Примери за използване на Additional risk minimisation measures на Английски и техните преводи на Български
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Colloquial
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Official
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Medicine
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Ecclesiastic
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Ecclesiastic
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Computer
effective use of the medicinal product should be updated to remove the additional risk minimisation measures.
the PRAC concluded that the benefit-risk balance of Tysabri remains favourable subject to amendments to the product information and additional risk minimisation measures as described below.
the PRAC agreed with the MAH's proposal to remove the additional risk minimisation measures.
other changes to the product information and additional risk minimisation measures.
likely effectiveness of additional risk minimisation measures.
malignancies to be addressed by the additional risk minimisation measures(e.g. seriousness,
the terms of the MA and the risks related to the use of HES solutions for infusion outside these terms, as well as the new additional risk minimisation measures.
The PRAC concluded that no additional risk minimisation measures to ensure safe
other changes to the product information and additional risk minimisation measures, in the form of a DHPC letter.
likely effectiveness of additional risk minimisation measures and available since the previous CMDh position adopted in January 2018.
contraindications and other additional risk minimisation measures.
The MAH shall submit within 1 month of the Commission decision an updated Risk Management Plan which shall include a risk minimisation plan which includes additional risk minimisation measures to address the identified risks of bladder cancer
other changes to the product information and additional risk minimisation measures.
the PRAC considered new additional risk minimisation measures in addition to the ones already implemented as part of the previous PSUR,
implementation of a sequential treatment scheme) and on the published literature, that the additional risk minimisation measures proposed by the Marketing Authorisation Holder and discussed during the assessment would not be
likely effectiveness of additional risk minimisation measures.
other changes to the product information and additional risk minimisation measures.
new proposals for additional risk minimisation measures, including restrictions on use
Additional risk minimisation measures.
other changes to the product information and additional risk minimisation measures.