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
- Methadone
- Procedure number
- PSUSA/00002004/202205
- Regulatory outcome
- Variation
Documents
Methadone - List of nationally authorised medicinal products - PSUSA/00002004/202205
English (EN) (225.23 KB - PDF)
Methadone - CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002004/202205
English (EN) (127.46 KB - PDF)
български (BG) (181.26 KB - PDF)
español (ES) (130.58 KB - PDF)
čeština (CS) (153.01 KB - PDF)
dansk (DA) (119.74 KB - PDF)
Deutsch (DE) (151 KB - PDF)
eesti keel (ET) (150.6 KB - PDF)
ελληνικά (EL) (188.11 KB - PDF)
français (FR) (116.42 KB - PDF)
hrvatski (HR) (195.99 KB - PDF)
íslenska (IS) (105.84 KB - PDF)
italiano (IT) (150.61 KB - PDF)
latviešu valoda (LV) (171 KB - PDF)
lietuvių kalba (LT) (152.11 KB - PDF)
magyar (HU) (160.5 KB - PDF)
Malti (MT) (185.1 KB - PDF)
Nederlands (NL) (107.69 KB - PDF)
norsk (NO) (118.93 KB - PDF)
polski (PL) (156.88 KB - PDF)
português (PT) (149.73 KB - PDF)
română (RO) (170.12 KB - PDF)
slovenčina (SK) (218.45 KB - PDF)
slovenščina (SL) (145.15 KB - PDF)
Suomi (FI) (113.91 KB - PDF)
svenska (SV) (133.36 KB - PDF)