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PRAC assesses that NAION could be a very rare side effect of Ozempic, Rybelsus and Wegovy
| 19 March 2026 |
EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) recommends that the product information for semaglutide medicines should include information that the rare eye condition NAION could be a very rare side effect. Treatment should be stopped if symptoms of NAION occur.
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For Clinical Trials with ATMP: Guidance to the content of the Investigator´s Brochure published
| 06 March 2026 |
See the Danish Medicines Agency’s guidance on the content of the Investigator’s Brochure for clinical trials with ATMPs
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