Source: European Medicines Agency (EU) Revision Year: 2024 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 |
|---|
|
Solution for injection (injection). Solution for injection (injection) in pre-filled pen (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 in Chinese hamster ovary (CHO) cells by recombinant DNA technology.
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 |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
