17 results
Keyword crestor Remove keyword
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Referral: Crestor 5 mg
rosuvastatin calcium, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 21/04/2005, EC decision date: 09/08/2005, Last updated: 09/08/2005Crestor 5 mg … Commission final decision Overview Crestor (rosuvastatin calcium) is … Marketing Authorisation for Crestor (10 to 40 mg) was originally … -
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Referral: Crestor and associated names
rosuvastatin, Article 29 paediatrics
Status: European Commission final decision, opinion/position date: 30/06/2014, Last updated: 01/08/2014Crestor and associated names … cholesterol-lowering medicine Crestor to allow its use in children … aged between 6 to 10 years. Crestor and associated names are … -
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Opinion/decision on a Paediatric investigation plan (PIP): rosuvastatin calcium
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Cardiovascular diseases
PIP number: Rosuvastatin (calcium), Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 24/11/2010, Last updated: 07/12/2009, Compliance check: V, 11/10/2013Key facts Crestor and associated names rosuvastatin … for rosuvastatin (calcium) (Crestor and associated names) (EMEA-000022-PIP01-07-M04 … rosuvastatin (calcium) (Crestor and associated names) (EMEA-000022-PIP01-07-M04 … -
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Press release: European Medicines Agency: Committee for Medicinal Products for Human Use 15-18 November 2004
Last updated: 18/11/2004Crestor … Community-wide referral procedure for Crestor (rosuvastatin) 5 mg from … differing views on whether Crestor 5 mg should be the recommended … -
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Human medicine European public assessment report (EPAR): Repatha (updated)
Evolocumab, Dyslipidemias; Hypercholesterolemia
Date of authorisation: 17/07/2015, Revision: 21, Authorised, Last updated: 16/06/2022 -
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Human medicine European public assessment report (EPAR): Vosevi
Sofosbuvir, velpatasvir, voxilaprevi, Hepatitis C, Chronic
Date of authorisation: 26/07/2017,
, Revision: 12, Authorised, Last updated: 02/06/2022
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Press release: European Medicines Agency: Committee for Medicinal Products for Human Use 18 – 21 April 2005
CHMP, Last updated: 21/04/2005a referral procedure for Crestor (rosuvastatin) 5mg from AstraZeneca … recommendations for the Crestor starting dose (5 mg or 10 … is favourable for either Crestor 5mg or 10mg as alternative … -
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Committee for Medicinal Products for Human Use (CHMP): 22-25 April 2014
European Medicines Agency, London, UK, from 22/04/2014 to 25/04/2014, Last updated: 09/08/2013 -
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Committee for Medicinal Products for Human Use (CHMP): 20-23 January 2014
European Medicines Agency, London, UK, from 20/01/2014 to 23/01/2014, Last updated: 09/08/2013 -
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News: 2012 annual report on EudraVigilance published
Last updated: 26/07/2013 -
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Public data from Article 57 database
Last updated: 02/06/2021 -
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Annual reports and work programmes (updated)
Last updated: 10/06/2022 -
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News: Annual report 2009 published: "Agency achieved very good results in one of the most challenging years in its history"
Last updated: 20/05/2010 -
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Monthly reports of the CHMP Pharmacovigilance Working Party
Last updated: 31/12/2009 -
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Workshop on identifying opportunities for 'big data' in medicines development and regulatory science
CCT Venue Plus, London, UK, from 14/11/2016 to 15/11/2016, Last updated: 04/01/2017 -
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CHMP: meeting archive 2001-2009
Last updated: 18/11/2013 -
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CHMP: meeting archive 2013-2015
Last updated: 12/05/2016