EMEA-002608-PIP01-19 - paediatric investigation plan

2-(3-(1-carboxy-5-[(6-[18F]fluoropyridine-3-carbonyl)-amino]-pentyl)-ureido)-pentanedioic acid

Key facts

• Active Substance:
  2-(3-(1-carboxy-5-[(6-[18F]fluoropyridine-3-carbonyl)-amino]-pentyl)-ureido)-pentanedioic acid
• Therapeutic area:
  Oncology
• Decision number:
  P/0357/2019
• PIP number:
  EMEA-002608-PIP01-19
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Diagnosis of prostate cancer
• Route(s) of administration:
  Intravenous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  04/10/2019

Decision

P/0357/2019: EMA decision of 4 October 2019 on the granting of a product specific waiver for 2-(3-(1-carboxy-5-[(6-[18F]fluoropyridine-3-carbonyl)- amino]-pentyl)-ureido)-pentanedioic acid (EMEA-002608-PIP01-19)

AdoptedReference Number: EMA/523628/2019