TRECONDI Powder for solution for infusion Ref.[9055] Active ingredients: Treosulfan

Source: European Medicines Agency (EU)  Revision Year: 2020  Publisher: medac, Gesellschaft für klinische Spezialpräparate mbH, Theaterstr. 6, 22880, Wedel, Germany

Product name and form

Trecondi 1 g powder for solution for infusion.

Trecondi 5 g powder for solution for infusion.

Pharmaceutical Form

Powder for solution for infusion.

White crystalline powder.

Qualitative and quantitative composition

Trecondi 1 g powder for solution for infusion: One vial contains 1 g of treosulfan.

Trecondi 5 g powder for solution for infusion: One vial contains 5 g of treosulfan.

When reconstituted according to section 6.6, 1 mL of the solution for infusion contains 50 mg treosulfan.

Active Ingredient Description
Treosulfan

Treosulfan is a prodrug of a bifunctional alkylating agent with cytotoxic activity to haematopoietic precursor cells. The activity of treosulfan is due to the spontaneous conversion into a mono-epoxide intermediate and L-diepoxybutan. Treosulfan has a broad antineoplastic and antileukaemic activity.

List of Excipients

None.

Pack sizes and marketing

Trecondi 1 g powder for solution for infusion: Colourless type III glass vial, with rubber stopper and aluminium cap containing 1 g of treosulfan.

Trecondi 5 g powder for solution for infusion: Colourless type III glass vial, with rubber stopper and aluminium cap containing 5 g of treosulfan.

Trecondi is available in packs of 1 or 5 vials.

Not all pack sizes may be marketed.

Marketing authorization holder

medac, Gesellschaft für klinische Spezialpräparate mbH, Theaterstr. 6, 22880, Wedel, Germany

Marketing authorization dates and numbers

EU/1/18/1351/001 (1 g, 1 vial)
EU/1/18/1351/002 (1 g, 5 vials)
EU/1/18/1351/003 (5 g, 1 vial)
EU/1/18/1351/004 (5 g, 5 vials)

Date of first authorisation: 20 June 2019

Drugs

Drug Countries
TRECONDI Austria, Estonia, Finland, France, Ireland, Lithuania, Netherlands, Poland, United Kingdom

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