Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Shire Pharmaceuticals Ireland Limited, Block 2 & 3 Miesian Plaza, 50 – 58 Baggot Street Lower, Dublin 2, D02 Y754, Ireland
Firazyr 30 mg solution for injection in pre-filled syringe.
| Pharmaceutical Form |
|---|
|
Solution for injection. The solution is a clear and colourless liquid. |
Each pre-filled syringe of 3 ml contains icatibant acetate equivalent to 30 mg icatibant.
Each ml of the solution contains 10 mg of icatibant.
Excipient(s) with known effect: For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Icatibant |
Icatibant is a selective competitive antagonist at the bradykinin type 2 (B2) receptor. It is a synthetic decapeptide with a structure similar to bradykinin, but with 5 non-proteinogenic amino acids. In HAE increased bradykinin concentrations are the key mediator in the development of the clinical symptoms. |
| List of Excipients |
|---|
|
Sodium chloride |
3 ml of solution in a 3 ml pre-filled syringe (type I glass) with plunger stopper (bromobutyl coated with fluorocarbon polymer). A hypodermic needle (25 G; 16 mm) is included in the pack.
Pack size of one pre-filled syringe with one needle or a multipack containing three pre-filled syringes with three needles.
Not all pack sizes may be marketed.
Shire Pharmaceuticals Ireland Limited, Block 2 & 3 Miesian Plaza, 50 – 58 Baggot Street Lower, Dublin 2, D02 Y754, Ireland
EU/1/08/461/001
EU/1/08/461/002
Date of first authorisation: 11 July 2008
Date of latest renewal: 13 March 2013
| Drug | Countries | |
|---|---|---|
| FIRAZYR | Austria, Brazil, Canada, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, United Kingdom, United States |
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