Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Novartis Pharmaceuticals UK Limited, 2nd Floor, The WestWorks Building, White City Place, 195 Wood Lane, London, W12 7FQ, United Kingdom
Myfortic 180 mg gastro-resistant tablets.
Myfortic 360 mg gastro-resistant tablets.
| Pharmaceutical Form |
|---|
|
Gastro-resistant tablet. 180mg: Lime green, film-coated round tablet, with bevelled edges and the imprint (debossing) “C” on one side. 360mg: Pale orange red film-coated ovaloid tablet, with imprint (debossing) “CT” on one side. |
Each gastro-resistant tablet contains 180 mg or 360 mg mycophenolic acid (as mycophenolate sodium).
Excipient with known effect: Lactose, anhydrous: 45 mg or 90 mg per tablet.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Mycophenolic acid |
Mycophenolic acid is a potent, selective, uncompetitive and reversible inhibitor of inosine monophosphate dehydrogenase, and therefore inhibits the de novo pathway of guanosine nucleotide synthesis without incorporation into DNA. Mycophenolic acid has more potent cytostatic effects on lymphocytes than on other cells and is indicated in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in adult patients receiving allogeneic renal transplants. |
| List of Excipients |
|---|
|
Core: Maize starch Coating: Hypromellose phthalate |
The tablets are packed in polyamide/aluminium/PVC/aluminium blister packs of 10 tablets per blister in quantities of 20, (180mg only), 50, 100, 120 or 250 tablets per carton.
Not all pack sizes may be marketed.
Novartis Pharmaceuticals UK Limited, 2nd Floor, The WestWorks Building, White City Place, 195 Wood Lane, London, W12 7FQ, United Kingdom
Myfortic 180mg gastro-resistant tablets: PL 00101/0664
Myfortic 360mg gastro-resistant tablets: PL 00101/0665
Date of first authorisation: 5 July 2004
Date of latest renewal: 10 October 2008
| Drug | Countries | |
|---|---|---|
| MYFORTIC | Austria, Australia, Brazil, Canada, Cyprus, Germany, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Lithuania, Malta, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, United States, South Africa |
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