SmPC- Sorafenib 200 mg film-coated tablets: Change history
View Summary of Product Characteristics (SmPC- Sorafenib 200 mg film-coated tablets)
Last updated on this site: 06 Mar 2026
Description of update: To update section 5.3 of the SmPC and the PIL in-line with information of reference product (Nexavar 200 mg film-coated tablets; MAH: Bayer AG, Germany; EU procedure number: EMEA/H/C/000690/II/0059).
Date of approval: 24/02/2026
SmPC sections updated: 5.3 and 10
Last updated on this site: 06 Mar 2026
Description of update: To update section 5.3 of the SmPC and the PIL in-line with information of reference product (Nexavar 200 mg film-coated tablets; MAH: Bayer AG, Germany; EU procedure number: EMEA/H/C/000690/II/0059).
Date of approval: 24/02/2026
SmPC sections updated: 5.3 and 10
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Changes: (Updated: 06 Mar 2026)
Description of update: To update section 5.3 of the SmPC and the PIL in-line with information of reference product (Nexavar 200 mg film-coated tablets; MAH: Bayer AG, Germany; EU procedure number: EMEA/H/C/000690/II/0059).
Date of approval: 24/02/2026
SmPC sections updated: 5.3 and 10
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Changes: (Updated: 04 Mar 2025)
To update sections 4.1, 4.2, 4.4, 4.8, and 5.1 of the SmPC to bring in line with the reference product Nexavar 200 mg film coated tablets (MAH: Bayer AG, Germany, EU procedure number: EMEA/H/C/000690). Consequentially, the PIL is also being updated.
SmPC sections updated: 4.1, 4.2, 4.4, 4.8, 5.1 & 10.
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Changes: (Updated: 05 Jul 2023)
New SmPC for new product