SmPC- Enalapril maleate 2.5 mg Tablets: Change history

Last updated on this site: 21 Jul 2026

· Description of update: GRANT / RENEWAL OF MARKETING AUTHORISATION

· Date of approval: 15/07/2026

· SmPC sections updated: 9 and 10

Changes: (Updated: 21 Jul 2026)

· Description of update: GRANT / RENEWAL OF MARKETING AUTHORISATION
· Date of approval: 15/07/2026
· SmPC sections updated: 9 and 10
Changes: (Updated: 16 Feb 2026)

Update to SmPC section 4.4 & PIL section 2 in line with MHRA request for single-agent ACE inhibitors: delayed onset of angioedema and angiotensin converting enzyme (ACE) inhibitors.
Approval date 07/02/2026.
SmPC sections updated: 4.4 and 10.
PIL sections updated: 2 and 6.
Changes: (Updated: 18 Nov 2024)

To update SmPC sections 4.3, 4.4, 4.5, and PIL information in line with the reference product (Innovace 5 mg Tablets, Procedure number: SE/H/0404/002/DC, MAH: Organon Pharma (Ireland) Limited).

Additional editorial updates to SPC section 4.2, 4.8 and 5.2, and PIL.
Changes: (Updated: 26 Feb 2024)

Description of update: New product launch. UK launch date: 23/02/2024.

Changes: (Updated: 21 Jul 2026)