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Displaying 161 - 180 of 1154
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
MHRA-101467-PIP01-24
  • apitegromab
  • Treatment of spinal muscular atrophy
  • Other: Neuromuscular disorders
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-100392-PIP01-21-M05 (update)
  • Highly purified single-stranded, 5’-capped mRNA encoding full-length SARS-CoV-2 spike protein (BNT162b2)
  • TOZINAMERAN
  • TOZINAMERAN/FAMTOZINAMERAN
  • TOZINAMERAN/RILTOZINAMERAN
  • RAXTOZINAMERAN
  • Prevention of coronavirus disease 2019 (COVID-19)
  • Comirnaty
  • Comirnaty 30 micrograms/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty 30 micrograms/dose dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty 10 micrograms/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty Original/Omicron BA.1 (15/15 micrograms)/dose dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty Original/Omicron BA.4-5 (15/15 micrograms)/dose dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty Original/Omicron BA.4-5 (5/5 micrograms)/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty 30 micrograms/dose dispersion for injection, single dose vial, COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty Original/Omicron BA.4-5 15/15 micrograms per dose dispersion for injection, single dose vial COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty Original/Omicron BA.4-5 1.5/1.5 micrograms/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty Original/Omicron BA.4-5 (5/5 micrograms)/dose dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty Original/Omicron BA.4-5 (5/5 micrograms)/dose dispersion for injection, single dose vial COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty Omicron XBB.1.5 30 micrograms/dose dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty Omicron XBB.1.5 30 micrograms/dose dispersion for injection, single dose vial COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty Omicron XBB.1.5 10 micrograms/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty Omicron XBB.1.5 30 micrograms/dose dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty Omicron XBB.1.5 10 micrograms/dose dispersion for injection, single dose vial COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty Omicron XBB.1.5 3 micrograms/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes
MHRA-101445-PIP01-24
  • CANNABIDIOL
  • Treatment of fragile X syndrome
  • Psychiatry
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-100558-PIP01-22-M01 (update)
  • milvexian
  • Prevention of thromboembolism in patients with cardiovascular diseases
  • Cardiovascular Diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101486-PIP01-24
  • Avalotcagene Ontaparvovec
  • Treatment of ornithine transcarbamylase deficiency
  • Not Yet Available
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101523-PIP01-24
  • Raludotatug deruxtecan
  • Treatment of Ovarian cancer
  • Treatment of fallopian tube cancer
  • Treatment of primary peritoneal cancer
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101497-PIP01-24
  • laruparetigene zovaparvovec
  • Recombinant Adeno-Associated Viral Vector Expressing a Human RPGR1-14,ORF15gene (rAAV2tYF-GRK1-RPGR)
  • Treatment of X-linked retinitis pigmentosa (XLRP)
  • Not available at present
  • Ophthamology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-100492-PIP01-22-M02 (update)
  • MOLGRAMOSTIM
  • Treatment of pulmonary alveolar proteinosis
  • MOLBREEVI
  • Pneumology - Allergology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101521-PIP01-24
  • Derivative of 6-(piperidine-1-carbonyl)pyridine-3-ol
  • Treatment of glomerulonephritis and nephrotic syndrome
  • Uro-Nephrology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101506-PIP01-24
  • Zongertinib
  • Treatment of non-small cell lung cancer
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101482-PIP01-24-M01 (update)
  • BELATACEPT
  • Prevention of rejection of transplanted kidney
  • NULOJIX
  • NULOJIX
  • NULOJIX
  • NULOJIX
  • NULOJIX
  • NULOJIX
  • NULOJIX
  • NULOJIX
  • NULOJIX
  • NULOJIX
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100247-PIP01-21-M02 (update)
  • BEROTRALSTAT DIHYDROCHLORIDE
  • Treatment of hereditary angioedema
  • Orladeyo
  • Orladeyo
  • Orladeyo
  • Orladeyo
  • Orladeyo
  • Orladeyo
  • Orladeyo
  • Orladeyo
  • Orladeyo
  • Orladeyo
  • Orladeyo
  • Orladeyo
  • Orladeyo
  • Pneumology - Allergology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101489-PIP01-24
  • Enlicitide (decanoate)
  • Treatment of hypercholesterolemia
  • Cardiovascular Diseases
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101442-PIP01-24
  • Modified messenger ribonucleic acid encoding individual patient-specific tumour neoantigens V940 (mRNA-4157)
  • Treatment of urothelial carcinoma
  • Treatment of cutaneous squamous cell carcinoma
  • Treatment of renal cell carcinoma
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101384-PIP01-24
  • Telisotuzumab adizutecan
  • Treatment of colorectal carcinoma.
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101500-PIP01-24
  • Zanidatamab
  • Treatment of gastroesophageal adenocarcinoma (GEA).
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101499-PIP01-24
  • Zanidatamab
  • Treatment of HER2-positive breast cancer
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101426-PIP01-24
  • Deutetrabenazine
  • Treatment of tardive dyskinesia
  • Austedo
  • Austedo
  • Austedo
  • Austedo
  • Austedo
  • Austedo
  • Austedo
  • Austedo
  • Austedo
  • Austedo
  • Austedo
  • Neurology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101319-PIP01-23-M01 (update)
  • denecimig
  • Treatment of haemophilia A
  • Not available at present
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101129-PIP01-23
  • Domvanalimab
  • Treatment of lung cancer
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No