PIL- Tenofovir disoproxil Accordpharma 245mg Film-coated Tablets: Change history
View Patient Information Leaflet (PIL- Tenofovir disoproxil Accordpharma 245mg Film-coated Tablets)
Last updated on this site: 05 Nov 2024
To update section 4.4 and 4.8 of SmPC and sections 2 and 4 of the leaflet in line with the reference product (Viread 245 mg film-coated tablets; EMA procedure number: EMEA/H/C/000419; MAH: Gilead Science International limited, Ireland).
Additionally, section 4.2 of the SmPC has been updated with editorial changes in line with the reference product.
Last updated on this site: 05 Nov 2024
To update section 4.4 and 4.8 of SmPC and sections 2 and 4 of the leaflet in line with the reference product (Viread 245 mg film-coated tablets; EMA procedure number: EMEA/H/C/000419; MAH: Gilead Science International limited, Ireland).
Additionally, section 4.2 of the SmPC has been updated with editorial changes in line with the reference product.
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Changes: (Updated: 05 Nov 2024)
To update section 4.4 and 4.8 of SmPC and sections 2 and 4 of the leaflet in line with the reference product (Viread 245 mg film-coated tablets; EMA procedure number: EMEA/H/C/000419; MAH: Gilead Science International limited, Ireland).
Additionally, section 4.2 of the SmPC has been updated with editorial changes in line with the reference product.
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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).
PIL sections updated: 4, 6.
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Changes: (Updated: 09 Mar 2023)
Initial upload