Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP Amsterdam, The Netherlands
Thyrogen 0.9 mg powder for solution for injection.
| Pharmaceutical Form |
|---|
|
Powder for solution for injection. White to off-white lyophilised powder. |
Each vial of Thyrogen contains a nominal value of 0.9 mg thyrotropin alfa. Following reconstitution, each vial of Thyrogen contains 0.9 mg of thyrotropin alfa in 1.0 ml.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Thyrotropin |
Thyrotropin alfa (recombinant human thyroid stimulating hormone) is a heterodimeric glycoprotein produced by recombinant DNA technology. Binding of thyrotropin alfa to TSH receptors on thyroid epithelial cells stimulates iodine uptake and organification, and synthesis and release of thyroglobulin, triiodothyronine (T3) and thyroxine (T4). |
| List of Excipients |
|---|
|
Mannitol |
Clear Type I glass 5 ml vials. The closure consists of a siliconised butyl stopper with a tamper proof flip-off cap. Each vial contains 1.1 mg thyrotropin alfa. After reconstitution with 1.2 ml water for injection, 1.0 ml of solution (equal to 0.9 mg Thyrogen) is withdrawn and administered to the patient.
To provide sufficient volume to allow accurate dispensing, each vial of Thyrogen is formulated to contain an overfill of 0.2 ml.
Package size: one or two vials per carton.
Not all pack sizes may be marketed.
Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP Amsterdam, The Netherlands
EU/1/99/122/001
EU/1/99/122/002
Date of first authorisation: 9 March 2000
Date of last renewal: 9 March 2010
| Drug | Countries | |
|---|---|---|
| THYROGEN | Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Poland, Romania, Singapore, Turkey, United Kingdom, United States, South Africa |
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