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EU approval for AFYX’s low-dose oral misoprostol tablet

AFYX Therapeutics has received approval for its low-dose oral misoprostol tablet for induction of labour in 20 European countries and Northern Ireland in May, 2026.

The approval represents an important regulatory milestone for AFYX and reflects our continued focus on women’s health and medicines developed for use within established clinical care settings.

Induction of labour is a medical procedure that should only be performed when clinically indicated and under the supervision of qualified healthcare professionals, in accordance with local clinical protocols and the approved product information.

AFYX is now preparing the next steps required to make the product available in approved markets, working with relevant partners and authorities as applicable.

For healthcare professionals, prescribing and use should always be based on the approved Summary of Product Characteristics and local guidance.

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