Adjusol trimethoprim sulfa liquide and its associated names
Table of contents
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
|
| Current status |
European Commission final decision
|
| 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. |
| Authorisation model |
Nationally authorised product(s)
|
| Opinion date |
10/12/2020
|
| EC decision date |
25/02/2021
|
All documents
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List item
Adjusol trimethoprim sulfa liquide Article-34 referral - Questions and answers on Adjusol trimethoprim sulfa liquide and its associated names (PDF/109.29 KB)
First published: 19/03/2021
EMA/822260/2021 -
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List item
Adjusol trimethoprim sulfa liquide Article-34 referral - Annex I, II, III (PDF/434.64 KB)
First published: 19/03/2021 -
Description of documents published
Please note that some of the listed documents apply only to certain procedures.
- Overview - lay-language summary of the stage of the procedure
- Notification – a letter from a Member State, the European Commission or the marketing authorisation holder requesting the initiation of the procedure
- List of questions – questions agreed by the Committee requesting further information from the marketing authorisation holder(s) / applicant(s) to evaluate the issues identified
- Timetable for the procedure – agreed timeframe to respond to the list of questions, to assess the issues and to adopt a conclusion
- List of medicines concerned by the procedure – medicine(s) / active substance(s) concerned, and marketing authorisation holder(s) / applicant(s)
- List of questions to be addressed by the stakeholders – call for data to be submitted by stakeholders (e.g. veterinary healthcare professionals, farmers, academia) (if applicable)
- Stakeholder submission form – form to be used by stakeholders to submit data (if applicable)
- Scientific conclusions – scientific conclusions of CVMP
- Divergent positions – divergent positions of the CVMP members (if applicable)
- Changes to the summary of product characteristics, labelling and package leaflet (amended sections or fully revised version) (if applicable)
- Condition(s) to the marketing authorisation(s) – condition(s) for the safe and effective use of the medicine(s) (if applicable)
- Condition for lifting the suspension – condition to be fulfilled for the suspension of the marketing authorisation(s) to be lifted (if applicable)