Vey Tosal 100 mg/ml + 0.05 mg/ml solution for injection for horses, cattle, dogs and cats and associated names
Table of contents
Overview
On 15 February 2023, the European Medicines Agency (the Agency) completed an arbitration procedure following a disagreement amongst Member States of the European Union (EU) regarding the authorisation of the medicine Vey Tosal 100 mg/ml+0.05 mg/ml solution for injection for horses, cattle, dogs and cats and associated names (thereafter called Vey Tosal). The Agency’s Committee for Veterinary Medicinal Products (CVMP) concluded that the benefits of Vey Tosal outweigh its risks, and that the marketing authorisation can be granted in Czechia and in the following Member States of the EU: Austria, Belgium, Bulgaria, Croatia, Cyprus, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden and the United Kingdom (Northern Ireland).
Key facts
| Approved name |
Vey Tosal 100 mg/ml + 0.05 mg/ml solution for injection for horses, cattle, dogs and cats and associated names
|
| International non-proprietary name (INN) or common name |
|
| Reference number |
EMEA/V/A/148
|
| Type |
Article 33
Mutual-recognition and decentralised referral: initiated because of disagreement between Member States within the framework of the mutual-recognition or decentralised procedure. |
| Authorisation model |
Nationally authorised product(s)
|
| Opinion date |
15/02/2023
|
| EC decision date |
03/04/2023
|
All documents
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List item
Questions and answers on Vey Tosal 100 mg/ml + 0.05 mg/ml solution for injection for horses, cattle, dogs and cats and associated names (butafosfan, cyanocobalamin) (PDF/110.52 KB)
First published: 25/04/2023
EMA/144351/2023 -
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List item
Vey Tosal Article 33(4) referral - Annex I, II, III (PDF/253.88 KB)
First published: 25/04/2023 -
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)