Key facts

Invented name
  • Glivec
  • Glivec
Active Substance
imatinib mesilate
Therapeutic area
Cardiovascular diseases
Decision number
P/85/2011
PIP number
EMEA-000463-PIP02-10
Pharmaceutical form(s)
  • Film-coated tablet
  • Capsule (hard)
  • Age-appropriate oral solid dosage form
Condition(s) / indication(s)
Treatment of pulmonary arterial hypertension
Route(s) of administration
Oral use
Contact for public enquiries

Novartis Europharm Limited

 

paediatric.enquiries@novartis.com
Phone: +41 61 324 1111
Fax: +41 61 324 8001

 

Decision type
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Decision date

Decision

P/85/2011: EMA decision of 8 April 2011 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for imatinib (mesilate) (Glivec) (EMEA-000463-PIP02-10)

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