Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Laboratoires Delbert, 49 Rue Rouelle, 75015 Paris, France
Ceplene 0.5 mg/0.5 mL solution for injection.
| Pharmaceutical Form |
|---|
|
Solution for injection. Clear, colourless aqueous solution. |
One vial of 0.5 mL of solution contains 0.5 mg of histamine dihydrochloride.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Histamine |
Histamine/IL-2 is an immunotherapy which aims to induce immune-mediated destruction of residual myeloid leukaemic cells and thereby to prevent relapse of leukaemia. The role of histamine is to protect lymphocytes, in particular NK cells and T cells, which are responsible for the immune-mediated destruction of residual leukaemic cells. |
| List of Excipients |
|---|
|
Sodium chloride |
2 mL type I glass vial, with bromobutyl rubber stopper and flip-off aluminium over seal, containing 0.5 mL of solution (0.70 mL including overfill).
Each carton contains 14 vials.
Laboratoires Delbert, 49 Rue Rouelle, 75015 Paris, France
EU/1/08/477/001
Date of first authorisation: 07/10/2008
Date of latest renewal: 26/07/2018
| Drug | Countries | |
|---|---|---|
| CEPLENE | Austria, Estonia, Croatia, Ireland, Lithuania, Poland, Romania |
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