12 results
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Opinion/decision on a Paediatric investigation plan (PIP): Mirvetuximab soravtansine
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-001921-PIP01-16, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for injection/infusion
Decision date: 31/01/2017, Last updated: 17/03/2017, Compliance check: XKey facts Mirvetuximab soravtansine OncologyP/0032/2017EMEA-001921-PIP01-16 … product specific waiver for mirvetuximab soravtansine (EMEA-001921-PIP01-16) PDF … product specific waiver for mirvetuximab soravtansine (EMEA-001921-PIP01-16) in … -
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National expert: Philipp Harter, European Medicines Agency (updated)
- Declaration of interests - 84.81 KB | PDF
- Curriculum Vitae - 17.39 KB | PDF
04/2019-06/2022 Immunogen Mirvetuximab Soravtansin Ovarian Cancer 02/2019-10/2022 … 01/2020-(current) Immunogen Mirvetuximab Soravtansin Ovarian Cancer 01/2020-(current … -
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National expert: Ignace Vergote, European Medicines Agency (updated)
- Declaration of interests - 85.01 KB | PDF
- Curriculum Vitae - 16.73 KB | PDF
01/2020-(current) Immunogen Mirvetuximab soravtansine ovarian cancer VERGOTE … -
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National expert: Fausto Roila, European Medicines Agency (updated)
- Declaration of interests - 86.05 KB | PDF
- Curriculum Vitae - 18.02 KB | PDF
ImmunoGen, Inc., IQVIA Biontech Mirvetuximab soravtansina IMGN853 Advanced High-Grade … -
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National expert: Alexandra Leary, European Medicines Agency (updated)
- Declaration of interests - 85.56 KB | PDF
- Curriculum Vitae - 17.33 KB | PDF
04/2022-(current) immunogen mirvetuximab ovarian cancer 05/2021-(current … -
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Human medicine European public assessment report (EPAR): Blenrep
belantamab mafodotin, Multiple Myeloma
Date of authorisation: 25/08/2020,
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, Revision: 4, Authorised, Last updated: 12/10/2022
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Paediatric Committee (PDCO): 8-11 November 2016
European Medicines Agency, London, UK, from 08/11/2016 to 11/11/2016, Last updated: 30/06/2014 -
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Paediatric Committee (PDCO): 13-16 December 2016
European Medicines Agency, London, UK, from 13/12/2016 to 16/12/2016, Last updated: 30/06/2014treatment of hypertension; • Mirvetuximab soravtansine, EMEA-001921-PIP01-16, from … -
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News: EMA 2017 annual report published
Last updated: 02/05/2018 -
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PDCO: meeting archive 2015-2017
Last updated: 19/04/2022 -
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Annual reports and work programmes
Last updated: 10/06/2022 -
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Guidance documents
Last updated: 19/07/2022