EMEA-002108-PIP01-16 - paediatric investigation plan

H-Tyr-Gly-Arg-Lys-Lys-Arg-Arg-Gln-Arg-Arg-Arg-Lys-Leu-Ser-Ser-Ile-Glu-Ser-Asp-Val-OH(YGRKKRRQRRRKLSSIESDV)

Key facts

• Active Substance:
  H-Tyr-Gly-Arg-Lys-Lys-Arg-Arg-Gln-Arg-Arg-Arg-Lys-Leu-Ser-Ser-Ile-Glu-Ser-Asp-Val-OH(YGRKKRRQRRRKLSSIESDV)
• Therapeutic area:
  Neurology
• Decision number:
  P/0208/2017
• PIP number:
  EMEA-002108-PIP01-16
• Pharmaceutical form(s):
  Solution for infusion
• Condition(s) / indication(s):
  Treatment of acute ischaemic stroke
• Route(s) of administration:
  Intravenous use
• Contact for public enquiries:

  NoNO Inc.

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

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  09/08/2017

Decision

P/0208/2017: EMA decision of 9August 2017 on the granting of a product specific waiver for H-Tyr-Gly-Arg-Lys-Lys-Arg-Arg-Gln-Arg-Arg-Arg-Lys-Leu-Ser-Ser-Ile-Glu-Ser-Asp-Val-OH (YGRKKRRQRRRKLSSIESDV), (EMEA-002108-PIP01-1...

AdoptedReference Number: EMA/459054/2017