SmPC- Enalapril maleate 2.5 mg Tablets: Change history
View Summary of Product Characteristics (SmPC- Enalapril maleate 2.5 mg Tablets)
Last updated on this site: 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.
Last updated on this site: 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.
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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.
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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.
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Changes: (Updated: 26 Feb 2024)
Description of update: New product launch. UK launch date: 23/02/2024.