Other safety alerts
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| European Union: CVMP reviewing potential risk of musculoskeletal disorders with Librela |
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European Medicines Agency (EMA)’s announces that the Committee for Veterinary Medicinal Products (CVMP) is aware of suspected adverse events that have been reported for Librela (bedinvetmab), a medicine for the treatment of pain caused by osteoarthritis in dogs, which are not currently listed in the EU product information. These reports include very rare cases with the suspicion of an abnormal progress of osteoarthritis in dogs following the use of Librela. In a limited number of cases, radiographical findings have also been observed that are not usually seen in the normal progression of osteoarthritis.
The CVMP has therefore requested the MAH, Zoetis, to carry out an in-depth analysis of all available information on suspected musculoskeletal disorders reported since the medicine’s authorisation. Results of this analysis are expected to be submitted by the MAH by end of September 2025.
The CVMP will review the information provided by the MAH, as well as all available evidence to assess the potential risk of musculoskeletal disorders in dogs treated with Librela and determine whether any change, for example an update of the product information, will be needed. EMA will communicate further once the review has concluded towards the end of 2025, or sooner if new important information arises.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/en/news/meeting-highlights-committee-veterinary-medicinal-products-cvmp-15-17-july-2025
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Saturday, Jul 19, 2025
Issued at HKT 12:00
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