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
- Methylphenidate
- Procedure number
- PSUSA/00002024/201810
- Regulatory outcome
- Variation
Documents
Methylphenidate: List of nationally authorised medicinal products - PSUSA/00002024/201810
English (EN) (526.16 KB - PDF)
Methylphenidate: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002024/201810
English (EN) (112.62 KB - PDF)
български (BG) (216.79 KB - PDF)
español (ES) (173.93 KB - PDF)
čeština (CS) (211.11 KB - PDF)
dansk (DA) (190.78 KB - PDF)
Deutsch (DE) (180.81 KB - PDF)
eesti keel (ET) (166.13 KB - PDF)
ελληνικά (EL) (198.51 KB - PDF)
français (FR) (173.04 KB - PDF)
hrvatski (HR) (228.4 KB - PDF)
íslenska (IS) (174.15 KB - PDF)
italiano (IT) (176.14 KB - PDF)
latviešu valoda (LV) (233.67 KB - PDF)
lietuvių kalba (LT) (230.8 KB - PDF)
magyar (HU) (240.6 KB - PDF)
Malti (MT) (238.09 KB - PDF)
Nederlands (NL) (177.39 KB - PDF)
norsk (NO) (226.4 KB - PDF)
polski (PL) (233.47 KB - PDF)
português (PT) (193.33 KB - PDF)
română (RO) (241.22 KB - PDF)
slovenčina (SK) (241.97 KB - PDF)
slovenščina (SL) (102.29 KB - PDF)
Suomi (FI) (166.2 KB - PDF)
svenska (SV) (173.8 KB - PDF)
Methylphenidate: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002024/201810
English (EN) (37.83 KB - PDF)
български (BG) (118.81 KB - PDF)
español (ES) (42.15 KB - PDF)
čeština (CS) (106.34 KB - PDF)
dansk (DA) (51.58 KB - PDF)
Deutsch (DE) (41.35 KB - PDF)
eesti keel (ET) (40.47 KB - PDF)
ελληνικά (EL) (120.96 KB - PDF)
français (FR) (40.23 KB - PDF)
hrvatski (HR) (114.21 KB - PDF)
íslenska (IS) (36.3 KB - PDF)
italiano (IT) (41.46 KB - PDF)
latviešu valoda (LV) (122.54 KB - PDF)
lietuvių kalba (LT) (106.61 KB - PDF)
magyar (HU) (105.54 KB - PDF)
Malti (MT) (129.24 KB - PDF)
Nederlands (NL) (41.23 KB - PDF)
norsk (NO) (109.35 KB - PDF)
polski (PL) (123.5 KB - PDF)
português (PT) (63.31 KB - PDF)
română (RO) (122.08 KB - PDF)
slovenčina (SK) (114.7 KB - PDF)
slovenščina (SL) (101.18 KB - PDF)
Suomi (FI) (38.53 KB - PDF)
svenska (SV) (39.43 KB - PDF)