EMEA-002461-PIP01-18 - paediatric investigation plan

genetically modified Mycobacterium bovis BCG

Key facts

• Active substance:
  genetically modified Mycobacterium bovis BCG
• Therapeutic area:
  Oncology
• Decision number:
  P/0078/2019
• PIP number:
  EMEA-002461-PIP01-18
• Pharmaceutical form(s):
  Powder for intravesical suspension
• Condition(s) / indication(s):
  Treatment of ureter and bladder carcinoma
• Route(s) of administration:
  Intravesical use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  22/03/2019
• Compliance check done:
  No

Decision

P/0078/2019: EMA decision of 22 March 2019 on the granting of a product specific waiver for genetically modified Mycobacterium bovis BCG (EMEA-002461-PIP01-18)

Adopted Reference Number: EMA/121698/2019