Other safety alerts
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| European Union: CVMP recommends updating Librela’s product information |
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European Medicines Agency (EMA) announces that the Committee for Veterinary Medicinal Products (CVMP) recommended that the product information for Librela (bedinvetmab), a medicine for the alleviation of pain caused by osteoarthritis in dogs, be updated. This follows a review which concluded that very rare cases of musculoskeletal disorders may occur in dogs treated with Librela.
The recommendation is based on the evaluation of a review requested from the marketing authorisation holder (MAH), Zoetis, and of reports of suspected cases of musculoskeletal disorders in the Union Pharmacovigilance Database.
Sections 3.5 ‘Special precautions for use’ and 3.6 ‘Adverse events’ of the product information should be updated to include information on very rare cases of musculoskeletal adverse events that may occur in dogs treated with Librela.
In addition to this request to update the product information, the MAH was asked to continue to closely monitor cases of suspected musculoskeletal disorders and to keep EMA updated.
The MAH is now expected to submit a variation without undue delay to update the product information to include the new information about musculoskeletal side effects. Further information will be included in the CVMP highlights after finalisation of the variation.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/en/news/meeting-highlights-committee-veterinary-medicinal-products-cvmp-10-12-march-2026
In Hong Kong, the above product is not a registered pharmaceutical product. Related news was previously issued by EMA, and was posted on the Drug Office website on 19 Jul 2025.
Ends/Monday, Mar 16, 2026
Issued at HKT 14:30
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