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Summary of opinion: Azacitidine Mylan
azacitidine, opinion date: 30/01/2020, Positive, Last updated: 04/02/2020 -
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Summary of opinion: Revolade
eltrombopag, opinion date: 17/10/2019, Negative, Last updated: 18/10/2019 -
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Summary of opinion: Arsenic trioxide Mylan
arsenic trioxide, opinion date: 30/01/2020, Positive, Last updated: 31/01/2020 -
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Summary of opinion: Cinacalcet Accordpharma
cinacalcet, opinion date: 30/01/2020, Positive, Last updated: 31/01/2020 -
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Summary of opinion: Trepulmix
treprostinil sodium, opinion date: 30/01/2020, Positive, Last updated: 31/01/2020 -
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Summary of opinion: Azacitidine betapharm
azacitidine, opinion date: 30/01/2020, Positive, Last updated: 31/01/2020 -
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Summary of opinion: Ofev
nintedanib, opinion date: 27/02/2020, Positive, Last updated: 28/02/2020 -
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Summary of opinion: Tigecycline Accord
tigecycline, opinion date: 27/02/2020, Positive, Last updated: 28/02/2020 -
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Summary of opinion: Adcetris
brentuximab vedotin, opinion date: 26/03/2020, Positive, Last updated: 27/03/2020 -
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Summary of opinion: Jorveza
budesonide, opinion date: 26/03/2020, Positive, Last updated: 27/03/2020 -
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Opinion/decision on a Paediatric investigation plan (PIP): Kymriah, tisagenlecleucel (updated)
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Oncology, PIP number: EMEA-001654-PIP02-17-M01, decision date: 11/09/2019, Last updated: 26/03/2020, compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Cometriq, cabozantinib (updated)
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Oncology, PIP number: EMEA-001143-PIP01-11-M02, decision date: 11/09/2019, Last updated: 26/03/2020, compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Translarna, Ataluren (updated)
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Neurology, PIP number: EMEA-000115-PIP01-07-M10, decision date: 11/09/2019, Last updated: 26/03/2020, compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Vyxeos liposomal (previously known as Vyxeos), daunorubicin, cytarabine
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Oncology, PIP number: EMEA-001858-PIP02-16-M03, 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): 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): Takhzyro, Lanadelumab (DX-2930)
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Other, PIP number: EMEA-001864-PIP01-15-M04, decision date: 23/07/2019, Last updated: 18/11/2019, 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): Ninlaro, Ixazomib
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Oncology, PIP number: EMEA-001410-PIP02-17-M02, decision date: 16/07/2019, Last updated: 14/11/2019, compliance check: X -
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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: Neurology, PIP number: EMEA-000876-PIP03-14-M03, decision date: 16/07/2019, Last updated: 14/11/2019, compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): NexoBrid, Concentrate of proteolytic enzymes in bromelain
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Other, PIP number: EMEA-000142-PIP02-09-M08, decision date: 16/07/2019, Last updated: 13/11/2019, compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Darzalex, Daratumumab
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Oncology, PIP number: EMEA-002152-PIP02-17-M01, decision date: 12/06/2019, Last updated: 08/11/2019, compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Imbruvica, Ibrutinib
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Oncology, PIP number: EMEA-001397-PIP03-14-M04, decision date: 12/06/2019, Last updated: 08/11/2019, compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Ocaliva, Obeticholic acid
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Gastroentology-Hepatology, PIP number: EMEA-001304-PIP02-13-M04, decision date: 12/06/2019, Last updated: 08/11/2019, compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Strensiq, asfotase alfa
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Endocrinology, -gynacology-fertility-metabolism, PIP number: EMEA-000987-PIP01-10-M04, decision date: 15/05/2019, Last updated: 30/10/2019, compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Natpar, Recombinant parathyroid hormone
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Endocrinology, -gynacology-fertility-metabolism, PIP number: EMEA-001526-PIP01-13-M03, decision date: 17/04/2019, Last updated: 24/06/2019, compliance check: X