EMEA-001425-PIP01-13-M04

Key facts

Invented name
Cotellic
Active substance
Cobimetinib
Therapeutic area
Oncology
Decision number
P/0306/2019
PIP number
EMEA-001425-PIP01-13-M04
Pharmaceutical form(s)
  • Film-coated tablet
  • Age-appropriate oral formulation
Condition(s) / indication(s)
Treatment of all conditions included in the category of malignant neoplasms (except haematopoietic and lymphoid tissue) with Ras, Raf or MEK pathway activation
Route(s) of administration
Oral use
Contact for public enquiries
Roche Registration Limited

E-mail: global.paediatrics@roche.com
Tel.: +41 616879411

Decision type
PM: decision on the application for modification of an agreed PIP

Decision

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