EMEA-000524-PIP01-08 - paediatric investigation plan

Teplizumab

Key facts

• Active Substance:
  Teplizumab
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/8/2010
• PIP number:
  EMEA-000524-PIP01-08
• Pharmaceutical form(s):
  Concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of type I diabetes mellitus
• Route(s) of administration:
  Intravenous use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  29/01/2010

Decision

P/8/2010: European Medicines Agency Decision of 29 January 2010 on the agreement of a Paediatric Investigation Plan and on the granting of a deferral and on the granting of a waiver for Teplizumab (EMEA-000524-PIP01-08)...

AdoptedReference Number: EMA/44293/2010