Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium
Enbrel 25 mg powder for solution for injection.
| Pharmaceutical Form |
|---|
|
Powder for solution for injection (powder for injection). The powder is white. |
Each vial contains 25 mg of etanercept.
Etanercept is a human tumour necrosis factor receptor p75 Fc fusion protein produced by recombinant DNA technology in a Chinese hamster ovary (CHO) mammalian expression system.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Etanercept |
Etanercept is a competitive inhibitor of TNF binding to its cell surface receptors, and thereby inhibits the biological activity of TNF. The mechanism of action of etanercept is thought to be its competitive inhibition of TNF binding to cell surface TNFR, preventing TNF-mediated cellular responses by rendering TNF biologically inactive. |
| List of Excipients |
|---|
|
Powder: Mannitol (E421) |
Clear glass vial (2 ml, type I glass) with rubber stoppers, aluminium seals, and flip-off plastic caps.
Cartons contain 4 vials of Enbrel with 8 alcohol swabs.
Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium
EU/1/99/126/002
Date of first authorisation: 03 February 2000
Date of last renewal: 26 November 2009
| Drug | Countries | |
|---|---|---|
| ENBREL | Albania, Austria, Australia, Brazil, Canada, Cyprus, Germany, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa |
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