PIL- Posaconazole Accord 100 mg gastro-resistant tablets (PLGB 20075/1439): Change history
View Patient Information Leaflet (PIL- Posaconazole Accord 100 mg gastro-resistant tablets (PLGB 20075/1439))
Last updated on this site: 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
PIL sections updated: 1, 2 and 6
Last updated on this site: 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
PIL sections updated: 1, 2 and 6
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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
PIL sections updated: 1, 2 and 6
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Changes: (Updated: 03 Jun 2026)
To register the addition Accord Healthcare single member S.A., 64th Km National Road, Athens, Lamia, Schimatari,32009, Greece as an alternative site responsible for importation and batch release including batch control/testing (Physical, chemical & microbiological) of the finished product. Consequently the PIL has been updated.
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Changes: (Updated: 09 Nov 2023)
Description of update: New product launch. Launched in the UK: 30/10/2023.