Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Passauer Pharma GmbH, Eiderstedter Weg 3, 14129 Berlin, Germany, Tel.: 0049 (0)30 744 60 12, Fax: 0049 (0)30 744 60 41
Myclausen 500 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet. White round film-coated tablets. |
Each film-coated tablet contains 500 mg mycophenolate mofetil.
For the full list of excipients, see section 6.1
| Active Ingredient | Description | |
|---|---|---|
| Mycophenolate mofetil |
Mycophenolate mofetil is the 2-morpholinoethyl ester of mycophenolic acid (MPA). MPA 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. |
| List of Excipients |
|---|
|
Tablet core: Microcrystalline cellulose Tablet coating: Polyvinyl alcohol (partially hydrolysed) |
PVC-aluminium blisters containing 10 film-coated tablets.
Each carton contains either 50 or 150 film-coated tablets.
Not all pack sizes may be marketed.
Passauer Pharma GmbH, Eiderstedter Weg 3, 14129 Berlin, Germany, Tel.: 0049 (0)30 744 60 12, Fax: 0049 (0)30 744 60 41
EU/1/10/647/001-002
Date of first authorisation: 7 October 2010
Date of latest renewal: 27 May 2015
| Drug | Countries | |
|---|---|---|
| MYCLAUSEN | Austria, Cyprus, Germany, Estonia, Croatia, Ireland, Lithuania, Poland |
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