Adjusol trimethoprim sulfa liquide and its associated names

Current status:
European Commission final decision

Overview

On 10 December 2020, the European Medicines Agency (the Agency) completed a review of Adjusol trimethoprim sulfa liquide and its associated names. The Agency’s Committee for Medicinal Products for Veterinary Use (CVMP) concluded that there is a need to harmonise the product information [summary of product characteristics (SPC), labelling and package leaflet] for the aforementioned product in the European Union (EU).

Key facts

Approved name
Adjusol trimethoprim sulfa liquide and its associated names
Reference number
EMEA/V/A/134
Type
Article 34

Divergent decision referral: initiated in order to obtain harmonisation within the EU of the conditions of authorisation for products already authorised by Member States.

Status
European Commission final decision
Opinion date
10/12/2020
EC decision date
25/02/2021

All documents

Document description

  • Opinion - contains the CVMP opinion of the referred medicine(s)
  • List of the medicines affected by the referral (Annex I)
  • Scientific conclusions of the Committee (Annex II)

The following two documents may not always be available:

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