Source: European Medicines Agency (EU) Revision Year: 2018 Publisher: Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
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. |
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) |
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.
Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
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
| Drug | Countries | |
|---|---|---|
| HYCAMTIN | Austria, Australia, Brazil, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Japan, Lithuania, Netherlands, Poland, Romania, Singapore, Turkey, United Kingdom, United States, South Africa |
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