Source: European Medicines Agency (EU) Revision Year: 2026 Publisher: Pharma Mar, S.A., Avda. de los Reyes 1, Polígono Industrial La Mina, 28770 Colmenar Viejo (Madrid), Spain, Tel: +34 91 846 60 00, Fax: +34 91 846 60 01
ZEPZELCA 2 mg powder for concentrate for solution for infusion.
ZEPZELCA 4 mg powder for concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
|
Powder for concentrate for solution for infusion (powder for concentrate). White to off-white powder. |
ZEPZELCA 2 mg powder for concentrate for solution for infusion: Each vial of powder contains 2 mg of lurbinectedin.
ZEPZELCA 4 mg powder for concentrate for solution for infusion: Each vial of powder contains 4 mg of lurbinectedin.
One mL of reconstituted solution contains 0.5 mg of lurbinectedin.
For the full list of excipients, see section 6.1.
| Active Ingredient |
|---|
|
Lurbinectedin inhibits the oncogenic transcription process through (i) its binding to CG-rich sequences of DNA, located within promoters of protein-coding genes; (ii) the eviction of oncogenic transcription factors from their binding sites; and (iii) the stalling of elongating RNA polymerase II and its specific degradation by the ubiquitin/proteasome machinery with all these processes leading to subsequent cell cycle arrest and tumour cell apoptosis. |
| List of Excipients |
|---|
|
Sucrose |
ZEPZELCA 2 mg powder for concentrate for solution for infusion:
20 mL vial (clear type 1 glass) with a stopper (butyl rubber) and white coloured overseal (aluminium), containing 2 mg lurbinectedin.
Pack size of 1 vial.
ZEPZELCA 4 mg powder for concentrate for solution for infusion:
30 mL vial (clear type 1 glass) with a stopper (butyl rubber) and blue coloured overseal (aluminium), containing 4 mg lurbinectedin.
Pack size of 1 vial.
Pharma Mar, S.A., Avda. de los Reyes 1, Polígono Industrial La Mina, 28770 Colmenar Viejo (Madrid), Spain, Tel: +34 91 846 60 00, Fax: +34 91 846 60 01
EU/1/26/2032/001
EU/1/26/2032/002
| Drug | Countries | |
|---|---|---|
| ZEPZELCA | Ecuador, Israel, Lithuania, United States |
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