Übersetzung für "Marketing authorization holder" in Deutsch

The marketing authorization holder shall be notified of the results of the examination within the same time-limit.

Ameluz is marketed in Switzerland by Louis Widmer, which also functions as local marketing authorization holder.

In case of Suspected Adverse Reaction: Please inform the marketing authorization holder.

The Member States and the marketing authorization holder shall forward to the Committee all available information relating to the matter in question.

The Member State concerned or the Commission shall clearly identify the question which is referred to the Committee for consideration and shall inform the marketing authorization holder.

It shall inform the reference Member State which granted the initial authorization, the other Member States concerned by the application, the Agency, and the marketing authorization holder.

The Member State concerned, the marketing authorization holder or the Commission shall clearly identify the question which is referred to the Committee for consideration and, where appropriate, shall inform the holder.

The Member State and the marketing authorization holder shall forward to the Committee all available information relating to the matter in question.

In the case referred to in Article 31, the marketing authorization holder may be asked to explain himself orally or in writing.

The Committee may suspend the time limit referred to in paragraph 1 in order to allow the marketing authorization holder to prepare explanations.

Within 15 days of the receipt of the opinion, the marketing authorization holder may notify the Agency in writing of his intention to appeal.

As part of the pharmacovigilance activities included in the adopted risk management plan, the marketing authorization holder (MAH) agreed to report on a randomised clinical study (HPS2-THRIVE1) designed to assess the incremental benefit of nicotinic acid/laropiprant versus placebo as add-on to simvastatin 40mg, with or without ezetimibe.

The marketing authorization holder (MAH) shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP.

The marketing authorization holder (MAH) shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.

For any information about this medicine, please contact the local representative of the Marketing Authorization Holder:

For any information about this veterinary medicinal product, please contact the marketing authorization holder.

In the case referred to in Article 35, the marketing authorization holder may be asked to explain himself orally or in writing.

The Committee may suspend the time-limit referred to in paragraph 1 in order to allow the marketing authorization holder to prepare explanations.

The Member States shall agree to the final healthcare educational pack with the Marketing Authorization Holder (MAH) prior to launch of the product in their territory.

For any information about this veterinary medicinal product, please contact the local representative of the marketing authorization holder.

The marketing authorization holder should provide a suitable system for quantifying active ingredient at blending stage as soon as feasible.

If several applications submitted in accordance with Articles 12, 13(1) and 14 have been made for marketing authorization for a particular veterinary medicinal product and Member States have adopted divergent decisions concerning the authorization of that veterinary medicinal product, or suspension or withdrawal of that authorization, a Member State, or the Commission, or the marketing authorization holder may refer the matter to the Committee for application of the procedure laid down in Article 36.