EMEA-002682-PIP01-19 - paediatric investigation plan

3-[4-(4-Aminopiperidin-1-yl)-3-(3,5-difluorophenyl)quinolin-6-yl]-2-hydroxybenzonitrile (CRN00808)

Key facts

• Active substance:
  3-[4-(4-Aminopiperidin-1-yl)-3-(3,5-difluorophenyl)quinolin-6-yl]-2-hydroxybenzonitrile (CRN00808)
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0038/2020
• PIP number:
  EMEA-002682-PIP01-19
• Pharmaceutical form(s):
  Capsule, hard
• Condition(s) / indication(s):
  Treatment of acromegaly
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  29/01/2020
• Compliance check done:
  Не

Decision

P/0038/2020: EMA decision of 29 January 2020 on the granting of a product specific waiver for 3-[4-(4-Aminopiperidin-1-yl)-3-(3,5- difluorophenyl)quinolin-6-yl]-2-hydroxybenzonitrile (CRN00808) (EMEA-002682-PIP01-19)

Adopted Reference Number: EMA/23328/2020