Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Amgen Europe B.V., Minervum 7061, 4817 ZK Breda, The Netherlands
Repatha 140 mg solution for injection in pre-filled syringe.
Repatha 140 mg solution for injection in pre-filled pen.
Repatha 420 mg solution for injection in cartridge.
| Pharmaceutical Form |
|---|
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Solution for injection (injection). Solution for injection (injection) (SureClick). Solution for injection (injection) (automated mini-doser). The solution is clear to opalescent, colourless to yellowish, and practically free from particles. |
Repatha 140 mg solution for injection in pre-filled syringe: Each pre-filled syringe contains 140 mg of evolocumab in 1 mL of solution.
Repatha 140 mg solution for injection in pre-filled pen: Each pre-filled pen contains 140 mg of evolocumab in 1 mL of solution.
Repatha 420 mg solution for injection in cartridge: Each cartridge contains 420 mg of evolocumab in 3.5 mL of solution (120 mg/mL).
Repatha is a human IgG2 monoclonal antibody produced using recombinant DNA technology in Chinese hamster ovary (CHO) cells.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Evolocumab |
Evolocumab binds selectively to PCSK9 and prevents circulating PCSK9 from binding to the low density lipoprotein receptor (LDLR) on the liver cell surface, thus preventing PCSK9-mediated LDLR degradation. Increasing liver LDLR levels results in associated reductions in serum LDL-cholesterol (LDL-C). |
| List of Excipients |
|---|
|
Proline |
One mL solution in a single use pre-filled syringe made from type I glass with stainless steel 27 gauge needle.
The needle cover of the pre-filled syringe is made from dry natural rubber (a derivative of latex, see section 4.4).
Pack size of one pre-filled syringe.
One mL solution in a single use pre-filled pen made from type I glass with stainless steel 27 gauge needle.
The needle cover of the pre-filled pen is made from dry natural rubber (a derivative of latex, see section 4.4).
Pack sizes of one, two, three or multipack of six (3x2) pre-filled pens.
A 3.5 mL solution in a single use cartridge made from cyclic olefin polymer with elastomer septum and piston as product-contact materials, and a resin cap. The pre-filled cartridge is assembled with a telescopic screw device component. The cartridge assembly is co-packed with an administration device. The fluid path within the administration device is made from stainless steel and non-DEHP polyvinyl chloride, with a stainless steel 29 gauge needle. The administration device contains silver oxide-zinc batteries and includes an adhesive patch made from polyester tape with an acrylate adhesive. The administration device is designed for use only with the provided 3.5 mL pre-filled cartridge assembly.
Pack sizes of one cartridge/automated mini-doser or multipack of three (3x1) cartridges/automated mini-dosers.
Not all pack sizes may be marketed.
Amgen Europe B.V., Minervum 7061, 4817 ZK Breda, The Netherlands
Repatha 140 mg solution for injection in pre-filled syringe:
EU/1/15/1016/001 – 1 pre-filled syringe
Repatha 140 mg solution for injection in pre-filled pen:
EU/1/15/1016/002 – 1 pre-filled pen
EU/1/15/1016/003 – 2 pre-filled pens
EU/1/15/1016/004 – 3 pre-filled pens
EU/1/15/1016/005 – 6 (3x2) pre-filled pens (multipack)
Repatha 420 mg solution for injection in cartridge:
EU/1/15/1016/006 – 1 cartridge with co-packed automated mini-doser
EU/1/15/1016/007 – 3 (3x1) cartridges with co-packed automated mini-dosers (multipack)
Date of first authorisation: 17 July 2015
| Drug | Countries | |
|---|---|---|
| REPATHA | Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, United States |
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