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Terfenadine: closer monitoring of the side-effect profile

Active substance: terfenadine

After a hearing regarding terfenadine, including evaluation of the safety report, no changes in the benefit/risk profile could be determined.

To the risk assessment procedure (available in German only)

Risikoinfo_Downloadtitel_Risikobewertungsverfahren , Download_VeroeffentlichtAm_EN PDF, 77KB, File is accessible