Use of OOS batches of authorised cell/tissue-based ATMPs – Section 11.5 of the Guidelines on GMP for ATMPs

27 июня 2019
ATMP, authorized, batches, CAT, cell/tissue-based, EMA, GMP, guidelines, implementation, MA, OOS, patient, provision, Q&A, section 11.5, use,

On 25 June 2019 EMA has published document entitled Questions and answers on the use of out-of-specification batches of authorised cell/tissue-based advanced therapy medicinal products prepared by EMA’s CAT, together with the GMDP Inspectors Working Group and the Blood Products Working Party. Source: EMA Related entries: GMP for Advanced Therapy Medicinal Products (ATMPs)

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Omega-3 fatty acid medicines are not effective in preventing further heart problems after a heart attack!

25 июня 2019
benefit, benefit-risk balance, blood vessels, clinical, CT, DHA, effective, EPA, fish oils, heart attack, heart problems, hypertriglyceridaemia, indication, MA, marketing authorisation, medicinal product, medicines, MI, myocardial infarction, not, Omacor, Omega-3 fatty acid, open-label study, oral use, PI, preventing, product information, re-examination, reference, scientific conclusions, secondary prevention, supplementation, treatment, trials, variation,

On 29 March 2019 EMA confirmed that omega-3 fatty acid medicines containing a combination of an ethyl ester of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) – EPA and DHA are commonly found in fish oils – at a dose of 1 g per day are not effective in preventing further problems with the heart

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