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Etanercept

Enbrel®

   
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Concentration
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08000293
25 mg/ml
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08000399
50 mg/ml
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08000399
50 mg/ml
Note: For full product details, please login.
08000399
50 mg/ml
Note: For full product details, please login.
08000399
50 mg/ml
Note: For full product details, please login.
08000399
50 mg/ml
Note: For full product details, please login.
08000293
25 mg/ml
Note: For full product details, please login.

Drug name: Enbrel ®

INN: Etanercept

API type: 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. Etanercept is a dimer of a chimeric protein genetically engineered by fusing the extracellular ligand binding domain of human tumour necrosis factor receptor-2 (TNFR2/p75) to the Fc domain of human IgG1. This Fc component contains the hinge, CH2and CH3regions, but not the CH1region of IgG1. Etanercept contains 934amino acids and has an apparent molecular weight of approximately 150 kilodaltons. The specific activity of etanercept is 1.7x 106units/mg.

Pharmacotherapeutic group: Immunosuppressants, Tumour Necrosis Factor alpha (TNF-α) inhibitors

ATC code: L04AB01

General function:

Short description:

Original license holder:

Marketing authorisation numbers: EU/1/99/126/001 - 022

Marketing authorisation holder: Pfizer Limited; Ramsgate Road; Sandwich; Kent CT13 9NJ; United Kingdom

Name of the manufacturer of the biological active substance: Boehringer Ingelheim Pharma KG; Birkendorfer Strasse 65; D-88397 Biberach an der Riss; Germany

Name and address of the manufacturer responsible for batch release: Wyeth Pharmaceuticals; New Lane Havant; Hampshire, PO9 2NG; United Kingdom

Max shelf life: 48 months

Storage conditions: 2°C – 8°C

List of excipients: Powder: Mannitol (E421) Sucrose, Trometamol
Solvent: Water for injections