5 results
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Referral: Ambroxol and bromhexine-containing medicines
ambroxol, bromhexine, Article 31 referrals
Status: European Commission final decision, opinion/position date: 18/11/2015, EC decision date: 14/01/2016, Last updated: 05/02/2016 -
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Referral: Terfenadine
terfenadine, Article 31 referrals
Status: European Commission final decision, opinion/position date: 20/11/1997, EC decision date: 22/09/1998, Last updated: 22/01/1998 -
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Annex to the European Commission guideline on 'Excipients in the labelling and package leaflet of medicinal products for human use'
Last updated: 12/09/2022 -
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Public data from Article 57 database
Last updated: 17/10/2022 -
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Guidance documents
Last updated: 19/07/2022