COSMEGEN Lyophilised powder for solution for injection Ref.[8698] Active ingredients: Dactinomycin

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Recordati Rare Diseases, Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92800 Puteaux, France

Product name and form

COSMEGEN LYOVAC 500 micrograms powder for solution for injection.

Pharmaceutical Form

Lyophilised powder for solution for injection.

Qualitative and quantitative composition

Cosmegen Lyovac is supplied as a yellow-orange, lyophilised powder, in a vial containing 500 micrograms dactinomycin with 20 mg mannitol E421.

Active Ingredient Description
Dactinomycin

Dactinomycin is an antineoplastic antibiotic derived from Streptomyces parvullus. Stable complexes are formed with DNA through intercalation and DNA-dependent RNA synthesis is selectively inhibited. Protein and DNA synthesis are inhibited to a lesser extent.

List of Excipients

Mannitol E421

Pack sizes and marketing

Glass vials containing 500 micrograms dactinomycin with 20 mg mannitol.

Marketing authorization holder

Recordati Rare Diseases, Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92800 Puteaux, France

Marketing authorization dates and numbers

PL 15266/0018

Date of grant at last renewal: 12 July 2006

Drugs

Drug Countries
COSMEGEN Canada, Estonia, France, Japan, Malta, New Zealand, Romania, United Kingdom, United States

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