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Displaying 21 - 40 of 1097
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
MHRA-101303-PIP01-23
  • OBINUTUZUMAB
  • Treatment of glomerulonephritis and nephrotic syndrome
  • Gazyvaro
  • Immunology -Rheumatology-Transplantation
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 10/03/2025
MHRA-101725-PIP01-24
  • GUSELKUMAB
  • Treatment of psoriasis
  • TREMFYA
  • TREMFYA
  • TREMFYA
  • TREMFYA
  • TREMFYA
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted 10/03/2025
MHRA-101687-PIP01-24-M01 (update)
  • MEPOLIZUMAB
  • Treatment of Hypereosinophilic Syndrome
  • Nucala
  • Nucala
  • Nucala
  • Nucala
  • Nucala
  • Nucala
  • Nucala
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 10/03/2025
MHRA-101677-PIP01-24
  • Rilvegostomig
  • Treatment of Lung Cancer Treatment of Biliary Tract Cancer
  • Rilvegostomig
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 10/03/2025
MHRA-101690-PIP01-24
  • EMPAGLIFLOZIN
  • Derivative of 3‐phenyl‐3H,4H,6H,7H-pyrano[3,4‐d]imidazol‐4‐one (BI 690517)
  • Treatment of heart failure
  • Not available at present
  • Cardiovascular Diseases
W: decision granting a waiver in all age groups for the listed condition(s). No 10/03/2025
MHRA-101546-PIP01-24
  • SECUKINUMAB
  • Treatment of vasculitides
  • Cosentyx
  • Cosentyx
  • Cosentyx
  • Cosentyx
  • Cosentyx
  • Cosentyx
  • Cosentyx
  • Cosentyx
  • Cosentyx
  • Cosentyx
  • Cosentyx
  • Cosentyx
  • Immunology -Rheumatology-Transplantation
W: decision granting a waiver in all age groups for the listed condition(s). No 10/03/2025
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