Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Lipomed GmbH, Hegenheimer Strasse 2, D-79576, Weil/Rhein, Germany
LITAK 2 mg/ml solution for injection.
| Pharmaceutical Form |
|---|
|
Solution for injection. Clear, colourless solution. |
Each ml of solution contains 2 mg of cladribine (2-CdA). Each vial contains 10 mg of cladribine in 5 ml of solution.
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 |
|---|
|
Sodium chloride |
10 ml type I glass vial with rubber stopper (bromobutyl) and flip-off aluminium cap.
Packs contain 1 or 5 vials, each with 5 ml of solution. Not all pack-sizes may be marketed.
Lipomed GmbH, Hegenheimer Strasse 2, D-79576, Weil/Rhein, Germany
EU/1/04/275/001
EU/1/04/275/002
Date of first authorisation: 14/04/2004
Date of last renewal: 27/03/2009
| Drug | Countries | |
|---|---|---|
| LITAK | Austria, Australia, Cyprus, Ecuador, Estonia, Spain, Finland, France, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, Poland, Romania, Tunisia, United Kingdom, South Africa |
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