EMEA-001425-PIP01-13-M05

Table of contents

Key facts

Invented name
Cotellic
Active substance
Cobimetinib
Therapeutic area
Oncology
Decision number
P/0119/2021
PIP number
EMEA-001425-PIP01-13-M05
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 GmbH

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

Decision type
PM: decision on the application for modification of an agreed PIP
Compliance procedure number
EMEA-C-001425-PIP01-13-M05
Compliance opinion date
25/06/2021
Compliance outcome
positive

Decision

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