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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): 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): 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): 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): 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): 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 -
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Opinion/decision on a Paediatric investigation plan (PIP): Sovaldi, Sofosbuvir
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Infectious diseases, PIP number: EMEA-001276-PIP01-12-M02, decision date: 15/06/2018, Last updated: 28/11/2018, compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Viekirax, Ombitasvir / paritaprevir / ritonavir
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Infectious diseases, PIP number: EMEA-001440-PIP01-13-M02, decision date: 15/06/2018, Last updated: 22/11/2018, 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): 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 -
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Opinion/decision on a Paediatric investigation plan (PIP): Caprelsa, Vandetanib
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Oncology, PIP number: EMEA-000052-PIP01-07-M03, decision date: 30/11/2013, Last updated: 06/01/2014, compliance check: V, 20/06/2014 -
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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): Kalydeco, ivacaftor
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Other, PIP number: EMEA-000335-PIP01-08-M13, decision date: 16/02/2018, Last updated: 15/02/2019, compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Tagrisso, Osimertinib (as mesylate)
Decision type: W: decision granting a waiver in all age groups for all conditions/indications, therapeutic area: Oncology, PIP number: EMEA-002125-PIP01-17, decision date: 09/08/2017, compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Pixuvri, pixantrone (dimaleate)
Decision type: W: decision granting a waiver in all age groups for all conditions/indications, therapeutic area: Oncology, PIP number: EMEA-000713-PIP02-10-M05, decision date: 20/07/2018, Last updated: 28/11/2018, compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Vidaza, azacitidine
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Haematology-Hemostaseology, PIP number: EMEA-001272-PIP02-13-M01, decision date: 02/10/2015, Last updated: 23/11/2015, compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Adcetris, Brentuximab vedotin
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Oncology, PIP number: EMEA-000980-PIP01-10-M05, decision date: 11/08/2017, compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Ofev, nintedanib
Decision type: W: decision granting a waiver in all age groups for all conditions/indications, therapeutic area: Pneumology-allergology, PIP number: EMEA-001006-PIP02-15, decision date: 27/10/2015, compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Coagadex, Human coagulation factor X
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Haematology-Hemostaseology, PIP number: EMEA-000971-PIP01-10-M03, decision date: 19/12/2017, Last updated: 05/03/2018, compliance check: V, 26/01/2018 -
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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): Humenza, Split influenza virus, inactivated containing antigen equivalent to A/California/7/2009 (H1N1)-like strain (A/California/7/2009 (NYMC X-179A)), adjuvanted
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Vaccines, PIP number: EMEA-000669-PIP01-09-M02, decision date: 04/01/2019, Last updated: 16/04/2019, 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): Exviera, Dasabuvir (sodium monohydrate)
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Infectious diseases, PIP number: EMEA-001439-PIP01-13-M02, decision date: 15/06/2018, Last updated: 22/11/2018, 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): 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