EMEA-000290-PIP01-08-M04

Key facts

Invented name
Tasigna
Active substance
nilotinib
Therapeutic area
Oncology
Decision number
P/0297/2015
PIP number
EMEA-000290-PIP01-08-M04
Pharmaceutical form(s)
  • Capsule
  • hard
Condition(s) / indication(s)
Treatment of chronic myeloid leukaemia
Route(s) of administration
Oral use
Contact for public enquiries
Novartis Europharm Limited
Switzerland
Tel. +41 3241111
Fax +41 3248001
E-mail: paediatric.enquiries@novartis.com
Decision type
PM: decision on the application for modification of an agreed PIP
Compliance procedure number
EMEA-C-000290-PIP01-08-M04
Compliance opinion date
11/11/2016
Compliance outcome
positive

Decision

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