Methylprednisolone injection for cattle
Table of contents
Overview
On 16 March 2017, the European Medicines Agency (the Agency) completed a review of the consumer safety of the withdrawal periods for cattle (meat and offal) for veterinary medicinal products containing methylprednisolone hydrogen succinate presented as solutions for injection.
The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that, in the absence of appropriate residue depletion data, a withdrawal period for meat and offal derived from treated cattle cannot be set. The CVMP recommended the refusal of the granting of a marketing authorisation for the target species cattle and variation of the existing marketing authorisations in order to remove any reference to the target species cattle for veterinary medicinal products containing methylprednisolone hydrogen succinate.
Key facts
Approved name |
Methylprednisolone injection for cattle
|
International non-proprietary name (INN) or common name |
methylprednisolone hydrogen succinate
|
Reference number |
EMEA/V/A/119
|
Type |
Article 35
Community interest referral: initiated in cases involving the interests of the Community or concerns relating to the protection of human or animal health or the environment. |
Status |
European Commission final decision
|
Opinion date |
16/03/2017
|
EC decision date |
20/06/2017
|
All documents
-
List item
Methylprednisolone Article-35 referral - Questions and answers on veterinary medicinal products containing methylprednisolone hydrogen succinate presented as solutions for injection for use in the target species cattle (PDF/87.46 KB)
First published: 04/08/2017
Last updated: 04/08/2017
EMA/398380/2017 -
-
List item
Methylprednisolone Article-35 referral - Annexes I, II, III, IV (PDF/64.55 KB)
First published: 04/08/2017
Last updated: 04/08/2017 -
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:
- Changes to the summary of product characteristics, labeling or package leaflet ('annex III') - available when changes have been recommended by the Committee
- Conditions of the marketing authorisation (Annex IV) - available when the Committee recommends measures to be taken for the marketing authorisation(s) such as safety measures or extra studies