- Active Ingredients
Product Documentation
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View RMM (Bosentan Patient Alert Card)
Last updated on this site: 20 Sep 2022
Initial upload
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at yellowcard.mhra.gov.uk. By reporting side effects, you can help provide more information on the safety of this medicine.
Report a side effect or a product complaintBosentan Accord 62.5mg Film-coated Tablets
- PL Number:
- 20075/0382
- MA Holder:
- Accord Healthcare Limited
- Product Classification:
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POM
- Product Status:
- Active
Product Documentation
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View Summary of Product Characteristics (SmPC- Bosentan Accord 62.5mg Film-coated Tablets)
Last updated on this site: 07 Oct 2026
Description of update: To update sections 3, 4.4, 4.8, 6.4, 6.5, 6.6 of the SmPC and sections 1, 9, 18 sections of the Labelling and sections 2, 5, 6 of the PL for the medicinal products Bosentan 62.5 mg Film-coated Tablets and Bosentan 125 mg Film-coated Tablets to implement the commitment to amend the PI documents further to the comments received from CMS within three months of RUP procedure. Additional updates have been made to SmPC sections 4.2, 4.3, 4.5, 5.1 and 5.2.
Date of approval: 01/10/2026
SmPC sections updated: 3, 4.2, 4.3, 4.4, 4.5, 4.8, 5.1, 5.2, 6.4, 6.5, 6.6 and 10
View Patient Information Leaflet (PIL- Bosentan Accord 62.5, 125mg Film-coated Tablets)Last updated on this site: 07 Oct 2026
Description of update: To update sections 3, 4.4, 4.8, 6.4, 6.5, 6.6 of the SmPC and sections 1, 9, 18 sections of the Labelling and sections 2, 5, 6 of the PL for the medicinal products Bosentan 62.5 mg Film-coated Tablets and Bosentan 125 mg Film-coated Tablets to implement the commitment to amend the PI documents further to the comments received from CMS within three months of RUP procedure. Additional updates have been made to SmPC sections 4.2, 4.3, 4.5, 5.1 and 5.2.
Date of approval: 01/10/2026
PIL sections updated: Heading, 2, 4, 5 and 6
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at yellowcard.mhra.gov.uk. By reporting side effects, you can help provide more information on the safety of this medicine.
Report a side effect or a product complaint
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