- Active Ingredients
Product Documentation
-
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 180mg Gastro-resistant Tablets
- PL Number:
- 20075/0391
- MA Holder:
- Accord Healthcare Limited
- Product Classification:
-
POM
- Product Status:
- Active
Product Documentation
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View Summary of Product Characteristics (SmPC - Mycophenolic acid 180mg Gastro-resistant Tablets)
Last updated on this site: 09 Aug 2024
Update of the SmPC section 4.6 to implement the wording agreed by PRAC following the outcome of the PSUR procedure PSUSA/10550/202305.
View Patient Information Leaflet (PIL - Mycophenolic acid 180mg Gastro-resistant Tablets)Last updated on this site: 10 Jul 2025
Type IA in B.II.b.1 Substitution or addition of a manufacturing site for part or all of the manufacturing process of the finished product
a) Secondary conditioning site
"Addition of a manufacturing site as an alternative site responsible for secondary packaging of the finished product:
Accord Healthcare Single Member S.A.
64th Km National Road Athens,
Lamia, Schimatari, 32009, Greece"
Type IA in B.II.b.1 Substitution or addition of a manufacturing site for part or all of the manufacturing process of the finished product
b) Primary conditioning site
"Addition of a manufacturing site as an alternative site responsible for primary packaging of the finished product:
Accord Healthcare Single Member S.A.
64th Km National Road Athens,
Lamia, Schimatari, 32009, Greece"
Type IA in B.II.b.2 Change in importer, batch release measures and quality control testing of the finished product
c.2) Replacement or addition of a manufacturer responsible for batch release. Including batch control or testing
"Addition of a manufacturing site as an alternative site responsible for importation and batch release including batch control/testing of the finished product.:
Accord Healthcare Single Member S.A.
64th Km National Road Athens,
Lamia, Schimatari, 32009, Greece
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.