SmPC- Posaconazole Accord 100 mg gastro-resistant tablets (PLGB 20075/1439): Change history
View Summary of Product Characteristics (SmPC- Posaconazole Accord 100 mg gastro-resistant tablets (PLGB 20075/1439))
Last updated on this site: 07 Oct 2026
Description of update: To update sections 4.1, 4.2, 4.4, 4.5, 4.8, 5.1, 5.2 of the SmPC and section 1, 2 of the leaflet in-line with the information of the reference product, Noxafil 100 mg gastro-resistant tablets; MA Number: PLGB 53095/0042; MAH: Merck Sharp & Dohme (UK) Limited). In addition, editorial changes have been made in sections 2, 4 of PIL in-line with the reference product.
Date of approval: 30/09/2026
SmPC sections updated: 4.1, 4.2, 4.4, 4.5, 4.8, 5.1, 5.2 and 10
Last updated on this site: 07 Oct 2026
Description of update: To update sections 4.1, 4.2, 4.4, 4.5, 4.8, 5.1, 5.2 of the SmPC and section 1, 2 of the leaflet in-line with the information of the reference product, Noxafil 100 mg gastro-resistant tablets; MA Number: PLGB 53095/0042; MAH: Merck Sharp & Dohme (UK) Limited). In addition, editorial changes have been made in sections 2, 4 of PIL in-line with the reference product.
Date of approval: 30/09/2026
SmPC sections updated: 4.1, 4.2, 4.4, 4.5, 4.8, 5.1, 5.2 and 10
-
Changes: (Updated: 07 Oct 2026)
Description of update: To update sections 4.1, 4.2, 4.4, 4.5, 4.8, 5.1, 5.2 of the SmPC and section 1, 2 of the leaflet in-line with the information of the reference product, Noxafil 100 mg gastro-resistant tablets; MA Number: PLGB 53095/0042; MAH: Merck Sharp & Dohme (UK) Limited). In addition, editorial changes have been made in sections 2, 4 of PIL in-line with the reference product.Date of approval: 30/09/2026
SmPC sections updated: 4.1, 4.2, 4.4, 4.5, 4.8, 5.1, 5.2 and 10
-
Changes: (Updated: 05 Oct 2026)
Description of update: To update sections 4.1, 4.2, 4.4, 4.5, 4.8, 5.1, 5.2 of the SmPC and section 1, 2 of the leaflet in-line with the information of the reference product, Noxafil 100 mg gastro-resistant tablets; MA Number: PLGB 53095/0042; MAH: Merck Sharp & Dohme (UK) Limited). In addition, editorial changes have been made in sections 2, 4 of PIL in-line with the reference product.
Date of approval: 30/09/2026
SmPC sections updated: 4.1, 4.2, 4.4, 4.5, 4.8, 5.1, 5.2 and 10
-
Changes: (Updated: 09 Apr 2025)
To update section 5.1 of the SmPC in line with recommendation published by EMA for relocation of MIC data from the product information.
-
Changes: (Updated: 09 Nov 2023)
Description of update: New product launch. Launched in the UK: 30/10/2023.