PIL - Ramipril 2.5mg, 5mg, 10mg Tablets: Change history

Last updated on this site: 27 Jun 2024

- To remove a batch release site from the leaflet.

- To correct grammar error found in section 2 of the leaflet.

- To amend to bring the reporting of side effects statement in line with latest QRD Appendix V (29 February 2024) wording in section 4.

Changes: (Updated: 27 Jun 2024)

- To remove a batch release site from the leaflet.
- To correct grammar error found in section 2 of the leaflet.
- To amend to bring the reporting of side effects statement in line with latest QRD Appendix V (29 February 2024) wording in section 4.
Changes: (Updated: 22 May 2024)

Description of update:
1.To register the deletion of Balkanpharma - Dupnitsa AD, 3 Samokovsko Shosse Street, Dupnitsa 2600, Bulgaria as a product manufacturer, batch release, assembler packager and QC site. Consequentially, the leaflet has been updated.
2.To register the deletion of active substance manufacturer Zhejiang Huahai Pharmaceutical Co. Ltd, Xunqíao, China-317 024 Linhai, Zhejiang Province.
Additionally, editorial amends have been made to sections 2 & 4.
PIL sections updated: 2, 4 & 6.
SmPC not updated.
Changes: (Updated: 21 Oct 2022)

Single Variation
Variation Type: IB C.I.2.a

Variation Description:
To register an update to sections 4.3, 4.4, 4.5, 4.6, 4.8 and 5.1 of the SPC in line with the reference product (Tritace 5mg Tablets; PL 04425/0358). Consequentially, the leaflet has been updated.
Addition of ‘sodium-free’ statement in SPC section 4.4 and PIL.
Update to product descriptions in PIL section 6.

SmPC sections updated – 4.3, 4.4, 4.5, 4.6, 4.8, 5.1 and 10
PIL sections updated – Heading, 2, 3, 4, 5 and 6
Changes: (Updated: 21 Sep 2022)

Initial upload

Changes: (Updated: 27 Jun 2024)