurology", "pharmaceutical_forms": "Oromucosal solution", "condition_indication": "Epileptic seizures", "routes_of_administration": "Oromucosal use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "11/08/2009", "compliance_outcome": "Positive", "compliance_opinion_date": "06/08/2010", "compliance_procedure_number": "EMEA-C-000395-PIP01-08", "contact_for_public_enquiries": "Auralis Limited; E-mail: medinfo@auralis.co.uk; Country: United Kingdom; Phone: +44 1748828868; Fax: +44 8703837414", "first_published_date": "22/10/2009", "last_updated_date": "22/10/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000395-pip01-08" }, { "decision_number": "P/156/2009", "pip_number": "EMEA-000411-PIP01-08", "active_substance": "mifepristone;misoprostol", "invented_name": "", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Tablet", "condition_indication": "Medical Abortion", "routes_of_administration": "Oral use;Vaginal use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "11/08/2009", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Sun Pharmaceutical Industries Europe B.V.; E-mail: secretary.netherlands@sunpharma-europe.com; Country: Netherlands; Phone: +31 235685501; Fax: +31 235685505", "first_published_date": "22/10/2009", "last_updated_date": "22/10/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000411-pip01-08" }, { "decision_number": "P/182/2009", "pip_number": "EMEA-000514-PIP01-08", "active_substance": "paracetamol;opium", "invented_name": "", "therapeutic_area": "Pain", "pharmaceutical_forms": "Capsule, hard", "condition_indication": "Pain", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "07/09/2009", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Solvay Pharma; E-mail: jean-pascal.yaher@solvay.com; Country: France; Phone: +33 146258513; Fax: +33 146258626", "first_published_date": "22/10/2009", "last_updated_date": "22/10/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000514-pip01-08" }, { "decision_number": "P/125/2009", "pip_number": "EMEA-000005-PIP01-07-M01", "active_substance": "valsartan", "invented_name": "Diovan", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Film-coated tablet;Age appropriate oral liquid dosage formulation", "condition_indication": "Heart failure following recent myocardial infarction;Treatment of heart failure;Treatment of hypertension", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "26/06/2009", "compliance_outcome": "Positive", "compliance_opinion_date": "21/08/2009", "compliance_procedure_number": "EMEA-C-000005-PIP01-07-M01", "contact_for_public_enquiries": "Novartis Europharm LimitedE-mail: paediatric.enquiries@novartis.comTel. +41 613241111", "first_published_date": "22/10/2009", "last_updated_date": "22/10/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000005-pip01-07-m01" }, { "decision_number": "P/175/2009", "pip_number": "EMEA-000042-PIP01-07", "active_substance": "N-Acetyl-L-Cysteine (corresponds to L-Cysteine), L-Alanine, L-Alanyl-L-Glutamine (corresponds to L-Alanine and L-Glutamine), L-Arginine, Glycine, Glycyl-L-Tyrosine (corresponds to Glycine and L-Tyrosine), L-Histidine, L-Isoleucine, L-Leucine, L-Lysine acetate (corresponds to L-Lysine), LMethionine, L-Phenylalanine, L-Proline, L-Serine, Taurine, L-Threonine, L-Tryptophan, L-Valine", "invented_name": "", "therapeutic_area": "Nutrition", "pharmaceutical_forms": "Solution for infusion", "condition_indication": "Supplementation of amino-acids where parenteral nutrition is required.", "routes_of_administration": "Intravenous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "07/09/2009", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Fresenius Kabi Deutschland GmbH; E-mail: pr-fre@fresenius.com; Country: Germany; Phone: +49 61726080; Fax: +49 61726082294", "first_published_date": "22/10/2009", "last_updated_date": "22/10/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000042-pip01-07" }, { "decision_number": "P/188/2009", "pip_number": "Vicriviroc maleate", "active_substance": "vicriviroc maleate", "invented_name": "", "therapeutic_area": "Infectious diseases", "pharmaceutical_forms": "Tablet", "condition_indication": "Treatment of human immunodeficiency virus (HIV-1) infection", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "11/09/2009", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Schering-Plough Europe; E-mail: paediatric@spcorp.com; Country: Netherlands; Phone: +31 412662755; Fax: +31 412662571", "first_published_date": "22/10/2009", "last_updated_date": "22/10/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/vicriviroc-maleate" }, { "decision_number": "P/172/2009", "pip_number": "Sitagliptin phosphate monohydrate / simvastatin", "active_substance": "sitagliptin phosphate monohydrate;simvastatin", "invented_name": "", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "07/09/2009", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Merck Sharp & Dohme (Europe), Inc.; Belgium; E-mail: pip.information@merck.com; Tel. +31 412663179; Fax +31 412662571", "first_published_date": "22/10/2009", "last_updated_date": "22/10/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/sitagliptin-phosphate-monohydrate-simvastatin-1" }, { "decision_number": "P/140/2009", "pip_number": "Estradiol valerate / Dienogest", "active_substance": "Estradiol valerate;Dienogest", "invented_name": "Qlaira", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Excessive, frequent and irregular menstruation;Contraception", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "15/07/2009", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Bayer Schering Pharma AG; E-mail: pediatrics.medical-affairs-europe@bayerhealthcare.com; Country: Germany; Phone: +49 3046815333; Fax: +49 3046895333", "first_published_date": "16/09/2009", "last_updated_date": "16/09/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/estradiol-valerate-dienogest" }, { "decision_number": "P/147/2009", "pip_number": "Aqueous extract of grass pollen from Dactylis glomerata, Festuca pratensis, Holcus lanatus, Lolium perenne, Phleum pratense and Poa pratensis", "active_substance": "aqueous extract of grass pollen from Dactylis glomerata, Festuca pratensis, Holcus lanatus, Lolium perenne, Phleum pratense and Poa pratensis", "invented_name": "", "therapeutic_area": "Pneumology-allergology", "pharmaceutical_forms": "Solution for sublingual use", "condition_indication": "Treatment of rhinitis or rhinoconjunctivitis due to grass pollen", "routes_of_administration": "Sublingual use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "20/07/2009", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Allergopharma J. Ganzer KG; E-mail: Anja.Menzel@Allergopharma.de; Country: Germany; Phone: +49 4072765464; Fax: +49 4072765466", "first_published_date": "16/09/2009", "last_updated_date": "16/09/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/aqueous-extract-grass-pollen-dactylis-glomerata-festuca-pratensis-holcus-lanatus-lolium-perenne-phleum-pratense-poa-pratensis" }, { "decision_number": "P/138/2009", "pip_number": "Omacetaxine mepesuccinate", "active_substance": "omacetaxine mepesuccinate", "invented_name": "", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Powder for solution for injection", "condition_indication": "Philadelphia chromosome positive chronic myeloid leukaemia in patients who have the T315I Bcr-Abl kinase domain mutation and who are resistant to prior imatinib therapy.", "routes_of_administration": "Subcutaneous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "15/07/2009", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "ChemGenex Europe S.A.S.; E-mail: abenichou@chemgenex.com; Country: France; Phone: +33 478429526; Fax: +33 478425571", "first_published_date": "16/09/2009", "last_updated_date": "16/09/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/omacetaxine-mepesuccinate" }, { "decision_number": "P/133/2009", "pip_number": "Insulin glargine", "active_substance": "insulin glargine", "invented_name": "Lantus; Lantus", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Solution for injection;Solution for injection in a vial;Solution for injection in a cartridge", "condition_indication": "Treatment of type I diabetes mellitus;Treatment of type II diabetes mellitus", "routes_of_administration": "Subcutaneous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "15/07/2009", "compliance_outcome": "Positive", "compliance_opinion_date": "18/11/2011", "compliance_procedure_number": "EMEA-C-000387-PIP01-08", "contact_for_public_enquiries": "Sanofi-Aventis Deutschland GmbH; E-mail: sylvie.gabriel@sanofi-aventis.com; Country: France; Phone: + 33 153774152; Fax: 33 153774133", "first_published_date": "16/09/2009", "last_updated_date": "16/09/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/insulin-glargine" }, { "decision_number": "P/139/2009", "pip_number": "Clostridium collagenase", "active_substance": "Clostridium collagenase", "invented_name": "", "therapeutic_area": "Uro-nephrology", "pharmaceutical_forms": "Powder and solvent for solution for injection", "condition_indication": "Dupuytren's Contracture;Peyronie's Disease", "routes_of_administration": "Intralesional use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "15/07/2009", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Pfizer Limited; Tel. + 44 1304646607; E-mail: pip_enquiries@pfizer.com", "first_published_date": "16/09/2009", "last_updated_date": "16/09/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/clostridium-collagenase" }, { "decision_number": "P/136/2009", "pip_number": "Insulin glargine", "active_substance": "insulin glargine", "invented_name": "Toujeo (previously Optisulin); Optisulin", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Solution for injection;Solution for injection in a vial;Solution for injection in a cartridge", "condition_indication": "Treatment of type I diabetes mellitus;Treatment of type II diabetes mellitus", "routes_of_administration": "Subcutaneous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "15/07/2009", "compliance_outcome": "Positive", "compliance_opinion_date": "18/11/2011", "compliance_procedure_number": "EMEA-C-000396-PIP01-08", "contact_for_public_enquiries": "Sanofi-Aventis Deutschland GmbH; E-mail: sylvie.gabriel@sanofi-aventis.com; Country: France; Phone: + 33 153774152; Fax: + 33 153774133", "first_published_date": "16/09/2009", "last_updated_date": "16/09/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/insulin-glargine-0" }, { "decision_number": "P/130/2009", "pip_number": "Drospirenone / ethinylestradiol, betadex clathrate / L-5-methyltetrahydrofolic acid, calcium salt", "active_substance": "drospirenone;L-5-methyltetrahydrofolic acid, calcium salt;ethinylestradiol;betadex clathrate", "invented_name": "", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Contraception;Inappropriate diet and eating habits", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "14/07/2009", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Bayer Schering Pharma AG; E-mail: pediatrics.medical-affairs-europe@bayerhealthcare.com; Country: Germany; Phone: +49 3046815333; Fax: +49 3046895333", "first_published_date": "16/09/2009", "last_updated_date": "16/09/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/drospirenone-ethinylestradiol-betadex-clathrate-l-5-methyltetrahydrofolic-acid-calcium-salt-1" }, { "decision_number": "P/116/2009", "pip_number": "Human plasma proteins", "active_substance": "Human plasma proteins", "invented_name": "", "therapeutic_area": "Haematology-Hemostaseology", "pharmaceutical_forms": "Solution for infusion", "condition_indication": "Thrombotic thrombocytopenic purpura;Treatment of acquired coagulation factor deficiency;Hereditary deficiency of clotting factors", "routes_of_administration": "Intravenous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "16/06/2009", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Octapharma Pharmazeutika Produktionsges.m.b.H; E-mail: medical-affairs@octapharma.com; Country: Austria; Phone: +43 1610321245; Fax: +43 1610329249", "first_published_date": "11/08/2009", "last_updated_date": "11/08/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/human-plasma-proteins" }, { "decision_number": "P/120/2009", "pip_number": "EMEA-000517-PIP01-08", "active_substance": "aliskiren hemifumarate;amlodipine besilate", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Essential hypertension", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "15/06/2009", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Novartis Europharm LimitedE-mail: paediatric.enquiries@novartis.comTel. +41 613241111", "first_published_date": "11/08/2009", "last_updated_date": "11/08/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000517-pip01-08" }, { "decision_number": "P/124/2009", "pip_number": "Colesevelam hydrochloride", "active_substance": "colesevelam hydrochloride", "invented_name": "Cholestagel; Cholestagel", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Heterozygous Familial Hypercholesterolaemia;Homozygous Familial Hypercholesterolaemia", "routes_of_administration": "Oral use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "19/06/2009", "compliance_outcome": "Positive", "compliance_opinion_date": "24/07/2009", "compliance_procedure_number": "EMEA-C-000543-PIP01-09", "contact_for_public_enquiries": "Genzyme Europe B.V.; E-mail: MedInfo@genzyme.com; Tel.: +31 356991499", "first_published_date": "11/08/2009", "last_updated_date": "11/08/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/colesevelam-hydrochloride" }, { "decision_number": "P/122/2009", "pip_number": "Human autologous mesenchymal adult stem cells extracted from adipose tissue", "active_substance": "human autologous mesenchymal adult stem cells extracted from adipose tissue", "invented_name": "", "therapeutic_area": "Gastroentology-Hepatology", "pharmaceutical_forms": "Suspension for injection", "condition_indication": "Treatment of anorectal fistula;Treatment of rectal fistula;Treatment of anal fistula", "routes_of_administration": "Intralesional use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "15/06/2009", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "CELLERIX, S.A.; E-mail: mpascual@cellerix.com; Country: Spain; Phone: +34 918049264; Fax: +34 918049263", "first_published_date": "11/08/2009", "last_updated_date": "11/08/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/human-autologous-mesenchymal-adult-stem-cells-extracted-adipose-tissue" }, { "decision_number": "P/115/2009", "pip_number": "Pravastatin sodium / Fenofibrate", "active_substance": "Pravastatin sodium;fenofibrate", "invented_name": "", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Capsule, hard", "condition_indication": "Disorders of lipoprotein metabolism and other hyperlipidaemias", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "15/06/2009", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Laboratoires SMB s.a.; E-mail: regulatory@smb.be; Country: Belgium; Phone: +32 24114828; Fax: +32 24120991", "first_published_date": "11/08/2009", "last_updated_date": "11/08/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/pravastatin-sodium-fenofibrate" }, { "decision_number": "P/118/2009", "pip_number": "EMEA-000515-PIP01-08", "active_substance": "aliskiren hemifumarate;amlodipine besilate", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Essential hypertension", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "15/06/2009", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Novartis Europharm LimitedE-mail: paediatric.enquiries@novartis.comTel. +41 613241111", "first_published_date": "11/08/2009", "last_updated_date": "11/08/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000515-pip01-08" }, { "decision_number": "P/121/2009", "pip_number": "Dienogest / ethinylestradiol (as betadex clathrate) / L-5-methyltetrahydrofolic acid, calcium salt", "active_substance": "Dienogest;ethinylestradiol bethadex clathrate;L-5-methyltetrahydrofolic acid, calcium salt", "invented_name": "", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Contraception;Inappropriate diet and eating habits;Treatment of acne vulgaris", "routes_of_administration": "Oral use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "15/06/2009", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Bayer Schering Pharma AG; E-mail: pediatrics.medical-affairs-europe@bayerhealthcare.com; Country: Germany; Phone: +49 3046815333; Fax: +49 3046895333", "first_published_date": "11/08/2009", "last_updated_date": "11/08/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/dienogest-ethinylestradiol-betadex-clathrate-l-5-methyltetrahydrofolic-acid-calcium-salt" }, { "decision_number": "P/117/2009", "pip_number": "EMEA-000512-PIP01-08", "active_substance": "recombinant human anti-Rhesus D monoclonal antibody (LFB-R593)", "invented_name": "", "therapeutic_area": "Immunology-Rheumatology-Transplantation", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Rh(D) alloimmunisation", "routes_of_administration": "Intravenous use;Intramuscular use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "16/06/2009", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "LFB Biotechnologies; E-mail: chwedura@lfb.fr; Country: France; Phone: + 33 320494413; Fax: + 33 320494418", "first_published_date": "11/08/2009", "last_updated_date": "11/08/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000512-pip01-08" }, { "decision_number": "P/111/2009", "pip_number": "Human Papillomavirus1 Type 6 L1 protein / Human Papillomavirus1 Type 11 L1 protein / Human Papillomavirus1 Type 16 L1 protein / Human Papillomavirus1 Type 18 L1 protein", "active_substance": "human Papillomavirus1 Type 6 L1 protein;human Papillomavirus1 Type 11 L1 protein;human papillomavirus1 type 16 L1 protein;human Papillomavirus1 Type 18 L1 protein", "invented_name": "Silgard; Silgard", "therapeutic_area": "Vaccines", "pharmaceutical_forms": "Suspension for injection;Suspension for injection in pre-filled syringe", "condition_indication": "Infection by Human Papillomavirus", "routes_of_administration": "Intramuscular use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "16/06/2009", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Merck Sharp & Dohme (Europe) Inc.; The Netherlands; E-mail: pip.information@merck.com; Tel. +31 4126 63179; Fax +31 4126 62571", "first_published_date": "11/08/2009", "last_updated_date": "11/08/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/human-papillomavirus1-type-6-l1-protein-human-papillomavirus1-type-11-l1-protein-human-papillomavirus1-type-16-l1-protein-human-papillomavirus1-type-18-l1-protein" }, { "decision_number": "P/109/2009", "pip_number": "EMEA-000369-PIP01-08", "active_substance": "clazosentan", "invented_name": "", "therapeutic_area": "Neurology", "pharmaceutical_forms": "Concentrate for solution for infusion", "condition_indication": "Sequelae of cerebrovascular disease induced by vasospasm", "routes_of_administration": "Intravenous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "16/06/2009", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "", "first_published_date": "11/08/2009", "last_updated_date": "11/08/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000369-pip01-08" }, { "decision_number": "P/113/2009", "pip_number": "EMEA-000465-PIP01-08", "active_substance": "triamcinolone acetonide", "invented_name": "", "therapeutic_area": "Ophthalmology", "pharmaceutical_forms": "Suspension for injection", "condition_indication": "Visualisation during vitrectomy", "routes_of_administration": "Intravitreal use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "15/06/2009", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Alcon Laboratories (UK) Ltd.; Doug.MacHatton@AlconLabs.com; United States; Phone: +1 8175518974; Fax: +1 8176154607", "first_published_date": "11/08/2009", "last_updated_date": "11/08/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000465-pip01-08" }, { "decision_number": "P/119/2009", "pip_number": "EMEA-000516-PIP01-08", "active_substance": "aliskiren hemifumarate;amlodipine besilate", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Essential hypertension", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "15/06/2009", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Novartis Europharm LimitedE-mail: paediatric.enquiries@novartis.comTel. +41 613241111", "first_published_date": "11/08/2009", "last_updated_date": "11/08/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000516-pip01-08" }, { "decision_number": "P/112/2009", "pip_number": "EMEA-000444-PIP01-08", "active_substance": "dexamethasone;ciprofloxacin hydrochloride", "invented_name": "", "therapeutic_area": "Oto-rhino-laryngology", "pharmaceutical_forms": "Ear drops, suspension", "condition_indication": "Other infective otitis externa;Otitis media, unspecified", "routes_of_administration": "Auricular use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "15/06/2009", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Alcon Laboratories (UK) Ltd.; Doug.MacHatton@AlconLabs.com; United States; Phone: +1 8175518974; Fax: +1 8176154607", "first_published_date": "11/08/2009", "last_updated_date": "11/08/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000444-pip01-08" }, { "decision_number": "P/92/2009", "pip_number": "Simvastatin / fenofibrate", "active_substance": "simvastatin;fenofibrate", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Combined dyslipidemia", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "18/05/2009", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "FOURNIER Laboratories Ireland Ltd; E-mail: hubert.thole@solvay.com; Country: Germany; Phone: +49 5118573564", "first_published_date": "09/07/2009", "last_updated_date": "09/07/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/simvastatin-fenofibrate" }, { "decision_number": "P/101/2009", "pip_number": "Cladribine", "active_substance": "cladribine", "invented_name": "", "therapeutic_area": "Neurology", "pharmaceutical_forms": "Tablet", "condition_indication": "Multiple Sclerosis", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "19/05/2009", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "KGaA; E-mail: service@merck.de; Country: Germany; Phone: +49 6151720; Fax: +49 6151722000", "first_published_date": "09/07/2009", "last_updated_date": "09/07/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/cladribine" }, { "decision_number": "P/84/2009", "pip_number": "Bromfenac sodium sesquihydrate", "active_substance": "bromfenac sodium sesquihydrate", "invented_name": "", "therapeutic_area": "Ophthalmology", "pharmaceutical_forms": "Eye drops, solution;Solution", "condition_indication": "Postoperative ocular inflammation", "routes_of_administration": "Ocular use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "15/05/2009", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Croma Pharma GmbH; E-mail: office@croma.at; Country: Austria; Phone: +43 2262684680; Fax: +43 226268468 165", "first_published_date": "09/07/2009", "last_updated_date": "09/07/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/bromfenac-sodium-sesquihydrate" }, { "decision_number": "P/90/2009", "pip_number": "Drospirenone / ethinylestradiol, betadex clathrate / L-5-methyltetrahydrofolic acid, calcium salt", "active_substance": "drospirenone;L-5-methyltetrahydrofolic acid, calcium salt;ethinylestradiol;betadex clathrate", "invented_name": "", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Contraception;Inappropriate diet and eating habits", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "18/05/2009", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Bayer Schering Pharma AG; E-mail: pediatrics.medical-affairs-europe@bayerhealthcare.com; Country: Germany; Phone: +49 3046815333; Fax: +49 3046895333", "first_published_date": "09/07/2009", "last_updated_date": "09/07/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/drospirenone-ethinylestradiol-betadex-clathrate-l-5-methyltetrahydrofolic-acid-calcium-salt" }, { "decision_number": "P/91/2009", "pip_number": "EMEA-000488-PIP01-08", "active_substance": "rubidium (82Rb)", "invented_name": "", "therapeutic_area": "Diagnostic", "pharmaceutical_forms": "Radionuclide generator", "condition_indication": "Visualisation of myocardial perfusion for diagnostic purposes", "routes_of_administration": "Intravenous use", "decision_type": "RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)", "decision_date": "18/05/2009", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Advanced Accelerator Applications; Email: infomed@adacap.com    ; Tel. +33 (0)450993070", "first_published_date": "09/07/2009", "last_updated_date": "09/07/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000488-pip01-08" }, { "decision_number": "P/89/09", "pip_number": "Drospirenone / ethinylestradiol, betadex clathrate / L-5-methyltetrahydrofolic acid, calcium salt", "active_substance": "drospirenone;L-5-methyltetrahydrofolic acid, calcium salt;ethinylestradiol;betadex clathrate", "invented_name": "", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Contraception;Inappropriate diet and eating habits", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "18/05/2009", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Bayer Schering Pharma AG; E-mail: pediatrics.medical-affairs-europe@bayerhealthcare.com; Country: Germany; Phone: +49 3046815333; Fax: +49 3046895333", "first_published_date": "09/07/2009", "last_updated_date": "09/07/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/drospirenone-ethinylestradiol-betadex-clathrate-l-5-methyltetrahydrofolic-acid-calcium-salt-0" }, { "decision_number": "P/100/2009", "pip_number": "EMEA-000118-PIP01-07-M01", "active_substance": "abatacept", "invented_name": "Orencia; Orencia", "therapeutic_area": "Immunology-Rheumatology-Transplantation", "pharmaceutical_forms": "Powder for concentrate for solution for infusion", "condition_indication": "Juvenile Arthritis;Rheumatoid arthritis", "routes_of_administration": "Intravenous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "19/05/2009", "compliance_outcome": "Positive", "compliance_opinion_date": "29/05/2009", "compliance_procedure_number": "EMEA-C-000118-PIP01-07-M01", "contact_for_public_enquiries": "Bristol-Myers Squibb Pharma EEIG E-mail: medical.information@bms.com Tel. +44 (0)1423 533610", "first_published_date": "09/07/2009", "last_updated_date": "09/07/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000118-pip01-07-m01" }, { "decision_number": "P/74/2009", "pip_number": "Bismuth subcitrate potassium / Metronidazole / Tetracycline hydrochloride", "active_substance": "bismuth subcitrate potassium;Metronidazole;tetracycline hydrochloride", "invented_name": "", "therapeutic_area": "Gastroentology-Hepatology", "pharmaceutical_forms": "Capsule", "condition_indication": "Helicobacter pylori infection", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "20/04/2009", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Axcan Pharma SA; E-mail: cboudes@axcan.com; Country: France; Phone: +33 130461916; Fax: +33 130466547", "first_published_date": "10/06/2009", "last_updated_date": "10/06/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/bismuth-subcitrate-potassium-metronidazole-tetracycline-hydrochloride" }, { "decision_number": "P/69/2009", "pip_number": "Calcipotriol hydrate / hydrocortisone", "active_substance": "calcipotriol hydrate;hydrocortisone", "invented_name": "", "therapeutic_area": "Dermatology", "pharmaceutical_forms": "Ointment", "condition_indication": "Psoriasis vulgaris", "routes_of_administration": "Cutaneous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "20/04/2009", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "LEO Pharma A/S; E-mail: paediatrics@leo-pharma.com; Tel. +45 4494 5888;  ", "first_published_date": "10/06/2009", "last_updated_date": "10/06/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/calcipotriol-hydrate-hydrocortisone" }, { "decision_number": "P/73/2009", "pip_number": "Mercaptopurine monohydrate", "active_substance": "Mercaptopurine monohydrate", "invented_name": "", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Oral suspension", "condition_indication": "Treatment of acute lymphoblastic leukaemia", "routes_of_administration": "Oral use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "20/04/2009", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Nova Laboratories Limited; E-mail: mercaptopurine.info@novalabs.co.uk; Country: United Kingdom; Phone: +44 1162230100; Fax: +44 1162230101", "first_published_date": "10/06/2009", "last_updated_date": "10/06/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/mercaptopurine-monohydrate" }, { "decision_number": "P/75/2009", "pip_number": "EMEA-000464-PIP01-08", "active_substance": "pasireotide", "invented_name": "", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Solution for injection;Powder and solvent for suspension for injection", "condition_indication": "Overproduction of pituitary ACTH;Pituitary dependant Cushing's disease;Pituitary dependant hyperadrenocorticism", "routes_of_administration": "Subcutaneous use;Intramuscular use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "20/04/2009", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Novartis Europharm LimitedE-mail: paediatric.enquiries@novartis.comTel. +41 613241111", "first_published_date": "10/06/2009", "last_updated_date": "10/06/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000464-pip01-08" }, { "decision_number": "P/49/2009", "pip_number": "Melatonin (Circadin)", "active_substance": "melatonin", "invented_name": "Circadin; Circadin", "therapeutic_area": "Neurology", "pharmaceutical_forms": "Prolonged-release tablet", "condition_indication": "Primary insomnia", "routes_of_administration": "Oral use", "decision_type": "RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)", "decision_date": "24/03/2009", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "RAD Neurim Pharmaceuticals EEC Ltd; E-mail: talin@neurim.com; Tel.: +972 37684902", "first_published_date": "18/05/2009", "last_updated_date": "18/05/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/melatonin-circadin" }, { "decision_number": "P/54/2009", "pip_number": "Bisoprolol fumarate / acetylsalicylic acid", "active_substance": "Bisoprolol fumarate;acetylsalicylic acid", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Capsule", "condition_indication": "Angina pectoris;Essential hypertension;Secondary hypertension", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "24/03/2009", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "ASA Pharma Plc; E-mail: anndonegan@asapharma.ie; Tel.: +353 5224853", "first_published_date": "18/05/2009", "last_updated_date": "18/05/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/bisoprolol-fumarate-acetylsalicylic-acid" }, { "decision_number": "P/50/2009", "pip_number": "Bisoprolol fumarate / acetylsalicylic acid", "active_substance": "Bisoprolol fumarate;acetylsalicylic acid", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Capsule", "condition_indication": "Angina pectoris;Essential hypertension;Secondary hypertension", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "24/03/2009", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "ASA Pharma Plc; E-mail: anndonegan@asapharma.ie; Tel.: +353 5224853", "first_published_date": "18/05/2009", "last_updated_date": "18/05/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/bisoprolol-fumarate-acetylsalicylic-acid-0" }, { "decision_number": "P/51/2009", "pip_number": "Bisoprolol fumarate / acetylsalicylic acid", "active_substance": "Bisoprolol fumarate;acetylsalicylic acid", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Capsule", "condition_indication": "Angina pectoris;Essential hypertension;Secondary hypertension", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "24/03/2009", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "ASA Pharma Plc; E-mail: anndonegan@asapharma.ie; Tel.: +353 5224853", "first_published_date": "18/05/2009", "last_updated_date": "18/05/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/bisoprolol-fumarate-acetylsalicylic-acid-1" }, { "decision_number": "P/43/2009", "pip_number": "EMEA-000433-PIP01-08", "active_substance": "Dirucotide acetate", "invented_name": "", "therapeutic_area": "Neurology", "pharmaceutical_forms": "Powder for solution for injection", "condition_indication": "Multiple Sclerosis", "routes_of_administration": "Intravenous use", "decision_type": "RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)", "decision_date": "23/03/2009", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Eli Lilly & Company Limited; E-mail: eu_paediatric@lilly.com ; Tel. +44 (0)1276 483000", "first_published_date": "18/05/2009", "last_updated_date": "18/05/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000433-pip01-08" }, { "decision_number": "P/42/2009", "pip_number": "Maribavir", "active_substance": "Maribavir", "invented_name": "", "therapeutic_area": "Infectious diseases", "pharmaceutical_forms": "Tablet;Age appropriate oral formulation", "condition_indication": "Cytomegaloviral disease", "routes_of_administration": "Oral use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "23/03/2009", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "ViroPharma SPRL; E-mail: john.watson@viropharma.com; Country: United Kingdom; Phone: +44 2075721222; Fax: +44 2075721221", "first_published_date": "18/05/2009", "last_updated_date": "18/05/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/maribavir" }, { "decision_number": "P/53/2009", "pip_number": "Bisoprolol fumarate / acetylsalicylic acid", "active_substance": "Bisoprolol fumarate;acetylsalicylic acid", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Capsule", "condition_indication": "Angina pectoris;Essential hypertension;Secondary hypertension", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "24/03/2009", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "ASA Pharma Plc; E-mail: anndonegan@asapharma.ie; Tel.: +353 5224853", "first_published_date": "18/05/2009", "last_updated_date": "18/05/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/bisoprolol-fumarate-acetylsalicylic-acid-2" }, { "decision_number": "P/52/2009", "pip_number": "Bisoprolol fumarate / acetylsalicylic acid", "active_substance": "Bisoprolol fumarate;acetylsalicylic acid", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Capsule", "condition_indication": "Angina pectoris;Essential hypertension;Secondary hypertension", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "24/03/2009", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "ASA Pharma Plc; E-mail: anndonegan@asapharma.ie; Tel.: +353 5224853", "first_published_date": "18/05/2009", "last_updated_date": "18/05/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/bisoprolol-fumarate-acetylsalicylic-acid-3" }, { "decision_number": "P/44/2009", "pip_number": "Dexamethasone", "active_substance": "dexamethasone", "invented_name": "", "therapeutic_area": "Ophthalmology", "pharmaceutical_forms": "Intravitreal implant in applicator", "condition_indication": "Chronic non-infectious intermediate or posterior uveitis", "routes_of_administration": "Intravitreal use", "decision_type": "RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)", "decision_date": "23/03/2009", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Allergan Pharmaceuticals International Limited; E-mail: ml-eu_reg_affairs@allergan.com; Tel. +44 (0)1628 4944444", "first_published_date": "18/05/2009", "last_updated_date": "18/05/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/dexamethasone-0" }, { "decision_number": "P/45/2009", "pip_number": "Glucose monohydrate", "active_substance": "glucose monohydrate", "invented_name": "", "therapeutic_area": "Pain", "pharmaceutical_forms": "Oral solution", "condition_indication": "Pain", "routes_of_administration": "Oral use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "24/03/2009", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Cblaya & Mhuguet S.L.; E-mail: miguel@aguanafree.com; Country: Spain; Phone: +34 629232280; Fax: +34 933713118", "first_published_date": "18/05/2009", "last_updated_date": "18/05/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/glucose-monohydrate" }, { "decision_number": "P/38/2009", "pip_number": "EMEA-000435-PIP01-08", "active_substance": "17-allylamino-17-demethoxygeldanamycin hydroquinone, hydrochloride", "invented_name": "", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Powder and solvent for solution for infusion", "condition_indication": "Treatment of gastrointestinal stromal tumours", "routes_of_administration": "Intravenous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "04/03/2009", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Voisin Consulting SARL; E-mail: Monique.allaire@infi.com; Tel.: +1 6174531105", "first_published_date": "18/05/2009", "last_updated_date": "18/05/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000435-pip01-08" }, { "decision_number": "P/64/2009", "pip_number": "EMEA-000278-PIP01-08-M01", "active_substance": "purified diphtheria toxoid;purified tetanus toxoid;Five component acellular pertussis [Purified Pertussis Toxoid (PT), Purified Filamentous Haemagglutinin (FHA), Purified Fimbriae Types 2 and 3 (FIM), and Purified Pertactin (PRN)];purified polyribosylribitol phosphate capsular polysaccharide of Haemophilus influenzae type b covalently bound to Tetanus protein (PRP-T);Inactivated Type 1 Poliovirus (Mahoney);Inactivated Type 2 Poliovirus (MEF-1);Inactivated Type 3 Poliovirus (Saukett)", "invented_name": "PEDIACEL", "therapeutic_area": "Vaccines", "pharmaceutical_forms": "Suspension for injection in pre-filled syringe;Suspension for injection in a vial", "condition_indication": "Active immunisation against infectious diseases caused by Haemophilus influenzae type b, Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis and poliovirus types 1, 2 and 3", "routes_of_administration": "Intramuscular use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "31/03/2009", "compliance_outcome": "Positive", "compliance_opinion_date": "18/09/2009", "compliance_procedure_number": "EMEA-C-000278-PIP01-08-M01", "contact_for_public_enquiries": "Sanofi Pasteur MSD SNC; E-mail: piplan@spmsd.com; Country: France; Phone: +33 437284000; Fax: Not available", "first_published_date": "18/05/2009", "last_updated_date": "18/05/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000278-pip01-08-m01" }, { "decision_number": "P/20/2009", "pip_number": "Anastrozole", "active_substance": "anastrozole", "invented_name": "Arimidex and associated names", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Tablet", "condition_indication": "Gynaecomastia;McCune-Albright syndrome;Short stature due to Growth Hormone deficiency;Testotoxicosis", "routes_of_administration": "Oral use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "06/02/2009", "compliance_outcome": "Positive", "compliance_opinion_date": "03/04/2009", "compliance_procedure_number": "EMEA-C-000283-PIP01-08", "contact_for_public_enquiries": "AstraZeneca AB (UK); Tel. +44 2037496236; E-mail: paediatrics@astrazeneca.com", "first_published_date": "23/04/2009", "last_updated_date": "23/04/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/anastrozole" }, { "decision_number": "P/28/2009", "pip_number": "EMEA-000189-PIP01-08", "active_substance": "pegylated recombinant factor VIIa", "invented_name": "", "therapeutic_area": "Haematology-Hemostaseology", "pharmaceutical_forms": "Powder and solvent for solution for injection", "condition_indication": "Hereditary factor VIII and factor IX deficiency", "routes_of_administration": "Intravenous use;Subcutaneous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "23/02/2009", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Novo Nordisk A/S; E-mail: pbq@novonordisk.com; Tel.: +45 44439347", "first_published_date": "23/04/2009", "last_updated_date": "23/04/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000189-pip01-08" }, { "decision_number": "P/22/2009", "pip_number": "Candesartan cilexetil", "active_substance": "Candesartan cilexetil", "invented_name": "Blopress and associated names", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Tablet;Suspension for oral use", "condition_indication": "Diabetic retinopathy;Essential hypertension;Heart Failure", "routes_of_administration": "Oral use", "decision_type": "RP: decision refers to a refusal on a proposed Paediatric Investigation Plan", "decision_date": "20/02/2009", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Takeda Global Research and Development Centre (Europe) Ltd; E-mail: m.mantock@tgrd.com; Tel.: +44 2077595248", "first_published_date": "23/04/2009", "last_updated_date": "23/04/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/candesartan-cilexetil" }, { "decision_number": "P/24/2009", "pip_number": "Drospirenone / ethinylestradiol bethadex clathrate", "active_substance": "drospirenone;ethinylestradiol bethadex clathrate", "invented_name": "Yaz and associated names", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Contraception;Treatment of acne", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "23/02/2009", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Bayer Schering Pharma AG; E-mail: joachim.marr@bayerhealthcare.com; Country: Germany; Phone: +49 3046817617; Fax: +49 3046815348", "first_published_date": "23/04/2009", "last_updated_date": "23/04/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/drospirenone-ethinylestradiol-bethadex-clathrate" }, { "decision_number": "P/36/2009", "pip_number": "Lapatinib ditosylate monohydrate", "active_substance": "Lapatinib ditosilate monohydrate", "invented_name": "", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Carcinoma of the head and neck (Covered by class waiver: oropharyngeal epithelial carcinoma, excluding nasopharyngeal carcinoma)", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "24/02/2009", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Glaxo Group Limited; Tel. +41 613 241 111; E-mail: paediatric.enquiries@novartis.com;  ", "first_published_date": "23/04/2009", "last_updated_date": "23/04/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/lapatinib-ditosylate-monohydrate" }, { "decision_number": "P/12/2009", "pip_number": "EMEA-000313-PIP01-08", "active_substance": "Ibuprofen;paracetamol", "invented_name": "", "therapeutic_area": "Pain", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Fever;Pain", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "27/01/2009", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "PAREXEL Consulting; E-mail:gemma.slade@parexel.com; Country: UK; Phone: +44 1895614615; Fax: +44 1895614375", "first_published_date": "23/04/2009", "last_updated_date": "23/04/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000313-pip01-08" }, { "decision_number": "P/32/2009", "pip_number": "EMEA-000344-PIP01-08", "active_substance": "aliskiren hemifumarate;hydrochlorothiazide", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Essential hypertension", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "23/02/2009", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Novartis Europharm LimitedE-mail: paediatric.enquiries@novartis.comTel. +41 613241111", "first_published_date": "23/04/2009", "last_updated_date": "23/04/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000344-pip01-08" }, { "decision_number": "P/21/2009", "pip_number": "Candesartan cilexetil", "active_substance": "Candesartan cilexetil", "invented_name": "Atacand and associated name", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Tablet;Suspension for oral use", "condition_indication": "Diabetic retinopathy;Essential hypertension;Heart Failure", "routes_of_administration": "Oral use", "decision_type": "RP: decision refers to a refusal on a proposed Paediatric Investigation Plan", "decision_date": "20/02/2009", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "", "first_published_date": "23/04/2009", "last_updated_date": "23/04/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/candesartan-cilexetil-0" }, { "decision_number": "P/34/2009", "pip_number": "EMEA-000126-PIP01-07", "active_substance": "pemetrexed disodium", "invented_name": "Alimta; 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Tel. +49 6132 778271; Email: Paediatrics@boehringer-ingelheim.com", "first_published_date": "06/03/2009", "last_updated_date": "06/03/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000377-pip01-08" }, { "decision_number": "P/17/2009", "pip_number": "Raltitrexed", "active_substance": "raltitrexed", "invented_name": "Tomudex", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Powder for solution for injection or infusion", "condition_indication": "Mesothelioma of the pleura", "routes_of_administration": "Intravenous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "27/01/2009", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Hospira UK Limited; E-mail: medinfouk@hospira.com; Tel.: +44 1926821010", "first_published_date": "06/03/2009", "last_updated_date": "06/03/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/raltitrexed" }, { "decision_number": "P/16/2009", "pip_number": "EMEA-000399-PIP01-08", "active_substance": "valsartan;hydrochlorothiazide;amlodipine besilate", "invented_name": "Imprida HCT; 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E-mail: paediatric.enquiries@novartis.com; Country: Switzerland; Phone: +41 61 324 1111; Fax: +41 61 324 8001", "first_published_date": "06/03/2009", "last_updated_date": "06/03/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000398-pip01-08" }, { "decision_number": "P/14/2009", "pip_number": "EMEA-000397-PIP01-08", "active_substance": "valsartan;hydrochlorothiazide;amlodipine besilate", "invented_name": "Copalia HCT; Copalia HCT", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Essential hypertension", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "27/01/2009", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Novartis Europharm Ltd.; E-mail: paediatric.enquiries@novartis.com; Country: Switzerland; 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E-mail: eu.paediatric-plans@gsk.com; Tel.: +1 438 899 8201", "first_published_date": "06/03/2009", "last_updated_date": "06/03/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/human-papillomavirus-type-16-l1-protein-human-papillomavirus-type-18-l1-protein" }, { "decision_number": "P/4/2009", "pip_number": "EMEA-000025-PIP01-07-M01", "active_substance": "mometasone furoate;formoterol fumarate dihydrate", "invented_name": "", "therapeutic_area": "Pneumology-allergology", "pharmaceutical_forms": "Pressurised metered dose inhaler (MDI) with HFA-227 as propellant;Suspension", "condition_indication": "Persistent asthma", "routes_of_administration": "Inhalation use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "27/01/2009", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Merck Sharp & Dohme (Europe), Inc.Email: pip.information@merck.com Tel. +31 412663179", "first_published_date": "06/03/2009", "last_updated_date": "06/03/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000025-pip01-07-m01" }, { "decision_number": "P/118/2008", "pip_number": "Ibuprofen, diphenhydramine hydrochloride", "active_substance": "Ibuprofen;diphenhydramine hydrochloride", "invented_name": "", "therapeutic_area": "Pain", "pharmaceutical_forms": "Capsule, soft", "condition_indication": "Mild to moderate pain with sleeplessness", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "01/12/2008", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Wyeth Consumer Healthcare; E-mail: whilesa@wyeth.com; Tel.: +44 2392682249", "first_published_date": "29/01/2009", "last_updated_date": "29/01/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/ibuprofen-diphenhydramine-hydrochloride" }, { "decision_number": "P/123/2008", "pip_number": "Clopidogrel", "active_substance": "clopidogrel", "invented_name": "Iscover; Iscover", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Oral formulation;Film-coated tablet", "condition_indication": "Thromboembolic events", "routes_of_administration": "Oral use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "05/12/2008", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Bristol-Myers Squibb Pharma EEIG; E-mail: sylvie.gabriel@sanofi-aventis.com; Country: France; Phone: +33 153774152; Fax: +33 153774133", "first_published_date": "29/01/2009", "last_updated_date": "29/01/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/clopidogrel-0" }, { "decision_number": "P/120/2008", "pip_number": "Omega-3-acid (85% ethyl esters of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in a ratio of 0.9-1.5), simvastatin", "active_substance": "omega-3-acid (85% ethyl esters of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in a ratio of 0.9-1.5);simvastatin", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Capsule, soft", "condition_indication": "Atherosclerotic cardiovascular disease following past myocardial infarction", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "01/12/2008", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Sigma-Tau SpA; E-mail: Giulia.Bruno@sigma-tau.it; Phone: +39 0691393657", "first_published_date": "29/01/2009", "last_updated_date": "29/01/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/omega-3-acid-85-ethyl-esters-eicosapentaenoic-acid-epa-docosahexaenoic-acid-dha-ratio-09-15-simvastatin" }, { "decision_number": "P/114/2008", "pip_number": "Sitagliptin phosphate monohydrate, metformin hydrochloride", "active_substance": "sitagliptin phosphate monohydrate;metformin hydrochloride", "invented_name": "Janumet; Janumet", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Treatment of type II diabetes mellitus", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "01/12/2008", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Merck Sharp and Dohme (Europe), Inc.; Belgium; E-mail: pip.information@merck.com; Tel. +31 412663179; Fax +31 412662571", "first_published_date": "29/01/2009", "last_updated_date": "29/01/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/sitagliptin-phosphate-monohydrate-metformin-hydrochloride" }, { "decision_number": "P/106/2008", "pip_number": "Perflubutane", "active_substance": "perflubutane", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Lyophilisate for suspension for injection", "condition_indication": "Visualisation of myocardial perfusion for diagnostic purposes", "routes_of_administration": "Intravenous use", "decision_type": "RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)", "decision_date": "28/11/2008", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Nycomed Danmark ApS; E-mail: kristina.allikmets@nycomed.com; Tel.: +45 46771655", "first_published_date": "29/01/2009", "last_updated_date": "29/01/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/perflubutane" }, { "decision_number": "P/110/2008", "pip_number": "EMEA-000044-PIP01-08", "active_substance": "TGp1PTH1-34 L-Asparaginyl-L-glutaminyl-L-glutamyl-L-glutaminyl-L-valy1-L-seryl-L-prolyl-L-leucyl-L-tyrosyl-L-lysil-L-asparaginyl-L-arginyl-L-seryl-L-valyl-L-seryl-L-glutamyl-L-isoleucyl-L-glutaminyl-Lleucyl-L-methionyl-L-histidyl-L-asparaginyl-L-leucyl-L-glycyl-L-lysyl-L-histidyl-L-leucyl-Lasparaginyl-L-seryl-L-methionyl-L-glutamyl-L-arginyl-L-valyl-L-glutamyl-L-tryptophanyl-L-leucyl-L-arginyl-L-lysyl-L-lysyl-L-leucyl-L-glutamyl-L-asparty-L-valyl-L-histidyl-L-asparaginyl-Lphenylalanine-, acetate salt", "invented_name": "", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Solitary bone cysts", "routes_of_administration": "Intraosseous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "01/12/2008", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Kuros Biosurgery International AG; E-mail: info@kuros.ch; Country: Switzerland; Phone: +41 442005647; Fax: +41 442005747", "first_published_date": "29/01/2009", "last_updated_date": "29/01/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000044-pip01-08" }, { "decision_number": "P/116/2008", "pip_number": "Sitagliptin phosphate monohydrate, metformin hydrochloride", "active_substance": "sitagliptin phosphate monohydrate;metformin hydrochloride", "invented_name": "Velmetia; Velmetia", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Treatment of type II diabetes mellitus", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "01/12/2008", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Merck Sharp and Dohme (Europe), Inc.; Belgium; E-mail: pip.information@merck.com; Tel. +31 412663179; Fax +31 412662571", "first_published_date": "29/01/2009", "last_updated_date": "29/01/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/sitagliptin-phosphate-monohydrate-metformin-hydrochloride-0" }, { "decision_number": "P/117/2008", "pip_number": "Sitagliptin phosphate monohydrate, metformin hydrochloride", "active_substance": "sitagliptin phosphate monohydrate;metformin hydrochloride", "invented_name": "Efficib; Efficib", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Treatment of type II diabetes mellitus", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "01/12/2008", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Merck Sharp and Dohme (Europe), Inc.; Belgium; E-mail: pip.information@merck.com; Tel. +31 412663179; Fax +31 412662571", "first_published_date": "29/01/2009", "last_updated_date": "29/01/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/sitagliptin-phosphate-monohydrate-metformin-hydrochloride-1" }, { "decision_number": "P/112/2008", "pip_number": "3-(1H-indol-3-yl)-4-(2-(4-methyl-1-piperazinyl)-4-quinazolinyl)-1H-pyrrole-2,5-dione acetate(1:1)", "active_substance": "3-(1H-indol-3-yl)-4-(2-(4-methyl-1-piperazinyl)-4-quinazolinyl)-1H-pyrrole-2,5-dione acetate(1:1)", "invented_name": "", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Chronic plaque psoriasis", "routes_of_administration": "Oral use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "01/12/2008", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Novartis Europharm Limited; E-mail: paediatric.enquiries@novartis.com; Tel.: +41 613246715", "first_published_date": "29/01/2009", "last_updated_date": "29/01/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/3-1h-indol-3-yl-4-2-4-methyl-1-piperazinyl-4-quinazolinyl-1h-pyrrole-25-dione-acetate11" }, { "decision_number": "P/129/2008", "pip_number": "Pirfenidone", "active_substance": "Pirfenidone", "invented_name": "", "therapeutic_area": "Pneumology-allergology", "pharmaceutical_forms": "Capsule", "condition_indication": "Idiopathic Pulmonary Fibrosis (in adults)", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "23/12/2008", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "InterMune, Inc.; E-mail: IR@intermune.com; Country: United States; Phone: +1 4154662200; Fax: +1 4154662300", "first_published_date": "29/01/2009", "last_updated_date": "29/01/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/pirfenidone" }, { "decision_number": "P/128/2008", "pip_number": "Eprotirome", "active_substance": "Eprotirome", "invented_name": "", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Gastro-resistant tablet", "condition_indication": "Primary hypercholesterolaemia", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "23/12/2008", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "KaroBio AB; E-mail: jens.kristensen@karobio.com; Country: Sweden; Phone: +46 707556005; Fax: +46 87745280", "first_published_date": "29/01/2009", "last_updated_date": "29/01/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/eprotirome" }, { "decision_number": "P/130/2008", "pip_number": "EMEA-000368-PIP01-08", "active_substance": "travoprost;brinzolamide", "invented_name": "", "therapeutic_area": "Ophthalmology", "pharmaceutical_forms": "Suspension", "condition_indication": "Treatment of glaucoma;Treatment of ocular hypertension", "routes_of_administration": "Eye drops", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "23/12/2008", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Alcon Laboratories (UK) Ltd.; Doug.MacHatton@AlconLabs.com; United States; Phone: +1 8175518974; Fax: +1 8176154607", "first_published_date": "29/01/2009", "last_updated_date": "29/01/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000368-pip01-08" }, { "decision_number": "P/98/2008", "pip_number": "Dienogest", "active_substance": "Dienogest", "invented_name": "", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Tablet", "condition_indication": "Treatment of endometriosis", "routes_of_administration": "Oral use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "03/11/2008", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Bayer Schering Pharma AG; E-mail: christian.seitz@bayerhealthcare.com; Phone: +49 3046815539", "first_published_date": "07/01/2009", "last_updated_date": "07/01/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/dienogest" }, { "decision_number": "P/96/2008", "pip_number": "EMEA-000130-PIP01-07", "active_substance": "paracetamol", "invented_name": "", "therapeutic_area": "Pain", "pharmaceutical_forms": "Solution for infusion", "condition_indication": "Moderate pain and fever", "routes_of_administration": "Intravenous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "03/11/2008", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Baxter World Trade SA/NV; E-mail: veronique_verstraeten@baxter.com; Country: Belgium; Phone: +32 26501679; Fax: +32 26501679", "first_published_date": "07/01/2009", "last_updated_date": "07/01/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000130-pip01-07" }, { "decision_number": "P/101/2008", "pip_number": "EMEA-000249-PIP01-08", "active_substance": "Influenza Virus Type A, H3N2Influenza Virus Type A, H1N1Influenza Virus Type B", "invented_name": "", "therapeutic_area": "Vaccines", "pharmaceutical_forms": "Nasal spray suspension", "condition_indication": "Influenza", "routes_of_administration": "Intranasal use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "03/11/2008", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "MedImmune, LLC; E-mail: dekkere@medimmune.com; Country: United States; Telephone: +1 3013984040", "first_published_date": "07/01/2009", "last_updated_date": "07/01/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000249-pip01-08" }, { "decision_number": "P/102/2008", "pip_number": "EMEA-000371-PIP01-08", "active_substance": "lenalidomide", "invented_name": "Revlimid", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Capsule, hard", "condition_indication": "Myelodysplastic Syndrome", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "06/11/2008", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Celgene Europe LimitedTel.  +41 327298500E-mail: medinfo.intl@celgene.com", "first_published_date": "07/01/2009", "last_updated_date": "07/01/2009", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000371-pip01-08" }, { "decision_number": "P/92/2008", "pip_number": "EMEA-000384-PIP01-08", "active_substance": "peginterferon alfa-2b", "invented_name": "ViraferonPeg; 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E-mail: stephen.matthews@eusapharma.com ; Tel. +44 (0)7384 547313", "first_published_date": "24/11/2008", "last_updated_date": "24/11/2008", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/chimeric-murine-human-anti-interleukin-6-monoclonal-antibody" }, { "decision_number": "P/73/2008", "pip_number": "Ezetimibe and simvastatin (fixed combination)", "active_substance": "ezetimibe;simvastatin", "invented_name": "INEGY and associated trade names", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Tablet", "condition_indication": "Hypercholesterolaemia;Mixed (combined) hyperlipidaemia;Sitosterolaemia", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "14/09/2008", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Merck Sharp & Dohme (Europe) Inc.Tel.: +33180464738E-mail: pip.information@merck.com", "first_published_date": "10/10/2008", "last_updated_date": "10/10/2008", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/ezetimibe-simvastatin-fixed-combination" }, { "decision_number": "P/75/2008", "pip_number": "Pramipexole dihydrochloride monohydrate", "active_substance": "pramipexole dihydrochloride monohydrate", "invented_name": "Mirapexin; 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Tel. +46 8 5532791; E-mail: paediatrics@astrazeneca.com", "first_published_date": "10/10/2008", "last_updated_date": "10/10/2008", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000268-pip01-08" }, { "decision_number": "P/79/2008", "pip_number": "Prilocaine, Lidocaine", "active_substance": "prilocaine;lidocaine", "invented_name": "", "therapeutic_area": "Uro-nephrology", "pharmaceutical_forms": "Cutaneous spray;Solution", "condition_indication": "Premature ejaculation", "routes_of_administration": "Cutaneous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "15/09/2008", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Plethora Solutions Limited; E-mail: gale.kennedy@plethorasolutions.co.uk; Country: UK; Phone: +44 2030775400; Fax: +44 2030775440", "first_published_date": "10/10/2008", "last_updated_date": "10/10/2008", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/prilocaine-lidocaine" }, { "decision_number": "P/78/2008", "pip_number": "Bortezomib", "active_substance": "bortezomib", "invented_name": "Velcade; Velcade", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Powder for solution for injection", "condition_indication": "Treatment of mantle cell lymphoma", "routes_of_administration": "Intravenous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "14/09/2008", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Janssen-Cilag International NV; E-mail: sglawe@jacde.jnj.com; Country: Germany; Phone: +49 1737467682", "first_published_date": "10/10/2008", "last_updated_date": "10/10/2008", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/bortezomib" }, { "decision_number": "P/65/2008", "pip_number": "Balaglitazone", "active_substance": "balaglitazone", "invented_name": "", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Tablet", "condition_indication": "Treatment of type II diabetes mellitus", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "15/08/2008", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Rheoscience A/S; Denmark; E-mail: aos@rheoscience.com; Tel. +45 440 1960", "first_published_date": "18/09/2008", "last_updated_date": "18/09/2008", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/balaglitazone" }, { "decision_number": "P/66/2008", "pip_number": "EMEA-000110-PIP01-07", "active_substance": "aciclovir;hydrocortisone", "invented_name": "", "therapeutic_area": "Infectious diseases", "pharmaceutical_forms": "Cream", "condition_indication": "Herpes simplex labialis", "routes_of_administration": "Topical use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "15/08/2008", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Medivir AB; E-mail: annelie.skagerlind@medivir.info; Country: Sweden                 ; Phone: +46 854683184; Fax: +46 854683199", "first_published_date": "18/09/2008", "last_updated_date": "18/09/2008", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000110-pip01-07" }, { "decision_number": "P/69/2008", "pip_number": "Eplivanserin hemifumarate", "active_substance": "Eplivanserin hemifumarate", "invented_name": "", "therapeutic_area": "Psychiatry", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Insomnia", "routes_of_administration": "Oral use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "11/08/2008", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Sanofi-aventis recherche & développement; E-mail: sylvie.gabriel@sanofi-aventis.com; Country: France; Phone: +33 153774152; Fax: +33 153774133", "first_published_date": "18/09/2008", "last_updated_date": "18/09/2008", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/eplivanserin-hemifumarate" }, { "decision_number": "P/68/2008", "pip_number": "Dexamethasone", "active_substance": "dexamethasone", "invented_name": "", "therapeutic_area": "Ophthalmology", "pharmaceutical_forms": "Intravitreal implant in an applicator", "condition_indication": "Other retinal vascular occlusion", "routes_of_administration": "Intravitreal use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "15/08/2008", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "AbbVie LtdE-mail: paediatricteam@abbvie.comTel. +44(0) 1628925033", "first_published_date": "18/09/2008", "last_updated_date": "18/09/2008", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/dexamethasone" }, { "decision_number": "P/70/2008", "pip_number": "EMEA-000064-PIP01-07", "active_substance": "nicotinic acid;simvastatin;laropiprant", "invented_name": "", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Modified-release tablet", "condition_indication": "Hypercholesterolaemia", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "20/08/2008", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Merck Sharp and Dohme (Europe), Inc.; Belgium; Tel. +33 180464738; E-mail: pip.information@merck.com", "first_published_date": "18/09/2008", "last_updated_date": "18/09/2008", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000064-pip01-07" }, { "decision_number": "P/64/2008", "pip_number": "EMEA-000071-PIP01-07", "active_substance": "peginterferon alfa-2b", "invented_name": "PegIntron; PegIntron", "therapeutic_area": "Gastroentology-Hepatology", "pharmaceutical_forms": "Powder and solvent for solution for injection in vial and in pre-filled pen", "condition_indication": "Treatment of chronic viral hepatitis C", "routes_of_administration": "Subcutaneous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "15/08/2008", "compliance_outcome": "Positive", "compliance_opinion_date": "17/10/2008", "compliance_procedure_number": "EMEA-C-000071-PIP01-07", "contact_for_public_enquiries": "Merck Sharp & Dohme (Europe), Inc.; The Netherlands; E-mail: pip.information@merck.com; Tel. +31 4126 63179; Fax +31 4126 62571", "first_published_date": "18/09/2008", "last_updated_date": "18/09/2008", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000071-pip01-07" }, { "decision_number": "P/63/2008", "pip_number": "Ribavirin", "active_substance": "ribavirin", "invented_name": "Rebetol; Rebetol", "therapeutic_area": "Gastroentology-Hepatology", "pharmaceutical_forms": "Oral solution;Capsule, hard", "condition_indication": "Treatment of chronic viral hepatitis C", "routes_of_administration": "Oral use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "15/08/2008", "compliance_outcome": "Positive", "compliance_opinion_date": "17/10/2008", "compliance_procedure_number": "EMEA-C-000070-PIP01-07", "contact_for_public_enquiries": "Merck Sharp & Dohme (Europe), Inc.; The Netherlands; E-mail: pip.information@merck.com; Tel. +31 4126 63179; Fax +31 4126 62571", "first_published_date": "18/09/2008", "last_updated_date": "18/09/2008", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/ribavirin" }, { "decision_number": "P/71/2008", "pip_number": "EMEA-000253-PIP01-08", "active_substance": "nicotinic acid;simvastatin;laropiprant", "invented_name": "", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Modified-release tablet", "condition_indication": "Hypercholesterolaemia", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "20/08/2008", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Merck Sharp and Dohme (Europe), Inc.; Belgium; Tel. +33 180464738; E-mail: pip.information@merck.com", "first_published_date": "18/09/2008", "last_updated_date": "18/09/2008", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000253-pip01-08" }, { "decision_number": "P/72/2008", "pip_number": "EMEA-000254-PIP01-08", "active_substance": "nicotinic acid;simvastatin;laropiprant", "invented_name": "", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Modified-release tablet", "condition_indication": "Hypercholesterolaemia", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "20/08/2008", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Merck Sharp and Dohme (Europe), Inc.; Belgium; Tel. +33 180464738; E-mail: pip.information@merck.com", "first_published_date": "18/09/2008", "last_updated_date": "18/09/2008", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000254-pip01-08" }, { "decision_number": "P/55/2008", "pip_number": "Epoetin theta", "active_substance": "epoetin theta", "invented_name": "", "therapeutic_area": "Haematology-Hemostaseology", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Treatment of anaemia", "routes_of_administration": "Intravenous use;Subcutaneous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "20/07/2008", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "CT Arzneimittel GmbH; E-mail: office@ct-arzneimittel.de; Country: Germany; Phone: +49 304090080; Fax: +49 3040900821", "first_published_date": "08/09/2008", "last_updated_date": "08/09/2008", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/epoetin-theta" }, { "decision_number": "P/57/2008", "pip_number": "Epoetin theta", "active_substance": "epoetin theta", "invented_name": "", "therapeutic_area": "Haematology-Hemostaseology", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Treatment of anaemia", "routes_of_administration": "Intravenous use;Subcutaneous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "20/07/2008", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Ratiopharm GmbH; E-mail: info@ratiopharm.de; Country: Germany; Phone: +49 73140202; Fax: +49 7314027832", "first_published_date": "08/09/2008", "last_updated_date": "08/09/2008", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/epoetin-theta-0" }, { "decision_number": "P/56/2008", "pip_number": "Epoetin theta", "active_substance": "epoetin theta", "invented_name": "", "therapeutic_area": "Haematology-Hemostaseology", "pharmaceutical_forms": "Solution for injection", "condition_indication": "Treatment of anaemia", "routes_of_administration": "Intravenous use;Subcutaneous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "20/07/2008", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Ratiopharm GmbH; E-mail: info@ratiopharm.de; Country: Germany; Phone: +49 73140202; Fax: +49 7314027832", "first_published_date": "08/09/2008", "last_updated_date": "08/09/2008", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/epoetin-theta-1" }, { "decision_number": "P/54/2008", "pip_number": "EMEA-000171-PIP01-07", "active_substance": "glucosamine hydrochloride;chondroitin sulfate", "invented_name": "", "therapeutic_area": "Immunology-Rheumatology-Transplantation", "pharmaceutical_forms": "Capsule, hard;Granules in sachet", "condition_indication": "Primary osteoarthritis", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "20/07/2008", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Bioiberica S.A.E-mail: gemma.slade@parexel.comPhone: : +44 1895614615", "first_published_date": "08/09/2008", "last_updated_date": "08/09/2008", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000171-pip01-07" }, { "decision_number": "P/58/2008", "pip_number": "EMEA-000225-PIP01-08", "active_substance": "amlodipine besilate;valsartan;hydrochlorothiazide", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Essential hypertension", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "20/07/2008", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Novartis Europharm LimitedE-mail: paediatric.enquiries@novartis.comTel. +41 613241111", "first_published_date": "08/09/2008", "last_updated_date": "08/09/2008", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000225-pip01-08" }, { "decision_number": "P/53/2008", "pip_number": "Atorvastatin calcium", "active_substance": "atorvastatin calcium", "invented_name": "Sortis and associated names", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Film-coated tablet;Age appropriate oral formulation", "condition_indication": "Pure hypercholesterolaemia (heterozygous, homozygous, or otherwise primary hypercholesterolaemia), combined (mixed) hyperlipidaemia; prevention of cardiovascular events", "routes_of_administration": "Oral use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "20/07/2008", "compliance_outcome": "Positive", "compliance_opinion_date": "13/11/2009", "compliance_procedure_number": "EMEA-C-000073-PIP01-07", "contact_for_public_enquiries": "Pfizer Limited; Tel. + 44 1304646607; E-mail: pip_enquiries@pfizer.com", "first_published_date": "08/09/2008", "last_updated_date": "08/09/2008", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/atorvastatin-calcium" }, { "decision_number": "P/33/2008", "pip_number": "EMEA-000027-PIP01-07", "active_substance": "tifacogin", "invented_name": "", "therapeutic_area": "Infectious diseases", "pharmaceutical_forms": "Solution for infusion", "condition_indication": "Septicaemia", "routes_of_administration": "Intravenous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "24/06/2008", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Novartis Europharm LimitedE-mail: paediatric.enquiries@novartis.comTel. +41 613241111", "first_published_date": "21/07/2008", "last_updated_date": "21/07/2008", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000027-pip01-07" }, { "decision_number": "P/32/2008", "pip_number": "EMEA-000024-PIP01-07", "active_substance": "zoledronic acid", "invented_name": "Zometa; Zometa", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Powder and solvent for solution for infusion;Concentrate for solution for infusion", "condition_indication": "Osteogenesis imperfecta;Prevention of fracture and bone loss in postmenopausal women with early-stage breast cancer treated with aromatase inhibitors;Prevention of skeletal related events in patients with advanced malignancies involving bone;Tumour-induced hypercalcaemia", "routes_of_administration": "Intravenous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "24/06/2008", "compliance_outcome": "Positive", "compliance_opinion_date": "12/12/2008", "compliance_procedure_number": "EMEA-C-000024-PIP01-07", "contact_for_public_enquiries": "Novartis Europharm LimitedE-mail: paediatric.enquiries@novartis.comTel. +41 613241111", "first_published_date": "21/07/2008", "last_updated_date": "21/07/2008", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000024-pip01-07" }, { "decision_number": "P/45/2007", "pip_number": "EMEA-000251-PIP01-08", "active_substance": "nicotinic acid;laropiprant", "invented_name": "", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Prolonged-release tablet", "condition_indication": "Heterozygous Familial Hypercholesterolaemia;Homozygous Familial Hypercholesterolaemia", "routes_of_administration": "Oral use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "23/06/2008", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Merck Sharp and Dohme (Europe), Inc.; Belgium; Tel. +33 180464738; E-mail: pip.information@merck.com", "first_published_date": "21/07/2008", "last_updated_date": "21/07/2008", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000251-pip01-08" }, { "decision_number": "P/40/2008", "pip_number": "AP214 Acetate (Αcetyl-(Lys)6-α-MSH, acetate salt)", "active_substance": "AP214 Acetate (Αcetyl-(Lys)6-α-MSH, acetate salt)", "invented_name": "", "therapeutic_area": "Uro-nephrology", "pharmaceutical_forms": "Concentrate for solution for infusion", "condition_indication": "Acute renal failure after thoracic aortic aneurysm repair surgery;Thoracic aortic aneurysm", "routes_of_administration": "Intravenous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "24/06/2008", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Action Pharma A/S; E-mail: tj@actionpharma.com; Country: Denmark; Phone: +45 45475000; Fax: +45 45475001", "first_published_date": "21/07/2008", "last_updated_date": "21/07/2008", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/ap214-acetate-acetyl-lys6-msh-acetate-salt" }, { "decision_number": "P/43/2008", "pip_number": "Vernakalant hydrochloride", "active_substance": "vernakalant hydrochloride", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Encapsulated tablet;Concentrate for solution for infusion", "condition_indication": "Atrial fibrillation", "routes_of_administration": "Oral use;Intravenous use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "24/06/2008", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Cardiome UK Limited; E-mail: jmallison@cardiome.com; Country: Canada; Phone: +1 6046776905; Fax: +1 6046766970", "first_published_date": "21/07/2008", "last_updated_date": "21/07/2008", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/vernakalant-hydrochloride" }, { "decision_number": "P/42/2008", "pip_number": "EMEA-000216-PIP01-08", "active_substance": "dutasteride;tamsulosin hydrochloride", "invented_name": "", "therapeutic_area": "Uro-nephrology", "pharmaceutical_forms": "Capsule", "condition_indication": "Treatment of benign prostatic hyperplasia", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "24/06/2008", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Merck Sharp & Dohme (Europe) Inc.; Tel.: +1 4388998201; E-mail: axel_breitstadt@merck.com", "first_published_date": "21/07/2008", "last_updated_date": "21/07/2008", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000216-pip01-08" }, { "decision_number": "P/46/2007", "pip_number": "EMEA-000252-PIP01-08", "active_substance": "nicotinic acid;laropiprant", "invented_name": "", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Prolonged-release tablet", "condition_indication": "Heterozygous Familial Hypercholesterolaemia;Homozygous Familial Hypercholesterolaemia", "routes_of_administration": "Oral use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "23/06/2008", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Merck Sharp and Dohme (Europe), Inc.; Belgium; Tel. +33 180464738; E-mail: pip.information@merck.com", "first_published_date": "21/07/2008", "last_updated_date": "21/07/2008", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000252-pip01-08" }, { "decision_number": "P/39/2008", "pip_number": "EMEA-000062-PIP01-07", "active_substance": "taranabant", "invented_name": "", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Capsule, soft", "condition_indication": "Obesity", "routes_of_administration": "Oral use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "24/06/2008", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Merck Sharp & Dohme (Europe) Inc.Tel.: +33180464738E-mail: pip.information@merck.com", "first_published_date": "21/07/2008", "last_updated_date": "21/07/2008", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000062-pip01-07" }, { "decision_number": "P/41/2008", "pip_number": "Elocalcitol", "active_substance": "Elocalcitol", "invented_name": "", "therapeutic_area": "Uro-nephrology", "pharmaceutical_forms": "Capsule", "condition_indication": "Treatment of benign prostatic hyperplasia", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "24/06/2008", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "BioXell SpA; E-mail: lorenza.olivieri@bioxell.com; Country: Italy; Phone: +39 0221049545; Fax: +39 0221049529", "first_published_date": "21/07/2008", "last_updated_date": "21/07/2008", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/elocalcitol" }, { "decision_number": "P/28/2008", "pip_number": "Adenovirus-mediated Herpes simplex virus-thymidine kinase gene", "active_substance": "adenovirus-mediated Herpes simplex virus-thymidine kinase gene", "invented_name": "", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Concentrate for solution for injection", "condition_indication": "Treatment of high-grade glioma", "routes_of_administration": "Intracerebral use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "23/05/2008", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Ark Therapeutics Ltd; E-mail: david.eckland@arktherapeutics.com; Country: United Kingdom; Phone: +44 2073887722; Fax: +44 2073887805", "first_published_date": "17/06/2008", "last_updated_date": "17/06/2008", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/adenovirus-mediated-herpes-simplex-virus-thymidine-kinase-gene" }, { "decision_number": "P/30/2008", "pip_number": "Caspofungin acetate", "active_substance": "caspofungin acetate", "invented_name": "Cancidas (previously Caspofungin MSD); Cancidas", "therapeutic_area": "Infectious diseases", "pharmaceutical_forms": "Powder for concentrate for solution for infusion;Powder for solution for infusion", "condition_indication": "Fungal infections", "routes_of_administration": "Intravenous use", "decision_type": "PM: decision on the application for modification of an agreed PIP", "decision_date": "23/05/2008", "compliance_outcome": "Positive", "compliance_opinion_date": "04/06/2008", "compliance_procedure_number": "EMEA-C-000010-PIP01-07-M01", "contact_for_public_enquiries": "Merck Sharp & Dohme (Europe) Inc.Tel.: +33180464738E-mail: pip.information@merck.com", "first_published_date": "17/06/2008", "last_updated_date": "17/06/2008", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/caspofungin-acetate" }, { "decision_number": "P/23/2008", "pip_number": "EMEA-000017-PIP01-07", "active_substance": "albumin interferon alfa-2b", "invented_name": "", "therapeutic_area": "Gastroentology-Hepatology", "pharmaceutical_forms": "Powder and solvent for solution for injection", "condition_indication": "Treatment of chronic hepatitis C", "routes_of_administration": "Subcutaneous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "23/05/2008", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Novartis Europharm LimitedE-mail: paediatric.enquiries@novartis.comTel. +41 613241111", "first_published_date": "17/06/2008", "last_updated_date": "17/06/2008", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000017-pip01-07" }, { "decision_number": "P/29/2008", "pip_number": "Arzoxifene", "active_substance": "arzoxifene", "invented_name": "", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Breast carcinoma;Postmenopausal osteoporosis", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "23/05/2008", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Eli Lilly and Company LtdE-mail: eu_paediatric@lilly.com Phone: +44 1256315000", "first_published_date": "17/06/2008", "last_updated_date": "17/06/2008", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/arzoxifene" }, { "decision_number": "P/22/2008", "pip_number": "Docetaxel", "active_substance": "docetaxel", "invented_name": "Taxotere; Taxotere", "therapeutic_area": "Oncology", "pharmaceutical_forms": "Concentrate and solvent for solution for infusion", "condition_indication": "Nasopharyngeal carcinoma", "routes_of_administration": "Intravenous use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "16/05/2008", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Aventis Pharma SA; E-mail: sylvie.gabriel@sanofi-aventis.com; Country: France; Phone: +33 153774152; Fax: +33 153774133", "first_published_date": "04/06/2008", "last_updated_date": "04/06/2008", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/docetaxel" }, { "decision_number": "P/20/2008", "pip_number": "EMEA-000085-PIP01-07", "active_substance": "Flibanserin", "invented_name": "", "therapeutic_area": "Endocrinology-Gynaecology-Fertility-Metabolism", "pharmaceutical_forms": "Film-coated tablet", "condition_indication": "Hypoactive Sexual Desire Disorder in Women", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "28/04/2008", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Boehringer Ingelheim International GmbH; Tel. +49 6132 778271; Email: Paediatrics@boehringer-ingelheim.com", "first_published_date": "16/05/2008", "last_updated_date": "16/05/2008", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000085-pip01-07" }, { "decision_number": "P/21/2008", "pip_number": "Roflumilast", "active_substance": "roflumilast", "invented_name": "", "therapeutic_area": "Pneumology-allergology", "pharmaceutical_forms": "Tablet", "condition_indication": "Chronic obstructive pulmonary disease", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "28/04/2008", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Nycomed GmbH; E-mail: corporatecommunications@nycomed.com; Country: Germany; Phone: +49 7531840; Fax: +49 7531842474", "first_published_date": "16/05/2008", "last_updated_date": "16/05/2008", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/roflumilast" }, { "decision_number": "P/16/2008", "pip_number": "EMEA-000104-PIP01-07", "active_substance": "naproxcinod", "invented_name": "", "therapeutic_area": "Immunology-Rheumatology-Transplantation", "pharmaceutical_forms": "Capsule, hard", "condition_indication": "Primary osteoarthritis", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "31/03/2008", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "NicOx S.A.; E-mail: emea.contact@nicox.com; Country: France; Phone: +33 97245300; Fax: +33 97245379", "first_published_date": "22/04/2008", "last_updated_date": "22/04/2008", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000104-pip01-07" }, { "decision_number": "P/15/2008", "pip_number": "Flosfluridine tidoxil", "active_substance": "Flosfluridine tidoxil", "invented_name": "", "therapeutic_area": "Dermatology", "pharmaceutical_forms": "Capsule", "condition_indication": "Treatment of actinic keratosis", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "31/03/2008", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Heidelberg Pharma AG; E-mail: e.boehm@hdpharma.com; Country: Germany; Phone: +49 6203100963; Fax: +49 6203100918", "first_published_date": "04/04/2008", "last_updated_date": "04/04/2008", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/flosfluridine-tidoxil" }, { "decision_number": "P/9/2008", "pip_number": "EMEA-000008-PIP01-07", "active_substance": "Losartan potassium", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Film-coated tablet;Age appropriate oral liquid dosage formulation", "condition_indication": "Proteinuria;Treatment of heart failure;Treatment of hypertension", "routes_of_administration": "Oral use", "decision_type": "P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)", "decision_date": "29/02/2008", "compliance_outcome": "Positive", "compliance_opinion_date": "06/02/2009", "compliance_procedure_number": "EMEA-C-000008-PIP01-07", "contact_for_public_enquiries": "Merck, Sharp & Dohme (Europe) Inc.; Tel. +31 412770000; E-mail: regaffairseurope@organon.com", "first_published_date": "19/03/2008", "last_updated_date": "19/03/2008", "pip_url": "https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000008-pip01-07" }, { "decision_number": "P/3/2008", "pip_number": "EMEA-000045-PIP01-07", "active_substance": "telmisartan;ramipril", "invented_name": "", "therapeutic_area": "Cardiovascular diseases", "pharmaceutical_forms": "Tablet", "condition_indication": "Risk of myocardial infarction, stroke, death from cardiovascular causes, or hospitalization forcongestive heart failure in patients at high risk of developing major cardiovascular events", "routes_of_administration": "Oral use", "decision_type": "W: decision granting a waiver in all age groups for all conditions or indications", "decision_date": "01/02/2008", "compliance_outcome": "", "compliance_opinion_date": "", "compliance_procedure_number": "", "contact_for_public_enquiries": "Boehringer Ingelheim International GmbH; 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