56 results
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Direct healthcare professional communication (DHPC): Vaxneuvance (pneumococcal polysaccharide conjugate vaccine (15-valent, adsorbed)) suspension for injection in pre-filled syringe: Important information regarding the potential for breakage of Vaxneuvance pre-filled syringes (updated)
Active substance: Pneumococcal polysaccharide conjugate vaccine (15-valent, adsorbed), DHPC type: Quality defect, Last updated: 20/09/2023 -
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Direct healthcare professional communication (DHPC): Replacement BAXJECT II / BAXJECT II Hi-Flow Reconstitution Devices co-packaged with Advate/Feiba/Rixubis
Active substance: Octocog alfa, Factor VIII Inhibitor Bypassing Activity, Nonacog gamma, DHPC type: Quality defect, Last updated: 14/08/2023 -
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Direct healthcare professional communication (DHPC): Simponi (golimumab) 50 mg and 100 mg: important changes to the injection instructions for the SmartJect Pre-filled Pen
Active substance: Golimumab, DHPC type: Quality defect, Last updated: 10/08/2023 -
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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): 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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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): 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): 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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How to prepare and review a summary of product characteristics
Last updated: 30/08/2023 -
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Product-information templates - Human
Last updated: 23/06/2023 -
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Guideline on the summary of product characteristics (SPC) for veterinary medicinal products containing antimicrobial substances - Scientific guideline
Last updated: 23/06/2023 -
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Electronic product information (ePI)
Last updated: 30/05/2023 -
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Product-information requirements
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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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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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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Electronic product information for human medicines in the European Union – key principles
Last updated: 29/01/2020