- Active Ingredients
Product Documentation
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View RMM (Risk of miscarriage and birth defects: Patient Guide)
Last updated on this site: 10 May 2024
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 complaintMycophenolic acid 360mg Gastro-resistant Tablets
- PL Number:
- 20075/0392
- MA Holder:
- Accord Healthcare Limited
- Product Classification:
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POM
- Product Status:
- Active
Product Documentation
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View Patient Information Leaflet (PIL - Mycophenolic acid 360mg Gastro-resistant Tablets)
Last updated on this site: 04 Dec 2025
Description of update: To update sections 4.2, 4.3, 4.4, 4.5, 4.6, 4.8, 5.2, 5.3 of the SmPC and PIL in-line with the information of the reference product (Myfortic 180 mg, 360 mg gastro-resistant tablets; MAH: Novartis Pharma SAS, France; EU procedure number: FR/H/0239/001-002/DC). Section 4.4 of the SmPC and section 2 of the leaflet have been updated with excipient warning in line with Annex to the European Commission guideline on `Excipients in the labelling and package leaflet of medicinal products for human use'. Furthermore, section 6.6 of the SmPC has been updated with the instructions for handling of the medicinal product and with the QRD changes.
Date of approval: 07/11/2025
PIL sections updated: 2, 4, 5 and 6
View Summary of Product Characteristics (SmPC - Mycophenolic acid 360mg Gastro-resistant Tablets)Last updated on this site: 04 Dec 2025
Description of update: To update sections 4.2, 4.3, 4.4, 4.5, 4.6, 4.8, 5.2, 5.3 of the SmPC and PIL in-line with the information of the reference product (Myfortic 180 mg, 360 mg gastro-resistant tablets; MAH: Novartis Pharma SAS, France; EU procedure number: FR/H/0239/001-002/DC). Section 4.4 of the SmPC and section 2 of the leaflet have been updated with excipient warning in line with Annex to the European Commission guideline on `Excipients in the labelling and package leaflet of medicinal products for human use'. Furthermore, section 6.6 of the SmPC has been updated with the instructions for handling of the medicinal product and with the QRD changes.
Date of approval: 07/11/2025
SmPC sections updated: 4.2, 4.3, 4.4, 4.5, 4.6, 4.8, 5.2, 5.3, 6.6 and 10
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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