BEROMUN Powder for solution for infusion Ref.[9704] Active ingredients: Tasonermin

Source: European Medicines Agency (EU)  Revision Year: 2020  Publisher: BELPHARMA s.a., 2, Rue Albert 1er, L-1117, Luxembourg, Grand Duchy of Luxembourg

Product name and form

Beromun 1 mg powder for solution for infusion.

Pharmaceutical Form

Powder for solution for infusion (powder for infusion).

The powder is white to off-white.

Qualitative and quantitative composition

Each vial contains 1 mg tasonermin*, corresponding to 3.0-6.0 × 107 IU (International Units).

* tumor necrosis factor alfa-1a (TNFα-1a) produced by recombinant DNA technology in E. coli.

Excipient(s) with known effect: Each vial contains 20.12 mg (0.87 mmol) sodium. After reconstitution in 0.9% physiological sodium chloride solution the amount is 37.82 mg (1.64 mmol) sodium.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Tasonermin

Tasonermin is cytotoxic or cytostatic in vitro for a variety of tumour cell lines of different histogenesis. Tasonermin affects the morphology and reduces proliferation of endothelial cells. Also, it has profound effects on cellular components of the immune system.
List of Excipients

Sodium dihydrogen phosphate dihydrate
Disodium phosphate dodecahydrate
Human serum albumin

Pack sizes and marketing

Powder vial: Type I glass vial with chlorobutyl rubber stopper and sealed with aluminium flip-off cap.

Each pack contains 4 vials.

Marketing authorization holder

BELPHARMA s.a., 2, Rue Albert 1er, L-1117, Luxembourg, Grand Duchy of Luxembourg

Marketing authorization dates and numbers

EU/1/99/097/001

Date of first authorisation: 13 April 1999
Date of latest renewal: 13 April 2009

Drugs

Drug Countries
BEROMUN Austria, Estonia, Spain, Finland, France, Croatia, Ireland, Lithuania, Poland, United Kingdom
 
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