EMEA-003344-PIP02-22 - paediatric investigation plan

sodium ({(2S)-1,4-bis[2-(4-chloro-3-fluorophenoxy)acetamido]bicyclo[2.2.2]octan-2-yl}oxy)methyl hydrogen phosphate-2-amino-2-(hydroxymethyl)propane-1,3-diol (1/1/1)

Key facts

• Active substance:
  sodium ({(2S)-1,4-bis[2-(4-chloro-3-fluorophenoxy)acetamido]bicyclo[2.2.2]octan-2-yl}oxy)methyl hydrogen phosphate-2-amino-2-(hydroxymethyl)propane-1,3-diol (1/1/1)
• Therapeutic area:
  Neurology
• Decision number:
  P/0127/2023
• PIP number:
  EMEA-003344-PIP02-22
• Pharmaceutical form(s):
  Granules
• Condition(s) / indication(s):
  Treatment of amyotrophic lateral sclerosis
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  14/04/2023
• Compliance check done:
  No

Decision

P/0127/2023 : EMA decision of 14 April 2023 on granting of product specific waiver for sodium ({(2S)-1,4-bis[2-(4-chloro-3- fluorophenoxy)acetamido]bicyclo[2.2.2]octan-2-yl}oxy)methyl hydrogen phosphate-2-amino-2- (hydroxymethyl)propane-1,3-diol (1/1/1)

Reference Number: EMA/134835/2023