MHRA-101355-PIP01-24

Key Facts

Active Substance
Active Substance:
  • (3S,10S,14S)-1-[4-[[(2S)-4-carboxy-2-[(2S)-4-carboxy-2-(6-[18F] fluoropyridin-3-amido)butanamido]butanamido]methyl]phenyl]-3-[(naphthalen-2-yl)methyl]-1,4,12-trioxo-2,5,11,13-tetraazahexadecane-10,14,16-tricarboxylic acid ([18F]PSMA-1007)
Invented Name
Radelumin
PIP Number MHRA-101355-PIP01-24
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Solution for injection
Therapeutic area
  • Diagnostic
  • Oncology
Conditions / Indications
Conditions / Indications:
  • Visualisation of prostate specific membrane antigen in prostate cancer
Route(s) of administration
Route(s) of administration:
  • Intravenous use
PIP applicant
  • ABX advanced biochemical compounds Biomedizinische Forschungsreagenzien GmbH
  • Country Germany
  • Tel 0049352840418353
  • Email regulatory-mc@abx.de
Decision Type
Decision Type
W: decision granting a waiver in all age groups for the listed condition(s).
Compliance Check
Compliance Check
No
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):(3S,10S,14S)-1-[4-[[(2S)-4-carboxy-2-[(2S)-4-carboxy-2-(6-[18F] fluoropyridin-3-amido)butanamido]butanamido]methyl]phenyl]-3-[(naphthalen-2-yl)methyl]-1,4,12-trioxo-2,5,11,13-tetraazahexadecane-10,14,16-tricarboxylic acid ([18F]PSMA-1007) .pdf
Published Date 30/04/2024