8162 results
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Veterinary medicine European public assessment report (EPAR): Netvax
Clostridium-perfringens-type-A alpha toxoid, Chicken
Date of authorisation: 16/04/2009, Revision: 2, Withdrawn, Last updated: 11/06/2014necrotic enteritis of chickens due to Clostridium perfringens … necrotic enteritis of chickens due to Clostridium perfringensChickenQI01AB08 … necrotic enteritis of chickens due to Clostridium perfringens Clostridium-perfringens-type-A … -
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National expert: Pierre Duez, Federal Agency for Medicines and Health Products (updated)
- Declaration of interests - 13.28 KB | PDF
- Curriculum Vitae - 360.3 KB | PDF
Pierre Duez … Pierre Duez … Vitae Personal information Pierre Duez Work experience … -
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Direct healthcare professional communication (DHPC): ADAKVEO (crizanlizumab): revocation of EU marketing authorisation due to lack of therapeutic efficacy
Active substance: Crizanlizumab, DHPC type: Lack of effect, Referral - Article 20 procedure, Last updated: 15/06/2023EU marketing authorisation due to lack of therapeutic efficacy Anemia … EU marketing authorisation due to lack of therapeutic effica … marketing authorisation due to lack of therapeutic efficacy … -
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Direct healthcare professional communication (DHPC): Picato (ingenol mebutate): Suspension of the marketing authorisation due to risk of skin malignancy
Active substance: Ingenol mebutate, DHPC type: Interim measures, Referral - Article 20 procedure, Last updated: 14/02/2020the marketing authorisation due to risk of skin malignancy Keratosis … the marketing authorisation due to risk of skin malignancy … -
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Direct healthcare professional communication (DHPC): Restrictions in use of cyproterone acetate due to risk of meningioma
Active substance: cyproterone, DHPC type: Referral - Article 31, Last updated: 29/04/2020use of cyproterone acetate due to risk of meningioma Androgen … use of cyproterone acetate due to risk of meningioma 29/04/2020 … -
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Press release: Mitigating risks due to the use of antibiotics in animals
Last updated: 19/12/2014Mitigating risks due to the use of antibiotics … Mitigating risks due to the use of antibiotics … Mitigating risks due to the use of antibiotics … -
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Press release: Restrictions in use of cyproterone due to meningioma risk
PRAC, Last updated: 14/02/2020ctions in use of cyproterone due to meningioma risk … considered to be a cancer, but due to their location in and … -
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Press release: Restrictions in use of cyproterone due to meningioma risk
CMDh, Last updated: 27/03/2020ctions in use of cyproterone due to meningioma risk … considered to be a cancer, but due to their location in and … -
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Press release: PRAC recommends further restrictions for multiple sclerosis medicine Zinbryta due to risk of serious liver damage
PRAC, Last updated: 27/10/2017sclerosis medicine Zinbryta due to risk of serious liver … sclerosis medicine Zinbryta due to risk of serious liver … sclerosis medicine Zinbryta due to risk of serious liver … -
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Press release: EMA recommends suspension of medicines due to unreliable studies from Micro Therapeutic Research Labs
Last updated: 24/03/2017recommends suspension of medicines due to unreliable studies from … recommends suspension of medicines due to unreliable studies from … recommends suspension of medicines due to unreliable studies from … -
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Stakeholder meeting on product shortages due to manufacturing and quality problems: developing a proactive approach to prevention
European Medicines Agency, London, UK, 09/10/2015, Last updated: 27/01/2016meeting on product shortages due to manufacturing and quality … meeting on product shortages due to manufacturing and quality … meeting on Product Shortages due to manufacturing and quality … -
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Workshop on product shortages due to manufacturing and quality problems: Developing a proactive approach to prevention
European Medicines Agency, London, UK, 14/10/2013, Last updated: 09/10/2013Workshop on product shortages due to manufacturing and quality … Workshop on product shortages due to manufacturing and quality … Workshop on product shortages due to manufacturing and quality … -
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News: EMA to host workshop on prevention of product shortages due to manufacturing and quality problems
Last updated: 10/10/2013prevention of product shortages due to manufacturing and quality … prevention of product shortages due to manufacturing and quality … manufacturing supply chain due to manufacturing/GMP compliance … -
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News: EMA workshop on prevention of product shortages due to manufacturing and quality problems takes place today
Last updated: 14/10/2013prevention of product shortages due to manufacturing and quality … prevention of product shortages due to manufacturing and quality … -
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News: Fees for type IA variations to be due at start of procedure
Last updated: 02/12/2011type IA variations to be due at start of procedure … type IA variations to be due at start of procedure … -
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Press release: Xigris (drotrecogin alfa (activated)) to be withdrawn due to lack of efficacy
Last updated: 25/10/2011activated)) to be withdrawn due to lack of efficacy … activated)) to be withdrawn due to lack of efficacy … activated)) to be withdrawn due to lack of efficacy PROWESS-SHOCK … -
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Press release: Thelin (sitaxentan) to be withdrawn due to cases of unpredictable serious liver injury
Last updated: 10/12/2010sitaxentan) to be withdrawn due to cases of unpredictable … sitaxentan) to be withdrawn due to cases of unpredictable … sitaxentan) to be withdrawn due to cases of unpredictable … -
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News: Questions & answers: EU actions to prevent medicine shortages due to Brexit
Last updated: 26/03/2019prevent medicine shortages due to Brexit … -
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Press release: Suspension of fenspiride medicines due to potential risk of heart rhythm problems
PRAC, Last updated: 15/02/2019sion of fenspiride medicines due to potential risk of heart … -
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News: Change of time zone due to EMA's relocation in March 2019
Last updated: 01/03/2019Change of time zone due to EMA's relocation in March … -
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Direct healthcare professional communication (DHPC): Hydroxyethyl starch (HES) solutions for infusion: suspension of marketing authorisations due to continued use in contraindicated patient populations with increased risk of serious harm
Active substance: hydroxyethyl starch, DHPC type: Post-authorisation measure, Last updated: 26/07/2022marketing authorisations due to continued use in contraindicated … marketing authorisations due to continued use in contraindicated … marketing authorisations due to continued use in contraindicated … -
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Direct healthcare professional communication (DHPC): CHAMPIX (varenicline) - lots to be recalled due to presence of impurity N-nitroso-varenicline above the acceptable intake limit
Active substance: varenicline, DHPC type: Medicine shortage, Last updated: 30/09/2021varenicline) - lots to be recalled due to presence of impurity N-nitroso-varenicline … varenicline) - lots to be recalled due to presence of impurity N-nitroso-varenicline … batches took place in June 2021 due to the presence of nitrosamine … -
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Press release: Update on review of valsartan medicines due to detection of NDMA: EMA reviewing valsartan produced by another company Zhejiang Tianyu
Last updated: 10/08/2018review of valsartan medicines due to detection of NDMA: EMA … review of valsartan medicines due to detection of NDMA PDF … review of valsartan medicines due to detection of NDMA … -
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Press release: Pharmaceutics International Inc., US: supply of non-critical medicines to EU to be stopped due to manufacturing failings
CHMP, Last updated: 16/09/2016medicines to EU to be stopped due to manufacturing failings … medicines to EU to be stopped due to manufacturing failings … medicines to EU to be stopped due to manufacturing failings … -
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Press release: European Medicines Agency recommends changes in the product information for Protelos / Osseor due to the risk of severe hypersensitivity reactions
CHMP, Last updated: 16/11/2007information for Protelos / Osseor due to the risk of severe hypersensitivity … information for Protelos/Osseor due to the risk of severe hypersensitivity … information for Protelos/Osseor due to the risk of severe hypersensitivity …