EMEA-001425-PIP01-13-M03

Key facts

Invented name
Cotellic
Active substance
Cobimetinib
Therapeutic area
Oncology
Decision number
P/0216/2018
PIP number
EMEA-001425-PIP01-13-M03
Pharmaceutical form(s)
Film-coated tablet
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
  • Age-appropriate oral formulation
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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