HYCAMTIN Powder for concentrate for solution for infusion Ref.[8585] Active ingredients: Topotecan

Source: European Medicines Agency (EU)  Revision Year: 2018  Publisher: Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

Product name and form

HYCAMTIN 1 mg powder for concentrate for solution for infusion.

HYCAMTIN 4 mg powder for concentrate for solution for infusion.

Pharmaceutical Form

Powder for concentrate for solution for infusion.

Light yellow to greenish powder.

Qualitative and quantitative composition

HYCAMTIN 1 mg powder for concentrate for solution for infusion:

Each vial contains 1 mg topotecan (as hydrochloride).

The total content of active substance in the vial provides 1 mg per ml of active substance when reconstituted as recommended.

HYCAMTIN 4 mg powder for concentrate for solution for infusion:

Each vial contains 4 mg topotecan (as hydrochloride).

The total content of active substance in the vial provides 1 mg per ml of active substance when reconstituted as recommended.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Topotecan

Topotecan involves the inhibition of topoisomerase-I, an enzyme intimately involved in DNA replication.

List of Excipients

Tartaric acid (E334)
Mannitol (E421)
Hydrochloric acid (E507)
Sodium hydroxide

Pack sizes and marketing

HYCAMTIN 1 mg powder for concentrate for solution for infusion:

Type I flint glass vial with grey butyl rubber stopper and aluminium seal with plastic flip-off cap containing 1 mg of topotecan.

HYCAMTIN 1 mg is available in packs containing 1 vial and 5 vials.

HYCAMTIN 4 mg powder for concentrate for solution for infusion:

Type I flint glass vial, with grey butyl rubber stopper and aluminium seal with plastic flip-off cap containing 4 mg of topotecan.

HYCAMTIN 4 mg is available in packs containing 1 vial and 5 vials.

Not all pack sizes may be marketed.

Marketing authorization holder

Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

Marketing authorization dates and numbers

HYCAMTIN 1 mg powder for concentrate for solution for infusion:

EU/1/96/027/004
EU/1/96/027/005

HYCAMTIN 4 mg powder for concentrate for solution for infusion:

EU/1/96/027/001
EU/1/96/027/003

Date of first authorisation: 12 November 1996
Date of latest renewal: 20 November 2006

Drugs

Drug Countries
HYCAMTIN Austria, Australia, Brazil, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Ireland, Israel, Japan, Lithuania, Netherlands, Poland, Romania, Singapore, Turkey, United Kingdom, United States, South Africa

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