CAELYX Concentrate for solution for infusion Ref.[7918] Active ingredients: Doxorubicin

Source: European Medicines Agency (EU)  Revision Year: 2019  Publisher: Janssen-Cilag International NV, Turnhoutseweg 30, B-2340, Beerse, Belgium

Product name and form

Caelyx 2 mg/ml concentrate for solution for infusion.

Pharmaceutical Form

Concentrate for solution for infusion.

The suspension is sterile, translucent and red.

Qualitative and quantitative composition

One ml of Caelyx contains 2 mg doxorubicin hydrochloride in a pegylated liposomal formulation.

Caelyx, 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:

Contains fully hydrogenated soy phosphatidylcholine (from soyabean) - see section 4.3.

Contains less than 1 mmol sodium (23 mg) per dose, and is essentially ‘sodium-free’.

For the full list of excipients, see section 6.1.

Active Ingredient Description

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

α-(2-[1,2-distearoyl-sn-glycero(3)phosphooxy]ethylcarbamoyl)--methoxypoly(oxyethylen)-40 sodium salt (MPEG-DSPE)
Fully hydrogenated soy phosphatidylcholine (HSPC)
Ammonium sulphate
Water for injections
Hydrochloric acid (for pH-adjustment)
Sodium hydroxide (for pH-adjustment)

Pack sizes and marketing

Type I glass vials, each with a siliconised grey bromobutyl stopper, and an aluminium seal, with a deliverable volume of 10 ml (20 mg) or 25 ml (50 mg).

Caelyx is supplied as a single pack or packs of ten vials.

Not all pack sizes may be marketed.

Marketing authorization holder

Janssen-Cilag International NV, Turnhoutseweg 30, B-2340, Beerse, Belgium

Marketing authorization dates and numbers


Date of first authorisation: 21 June 1996
Date of lastest renewal: 19 May 2006


Drug Countries
CAELYX Austria, Australia, Brazil, Canada, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Lithuania, Nigeria, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, South Africa

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.