15856 results
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Orphan designation: Recombinant human type I pancreatic elastase for the prevention of arteriovenous access dysfunction in haemodialysis patients (vonapanitase) for: Prevention of arteriovenous access dysfunction in haemodialysis patients
Date of designation: 16/01/2014, Withdrawn, Last updated: 09/07/2019prevention of arteriovenous access dysfunction in haemodialysis … prevention of arteriovenous access dysfunction in haemodialysis … -
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Human medicine European public assessment report (EPAR): COVID-19 Vaccine (inactivated, adjuvanted) Valneva
SARS-CoV-2 virus (inactivated) Wuhan strain hCoV-19 / Italy / INMI1-isl / 2020, COVID-19 virus infection
Date of authorisation: 24/06/2022,
, Revision: 4, Authorised, Last updated: 05/12/2022
‘available languages’ to access the language you need. … acknowledged. 23 June 2022 EMEA/H/C/006019 COVID-19 … hCoV-19 / Italy / INMI1-isl / 2020 … -
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Human medicine European public assessment report (EPAR): Fluenz Tetra
A/Victoria/2570/2019 (H1N1)pdm09 - like strain (A/Victoria/1/2020, MEDI 340505) A/Darwin/9/2021 (H3N2) - like strain (A/Norway/16606/2021, MEDI 355293) B/Austria/1359417/2021 - like strain (B/Austria/1359417/2021, MEDI 355292) B/Phuket/3073/2013 - like strain (B/Phuket/3073/2013, MEDI 306444, Influenza, Human
Date of authorisation: 04/12/2013, Revision: 22, Authorised, Last updated: 01/08/2022pharmacist. This summary was last updated in 08-2016. http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002617/human_med_001713.jsp&mid=WC0b01ac058001d124 http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002617/human_med_001713.jsp&mid=WC0b01ac058001d124 What … -
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Press release: European Medicines Agency recommends restricting Trobalt to last-line therapy in partial epilepsy
CHMP, Last updated: 31/05/2013recommends restricting Trobalt to last-line therapy in partial epilepsy … recommends restricting Trobalt to last-line therapy in partial epilepsy … recommends restricting Trobalt to last-line therapy in partial epilepsy … -
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Press release: Highlights of Management Board: June 2020 meeting
MB, Last updated: 12/06/2020hlights of Management Board: June 2020 meeting … Press release 12/06/2020 At its virtual meeting on 11 June, the Management Board was … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 June 2020
CHMP, Last updated: 26/06/2020for Human Use (CHMP) 22-25 June 2020 … News 26/06/2020 Eight new medicines recommended … medicines for approval at its June 2020 meeting. The Committee recommended … -
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Paediatric Committee (PDCO): 23-26 June 2020
European Medicines Agency, Amsterdam, The Netherlands, from 23/06/2020 to 26/06/2020, Last updated: 28/08/2020tric Committee (PDCO): 23-26 June 2020 … 23/06/2020 to 26/06 2020 European Medicines Agency … and other activities 23-26 June 2020 PDF icon application/pdf … -
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Extraordinary Management Board meeting: 25 June 2020
European Medicines Agency, Amsterdam, the Netherlands, 25/06/2020, Last updated: 04/09/2020Management Board meeting: 25 June 2020 … 25/06/2020 European Medicines Agency … EMA Executive Director: 25 June 2020 PDF icon application/pdf … -
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Management Board meeting: 11 June 2020
European Medicines Agency, Amsterdam, the Netherlands, 11/06/2020, Last updated: 16/06/2020Management Board meeting: 11 June 2020 … 11/06/2020 European Medicines Agency … the Management Board: 11 June 2020 PDF icon application/pdf … -
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National expert: Glenn Lastennet, National Agency For The Safety Of Medicine And Health Products (updated)
- Declaration of interests - 79.81 KB | PDF
- Curriculum Vitae - 17.48 KB | PDF
Glenn Lastennet … Glenn Lastennet … Vitae PERSONAL INFORMATION Glenn Lastennet WORK EXPERIENCE November … -
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Committee for Orphan Medicinal Products (COMP): 16-18 June 2020
European Medicines Agency, Amsterdam, the Netherlands, from 16/06/2020 to 18/06/2020, Last updated: 07/08/2020Medicinal Products (COMP): 16-18 June 2020 … 16/06/2020 to 18/06 2020 European Medicines Agency … of the COMP meeting 16-18 June 2020 PDF icon application/pdf … -
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Committee for Advanced Therapies (CAT): 17-19 June 2020
European Medicines Agency, Amsterdam, the Netherlands, from 17/06/2020 to 19/06/2020, Last updated: 24/07/2020Advanced Therapies (CAT): 17-19 June 2020 … Advanced Therapies (CAT): 17-19 June 2020 … -
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Opinion/decision on a Paediatric investigation plan (PIP): COVID-19 Vaccine (inactivated, adjuvanted) Valneva, SARS-CoV-2 virus, beta-propiolactone inactivated adjuvanted with CpG 1018 (VLA2001)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Vaccines
PIP number: EMEA-003077-PIP01-21, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension for injection
Decision date: 13/05/2022, Last updated: 14/07/2022, Compliance check: XhCoV-19 / Italy / INMI1-isl / 2020 … -
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Pharmacovigilance Risk Assessment Committee (PRAC): 8-11 June 2020
European Medicines Agency, Amsterdam, the Netherlands, from 08/06/2020 to 11/06/2020, Last updated: 27/02/2018Assessment Committee (PRAC): 8-11 June 2020 … 08/06/2020 to 11/06 2020 European Medicines Agency … draft agenda of meeting 8-11 June 2020 PDF icon application/pdf … -
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Press release: New long-lasting implant to treat opioid dependence
Last updated: 26/04/2019New long-lasting implant to treat opioid depen … Sixmo’s path to patient access. The opinion will now be sent … -
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Biosimilar medicines: Overview (updated)
Last updated: 27/01/2023Biosimilar medicines: Overview … information can be found under 'Biosimilar medicines - Overview'. biosimilar medicines before they can … in the EU. EMA evaluates biosimilars according to the same standards …
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Committee for Medicinal Products for Human Use (CHMP): 22-25 June 2020
European Medicines Agency, Amsterdam, the Netherlands, from 22/06/2020 to 25/06/2020, Last updated: 26/06/2020for Human Use (CHMP): 22-25 June 2020 … 22/06/2020 to 25/06 2020 European Medicines Agency … CHMP agenda of the 22-25 June 2020 meeting PDF icon application/pdf … -
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Data exclusivity / Generics / Biosimilars: Regulatory and procedural guidance
Last updated: 31/12/2009Data exclusivity / Generics / Biosimilars: Regulatory and procedural … product for human use Topics: Biosimilars Guidance …
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 June 2020
PRAC, Last updated: 12/06/2020Assessment Committee (PRAC) 8-11 June 2020 … News 12/06/2020 At its monthly meeting, EMA’s … draft agenda of meeting 8-11 June 2020 PDF icon application/pdf … -
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Committee for Medicinal Products for Veterinary Use (CVMP): 16-18 June 2020
European Medicines Agency, Amsterdam, the Netherlands, from 16/06/2020 to 18/06/2020, Last updated: 03/09/2020Veterinary Use (CVMP): 16-18 June 2020 … 16/06/2020 to 18/06 2020 European Medicines Agency … the CVMP meeting of 16-18 June 2020 PDF icon application/pdf … -
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News: Essential work to combat the COVID-19 pandemic to continue during EMA's closure on 1 June 2020
Last updated: 28/05/2020during EMA's closure on 1 June 2020 … News 28/05/2020 EMA has put measures in … the Agency's closure on 1 June 2020. Essential work in this area … -
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Press release: Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 16-18 June 2020
CVMP, Last updated: 19/06/2020Use (CVMP) meeting of 16-18 June 2020 … Use (CVMP) meeting of 16-18 June 2020 PDF icon application/pdf … icon application/pdf cvmp_june_2020_press_release_en.pdf 19/06 2020 EMA/CVMP/302233 … -
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Workshop on biosimilars
European Medicines Agency, London, UK, 31/10/2013, Last updated: 12/11/2013Workshop on biosimilars … Workshop on biosimilars … Agenda - Workshop on biosimilars 2013 7 Westferry Circus … -
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News: Biosimilar medicines can be interchanged
CHMP, Last updated: 19/09/2022Biosimilar medicines can be interchanged … information can be found under 'Biosimilar medicines - Overview'. biosimilar medicines approved in the … medicine or with an equivalent biosimilar. While interchangeable use of … -
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News: Facilitating global development of biosimilars
Last updated: 29/10/2014tating global development of biosimilars … quality issues related to biosimilar development : a revision … guideline was published in June 2014 and will come into effect …