Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: YES Pharmaceutical Development Services GmbH, Bahnstraรe 42-46, 61381 Friedrichsdorf, Germany
Celdoxome pegylated liposomal 2 mg/mL concentrate for dispersion for infusion.
| Pharmaceutical Form |
|---|
|
Concentrate for dispersion for infusion (sterile concentrate). A translucent red suspension with pH 6.5. |
Each mL concentrate for dispersion for infusion contains 2 mg doxorubicin hydrochloride in a pegylated liposomal formulation.
Celdoxome pegylated liposomal concentrate for dispersion for infusion, a liposome formulation, is doxorubicin hydrochloride encapsulated in liposomes with surface-bound methoxypolyethylene glycol (MPEG). This process is known as pegylation and protects liposomes from detection by the mononuclear phagocyte system (MPS), which increases blood circulation time.
Excipients with known effect: Each mL concentrate for dispersion for infusion contains 9.6 mg fully hydrogenated soy phosphatidylcholine (from soybean) (see section 4.3).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Doxorubicin |
Doxorubicin is a cytotoxic anthracycline antibiotic obtained from Streptomyces peucetius var. caesius. The exact mechanism of the antitumour activity of doxorubicin is not known. It is generally believed that inhibition of DNA, RNA and protein synthesis is responsible for the majority of the cytotoxic effects. |
| List of Excipients |
|---|
|
N-(carbonyl-methoxypolyethylene glycol 2000)-1,2-distearoyl-sn-glycero-3 phosphoethanolamine sodium salt (MPEG-DSPE) |
Type I glass vial with a bromobutyl rubber stopper and aluminium and PP flip-off cap containing a volume of 10 mL (20 mg) or 25 mL (50 mg).
Pack size:
1 vial
10 vials
Not all pack sizes may be marketed.
YES Pharmaceutical Development Services GmbH, Bahnstraรe 42-46, 61381 Friedrichsdorf, Germany
EU/1/22/1666/001
EU/1/22/1666/002
EU/1/22/1666/003
EU/1/22/1666/004
| Drug | Countries | |
|---|---|---|
| CELDOXOME PEGYLATED LIPOSOMAL | Austria, Estonia, Croatia, Ireland, Italy, Lithuania |
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