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Referral: Lartruvo
olaratumab, associated names: Lartruvo, Article 20 procedures
Status: European Commission final decision, opinion/position date: 31/01/2019, EC decision date: 19/07/2019, Last updated: 22/08/2019 -
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Referral: Direct-acting antivirals indicated for treatment of hepatitis C (interferon-free)
daclatasvir / dasabuvir / sofosbuvir / ledipasvir / simeprevir / ombitasvir/paritaprevir / ritonavir, associated names: Sovaldi, Olysio, Viekirax, Harvoni, Exviera, Daklinza, Article 20 procedures
Status: European Commission final decision, opinion/position date: 15/12/2016, EC decision date: 23/02/2017, Last updated: 09/03/2017 -
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Opinion/decision on a Paediatric investigation plan (PIP): Namuscla, Mexiletine (hydrochloride) (updated)
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Other, PIP number: EMEA-002012-PIP01-16-M02, decision date: 04/12/2019, Last updated: 02/04/2020, compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Waylivra, Volanesorsen (updated)
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Endocrinology, -gynacology-fertility-metabolism, PIP number: EMEA-001915-PIP01-15-M01, decision date: 04/12/2019, Last updated: 02/04/2020, compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Imbruvica, Ibrutinib (updated)
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Immunology-Rheumatology-Transplantation, PIP number: EMEA-001397-PIP04-17-M01, decision date: 06/12/2019, Last updated: 01/04/2020, compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Revestive, teduglutide (updated)
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Gastroentology-Hepatology, PIP number: EMEA-000482-PIP01-08-M05, decision date: 06/12/2019, Last updated: 31/03/2020, compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Prevymis, Letermovir (updated)
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Infectious diseases, PIP number: EMEA-001631-PIP01-14-M04, decision date: 04/11/2019, Last updated: 30/03/2020, compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Daklinza, Daclatasvir (updated)
Decision type: W: decision granting a waiver in all age groups for all conditions/indications, therapeutic area: Infectious diseases, PIP number: EMEA-001191-PIP01-11-M03, decision date: 08/11/2019, Last updated: 30/03/2020, compliance check: X -
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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): Bosulif, Bosutinib
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Oncology, PIP number: EMEA-000727-PIP01-09-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): 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): 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): Lenvima, Lenvatinib
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Oncology, PIP number: EMEA-001119-PIP02-12-M05, 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