46 results
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Referral: Florgane
florfenicol, Article 33
Status: European Commission final decision, opinion/position date: 06/03/2013, EC decision date: 23/05/2013, Last updated: 10/07/2013 -
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Product-information requirements
Last updated: 15/03/2021 -
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Linguistic review
Last updated: 08/02/2021 -
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Product-information templates - Human
Last updated: 08/02/2021 -
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Product information: Reference documents and guidelines
Last updated: 31/12/2020 -
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Excipients labelling
Last updated: 11/12/2020 -
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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: 11/12/2020 -
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How to prepare and review a summary of product characteristics
Last updated: 25/06/2020 -
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Electronic product information for human medicines in the European Union – key principles
Last updated: 29/01/2020 -
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Ethanol
Last updated: 22/11/2019 -
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Q&A: Mock-ups
Last updated: 18/06/2019 -
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European Medicines Agency (EMA) / Heads of Medicines Agencies (HMA) / European Commission (EC) workshop on electronic product information (ePI)
European Medicines Agency, London, UK, 28/11/2018, Last updated: 31/01/2019 -
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Mock-ups and specimens
Last updated: 07/01/2019 -
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Focus group meeting on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics harmonisation
European Medicines Agency, London, UK, 12/10/2018, Last updated: 15/11/2018 -
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Guideline on the summary of product characteristics (SPC) for veterinary medicinal products containing antimicrobial substances
Last updated: 21/09/2018 -
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Core summary of product characteristics for human plasma-derived and recombinant coagulation factor VIII products
Last updated: 13/08/2018 -
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Summary of product characteristics for anthelmintics
Last updated: 15/12/2017 -
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News: Better labelling of excipients for safe use of medicines
Last updated: 09/10/2017 -
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QRD guidance on the use of approved pictograms on the packaging of veterinary medicinal products authorised via the centralised, mutual recognition and decentralised procedures - Species pictograms
Last updated: 25/11/2016 -
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Points to consider for assessors - New factor VIII and factor IX products: potency determination for labelling and assays for testing post-infusion samples
Last updated: 07/10/2016 -
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Core summary of product characteristics for plasma-derived fibrin sealant/haemostatic products
Last updated: 01/01/2016 -
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Core summary of product characteristics for human fibrinogen products
Last updated: 24/07/2015 -
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Core summary of product characteristics for human plasma-derived and recombinant coagulation factor IX products
Last updated: 22/12/2014 -
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Exemptions to labelling and package-leaflet obligations
Last updated: 19/08/2014 -
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Declaration of the quantitativecomposition/potency labelling of biological medicinalproducts that contain modified proteins as activesubstance
Last updated: 21/03/2014