Veterinary medicinal products containing a combination of lincomycin and spectinomycin to be administered orally to pigs and, or poultry
Table of contents
Overview
Questions and answers on veterinary medicinal products containing a combination of lincomycin and spectinomycin to be administered orally to pigs and/or poultry
Outcome of a referral procedure under Article 35 of Directive 2001/82/EC (EMEA/V/A/110)
On 19 May 2016, the European Medicines Agency (the Agency) completed a review of the safety and effectiveness of, and antimicrobial resistance to, veterinary medicinal products containing a combination of lincomycin and spectinomycin to be administered orally to pigs and/or poultry. The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the overall benefit-risk balance for premixes for medicated feeding stuff and powders to be administered with the feed containing a combination of lincomycin and spectinomycin is negative, as the use of these products at the recommended dosing regimens entails a high risk of resistance selection and development due to exposure to low antimicrobial levels for prolonged periods. The CVMP recommended that all marketing authorisations for premixes for medicated feeding stuff and powders to be administered with the feed containing a combination of lincomycin and spectinomycin be withdrawn throughout the European Union (EU).
The CVMP also concluded that the overall benefit-risk balance for powders for use in the drinking water containing a combination of lincomycin and spectinomycin is positive and recommended harmonised indications, dosing regimens and warning sentences on prudent use.
Key facts
Approved name |
Veterinary medicinal products containing a combination of lincomycin and spectinomycin to be administered orally to pigs and, or poultry
|
International non-proprietary name (INN) or common name |
lincomycin and spectinomycin |
Associated names |
Please see Annex I
|
Reference number |
EMEA/V/A/110
|
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 |
19/05/2016
|
EC decision date |
22/08/2016
|
All documents
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Lincomycin and spectinomycin Article 35 referral - Questions and answers on veterinary medicinal products containing a combination of lincomycin and spectinomycin to be administered orally to pigs and/or poultry (PDF/81.46 KB)
First published: 16/09/2016
Last updated: 16/09/2016
EMA/462762/2016 -
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Lincomycin and spectinomycin Article 35 referral - Divergent_position (PDF/69.88 KB)
First published: 16/09/2016
Last updated: 16/09/2016 -
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Lincomycin and spectinomycin Article 35 referral - Annex I, II, III (PDF/150.65 KB)
First published: 16/09/2016
Last updated: 16/09/2016
EMA/462762/2016 -
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