PSUSA/00010130/202002 - periodic safety update report single assessment
Potassium para aminobenzoate
PSUSA
Human
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
- Potassium para aminobenzoate
- Procedure number
- PSUSA/00010130/202002
- Regulatory outcome
- Variation
Documents
Potassium para aminobenzoate: List of nationally authorised medicinal products - PSUSA/00010130/202002
Reference Number: EMA/669452/2020
English (EN) (102.78 KB - PDF)
First published:
Potassium para aminobenzoate: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010130/202002
English (EN) (51.08 KB - PDF)
First published:
български (BG) (275.2 KB - PDF)
First published:
10/12/2020
español (ES) (58.06 KB - PDF)
First published:
10/12/2020
čeština (CS) (255.92 KB - PDF)
First published:
10/12/2020
dansk (DA) (133.34 KB - PDF)
First published:
10/12/2020
Deutsch (DE) (58.11 KB - PDF)
First published:
10/12/2020
eesti keel (ET) (184.6 KB - PDF)
First published:
10/12/2020
ελληνικά (EL) (167.98 KB - PDF)
First published:
10/12/2020
français (FR) (55.11 KB - PDF)
First published:
10/12/2020
hrvatski (HR) (218.44 KB - PDF)
First published:
10/12/2020
íslenska (IS) (54.99 KB - PDF)
First published:
10/12/2020
italiano (IT) (212.62 KB - PDF)
First published:
10/12/2020
latviešu valoda (LV) (257.67 KB - PDF)
First published:
10/12/2020
lietuvių kalba (LT) (260.86 KB - PDF)
First published:
10/12/2020
magyar (HU) (221.84 KB - PDF)
First published:
10/12/2020
Malti (MT) (187.5 KB - PDF)
First published:
10/12/2020
Nederlands (NL) (215.81 KB - PDF)
First published:
10/12/2020
norsk (NO) (60.67 KB - PDF)
First published:
10/12/2020
polski (PL) (202.8 KB - PDF)
First published:
10/12/2020
português (PT) (67.53 KB - PDF)
First published:
10/12/2020
română (RO) (172.8 KB - PDF)
First published:
10/12/2020
slovenčina (SK) (224.51 KB - PDF)
First published:
10/12/2020
slovenščina (SL) (158.2 KB - PDF)
First published:
10/12/2020
Suomi (FI) (68.27 KB - PDF)
First published:
10/12/2020
svenska (SV) (213.69 KB - PDF)
First published:
10/12/2020