EMEA-001184-PIP01-11 - paediatric investigation plan

(2S,3R,4R,5S,6R)-2-(4-Chloro-3-{3-[(S)-(tetrahydrofuran-3-yl)oxy]-benzyl}-phenyl)-6-hydroxymethyltetrahydro-pyran-3,4,5-triol

linagliptin

Key facts

• Active Substance:
  • (2S,3R,4R,5S,6R)-2-(4-Chloro-3-{3-[(S)-(tetrahydrofuran-3-yl)oxy]-benzyl}-phenyl)-6-hydroxymethyltetrahydro-pyran-3,4,5-triol
  • linagliptin
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/247/2011
• PIP number:
  EMEA-001184-PIP01-11
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Treatment of type II diabetes mellitus
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Boehringer Ingelheim International GmbH

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

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  21/10/2011

Decision

P/247/2011: EMA decision of 21 October 2011 on the granting of a product specific waiver for (2S,3R,4R,5S,6R)-2-(4-Chloro-3-{3-[(S)-(tetrahydrofuran-3-yl)oxy]-benzyl}-phenyl)-6-hydroxymethyltetrahydro-pyran-3,4,5-triol /...

AdoptedReference Number: EMA/826136/2011