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179 results
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Opinion/decision on a Paediatric investigation plan (PIP): Soliris, Eculizumab
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Immunology-Rheumatology-Transplantation, PIP number: EMEA-000876-PIP05-15-M03, decision date: 19/07/2018, Last updated: 22/11/2018, 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): Vimizim, Recombinant human N-acetylgalactosamine-6-sulfatase (BMN110)
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Endocrinology, -gynacology-fertility-metabolism, PIP number: EMEA-000973-PIP01-10-M03, decision date: 30/03/2015, Last updated: 06/05/2015, compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Symkevi, 1-(2,2-difluoro-1,3-benzodioxol-5-yl)-N-{1-[(2R)-2,3-dihydroxypropyl]-6-fluoro-2-(1-hydroxy-2-methylpropan-2-yl)-1H-indol-5-yl}cyclopropanecarboxamide (VX-661), ivacaftor
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Pneumology-allergology, PIP number: EMEA-001640-PIP01-14-M05, decision date: 17/07/2019, Last updated: 18/11/2019, 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): Mysimba, Naltrexone (hydrochloride), bupropion (hydrochloride)
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Other, PIP number: EMEA-001373-PIP01-12-M03, decision date: 01/12/2017, compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Glivec, Imatinib (mesilate)
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-000463-PIP02-10, decision date: 08/04/2011, Last updated: 12/05/2011, compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Lojuxta, Lomitapide (updated)
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Other, PIP number: EMEA-001124-PIP01-10-M04, decision date: 10/09/2019, Last updated: 26/03/2020, compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Venclyxto, Venetoclax
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Haematology-Hemostaseology, PIP number: EMEA-002018-PIP02-16-M02, decision date: 17/07/2019, Last updated: 18/11/2019, compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Benlysta, belimumab
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Immunology-Rheumatology-Transplantation, PIP number: EMEA-000520-PIP01-08-M05, decision date: 15/07/2016, Last updated: 23/09/2016, compliance check: V, 16/11/2018 -
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Opinion/decision on a Paediatric investigation plan (PIP): Holoclar, Ex-vivo expanded human autologous epithelium containing stem cells
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Ophthalmology, PIP number: EMEA-001082-PIP02-11-M02, decision date: 07/12/2018, Last updated: 18/02/2019, compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Galafold, Migalastat (hydrochloride)
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Endocrinology, -gynacology-fertility-metabolism, PIP number: EMEA-001194-PIP01-11-M04, decision date: 17/04/2019, Last updated: 24/06/2019, compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Deltyba, Delamanid
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Infectious diseases, PIP number: EMEA-001113-PIP01-10-M06, decision date: 14/08/2019, Last updated: 20/11/2019, compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Briviact (in Italy: Nubriveo), Brivaracetam
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Neurology, PIP number: EMEA-000332-PIP02-17, decision date: 22/02/2018, Last updated: 18/04/2018, 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): Keytruda, Anti-PD1 humanized monoclonal antibody of the IgG4/kappa class (MK-3475) (pembrolizumab)
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Oncology, PIP number: EMEA-001474-PIP01-13-M01, decision date: 16/02/2018, compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Symtuza, darunavir, cobicistat, emtricitabine, tenofovir alafenamide
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Infectious diseases, PIP number: EMEA-001825-PIP01-15-M02, decision date: 01/10/2018, Last updated: 31/01/2019, compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Zydelig, Idelalisib
Decision type: W: decision granting a waiver in all age groups for all conditions/indications, therapeutic area: Oncology, PIP number: EMEA-001350-PIP02-13-M04, decision date: 09/11/2018, Last updated: 28/01/2019, compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Sirturo, Bedaquiline (fumarate)
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Infectious diseases, PIP number: EMEA-000912-PIP01-10-M04, decision date: 19/12/2018, Last updated: 18/02/2019, compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Soliris, Eculizumab
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-000876-PIP06-15, decision date: 28/07/2016, Last updated: 20/04/2018, compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Isentress, Raltegravir
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Infectious diseases, PIP number: EMEA-000279-PIP01-08-M05, decision date: 15/06/2016, Last updated: 02/03/2018, compliance check: V, 19/06/2017 -
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Opinion/decision on a Paediatric investigation plan (PIP): Taltz, ixekizumab
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Immunology-Rheumatology-Transplantation, PIP number: EMEA-001050-PIP01-10-M04, decision date: 20/11/2018, Last updated: 18/02/2019, compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Prepandrix, 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)
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Vaccines, PIP number: EMEA-000160-PIP01-07-M05, decision date: 14/08/2019, Last updated: 20/11/2019, 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): Lartruvo, Olaratumab
Decision type: W: decision granting a waiver in all age groups for all conditions/indications, therapeutic area: Oncology, PIP number: EMEA-001760-PIP01-15-M03, decision date: 22/03/2019, Last updated: 24/06/2019, compliance check: X