Примери за използване на Summaries of product characteristics на Английски и техните преводи на Български
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Amendments to the Summaries of Product Characteristics and Package Leaflets.
Rocephin is approved in 19 EU Member States with different nationally approved Summaries of Product Characteristics(SmPCs).
Please refer to the Summaries of Product Characteristics for these medicinal products. .
All references to the above mentioned indications should be deleted from the remaining relevant sections of the summaries of product characteristics.
Grounds for amendment of the summaries of product characteristics, labelling and package leaflets.
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 amendment of the summaries of product characteristics, labelling and package leaflets.
Symptomatic treatment of veno-lymphatic insufficiency All references to the above mentioned indications should be deleted from the remaining relevant sections of the summaries of product characteristics.
Grounds for amendment of the summaries of product characteristics, labelling and package leaflets.
This has led to divergences across Member States in the medicine's authorised uses,as seen in the differences in the summaries of product characteristics(SmPCs), labelling and package leaflets.
Grounds for amendment of the summaries of product characteristics, package leaflets and labelling.
Scientific conclusions andgrounds 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.
Procedure for harmonisation of summaries of product characteristics for the reference veterinary medicinal products.
Annex ii scientific conclusions and grounds for amendment of the summaries of product characteristics presented by the emea.
Please refer to the Summaries of Product Characteristics for Viread 33 mg/g granules and Viread 123 mg, 163 mg and 204 mg film-coated tablets.
Scientific conclusions andgrounds for amendment of the summaries of product characteristics and package leaflets.
Procedure for harmonisation of summaries of product characteristics for generic and hybrid veterinary medicinal products.
Annex ii scientific conclusions and grounds for amendment of the summaries of product characteristics, labelling and package leaflet.
Because of this, there are some differences in the summaries of product characteristics(SmPCs), labelling and package leaflets in the countries where the medicines are marketed.
The CVMP considered the scope of the referral was the harmonisation of the summaries of product characteristics, labelling and package leaflets;
(b) the transmission of assessment reports, summaries of product characteristics, labels and package leaflets or inserts for these medicinal products; .
Amendments to the relevant sections of the summaries of product characteristics and package leaflets.
Amendments in the relevant sections of the summaries of product characteristics, labelling and package leaflets.
Amendments in the relevant sections of the summaries of product characteristics, labelling and package leaflets.
Article 69a Procedure for harmonisation of summaries of product characteristics for generic and hybrid.
Scientific conclusions andgrounds for amendment of the summaries of product characteristics, labelling and package leaflets.
Amendments in the relevant sections of the summaries of product characteristics, labelling and package leaflets.
Scientific conclusions andgrounds for amendment of the summaries of product characteristics, labelling and package leaflets.
Scientific conclusions andgrounds for amendment of the summaries of product characteristics, labelling and package leaflets.
Annex II Scientific conclusions andgrounds for amendment of the summaries of product characteristics and package leaflets presented by the EMA.