EMA/PE/0000230592 - paediatric investigation plan

gemcitabine hydrochloride

Key facts

• Active substance:
  gemcitabine hydrochloride
• Therapeutic area:
  Neoplasms benign, malignant and unspecified (incl cysts and polyps)
• Decision number:
  EMA/PE/0000230592
• PIP number:
  EMA/PE/0000230592
• Pharmaceutical form(s):
  All pharmaceutical forms
• 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:
  14/04/2025
• Compliance check done:
  Non

Decision

EMA/PE/0000230592 : EMA decision of 14 April 2025 on the granting of a product specific waiver for gemcitabine hydrochloride

Adopted Reference Number: EMADOC-1700519818-2034435