Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands
KEYTRUDA 50 mg powder for concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
|
Powder for concentrate for solution for infusion. White to off-white lyophilised powder. |
One vial of powder contains 50 mg of pembrolizumab.
After reconstitution, 1 mL of concentrate contains 25 mg of pembrolizumab.
Pembrolizumab is a humanised monoclonal anti-programmed cell death-1 (PD-1) antibody (IgG4/kappa isotype with a stabilising sequence alteration in the Fc region) produced in Chinese hamster ovary cells by recombinant DNA technology.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Pembrolizumab |
Pembrolizumab is a humanised monoclonal antibody which binds to the programmed cell death-1 (PD-1) receptor and blocks its interaction with ligands PD-L1 and PD-L2. The PD-1 receptor is a negative regulator of T-cell activity that has been shown to be involved in the control of T-cell immune responses. |
| List of Excipients |
|---|
|
L-histidine |
15 mL Type I glass vial, with a grey bromobutyl stopper and an aluminium seal with an avocado coloured flip-off cap, containing 50 mg pembrolizumab.
Each carton contains one vial.
Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands
EU/1/15/1024/001
Date of first authorisation: 17 July 2015
| Drug | Countries | |
|---|---|---|
| KEYTRUDA | 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, South Africa |
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