13 results
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Referral: Metamizole containing medicinal products
metamizole, Article 31 referrals
Status: European Commission final decision, opinion/position date: 13/12/2018, EC decision date: 20/03/2019, Last updated: 28/03/2019Benlek, Berlosin, Buscapina Compositum, Dialgin, Dolocalma, Flamborin, Freshalgin … Pyralgina, Quarelin, Scopolan Compositum, Spasmalgon, Spasmoblok, Tempalgin … -
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Press release: EMA recommends aligning doses of metamizole medicines and their use during pregnancy and breastfeeding
CHMP, Last updated: 14/12/2018Benlek, Berlosin, Buscapina Compositum, Dialgin, Dolocalma, Flamborin … Pyralgina, Quarelin, Scopolan Compositum, Spasmalgon, Spasmoblok, Tempalgin … -
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Herbal medicinal product: Menthae piperitae aetheroleum
Mentha x piperita L., Peppermint oil, F: Assessment finalised, Last updated: 24/07/2020 -
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Referral: Codeine-containing medicines
codeine, Article 31 referrals
Status: CMDh final position, opinion/position date: 26/06/2013, Last updated: 02/08/2013 -
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Referral: Inhaled corticosteroids containing medicinal products indicated in the treatment of chronic obstructive pulmonary disease
beclometasone, budesonide, flunisolide, fluticasone propionate, fluticasone furoate, Article 31 referrals
Status: European Commission final decision, opinion/position date: 28/04/2016, EC decision date: 29/06/2016, Last updated: 15/07/2016 -
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Referral: Benzathine benzylpenicillin intended for administration to food-producing species
benzathine benzylpenicillin, associated names: See annex I, Article 35
Status: European Commission final decision, opinion/position date: 15/01/2003, EC decision date: 22/04/2003, Last updated: 26/07/2016 -
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Referral: Clobutinol
clobutinol, associated names: Silomat, Article 107 procedures (prior to July 2012)
Status: European Commission final decision, opinion/position date: 18/10/2007, EC decision date: 30/11/2007, Last updated: 19/10/2007 -
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Public data from Article 57 database
Last updated: 17/10/2022 -
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Joint EMEA(NRG)/EFPIA Workshop on Invented Names
London, 11/09/2006, Last updated: 01/09/2006 -
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News: EMA's medical literature monitoring enters into full operation
Last updated: 01/09/2015 -
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News: Safety monitoring of medicines: EMA to screen medical literature for 400 active substance groups
Last updated: 12/05/2015 -
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News: Regulatory information – Companies now required to update, complete and improve quality of information on authorised medicines submitted to the European Medicines Agency
Last updated: 16/06/2014 -
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Guidance documents
Last updated: 19/07/2022