Examples of using Summaries of product characteristics in English and their translations into Swedish
{-}
-
Medicine
-
Colloquial
-
Official
-
Ecclesiastic
-
Ecclesiastic
-
Official/political
-
Computer
-
Programming
-
Political
Grounds for amendment of the summaries of product characteristics and package leaflets.
establishes a procedure for harmonising summaries of product characteristics.
Grounds for amendment of the summaries of product characteristics, labelling and package leaflet.
Grounds for amendment of the summaries of product characteristics, labelling and package leaflet.
This Opinion recommended the maintenance of the Marketing Authorisations in accordance with the amendments to the relevant sections of the Summaries of Product Characteristics and Package Leaflets as set out in Annexes III and IV.
Scope of the harmonisation of summaries of product characteristics of a veterinary medicinal product.
according to the competent authority, they should be subject to the procedure for harmonisation of their summaries of product characteristics.
The transmission of assessment reports, summaries of product characteristics, labels and package.
Harmonised summaries of product characteristics for veterinary medicinal products shall contain all of the following information.
grounds for amendment of the summaries of product characteristics presented by the emea.
Copies of all the summaries of product characteristics as included in the terms of marketing authorisations granted by Member States, if relevant.
Furthermore the CHMP concluded that the following information should be included in the Summaries of Product Characteristics and relevant sections of the Package Leaflets.
The basis for referral was that there were divergences in the Summaries of Product Characteristics of Xefo and associated names approved across EU Member States,
The first stage will be a pilot project to collate and make available electronically summaries of product characteristics and patient leaflets.
Procedure for harmonisation of summaries of product characteristics for generic and hybrid veterinary medicinal products.
harmonise the nationally authorised summaries of product characteristics, package leaflet and labelling of the medicinal product Cozaar Comp. and associated names.
Scientific conclusions and grounds for amendment of the summaries of product characteristics and package leaflets presented by the emea overall summary of the scientific evaluation of piroxicam containing medicinal products see annex i.
copies of all the summaries of product characteristics in accordance with Article 11 as approved by Member States
When drawing up the list of reference veterinary medicinal products which shall be subject to harmonisation of their summaries of product characteristics, the coordination group may decide on prioritising its work on harmonisation of summaries of product characteristics, taking into account the recommendations of the Agency on class
On the basis of the grounds for referral, the point considered by the CPMP was a harmonisation of the Summaries of Product Characteristics, especially regarding the Therapeutic indications,
The database provided for in paragraph 1(l) shall include the summaries of product characteristics, the patient or user package leaflet and the information shown on the labelling.
Within 120 days of his appointment, the rapporteur shall present the coordination group a report regarding possible harmonisation of summaries of product characteristics for the similar veterinary medicinal products in the group
In order to meet these objectives, the procedure for harmonising summaries of product characteristics should be efficient
Scientific conclusions and grounds for amendment of the summaries of product characteristics and package leaflets presented by the emea.
Transmitting on request and making publicly available assessment reports, summaries of product characteristics, labels and package leaflets
The CHMP recommended the granting of the variation of the Marketing Authorisations for which the Summaries of Product Characteristics, Labelling and Package Leaflets are set out in Annex III
France referred Lederfoline and associated names to the EMEA due to divergences of the nationally authorised summaries of product characteristics particularly with respect to the sections“ indications”,“ posology” and“ contra-indications” of the summary of product characteristics. .
On the request of the competent authority in the reference Member State referred to in paragraph 3, the marketing authorisation holder shall provide the coordination group with a summary that specifies the differences between the summaries of product characteristics, its proposal for a harmonised summary of product characteristics,