SmPC- Azithromycin 250mg Film-coated Tablets: Change history
View Summary of Product Characteristics (SmPC- Azithromycin 250mg Film-coated Tablets)
Last updated on this site: 22 Jan 2026
Description of update: To update sections 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.1, 5.2 and 5.3 of the SmPC to implement the outcome of a Union referral procedure. Consequently, the PIL has been updated. In addition there are editorial updates to PIL.
Date of approval: 15/01/2026
SmPC sections updated: 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.1, 5.2, 5.3 and 10
Last updated on this site: 22 Jan 2026
Description of update: To update sections 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.1, 5.2 and 5.3 of the SmPC to implement the outcome of a Union referral procedure. Consequently, the PIL has been updated. In addition there are editorial updates to PIL.
Date of approval: 15/01/2026
SmPC sections updated: 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.1, 5.2, 5.3 and 10
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Changes: (Updated: 22 Jan 2026)
Description of update: To update sections 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.1, 5.2 and 5.3 of the SmPC to implement the outcome of a Union referral procedure. Consequently, the PIL has been updated. In addition there are editorial updates to PIL.
Date of approval: 15/01/2026
SmPC sections updated: 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.1, 5.2, 5.3 and 10
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Changes: (Updated: 25 Feb 2025)
To update section 5.1 of the SmPC in line with EMA guidance to relocate MIC data from the product information.
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Changes: (Updated: 04 Jan 2024)
Description of update:
To register updated sections 4.2, 4.4 and 4.7 of the SmPC fragments in line with the reference product (Zithromax 250 mg Capsules, PL 00057/0335, MAH. Consequently, the PIL has been updated.
Spelling/Grammatical changes have also been made to the PIL.
SmPC Sections updated: 4.2, 4.4, 4.7 and 10.
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Changes: (Updated: 04 Jan 2024)
Description of update:
To register updated sections 4.2, 4.4 and 4.7 of the SmPC fragments in line with the reference product (Zithromax 250 mg Capsules, PL 00057/0335, MAH. Consequently, the PIL has been updated.
Spelling/Grammatical changes have also been made to the PIL.
SmPC Sections updated: 4.2, 4.4, 4.7 and 10.
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Changes: (Updated: 20 Apr 2023)
Variation Description: To update section 4.6 of the SmPC and sections 2, 4 and 6 of the PIL to bring in line with reference product, Zithromax 250mg Capsules, MAH: Pfizer Limited, PL 00057/0335.
SmPC sections updated- 4.6 and 10.
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Changes: (Updated: 20 Sep 2022)
Initial upload