Veterinary medicinal products containing paromomycin to be administered parenterally to pigs
Table of contents
Current status
European Commission final decision
Overview
On 18 July 2019, the European Medicines Agency recommended suspending the marketing authorisations for paromomycin antibiotics given to pigs by injection into a muscle. The Agency’s Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of these medicines do not outweigh their risks because of inadequate data supporting their use in pigs and the possibility of bacterial resistance.
Key facts
| Approved name |
Veterinary medicinal products containing paromomycin to be administered parenterally to pigs
|
| International non-proprietary name (INN) or common name |
paromycin
|
| Associated names |
|
| Current status |
European Commission final decision
|
| Reference number |
EMEA/V/A/129
|
| 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. |
| Authorisation model |
Nationally authorised product(s)
|
| Opinion date |
18/07/2019
|
| EC decision date |
11/10/2019
|
All documents
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List item
Paromomycin Article-35 referral: Questions and answers on suspension of marketing authorisations for injectable veterinary medicines containing paromomycin given to pigs (PDF/119.15 KB)
First published: 20/11/2019
EMA/487471/2019 -
-
List item
Paromomycin Article-35 referral: Annex I, II, III (PDF/198.26 KB)
First published: 20/11/2019 -
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)