EMEA-002469-PIP01-18 - paediatric investigation plan

pyrimidinyl-aminopyridine dual leucine zipper kinase inhibitor (GDC-0134)

Key facts

• Active substance:
  pyrimidinyl-aminopyridine dual leucine zipper kinase inhibitor (GDC-0134)
• Therapeutic area:
  Neurology
• Decision number:
  P/0099/2019
• PIP number:
  EMEA-002469-PIP01-18
• Pharmaceutical form(s):
  Capsule, hard
• Condition(s) / indication(s):
  Treatment of amyotrophic lateral sclerosis
• Route(s) of administration:
  Oral use
• Decision type:
  RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
• Decision date:
  22/03/2019
• Compliance check done:
  No

Decision

P/0099/2019: EMA decision of 22 March 2019 on the refusal of a product specific waiver for pyrimidinyl-aminopyridine dual leucine zipper kinase inhibitor (GDC-0134) (EMEA-002469-PIP01-18)

Adopted Reference Number: EMA/145322/2019