PSUSA/00002896/202509 - periodic safety update report single assessment

About

Periodic safety update report single assessments (PSUSAs) are single assessments of related periodic safety update reports (PSURs) for active substances contained in medicines authorised in the European Union (EU). A PSUR is a pharmacovigilance report submitted regularly by a marketing-authorisation holder at defined time points following a medicine's authorisation.

Key facts

Active substance(s) in scope of the PSUSA procedure terbinafine Procedure number PSUSA/00002896/202509 Regulatory outcome Variation

Documents

Terbinafine : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002896/202509 English (EN) (100.91 KB - PDF) First published: 13/08/2026 View Other languages (22) български (BG) (100.63 KB - PDF) First published: 13/08/2026 View español (ES) (84.08 KB - PDF) First published: 13/08/2026 View čeština (CS) (104.88 KB - PDF) First published: 13/08/2026 View dansk (DA) (83.43 KB - PDF) First published: 13/08/2026 View Deutsch (DE) (109.43 KB - PDF) First published: 13/08/2026 View eesti (ET) (89.69 KB - PDF) First published: 13/08/2026 View ελληνικά (EL) (102.83 KB - PDF) First published: 13/08/2026 View français (FR) (84.64 KB - PDF) First published: 13/08/2026 View hrvatski (HR) (108.83 KB - PDF) First published: 13/08/2026 View italiano (IT) (95.09 KB - PDF) First published: 13/08/2026 View latviešu (LV) (109.53 KB - PDF) First published: 13/08/2026 View lietuvių (LT) (109.69 KB - PDF) First published: 13/08/2026 View magyar (HU) (215.9 KB - PDF) First published: 13/08/2026 View Malti (MT) (109.29 KB - PDF) First published: 13/08/2026 View Nederlands (NL) (84.8 KB - PDF) First published: 13/08/2026 View polski (PL) (101.34 KB - PDF) First published: 13/08/2026 View português (PT) (82.86 KB - PDF) First published: 13/08/2026 View română (RO) (102.73 KB - PDF) First published: 13/08/2026 View slovenčina (SK) (103.85 KB - PDF) First published: 13/08/2026 View slovenščina (SL) (95.94 KB - PDF) First published: 13/08/2026 View suomi (FI) (79.82 KB - PDF) First published: 13/08/2026 View svenska (SV) (81.46 KB - PDF) First published: 13/08/2026 View Terbinafine : List of nationally authorised medicinal products - PSUSA/00002896/202509 Reference Number: EMADOC-1700519818-3394728 English (EN) (417.56 KB - PDF) First published: 13/08/2026 View