SmPC- Apremilast 10 mg, 20 mg, 30 mg film-coated tablets: Change history
View Summary of Product Characteristics (SmPC- Apremilast 10 mg, 20 mg, 30 mg film-coated tablets)
Last updated on this site: 27 Apr 2026
Description of update: To update sections 4.4 and 4.8 of the SmPC in line with the reference product, Otezla 10 mg, 20 mg, 30 mg film-coated tablets. Consequently, the PIL has been updated. Additionally, editorial updates are being made to sections 4.2, 4.6, 4.8, 5.1,
5.2, 5.3 of the SmPC and the PIL.
Date of approval: 22/04/2026
SmPC sections updated: 4.2, 4.4, 4.6, 4.8, 5.1, 5.2, 5.3, 9 and 10
Last updated on this site: 27 Apr 2026
Description of update: To update sections 4.4 and 4.8 of the SmPC in line with the reference product, Otezla 10 mg, 20 mg, 30 mg film-coated tablets. Consequently, the PIL has been updated. Additionally, editorial updates are being made to sections 4.2, 4.6, 4.8, 5.1,
5.2, 5.3 of the SmPC and the PIL.
Date of approval: 22/04/2026
SmPC sections updated: 4.2, 4.4, 4.6, 4.8, 5.1, 5.2, 5.3, 9 and 10
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Changes: (Updated: 27 Apr 2026)
Description of update: To update sections 4.4 and 4.8 of the SmPC in line with the reference product, Otezla 10 mg, 20 mg, 30 mg film-coated tablets. Consequently, the PIL has been updated. Additionally, editorial updates are being made to sections 4.2, 4.6, 4.8, 5.1,
5.2, 5.3 of the SmPC and the PIL.
Date of approval: 22/04/2026
SmPC sections updated: 4.2, 4.4, 4.6, 4.8, 5.1, 5.2, 5.3, 9 and 10
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Changes: (Updated: 30 Jan 2026)
New Product Launch 27.01.26
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Changes: (Updated: 30 Jan 2026)
New Product launch 27.01.26