EMEA-002111-PIP01-17 - paediatric investigation plan

Miridesap

Key facts

• Active Substance:
  Miridesap
• Therapeutic area:
  Haematology-Hemostaseology
• Decision number:
  P/0174/2017
• PIP number:
  EMEA-002111-PIP01-17
• Pharmaceutical form(s):
  Concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of systemic light chain amyloidosis
• Route(s) of administration:
  Intravenous use
• Contact for public enquiries:

  GlaxoSmithKline Trading Services Limited

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

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  03/07/2017

Decision

P/0174/2017: EMA decision of 3 July 2017 on the granting of a product-specific waiver for miridesap (EMEA-002111-PIP01-17)

AdoptedReference Number: EMA/354128/2017