Source: European Medicines Agency (EU) Revision Year: 2018 Publisher: Merck Europe B.V., Gustav Mahlerplein 102, 1082 MA Amsterdam, The Netherlands
MAVENCLAD 10 mg tablets.
| Pharmaceutical Form |
|---|
|
Tablet. White, round, biconvex tablets of 8.5 mm diameter, engraved with ‘C’ on one side and ‘10’ on the other side. |
Each tablet contains 10 mg of cladribine.
Excipients with known effect: Each tablet contains 64 mg sorbitol.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Cladribine |
Cladribine is a nucleoside analogue of deoxyadenosine. In resting cells cladribine causes DNA single-strand breaks, rapid nicotinamide adenine dinucleotide consumption, ATP depletion and cell death. |
| List of Excipients |
|---|
|
Hydroxypropylbetadex (2-hydroxypropyl-ß-cyclodextrin) |
Oriented polyamide (OPA)/aluminium (Al)/polyvinyl chloride (PVC) – aluminium (Al) blister sealed in a cardboard wallet and fixed in a child-resistant outer carton.
Pack sizes of 1, 4, 5, 6, 7 or 8 tablets.
Not all pack sizes may be marketed.
Merck Europe B.V., Gustav Mahlerplein 102, 1082 MA Amsterdam, The Netherlands
EU/1/17/1212/001
EU/1/17/1212/002
EU/1/17/1212/003
EU/1/17/1212/004
EU/1/17/1212/005
EU/1/17/1212/006
Date of first authorisation: 22 August 2017
| Drug | Countries | |
|---|---|---|
| MAVENCLAD | Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, United States |
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