EMEA-001103-PIP01-10-M03

Key facts

Invented name
Exjade
Active substance
deferasirox
Therapeutic area
Haematology-Hemostaseology
Decision number
P/0175/2016
PIP number
EMEA-001103-PIP01-10-M03
Pharmaceutical form(s)
  • Dispersible tablet
  • Film-coated tablet
  • Granules
Condition(s) / indication(s)
Treatment of chronic iron overload requiring chelation therapy
Route(s) of administration
Oral use
Contact for public enquiries
Novartis Europharm Limited
Switzerland
Tel. +41 61 3241111
Fax +41 61 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-001103-PIP01-10-M03
Compliance opinion date
14/10/2016
Compliance outcome
positive

Decision

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