EMEA-002619-PIP01-19 - paediatric investigation plan

3-(((1S,2S,3R)-2,3-difluoro-1-hydroxy-7-(methylsulfonyl)-2,3-dihydro-1H-inden-4-yl)oxy)-5- fluorobenzonitrile

Key facts

• Active Substance:
  3-(((1S,2S,3R)-2,3-difluoro-1-hydroxy-7-(methylsulfonyl)-2,3-dihydro-1H-inden-4-yl)oxy)-5- fluorobenzonitrile
• Therapeutic area:
  Oncology
• Decision number:
  P/0154/2020
• PIP number:
  EMEA-002619-PIP01-19
• Pharmaceutical form(s):
  Tablet
• Condition(s) / indication(s):
  Treatment of renal neoplasms
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Merck, Sharp & Dohme (Europe) Inc.

  Tel. [phone]; E-mail: [e-mail]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  17/04/2020

Decision

P/0154/2020: EMA decision of 17 April 2020 on the granting of a product specific waiver for 3-(((1S,2S,3R)-2,3-difluoro-1-hydroxy-7- (methylsulfonyl)-2,3-dihydro-1H-inden-4-yl)oxy)-5-fluorobenzonitrile (EMEA-002619-PIP01-19)

AdoptedReference Number: EMA/173211/2020