EMEA-003162-PIP02-22 - paediatric investigation plan

batoclimab

Key facts

• Active substance:
  batoclimab
• Therapeutic area:
  Ophthalmology
• Decision number:
  P/0452/2022
• PIP number:
  EMEA-003162-PIP02-22
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of thyroid eye disease
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  28/10/2022
• Compliance check done:
  No

Decision

P/0452/2022: EMA decision of 28 October 2022 on the granting of a product specific waiver for batoclimab (EMEA-003162-PIP02-22)

Adopted Reference Number: EMA/834765/2022