Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands
Cyramza 10 mg/ml concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
|
Concentrate for solution for infusion (sterile concentrate). The concentrate is a clear to slightly opalescent and colourless to slightly yellow solution, pH 6.0. |
One ml of concentrate for solution for infusion contains 10 mg ramucirumab.
Each 10 ml vial contains 100 mg of ramucirumab.
Each 50 ml vial contains 500 mg of ramucirumab.
Ramucirumab is a human IgG1 monoclonal antibody produced in murine (NS0) cells by recombinant DNA technology.
Excipient with known effect:
Each 10 ml vial contains approximately 17 mg sodium.
Each 50 ml vial contains approximately 85 mg sodium.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Ramucirumab |
Ramucirumab is a human receptor-targeted antibody that specifically binds VEGF Receptor 2 and blocks binding of VEGF-A, VEGF-C, and VEGF-D. Vascular Endothelial Growth Factor (VEGF) Receptor 2 is the key mediator of VEGF induced angiogenesis. As a result, ramucirumab inhibits ligand stimulated activation of VEGF Receptor 2 and its downstream signalling components, including p44/p42 mitogen-activated protein kinases, neutralising ligand-induced proliferation and migration of human endothelial cells. |
| List of Excipients |
|---|
|
Histidine |
10 ml solution in a vial (Type I glass) with a chlorobutyl rubber stopper, an aluminium seal and a polypropylene cap.
50 ml solution in a vial (Type I glass) with a chlorobutyl rubber stopper, an aluminium seal and a polypropylene cap.
Pack of 1 vial of 10 ml.
Pack of 2 vials of 10 ml.
Pack of 1 vial of 50 ml.
Not all pack sizes may be marketed.
Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands
EU/1/14/957/001-003
Date of first authorisation: 19 December 2014
Date of latest renewal: 26 September 2019
| Drug | Countries | |
|---|---|---|
| CYRAMZA | Austria, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, United States |
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