SmPC - Paroxetine 30mg Film-coated Tablets: Change history
View Summary of Product Characteristics (SmPC - Paroxetine 30mg 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.
View Summary of Product Characteristics (SmPC - Paroxetine 30mg 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.
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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.
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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.
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Changes: (Updated: 21 Sep 2022)
Initial upload