- Active Ingredients
Product Documentation
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View RMM (RMM- Ambrisentan Patient Reminder Cards)
Last updated on this site: 23 Aug 2023
Website administration update only- no change to file
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 complaintAmbrisentan Accord 10mg Film-coated Tablets
- PL Number:
- 20075/1245
- MA Holder:
- Accord Healthcare Limited
- Product Classification:
-
POM
- Product Status:
- Active
Product Documentation
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View Patient Information Leaflet (PIL- Ambrisentan Accord 5mg, 10mg Film-coated Tablets)
Last updated on this site: 20 May 2024
Description of update:
This notification is submitted to amend the packaging components without the need to amend the SmPC. Changes notified are as follows:
To remove references to EIRE on the PIL as this is no longer a packshare.
PIL sections updated: 4 and 6.
View Summary of Product Characteristics (SmPC- Ambrisentan Accord 10mg Film-coated Tablets)Last updated on this site: 07 Nov 2024
Adaptation of the SmPC to the reference product Volibris (EU/1/08/451) following EMEA/H/C/000839/II/0067; further editorial changes have been made
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.