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Marketing Authorisation Holders (MAHs) of desogestrel- and etonogestrel-containing medicines are required to update product information to include meningioma as a side effect and implement new contraindications. For Litfulo, a boxed warning will be added on cardiovascular issues and serious infections.
These changes highlight significant safety concerns that may affect prescribing behaviors and patient safety. Prompt updates to product information are crucial to ensure that healthcare professionals are aware of these new risks.
MAHs must execute safety communication plans, update Risk Management Plans (RMPs), and revise product information including the Summary of Product Characteristics (SmPC) and Package Leaflet.
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MAHs of desogestrel- or etonogestrel-containing medicines must update product information to include meningioma as a side effect and implement new contraindications and warnings. A DHPC will be disseminated. For Litfulo, a boxed warning on cardiovascular problems, blood clots, cancer, and serious infections will be added, and educational materials must be amended.
Marketing Authorisation Holders (MAHs) must execute safety communication plans, update Risk Management Plans (RMPs), revise product information (SmPC and Package Leaflet), and update physician educational materials where applicable.
MAHs must execute safety communication plans, update Risk Management Plans (RMPs), and revise product information including the Summary of Product Characteristics (SmPC) and Package Leaflet.
During its July 2026 meeting, the EMA PRAC concluded with new safety information for desogestrel- and etonogestrel-containing contraceptives, including the risk of meningioma. A Direct Healthcare Professional Communication (DHPC) will be disseminated, and Marketing Authorisation Holders (MAHs) must update product information to reflect these changes. Additionally, for Litfulo (ritlecitinib), a boxed warning will be added related to serious cardiovascular and oncological risks, requiring MAHs to amend safety communication and educational materials.
What changed: Marketing Authorisation Holders (MAHs) of desogestrel- and etonogestrel-containing medicines are required to update product information to include meningioma as a side effect and implement new contraindications. For Litfulo, a boxed warning will be added on cardiovascular issues and serious infections.
Why it matters: These changes highlight significant safety concerns that may affect prescribing behaviors and patient safety. Prompt updates to product information are crucial to ensure that healthcare professionals are aware of these new risks.
Practical implication: MAHs must execute safety communication plans, update Risk Management Plans (RMPs), and revise product information including the Summary of Product Characteristics (SmPC) and Package Leaflet.
Published from the Firecrawl policy change extraction pipeline.
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