52 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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Direct healthcare professional communication (DHPC): Xalkori (crizotinib): Vision disorders, including risk of severe visual loss, need for monitoring in paediatric patients
Active substance: crizotinib, DHPC type: Adverse event, Last updated: 21/02/2023 -
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Direct healthcare professional communication (DHPC): Caprelsa (vandetanib): Restriction of indication
Active substance: Vandetanib, DHPC type: Restriction of indication, Last updated: 28/02/2023 -
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Direct healthcare professional communication (DHPC): Spikevax bivalent Original/Omicron BA.1, pre-filled syringe - Labelling deviation
Active substance: CX-024414 (single-stranded, 5’-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2), DHPC type: Adverse event, Last updated: 21/02/2023 -
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Direct healthcare professional communication (DHPC): Neofordex 40 mg (dexamethasone): removal of the score-line and the associated 20 mg posology
Active substance: dexamethasone, DHPC type: Change in dosing recommendation, Last updated: 17/02/2023 -
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Product-information requirements (updated)
Last updated: 15/05/2023 -
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Exemptions to labelling and package-leaflet obligations
Last updated: 19/04/2023 -
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Summary of product characteristics for antiparasitic veterinary medicinal products - Scientific guideline
Last updated: 16/12/2022 -
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Product-information templates - Human
Last updated: 28/09/2022 -
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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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Mock-ups and specimens
Last updated: 12/07/2022 -
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Mock-ups for veterinary medicines
Last updated: 02/02/2022 -
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Ethanol
Last updated: 31/01/2022 -
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Guideline on the summary of product characteristics (SPC) for veterinary medicinal products containing antimicrobial substances - Scientific guideline
Last updated: 28/01/2022 -
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ePI information workshop and exploratory workshop
Virtual event, from 05/07/2021 to 08/07/2021, Last updated: 21/07/2021 -
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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: 31/05/2021 -
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Linguistic review
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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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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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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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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Core summary of product characteristics for human plasma-derived and recombinant coagulation factor VIII products - Scientific guideline
Last updated: 13/08/2018 -
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News: Better labelling of excipients for safe use of medicines
Last updated: 09/10/2017