Displaying 1 - 20 of 1071
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
MHRA-101243-PIP01-23
  • 3-[2-(Dimethylamino)ethyl]-1H-indol-4-yl dihydrogen phosphate
  • Major depressive disorder
  • Psychiatry
W: decision granting a waiver in all age groups for the listed condition(s). No 12/02/2025
MHRA-101737-PIP01-24
  • GOZETOTIDE
  • Visualisation of prostate specific membrane antigen in prostate cancer
  • Isoprotrace
  • Isoprotrace 10 microgram, kit voor radiofarmaceutisch preparaat
  • Isoprotrace 10 Mikrogramm Kit für ein radioaktives Arzneimittel
  • Diagnostic
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 11/02/2025
MHRA-101711-PIP01-24-M01 (update)
  • IPTACOPAN HYDROCHLORIDE MONOHYDRATE
  • Treatment of C3 glomerulopathy
  • Fabhalta
  • Fabhalta
  • Fabhalta
  • Other: Complement-driven renal disease
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 11/02/2025
MHRA-100239-PIP01-21-M02 (update)
  • Multivalent pneumococcal polysaccharide conjugate to carrier protein
  • Prevention of disease caused by Streptococcus pneumoniae
  • Vaccines
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 11/02/2025
MHRA-100811-PIP01-22-M03 (update)
  • Vamorolone
  • Treatment of Duchenne muscular dystrophy
  • AGAMREE
  • AGAMREE
  • Agmaree
  • AGAMREE
  • Other: Neuromuscular Diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 11/02/2025
MHRA-101663-PIP01-24
  • AMIVANTAMAB
  • Treatment of colorectal carcinoma
  • Rybrevant
  • Rybrevant
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 11/02/2025
MHRA-100907-PIP01-23-M02 (update)
  • CEFTOLOZANE
  • TAZOBACTAM
  • Treatment of pneumonia
  • ZERBAXA
  • ZERBAXA
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 11/02/2025
MHRA-101324-PIP01-23-M02 (update)
  • REGADENOSON
  • Diagnosis myocardial perfusion disturbances.
  • Rapiscan
  • Rapiscan
  • Cardiovascular Diseases
  • Diagnostic
PM: decision on the application for modification of an agreed paediatric investigation plan. No 11/02/2025
MHRA-101591-PIP01-24
  • SACITUZUMAB GOVITECAN
  • Treatment of endometrial cancer
  • Trodelvy
  • Trodelvy
  • Trodelvy
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 11/02/2025
MHRA-100092-PIP01-21-M03 (update)
  • VENETOCLAX
  • Treatment of malignant neoplasms of the haematopoietic and lymphoid tissue
  • Treatment of solid malignant tumours
  • Venclyxto
  • Vencylxto
  • Venclyxto
  • Venclyxto
  • Venclyxto
  • Venclyxto
  • Venclyxto
  • Venclyxto
  • Haematology-Hemostaseology
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 11/02/2025
MHRA-101548-PIP01-24
  • Xaluritamig
  • Treatment of prostate malignant neoplasms.
  • Not available yet
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 11/02/2025
MHRA-100674-PIP01-22-M02 (update)
  • DARATUMUMAB
  • Treatment of lymphoid malignancies (except mature B-cell neoplasms)
  • Darzalex
  • Darzalex
  • Darzalex
  • Darzalex
  • DARZALEX FASPRO
  • Darzalex
  • Darzalex
  • Darzalex
  • Darzalex
  • Darzalex
  • Darzalex
  • Darzalex
  • Darzalex
  • Darzalex
  • Darzalex
  • Darzalex
  • DARZALEX FASPRO
  • Darzalex
  • Darzalex
  • Darzalex
  • Darzalex
  • Darzalex
  • Darzalex
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 11/02/2025
MHRA-101323-PIP02-24
  • tulisokibart
  • Treatment of Crohn's disease
  • Immunology -Rheumatology-Transplantation
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 11/02/2025
MHRA-101323-PIP01-23
  • tulisokibart
  • Treatment of ulcerative colitis
  • Immunology -Rheumatology-Transplantation
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 11/02/2025
MHRA-101244-PIP01-23
  • UPADACITINIB
  • Treatment of vitiligo
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Dermatology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 11/02/2025
MHRA-100999-PIP03-23
  • Ensitrelvir
  • Prevention of coronavirus disease 2019 (COVID-19).
  • Zokovea
  • Xocova
  • Infectious diseases
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 11/02/2025
MHRA-101248-PIP01-23
  • UPADACITINIB
  • Treatment of systemic lupus erythematosus
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Dermatology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 11/02/2025
MHRA-100999-PIP02-23
  • Ensitrelvir
  • Treatment of coronavirus disease 2019 (COVID-19)
  • Zokovea
  • Xocova
  • Infectious diseases
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 11/02/2025
MHRA-101091-PIP01-23
  • Borrelia outer surface protein A (OspA) serotypes (ST1-6) lipidated, fusion protein vaccine (VLA15 - PF-07307405)
  • Prevention of Lyme disease
  • Vaccines
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 11/02/2025
MHRA-101049-PIP01-23
  • retifanlimab
  • Treatment of Merkel cell carcinoma
  • ZYNYZ
  • retifanlimab
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 11/02/2025