EMEA-002043-PIP01-16 - paediatric investigation plan

doxorubicin hydrochloride

Key facts

• Active substance:
  doxorubicin hydrochloride
• Therapeutic area:
  Oncology
• Decision number:
  P/0041/2017
• PIP number:
  EMEA-002043-PIP01-16
• Pharmaceutical form(s):
  Powder for suspension for infusion
• Condition(s) / indication(s):
  Treatment of hepatocellular carcinoma
• Route(s) of administration:
  Intravenous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  31/01/2017
• Compliance check done:
  Nej

Decision

P/0041/2017: European Medicines Agency decision of 31 January 2017 on the granting of a product specific waiver for doxorubicin (hydrochloride) (EMEA-002043-PIP01-16)

Adopted Reference Number: EMA/38351/2017