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39 results
Medicine
European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter
Paediatric investigation plans Remove Paediatric investigation plans filter
PIP decision type
RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s) Remove RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s) filter
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s) Remove P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s) filter
PIP compliance check
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Opinion/decision on a Paediatric investigation plan (PIP): Eylea, aflibercept
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Ophthalmology
PIP number: EMEA-000236-PIP05-18, Route(s) of administration: Intravitreal use, Pharmaceutical form(s): Solution for injection
Decision date: 04/04/2019, Last updated: 13/03/2023, Compliance check: V, 15/10/2021 -
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Opinion/decision on a Paediatric investigation plan (PIP): Emicizumab
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001839-PIP01-15, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 15/07/2016, Last updated: 21/09/2021, Compliance check: V, 26/04/2019 -
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Opinion/decision on a Paediatric investigation plan (PIP): Descovy, emtricitabine, tenofovir alafenamide
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Infectious diseases
PIP number: EMEA-001577-PIP03-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 07/05/2018, Last updated: 21/09/2021, Compliance check: V, 20/09/2019 -
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Opinion/decision on a Paediatric investigation plan (PIP): Mometasone (furoate monohydrate), Olopatadine (hydrochloride) (GSP 301 NS)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Oto-rhino-laryngology
PIP number: EMEA-002514-PIP01-18, Route(s) of administration: Intranasal use, Pharmaceutical form(s): Nasal spray, suspension
Decision date: 15/05/2019, Last updated: 21/09/2021, Compliance check: V, 27/03/2020 -
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Opinion/decision on a Paediatric investigation plan (PIP): Lonafarnib
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Other
PIP number: EMEA-002516-PIP01-18, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 16/07/2019, Last updated: 20/09/2021, Compliance check: V, 27/03/2020 -
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Opinion/decision on a Paediatric investigation plan (PIP): glucarpidase
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Oncology
PIP number: EMEA-001391-PIP01-12, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for solution for infusion
Decision date: 30/07/2013, Last updated: 16/09/2021, Compliance check: V, 24/07/2020 -
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Opinion/decision on a Paediatric investigation plan (PIP): Lonapegsomatropin
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Endocrinology-Gynaecology-Fertility-Metabolism
PIP number: EMEA-002692-PIP01-19, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Powder and solvent for solution for injection
Decision date: 15/07/2020, Last updated: 16/09/2021, Compliance check: X, 04/09/2020 -
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Opinion/decision on a Paediatric investigation plan (PIP): Adenovirus associated viral vector serotype 2 containing the human RPE65 gene
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Ophthalmology
PIP number: EMEA-001684-PIP01-14, Route(s) of administration: Intraocular use, Pharmaceutical form(s): Solution for injection
Decision date: 02/10/2015, Last updated: 07/03/2019, Compliance check: V, 21/04/2017 -
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Opinion/decision on a Paediatric investigation plan (PIP): Ragweed pollen extract (Ambrosia artemisiifolia)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Pneumology-allergology
PIP number: EMEA-001881-PIP01-15, Route(s) of administration: Sublingual use, Pharmaceutical form(s): Oral lyophilisate
Decision date: 05/10/2016, Last updated: 23/11/2016, Compliance check: V, 15/11/2019 -
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Opinion/decision on a Paediatric investigation plan (PIP): Autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with lentiviral vector that encodes for the human Wiskott Aldrich Syndrome (WAS) cDNA sequence
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-001792-PIP01-15, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Dispersion for infusion
Decision date: 18/03/2016, Last updated: 25/04/2016, Compliance check: V, 24/03/2017 -
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Opinion/decision on a Paediatric investigation plan (PIP): Tetracaine (hydrochloride), Oxymetazoline hydrochloride
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Anaesthesiology
PIP number: EMEA-001764-PIP03-15, Route(s) of administration: Nasal use, Pharmaceutical form(s): Nasal spray, solution
Decision date: 18/03/2016, Last updated: 25/04/2016, Compliance check: V, 21/04/2017 -
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Opinion/decision on a Paediatric investigation plan (PIP): Truvada, emtricitabine, tenofovir disoproxil fumarate
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
PIP number: EMEA-001091-PIP02-15, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 03/12/2015, Last updated: 02/02/2016, Compliance check: V, 16/12/2016 -
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Opinion/decision on a Paediatric investigation plan (PIP): Tobramycin
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Pneumology-allergology
PIP number: EMEA-000184-PIP02-14, Route(s) of administration: Inhalation use, Pharmaceutical form(s): Nebuliser solution
Decision date: 06/08/2014, Last updated: 22/08/2014, Compliance check: V, 29/04/2016 -
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Opinion/decision on a Paediatric investigation plan (PIP): Human normal immunoglobulin
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-001637-PIP01-13, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 11/03/2014, Last updated: 16/04/2014, Compliance check: V, 16/01/2015 -
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Opinion/decision on a Paediatric investigation plan (PIP): Rupatadine fumarate
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Pneumology-allergology
PIP number: EMEA-000582-PIP01-09-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet, Granules, Oral liquid
Decision date: 26/02/2014, Last updated: 20/03/2014, Compliance check: V, 21/03/2014 -
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Opinion/decision on a Paediatric investigation plan (PIP): Raltegravir, lamivudine
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Infectious diseases
PIP number: EMEA-001442-PIP01-13, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 13/01/2014, Last updated: 05/02/2014, Compliance check: V, 21/03/2014 -
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Opinion/decision on a Paediatric investigation plan (PIP): Sodium benzylpenilloate, benzylpenicilloyl octa- L-lysine
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Diagnostic
PIP number: EMEA-001398-PIP02-13, Route(s) of administration: Skin scarification, Intradermal use, Pharmaceutical form(s): Powder and solvent for solution for injection
Decision date: 29/11/2013, Last updated: 06/01/2014, Compliance check: V, 12/09/2014 -
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Opinion/decision on a Paediatric investigation plan (PIP): Vfend, voriconazole
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Infectious diseases
PIP number: EMEA-000191-PIP01-08-M05, Route(s) of administration: Oral use, Intravenous use, Pharmaceutical form(s): Film-coated tablet, Powder for oral suspension, Powder for solution for infusion
Decision date: 05/07/2013, Last updated: 08/08/2013, Compliance check: V, 09/08/2013 -
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Opinion/decision on a Paediatric investigation plan (PIP): Humira, adalimumab
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Dermatology
PIP number: EMEA-000366-PIP04-12, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 03/05/2013, Last updated: 21/06/2013, Compliance check: V, 01/04/2016 -
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Opinion/decision on a Paediatric investigation plan (PIP): Synagis, palivizumab
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Neonatology-Paediatric Intensive Care
PIP number: EMEA-001309-PIP01-12, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Solution for injection, Powder and solvent for solution for injection
Decision date: 30/04/2013, Last updated: 31/05/2013, Compliance check: V, 09/08/2013 -
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Opinion/decision on a Paediatric investigation plan (PIP): Tysabri, natalizumab
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Neurology
PIP number: EMEA-001095-PIP02-12, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 19/10/2012, Last updated: 27/11/2012, Compliance check: V, 16/12/2016 -
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Opinion/decision on a Paediatric investigation plan (PIP): misoprostol
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Other
PIP number: EMEA-001159-PIP02-12, Route(s) of administration: Vaginal use, Pharmaceutical form(s): Vaginal delivery system
Decision date: 23/07/2012, Last updated: 23/08/2012, Compliance check: V, 11/10/2012 -
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Opinion/decision on a Paediatric investigation plan (PIP): Kineret, anakinra
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-001212-PIP01-11, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 28/03/2012, Last updated: 19/04/2012, Compliance check: V, 12/12/2014 -
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Opinion/decision on a Paediatric investigation plan (PIP): Azelastine (hydrochloride), fluticasone propionate
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Pneumology-allergology
PIP number: EMEA-000990-PIP02-10, Route(s) of administration: Nasal use, Pharmaceutical form(s): Nasal spray, suspension
Decision date: 06/04/2011, Last updated: 12/05/2011, Compliance check: V, 24/06/2011 -
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Opinion/decision on a Paediatric investigation plan (PIP): Rizatriptan
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Pain
PIP number: EMEA-000084-PIP02-10, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 28/01/2011, Last updated: 23/02/2011, Compliance check: V, 14/09/2011