Medicines with stricter reporting requirements Individual reimbursement Danish drug interaction databases Compassionate use permits Healthcare professionals having a relationship with a company Report a side effect from medicines Reporting of incidents and accidents with medical devices Medicinal cannabis Veterinary medicines
Theme

Vaccines against COVID-19

Medicines agencies around the world are collaborating to approve and follow vaccines against COVID-19. Once the vaccines are approved, medicines authorities around the world follow up with monitoring of adverse drug reactions. Read about results, processes and new vaccines against COVID-19 in our three themes or in the question-and-answer below.

Go to theme

News and notifications

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.

For Clinical Trials with ATMP: Guidance to the content of the Investigator´s Brochure published

06 March 2026

New functionalities in the CTIS-module Non-substantial modification

09 February 2026

Electronic dispatch of decision letters marks its fifth anniversary

04 February 2026