SmPC - Paroxetine 20mg Film-coated Tablets: Change history
View Summary of Product Characteristics (SmPC - Paroxetine 20mg Film-coated Tablets)
Last updated on this site: 05 Jan 2024
Description of update: To update section 4.8 of the SmPC in line with PRAC (PSUSA/00002319/202212) recommendation to add ADR leukopenia. Consequentially, the patient information leaflet has been updated.
SmPC Sections updated: 4.8 and 10.
Last updated on this site: 05 Jan 2024
Description of update: To update section 4.8 of the SmPC in line with PRAC (PSUSA/00002319/202212) recommendation to add ADR leukopenia. Consequentially, the patient information leaflet has been updated.
SmPC Sections updated: 4.8 and 10.
-
Changes: (Updated: 05 Jan 2024)
Description of update: To update section 4.8 of the SmPC in line with PRAC (PSUSA/00002319/202212) recommendation to add ADR leukopenia. Consequentially, the patient information leaflet has been updated.
SmPC Sections updated: 4.8 and 10.
-
Changes: (Updated: 14 Sep 2023)
To update sections 4.3, 4.4, 4.5 and 5.1 of the SPC in line with reference product, Seroxat 20mg, 30mg film-coated tablets (PL 10592/0001, 0002, MAH: SmithKline Beecham Limited).
Consequently, the PIL has been updated.
-
Changes: (Updated: 21 Jun 2023)
Variation Description: To update section 2.0 of the SmPC andPIL to reinstate the wording ‘For the full list of excipients, see section 6.1’. No update to 30mg SmPC. The excipient wording for sodium in PIL section 2 has been updated to include the heading ‘Information on sodium content’. The PIL has also been updated to align with the latest QRD template (Version 10.3, 09/2022) as well as the correction of grammar and spelling.
SmPC sections updated – 2 and 10.
-
Changes: (Updated: 21 Sep 2022)
Initial upload