Primary source: EMA - What's new RSS
A targeted signal management (TSM) procedure was implemented for Phenobarbital, mandating close monitoring of new cases of AHS and other related signals in veterinary medicinal products.
This TSM impacts the management of potential adverse reactions in animal health, ensuring that veterinary professionals and marketing authorization holders are informed and compliant with monitoring requirements to safeguard animal welfare.
MAHs of products containing phenobarbital must monitor new cases of AHS and submit yearly updates to IRIS. The annual statement submission deadline is set for the end of November each year.
Regulatory Intelligence Lead
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MAHs of products containing phenobarbital must monitor new cases of AHS and submit yearly updates to IRIS. The annual statement submission deadline is set for the end of November each year.
The European Medicines Agency (EMA) has introduced targeted signal management (TSM) for Phenobarbital due to safety concerns regarding 'anticonvulsant hypersensitivity syndrome' (AHS) and other signals observed in dogs and cats. This includes recommendations for close monitoring and annual statement submissions for veterinary medicinal products containing Phenobarbital.
What changed: A targeted signal management (TSM) procedure was implemented for Phenobarbital, mandating close monitoring of new cases of AHS and other related signals in veterinary medicinal products.
Why it matters: This TSM impacts the management of potential adverse reactions in animal health, ensuring that veterinary professionals and marketing authorization holders are informed and compliant with monitoring requirements to safeguard animal welfare.
Practical implication: MAHs of products containing phenobarbital must monitor new cases of AHS and submit yearly updates to IRIS. The annual statement submission deadline is set for the end of November each year.
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