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Opinion/decision on a Paediatric investigation plan (PIP): Anti proprotein convertase subtilisin kexin type 9 humanized monoclonal antibody (PF-04950615)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-001430-PIP01-13, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 02/04/2014, Last updated: 07/12/2016, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Anifrolumab
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-001435-PIP02-16, Route(s) of administration: Intravenous use, Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 16/03/2018, Last updated: 19/06/2018, Compliance check: X -
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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: 22/09/2016, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): exenatide
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-001755-PIP01-15, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Implant
Decision date: 18/03/2016, Last updated: 25/04/2016, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Risperidone
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Psychiatry
PIP number: EMEA-001034-PIP01-10, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 06/07/2011, Last updated: 09/08/2011, Compliance check: X -
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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): Recombinant human granulocyte colony stimulating factor coupled with recombinant human albumin fusion protein
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-001042-PIP02-11, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Powder for solution for injection
Decision date: 20/12/2011, Last updated: 19/01/2012, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Aluminium hydroxide adsorbed, depigmented glutaraldehyde polymerised, allergen extracts of Phleum pratense, Dactylis glomerata, Festuca elatior, Lolium perenne and Poa pratensis pollen (Grasses-Mix) and Secale cereale (Cultivated Rye) pollen (50/50)
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-000841-PIP01-10, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Suspension for injection
Decision date: 26/11/2010, Last updated: 21/12/2010, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Cadazolid
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-001108-PIP02-15, Route(s) of administration: Oral use, Pharmaceutical form(s): Granules for oral suspension
Decision date: 15/07/2016, Last updated: 08/06/2018, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): 17 beta-estradiol, etonogestrel
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-001718-PIP01-14, Route(s) of administration: Vaginal use, Pharmaceutical form(s): Vaginal delivery system
Decision date: 29/01/2016, Last updated: 29/03/2016, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): (1R,2R,4S)-4-{(2R)-2-[(3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,27-dihydroxy- 10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-1,5,11,28,29-pentaoxo-1,4,5,6,9,10,11,12,13,- 14,21,22,23,24,25,26,27,28,29,31,32,33,34,34a-tetracosahydro-3H-23,27-epoxypyrido[2,1-c][1,4]- oxazacyclohentriacontin-3-yl]propyl}-2-methoxycyclohexyldimethyl-phosphinate (MK-8669, or AP23573)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Oncology
PIP number: P/2/2010, Route(s) of administration: Oral use, Intravenous use, Pharmaceutical form(s): Gastro-resistant tablet, Age-appropriate dosage form, other, Age-appropriate dosage form for parenteral use
Decision date: 25/01/2010, Last updated: 25/02/2010, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Pollen from Dactylis glomerata, Festuca pratensis, Lolium perenne, Phleum pratense, Poa pratensis, Secale cereale and Artemisia vulgaris
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-000851-PIP01-10, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Suspension for injection
Decision date: 22/12/2010, Last updated: 24/01/2011, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Gevokizumab
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-001487-PIP01-13, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 13/06/2014, Last updated: 02/10/2018, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Chimeric monoclonal anti-Shiga toxin antibodies cαStx1 and cαStx2
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-001134-PIP01-11, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for injection
Decision date: 20/12/2011, Last updated: 19/01/2012, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Taspoglutide
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-000665-PIP01-09, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 07/05/2010, Last updated: 20/04/2011, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): (4R,5R)-1-[[4-[[4-[3,3-dibutyl-7-(dimethylamino)-2,3,4,5-tetrahydro-4-hydroxy-1,1-dioxido-1-benzothiepin-5-yl]phenoxy]methyl]phenyl]methyl]-4-aza-1-azoniabicyclo[2.2.2]octane chloride (SHP625)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-001475-PIP02-13, Route(s) of administration: Oral use, Pharmaceutical form(s): Oral liquid, Tablet
Decision date: 10/07/2015, Last updated: 19/10/2015, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): budesonide
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Neonatology-Paediactric Intensive care
PIP number: EMEA-001120-PIP01-10, Route(s) of administration: Inhalation use, Pharmaceutical form(s): Pressurised inhalation, solution
Decision date: 30/11/2011, Last updated: 21/12/2011, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Anastrozole
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: Anastrozole, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablets
Decision date: 06/02/2009, Last updated: 23/04/2009, Compliance check: V, 03/04/2009 -
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Opinion/decision on a Paediatric investigation plan (PIP): Vatreptacog alfa (activated)
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-000328-PIP02-09, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder and solvent for solution for injection
Decision date: 30/09/2011, Last updated: 13/06/2014, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Proteinase, metallo- (synthetic nociceptin receptor-binding) 1290102-81-6 (AGN214868)
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-001200-PIP01-11, Route(s) of administration: Intradermal use, Intramuscular use, Pharmaceutical form(s): Powder for solution for injection
Decision date: 26/02/2013, Last updated: 23/04/2013, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Rolofylline
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-000275-PIP01-08, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Emulsion for injection
Decision date: 18/05/2009, Last updated: 08/03/2019, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Peramivir
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-001856-PIP02-16, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 25/11/2016, Last updated: 06/01/2017, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): 6,7-dihydro-5H-pyrrolo[1,2-c] imidazol-5-yl) - (benzo derivative)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-000315-PIP01-08, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 07/09/2009, Last updated: 07/12/2009, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Fentanyl citrate
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Neonatology-Paediactric Intensive care
PIP number: EMEA-000712-PIP01-09, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for injection
Decision date: 23/11/2010, Last updated: 20/12/2010, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Entospletinib
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-002058-PIP01-16, Route(s) of administration: Oral use, Gastric use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate oral solid dosage form
Decision date: 04/10/2017, Last updated: 12/02/2018, Compliance check: X