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Opinion/decision on a Paediatric investigation plan (PIP): Humanised chimeric antibody with a humanised H chain and a chimeric (mouse V-domain, human C-domain) L chain against epidermal growth factor receptor conjugated to maleimidocaproyl monomethylauristatin F (ABT-414)L chain against epidermal growth factor receptor conjugated to maleimidocaproylmonomethylauristatin F (ABT-414)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), PIP number: EMEA-001732-PIP02-15, decision date: 04/11/2016, Last updated: 07/08/2019, compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Complex of povidone and iodine, dexamethasone (SHP640)
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Ophthalmology, PIP number: EMEA-001936-PIP01-16-M01, decision date: 07/12/2018, Last updated: 28/06/2019, compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): 5-(4-Fluoro-1-benzothiophen-2-yl)-8-methyl-1,9-dihydro-2H-[1,3]oxazolo[4,5-H][2,3]benzodiazepin-2-one (S44819)
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-002057-PIP01-16, decision date: 04/10/2017, Last updated: 27/06/2019, compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Dexxience, Betrixaban
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Cardiovascular diseases, PIP number: EMEA-001834-PIP02-16-M01, decision date: 18/06/2018, Last updated: 27/06/2019, compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Chemically modified extract of trees pollen from birch and alder
Decision type: RPM: decision refers to a refusal on the application for modification of an agreed PIP, therapeutic area: Pneumology-allergology, PIP number: EMEA-001012-PIP01-10-M01, decision date: 22/03/2019, Last updated: 25/06/2019, compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Chemically modified house dust mites allergen extract (Dermatophagoides pteronyssinus and Dermatophagoides farinae)
Decision type: RPM: decision refers to a refusal on the application for modification of an agreed PIP, therapeutic area: Pneumology-allergology, PIP number: EMEA-001011-PIP01-10-M01, decision date: 22/03/2019, Last updated: 25/06/2019, compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Uptravi, Selexipag
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Other, PIP number: EMEA-000997-PIP01-10-M02, decision date: 17/04/2019, Last updated: 25/06/2019, compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Refixia, Nonacog beta pegol
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Haematology-Hemostaseology, PIP number: EMEA-000731-PIP01-09-M03, decision date: 17/04/2019, Last updated: 25/06/2019, compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Otezla, apremilast
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Immunology-Rheumatology-Transplantation, PIP number: EMEA-000715-PIP02-11-M03, decision date: 22/03/2019, Last updated: 25/06/2019, compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Xeljanz, Tofacitinib
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Gastroentology-Hepatology, PIP number: EMEA-000576-PIP03-12-M02, decision date: 22/03/2019, Last updated: 25/06/2019, compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Xeljanz, Tofacitinib
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Immunology-Rheumatology-Transplantation, PIP number: EMEA-000576-PIP01-09-M10, decision date: 17/04/2019, Last updated: 25/06/2019, compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Stivarga, regorafenib
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Oncology, PIP number: EMEA-001178-PIP01-11-M04, decision date: 17/04/2019, Last updated: 25/06/2019, compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Mekinist, Trametinib (dimethyl sulfoxide)
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Oncology, PIP number: EMEA-001177-PIP01-11-M05, decision date: 22/03/2019, Last updated: 25/06/2019, compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Onasemnogenum abeparvovecum
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Neurology, PIP number: EMEA-002168-PIP01-17-M01, decision date: 17/04/2019, Last updated: 25/06/2019, compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Lefamulin
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Infectious diseases, PIP number: EMEA-002075-PIP01-16-M01, decision date: 22/03/2019, Last updated: 25/06/2019, compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Carotuximab
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Oncology, PIP number: EMEA-002138-PIP01-17-M01, decision date: 22/03/2019, Last updated: 25/06/2019, compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Avalglucosidase alfa
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Endocrinology, -gynacology-fertility-metabolism, PIP number: EMEA-001945-PIP01-16-M01, decision date: 25/06/2019, Last updated: 25/06/2019, compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): 3-[[5-chloro-1-[3-(methylsulfonyl)propyl]-1H-indol-2-yl]methyl]-1-(2,2,2-trifluoroethyl)-1,3-dihydro-3-[[5-chloro-1-[3-(methylsulfonyl)propyl]-1H-indol-2-yl]methyl]-1-(2,2,2-trifluoroethyl)-1,3-dihydro-2H-imidazo[4,5-c]pyridine-2-one (JNJ-53718678)
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Infectious diseases, PIP number: EMEA-001838-PIP01-15-M02, decision date: 22/03/2019, Last updated: 25/06/2019, compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Tralokinumab
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Dermatology, PIP number: EMEA-001900-PIP02-17-M02, decision date: 25/03/2019, Last updated: 25/06/2019, compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Emgality, Galcanezumab
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Neurology, PIP number: EMEA-001860-PIP03-16-M02, decision date: 22/03/2019, Last updated: 25/06/2019, compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Inebilizumab
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Neurology, PIP number: EMEA-001911-PIP01-15-M02, decision date: 17/04/2019, Last updated: 25/06/2019, compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Angiotensin II (LJPC-501)
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Cardiovascular diseases, PIP number: EMEA-001912-PIP02-16-M02, decision date: 15/04/2019, Last updated: 25/06/2019, compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Tafinlar, Dabrafenib (mesilate)
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Oncology, PIP number: EMEA-001147-PIP01-11-M06, decision date: 22/03/2019, Last updated: 24/06/2019, compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Zerbaxa, Ceftolozane, tazobactam
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Infectious diseases, PIP number: EMEA-001142-PIP01-11-M03, decision date: 29/03/2017, Last updated: 24/06/2019, compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Plegridy, peginterferon beta-1a
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Neurology, PIP number: EMEA-001129-PIP01-11-M03, decision date: 22/03/2019, Last updated: 24/06/2019, compliance check: X