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SmPC- Azithromycin 250mg Film-coated Tablets: Change history

  • 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.

    • 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.

    • 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.

       

    • 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.

    • Changes: (Updated: 20 Sep 2022)

      Initial upload

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