Key facts

Invented name
Mekinist
Active Substance
Trametinib (dimethyl sulfoxide)
Therapeutic area
Oncology
Decision number
P/0392/2020
PIP number
EMEA-001177-PIP01-11-M06
Pharmaceutical form(s)
  • Film-coated tablet
  • Powder for oral solution
Condition(s) / indication(s)
  • Treatment of all conditions included in the category of malignant neoplasms (except melanoma, haematopoietic and lymphoid tissue, and glioma)
  • Treatment of melanoma
Route(s) of administration
Oral use
Contact for public enquiries

Novartis Europharm Limited

Tel. +41 6132 41111
E-mail: paediatric.enquiries@novartis.com

Decision type
PM: decision on the application for modification of an agreed PIP
Decision date
Compliance procedure number
EMEA-C-001177-PIP01-11-M06
Compliance opinion date
Compliance outcome
Positive

Decision

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