EMEA-001474-PIP01-13-M01

Key facts

Invented name
Keytruda
Active substance
Anti-PD1 humanized monoclonal antibody of the IgG4/kappa class (MK-3475) (pembrolizumab)
Therapeutic area
Oncology
Decision number
P/0043/2018
PIP number
EMEA-001474-PIP01-13-M01
Pharmaceutical form(s)
  • Powder for concentrate for solution for infusion
  • Concentrate for solution for infusion
Condition(s) / indication(s)
Treatment of all conditions included in the category of malignant neoplasms (except nervous system, haematopoietic and lymphoid tissue)
Route(s) of administration
Intravenous use
Contact for public enquiries
Merck Sharp & Dohme (Europe), Inc 
Tel. +33 1804 64738
E-mail: pip.information@merck.com
Decision type
PM: decision on the application for modification of an agreed PIP

Decision

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