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Pembrolizumab

Keytruda®

   
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Concentration
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08000169
25 mg/ml
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08000169
25 mg/ml
Note: For full product details, please login.
08000169
25 mg/ml
Note: For full product details, please login.
08000169
25 mg/ml
Note: For full product details, please login.

Drug name: Keytruda®

INN: Pembrolizumab

API type: 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.

Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies

ATC code: L01XC18

General function:

Short description:

Original license holder:

Marketing authorisation numbers: EU/1/15/1024/001 - 002

Marketing authorisation holder: Merck Sharp & Dohme Limited; Hertford Road; Hoddesdon; Hertfordshire EN11 9BU; United Kingdom

Name of the manufacturer of the biological active substance: MedImmune, LL; C Frederick Manufacturing; Center (FMC); 633/636/660 Research Court Frederick; MD 21703-8619, USA

Name and address of the manufacturer responsible for batch release: Schering-Plough Labo NV; Industriepark 30, Heist-op-den-Berg; B-2220; Belgium

Max shelf life: 24 months

Storage conditions: 2°C – 8°C

List of excipients: L-histidine, L-histidine hydrochloride monohydrate, Sucrose, Polysorbate 80