18 results
Keyword Carisoprodol Remove keyword
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Referral: Carisoprodol
carisoprodol, associated names: Somadril, Article 107 procedures (prior to July 2012)
Status: European Commission final decision, opinion/position date: 15/11/2007, EC decision date: 05/02/2008, Last updated: 16/11/2007Carisoprodol … a review of the safety of carisoprodol. The Agency's Committee for … benefits of medicines containing carisoprodol no longer outweigh their … -
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Press release: European Medicines Agency recommends suspension of marketing authorisations for carisoprodol-containing medicinal products
CHMP, Last updated: 16/11/2007marketing authorisations for carisoprodol-containing medicinal products … medicinal products containing carisoprodol. Carisoprodol products are available in … is approved. The review of carisoprodol-containing medicinal products was initiated … -
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Press release: Meeting highlights from the Committee for Medicinal Products for Human Use,12-15 November 2007
CHMP, Last updated: 16/11/2007marketing authorisations for carisoprodol-containing medicines PDF icon application/pdf … -
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Press release: Meeting highlights from the Committee for Medicinal Products for Human Use,15-18 October 2007
CHMP, Last updated: 18/10/2007marketing authorisations for carisoprodol-containing medicines PDF icon application/pdf … -
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National expert: Ana Isabel Terleira Fernandez, Spanish Agency of Medicines and Medical Devices (updated)
- Declaration of interests - 86.19 KB | PDF
- Curriculum Vitae - 31.28 KB | PDF
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Human medicine European public assessment report (EPAR): Exviera
dasabuvir sodium, Hepatitis C, Chronic
Date of authorisation: 14/01/2015,
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, Revision: 19, Authorised, Last updated: 06/04/2021
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Human medicine European public assessment report (EPAR): Viekirax
Ombitasvir, paritaprevir, ritonavir, Hepatitis C, Chronic
Date of authorisation: 14/01/2015,, , Revision: 22, Authorised, Last updated: 12/03/2021
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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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Periodic safety update reports (PSURs) (updated)
Last updated: 16/04/2021 -
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Press release: Meeting highlights from the Committee for Medicinal Products for Human Use,17-20 September 2007
CHMP, Last updated: 21/09/2007 -
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News: Feedback requested on the draft list of EU reference dates for periodic safety update reports in preparation for introduction of the new pharmacovigilance legislation
Last updated: 04/04/2012 -
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Press release: EMEA reports strong performance in regulatory and public-health activities in 2007; the outlook for 2008 is even higher application numbers and a focus on advanced-therapy medicines
Last updated: 10/03/2008 -
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Periodic safety update reports
Last updated: 26/09/2018 -
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CHMP: meeting archive 2001-2009
Last updated: 18/11/2013 -
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News: European Medicines Agency to begin PSUR assessment based on active substances in both centrally and nationally authorised medicines
Last updated: 27/03/2013 -
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News: European Medicines Agency publishes list of EU reference dates and frequency of PSUR submission
Last updated: 01/10/2012 -
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Annual reports and work programmes
Last updated: 15/06/2020 -
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Guidance documents
Last updated: 31/01/2014