MHRA-101676-PIP01-24

Key Facts

Active Substance
Active Substance:
  • HUMAN ANTI-D IMMUNOGLOBULIN
Invented Name
  • Immunorho
  • Immunorho
  • Immunorho
  • Immunorho
  • Immunorho
  • Immunorho
  • Immunorho
  • Immunorho
  • Immunorho
  • Immunorho
  • Immunorho
  • Immunorho
PIP Number MHRA-101676-PIP01-24
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Solution for injection
Therapeutic area
  • Haematology-Hemostaseology
  • Other: Immunology
Conditions / Indications
Conditions / Indications:
  • Prevention of Rhesus (Rh) isoimmunisation
Route(s) of administration
Route(s) of administration:
  • Intramuscular use
PIP applicant
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):HUMAN ANTI-D IMMUNOGLOBULIN.pdf
Published Date 23/06/2025