EMEA-001147-PIP01-11-M06

Key facts

Invented name
Tafinlar
Active substance
Dabrafenib (mesilate)
Therapeutic area
Oncology
Decision number
P/0065/2019
PIP number
EMEA-001147-PIP01-11-M06
Pharmaceutical form(s)
  • Capsule, hard
  • Dispersible tablet
Condition(s) / indication(s)
  • Treatment of melanoma
  • Treatment of solid malignant tumours (excluding 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

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