PIL - Prochlorperazine Tablets BP 5mg: Change history
View Patient Information Leaflet (PIL - Prochlorperazine Tablets BP 5mg)
Last updated on this site: 16 May 2023
Variation Description: To update sections 4.1, 4.3, 4.4, 4.8, 5.1 and 5.3 of the SmPC to bring in line with the reference product Stemetil 5 mg tablets (PL 04425/0593; MAH: Sanofi; dated 13/05/2022). Consequently, sections 1, 2, 3, 4.2, 4.6, 4.7, 6.1, 6.6, 7, 8 and 9 of the SmPC has been updated in line with the QRD template and the PIL has been updated. Additional updates to: ATC code in SPC section 5.1, in line with WHO ATC Index; SmPC section 4.6 to include ‘fertility’ subsection; SmPC section 4.8 to align with MedDRA SOC; PIL lactose excipient information. Additional editorial updates to SmPC section 4.4 and PIL.
PIL sections updated – Heading, index, 1, 2, 3, 4, 5 and 6.
Last updated on this site: 16 May 2023
Variation Description: To update sections 4.1, 4.3, 4.4, 4.8, 5.1 and 5.3 of the SmPC to bring in line with the reference product Stemetil 5 mg tablets (PL 04425/0593; MAH: Sanofi; dated 13/05/2022). Consequently, sections 1, 2, 3, 4.2, 4.6, 4.7, 6.1, 6.6, 7, 8 and 9 of the SmPC has been updated in line with the QRD template and the PIL has been updated. Additional updates to: ATC code in SPC section 5.1, in line with WHO ATC Index; SmPC section 4.6 to include ‘fertility’ subsection; SmPC section 4.8 to align with MedDRA SOC; PIL lactose excipient information. Additional editorial updates to SmPC section 4.4 and PIL.
PIL sections updated – Heading, index, 1, 2, 3, 4, 5 and 6.
-
Changes: (Updated: 16 May 2023)
Variation Description: To update sections 4.1, 4.3, 4.4, 4.8, 5.1 and 5.3 of the SmPC to bring in line with the reference product Stemetil 5 mg tablets (PL 04425/0593; MAH: Sanofi; dated 13/05/2022). Consequently, sections 1, 2, 3, 4.2, 4.6, 4.7, 6.1, 6.6, 7, 8 and 9 of the SmPC has been updated in line with the QRD template and the PIL has been updated. Additional updates to: ATC code in SPC section 5.1, in line with WHO ATC Index; SmPC section 4.6 to include ‘fertility’ subsection; SmPC section 4.8 to align with MedDRA SOC; PIL lactose excipient information. Additional editorial updates to SmPC section 4.4 and PIL.
PIL sections updated – Heading, index, 1, 2, 3, 4, 5 and 6.
-
Changes: (Updated: 21 Sep 2022)
Initial upload