Примери за използване на Summary of product characteristics and package leaflet на Английски и техните преводи на Български
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Medicine
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Colloquial
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Official
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Ecclesiastic
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Ecclesiastic
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Computer
grounds for positive opinion subject to condition to the marketing authorisation and amendment of the summary of product characteristics and package leaflet presented by the European Medicines Agency.
pergolide containing medicinal products with amendments to their product information(Summary of product characteristics and Package leaflet), as outlined below.
dihydroergocryptine and lisuride containing medicinal products with amendments to their product information(Summary of product characteristics and Package leaflet), as outlined below.
associated names to amend the summary of product characteristics and package leaflet to include new precautionary measures and adverse reactions; and. .
Dairy Cattle with amendment to the summary of product characteristics and package leaflet of the reference Member State.
Annex III Amendments to relevant sections of the summary of product characteristics and package leaflets.
AMENDMENTS TO THE SUMMARY OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLET.
AMENDMENTS TO THE SUMMARY OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLET.
Annex III Amendments to relevant sections of the summary of product characteristics and package leaflets.
Amendments to be included in the relevant sections of the summary of product characteristics and package leaflets for Dianeal PD4 and Extraneal.
The amendments to the Summary of Product Characteristics and package leaflets may need to be subsequently updated by the national competent authorities,
GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLET PRESENTED BY THE EMEA.
The CHMP, as a consequence, recommended amendments to the relevant sections of the Summary of product characteristics and Package leaflets for the medicinal products containing bromocriptine,
THE GROUNDS FOR AMENDMENTS OF THE SUMMARY OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLET.
Scientific conclusions and grounds for the addition of three manufacturing sites to the marketing authorisations and amendment of the summaries of product characteristics and package leaflets presented by the EMA.
Grounds for the addition of three manufacturing sites to the marketing authorisations and amendment of the summaries of product characteristics and package leaflets.
grounds for the addition of a manufacturing site to the marketing authorisations and amendment of the summaries of product characteristics and package leaflets presented by the EMA.
Grounds for the addition of an additional manufacturing site to the marketing authorisations and amendment of the summaries of product characteristics and package leaflets.
Therefore, the CHMP recommended the variation to the terms of the marketing authorisations for which the relevant sections of the summaries of product characteristics and package leaflets are set out in Annex III for monovalent