EMEA-003007-PIP01-21 - paediatric investigation plan

Gemcitabine (hydrochloride)

Key facts

• Active Substance:
  Gemcitabine (hydrochloride)
• Therapeutic area:
  Oncology
• Decision number:
  P/0288/2021
• PIP number:
  EMEA-003007-PIP01-21
• Pharmaceutical form(s):
  All pharmaceutical forms
• Condition(s) / indication(s):
  Treatment of urothelial carcinoma
• Route(s) of administration:
  All routes of administration
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  13/08/2021

Decision

P/0288/2021 : EMA decision of 13 August 2021 on the granting of a product specific waiver for gemcitabine (hydrochloride) (EMEA-003007-PIP01-21)

AdoptedReference Number: EMA/384852/2021