Ema.europa.eu

Annual reviews of new information will be conducted to update the summary, requiring continuous monitoring and data submission in response to findings.

Marketing authorization holders (MAHs) must review and potentially update their product labeling to align with the new regulations by 11 April 2029 for products authorized before 11 May 2024.

Regulatory teams should integrate the new labeling information into their literature surveillance processes to ensure compliance and accurate communication surrounding Spikevax usage.

Regulatory requirements for daratumumab will need to be reviewed in light of the orphan designation status granted by the EMA.

Regulatory Intelligence teams must monitor updates regarding the ongoing CHMP evaluation and potential implications for existing marketing authorizations.

Update all internal and external communications, labels, and marketing materials to reflect the new product name, Svariya, instead of Rivaroxaban Koanaa.

Regulatory Intelligence Leads must incorporate the new reporting requirements and deadlines into their monitoring activities for affected products.