EMEA-003408-PIP01-23 - paediatric investigation plan

gallium (68Ga) boclatixafortide

Key facts

• Active substance:
  gallium (68Ga) boclatixafortide
• Therapeutic area:
  Other
• Decision number:
  P/0227/2023
• PIP number:
  EMEA-003408-PIP01-23
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Diagnosis of marginal zone lymphoma
• Route(s) of administration:
  Intravenous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  14/06/2023
• Compliance check done:
  No

Decision

P/0227/2023 : EMA decision of 14 June 2023 on the granting of a product specific waiver for gallium (68Ga) boclatixafortide (EMEA-003408-PIP01- 23)

Reference Number: EMA/234911/2023