52 results
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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 - Scientific guideline
Last updated: 07/10/2016 -
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Core summary of product characteristics for plasma-derived fibrin sealant/haemostatic products - Scientific guideline
Last updated: 01/01/2016 -
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Core summary of product characteristics for human fibrinogen products - Scientific guideline
Last updated: 24/07/2015 -
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Core summary of product characteristics for human plasma-derived and recombinant coagulation factor IX products - Scientific guideline
Last updated: 22/12/2014 -
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Declaration of the quantitative composition/potency labelling of biological medicinalproducts that contain modified proteins as active substance - Scientific guideline
Last updated: 21/03/2014 -
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Joint EMA / European Directorate for the Quality of Medicines and Healthcare workshop on characterisation of new clotting-factor concentrates with respect to potency assays used for labelling and testing of post-infusion samples
European Medicines Agency, London, UK, from 28/11/2013 to 29/11/2013, Last updated: 10/09/2013 -
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Summary of Product Characteristics Advisory Group
Last updated: 08/01/2013 -
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Warning on transmissible agents in summary of product characteristics and package leaflets for plasma-derived medicinal products - Scientific guideline
Last updated: 14/12/2011 -
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News: European Medicines Agency improves package leaflets
Last updated: 22/07/2011 -
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News: Recommendations on labelling and packaging for non-prescription medicines released for consultation
Last updated: 02/04/2011 -
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Potency declaration/labelling for biological medicinal products which contain modified proteins as active substance - Scientific guideline
Last updated: 14/03/2011 -
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Product information
Last updated: 31/12/2009 -
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Product information: Reference documents and guidelines
Last updated: 31/12/2009 -
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Working Group on Quality Review of Documents
Last updated: 31/12/2009 -
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Press release: The EMEA and the CMD(h) review Europe-wide experience with user consultation in the readability testing of package leaflets
Last updated: 15/11/2006 -
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Potency labelling for insulin analogue containing products with particular reference to the use of "international units" or "units" - Scientific guideline
Last updated: 24/05/2006 -
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Core summary of product characteristics for human plasma derived von Willebrand factor - Scientific guideline
Last updated: 17/11/2005 -
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Core summary of product characteristics for human prothrombin complex products - Scientific guideline
Last updated: 21/11/2004 -
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Core summary of product characteristics for human plasma coagulation factor VII products - Scientific guideline
Last updated: 29/07/2004 -
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Warning on transmissible agents in summary of product characteristics and package leaflets for plasma-derived medicinal products - Scientific guideline
Last updated: 26/11/2003 -
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Description of composition of pegylated (conjugated) proteins in the summary of product characteristics - Scientific guideline
Last updated: 14/05/2003 -
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Core summary of product characteristics for human plasma derived antithrombin - Scientific guideline
Last updated: 17/01/2002 -
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Press release: Towards electronic product information for EU medicines
Last updated: 21/11/2018 -
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Press release: Public consultation on key principles for the electronic product information of EU medicines
Last updated: 31/01/2019 -
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News: Enhancing consistency in wording of therapeutic indications to support healthcare decision-making
CHMP, Last updated: 21/10/2019