- 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 125mg Film-coated Tablets
- PL Number:
- 20075/0383
- MA Holder:
- Accord Healthcare Limited
- Product Classification:
-
POM
- Product Status:
- Active
Product Documentation
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View Summary of Product Characteristics (SmPC- Bosentan Accord 125mg Film-coated Tablets)
Last updated on this site: 06 Dec 2022
Section 6.5 - Addition of - "Aluminium-aluminium blister and PVC/PE/PVDC-aluminium blisters containing 10 film-coated tablets.
Bosentan Accord 125 mg film-coated tablets are available in cartons containing 120 film-coated tablets."
View Patient Information Leaflet (PIL- Bosentan Accord 62.5, 125mg Film-coated Tablets)Last updated on this site: 08 Dec 2025
Variation type IAIN no: B.II.b.2.c.2 - Addition of a manufacturer responsible for importation and/or batch release - Including batch control/testing
Addition of a site responsible for importation and batch release including batch control/testing of the product (physical, chemical and microbiological testing):
Accord Healthcare single member S.A.
64th Km National Road Athens,Lamia, Schimatari, 32009,
Greece
Variation type IAIN no: B.II.b.1.a - Replacement of a manufacturing site for part or all of the manufacturing process of the finished product - Secondary packaging site
Replacement of a site responsible for secondary packaging of the product:
from
Prodlekpol Sp. z o.o. , 14, Matuszewska, 03-876 Warsaw, Poland
to
Synoptis Industrial Sp. z o.o., Ul. Rabowicka 15, Swarzedz, 62-020, Poland
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
For any further assistance, please get in touch.