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Intended for UK patients and members of the public

Rosuvastatin 20mg Film-coated Tablets

Rosuvastatin 20mg Film-coated Tablets

PL Number:
20075/0404
MA Holder:
Accord Healthcare Limited
Product Classification:
POM
Product Status:
Active

Product Documentation

  • Description of update:

    SmPC sections 4.2, 4.4, 4.5, 4.6, 4.8, 5.1 and 5.2 for the above-listed MAs have been updated in line with the reference product Crestor 5mg, 10mg, 20mg and 40mg film-coated tablets NL/H/0343/001-004, Grünenthal B.V. Dated Sep 2024. Consequently, the PIL has been updated.

     

    Additionally, SmPC section 6.1 and PIL section 6 have been updated to remove the word ‘anhydrous’ in line with the ninth edition EP.

     

    Date of approval: 08/09/2025

    SmPC sections updated: 4.2, 4.4, 4.5, 4.6, 4.8, 5.1, 5.2, 6.1 and 10

  • SmPC sections 4.2, 4.4, 4.5, 4.6, 4.8, 5.1 and 5.2 for the above-listed MAs have been updated in line with the reference product Crestor 5mg, 10mg, 20mg and 40mg film-coated tablets NL/H/0343/001-004, Grünenthal B.V. Dated Sep 2024. Consequently, the PIL has been updated.

     

    Additionally, SmPC section 6.1 and PIL section 6 have been updated to remove the word ‘anhydrous’ in line with the ninth edition EP.

     

    Date of approval: 08/09/2025

    SmPC sections updated: 4.2, 4.4, 4.5, 4.6, 4.8, 5.1, 5.2, 6.1 and 10

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at yellowcard.mhra.gov.uk. By reporting side effects, you can help provide more information on the safety of this medicine.

Report a side effect or a product complaint

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