Key facts

Invented name
  • Exjade
  • 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
Decision date
Compliance procedure number
EMEA-C-001103-PIP01-10-M03
Compliance opinion date
Compliance outcome
Positive

Decision

P/0175/2016: EMA decision of 30 June 2016 on the acceptance of a modification of an agreed paediatric investigation plan for deferasirox (Exjade), (EMEA-001103-PIP01-10-M03)

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