SmPC- Tenofovir disoproxil Accordpharma 245 mg Film-coated Tablets: Change history
View Summary of Product Characteristics (SmPC- Tenofovir disoproxil Accordpharma 245 mg Film-coated Tablets)
Last updated on this site: 20 Nov 2023
Description of update: Renewal. Renewal date: 08/11/2023 (Common renewal date: 01/10/2023).
SmPC Sections updated: Section 4.4 (formatting only) and 10.
Last updated on this site: 20 Nov 2023
Description of update: Renewal. Renewal date: 08/11/2023 (Common renewal date: 01/10/2023).
SmPC Sections updated: Section 4.4 (formatting only) and 10.
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Changes: (Updated: 20 Nov 2023)
Description of update: Renewal. Renewal date: 08/11/2023 (Common renewal date: 01/10/2023).
SmPC Sections updated: Section 4.4 (formatting only) and 10.
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Changes: (Updated: 09 Aug 2023)
Type IB: C.I.2. a) Implementation of change(s) for which no new additional data is required to be submitted by the MAH
- Update SmPC and PIL in-line with the text of reference product Viread 245 mg film-coated tablets (Procedure number: EMEA/H/C/000419)
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Changes: (Updated: 29 Jun 2023)
Description of update: To update SmPC section 4.8 and leaflet section 4 to implement the wording agreed by the PRAC following the outcome of the PSUSA procedure (PSUSA/00010751/202203).
SmPC sections updated: 4.8, 10.
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Changes: (Updated: 09 Mar 2023)
Initial upload