EMEA-001234-PIP01-11 - paediatric investigation plan

(2R,3S,5R)-2-(2,5-Difluorophenyl)-5-[2,6-dihydro-2-(methylsulfonyl)pyrrolo[3,4-c]pyrazol-5(4H)-yl]tetrahydro-2H-pyran-3-amine (MK-3102)

Key facts

• Active Substance:
  (2R,3S,5R)-2-(2,5-Difluorophenyl)-5-[2,6-dihydro-2-(methylsulfonyl)pyrrolo[3,4-c]pyrazol-5(4H)-yl]tetrahydro-2H-pyran-3-amine (MK-3102)
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0266/2012
• PIP number:
  EMEA-001234-PIP01-11
• Pharmaceutical form(s):
  • Capsule
  • Capsule (hard)
• Condition(s) / indication(s):
  Treatment of type II diabetes mellitus
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Merck Sharp & Dohme (Europe), Inc.

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

• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  20/11/2012

Decision

P/0266/2012: EMA decision of 20 November 2012 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for (2R,3S,5R)-2-(2,5-difluorophenyl)-5-[2,6-dihydro-2-(...

AdoptedReference Number: EMA/721373/2012