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Displaying 141 - 160 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-100044-PIP01-21-M02 (update)
  • seltorexant
  • Treatment of major depressive disorder.
  • Not available at present
  • Psychiatry
PM: decision on the application for modification of an agreed paediatric investigation plan. No 28/10/2024
MHRA-100284-PIP01-21-M03 (update)
  • MEXILETINE HYDROCHLORIDE
  • Treatment of myotonic disorders
  • Namuscla
  • Namuscla
  • Other: Muscle disorders
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes 28/10/2024
MHRA-100670-PIP01-22-M01 (update)
  • Ibrexafungerp citrate
  • Treatment of invasive candidiasis
  • Brexafemme
  • Brexafemme
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes 28/10/2024
MHRA-101520-PIP01-24-M01 (update)
  • ECULIZUMAB
  • Treatment of neuromyelitis optica spectrum disorders.
  • SOLIRIS
  • SOLIRIS
  • Neurology
W: decision granting a waiver in all age groups for the listed condition(s). No 28/10/2024
MHRA-101117-PIP01-23-M02 (update)
  • ORITAVANCIN
  • Treatment of acute bacterial skin and skin structure infections (ABSSSI)
  • Tenkasi
  • Tenkasi
  • Tenkasi
  • Orbactiv
  • Tenkasi
  • Orbactiv
  • Tenkasi
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 28/10/2024
MHRA-100451-PIP01-22-M03 (update)
  • fidanacogene elaparvovec
  • Treatment of congenital factor IX deficiency (haemophilia B)
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 28/10/2024
MHRA-100502-PIP01-22-M03 (update)
  • Recombinant Influenza Hemagglutinin-strain A (H1N1 subtype)
  • Recombinant Influenza Hemagglutinin-strain A (H3N2 subtype)
  • Recombinant Influenza Hemagglutinin-strain B (Victoria lineage)
  • Recombinant Influenza Hemagglutinin-strain B (Yamagata lineage)
  • Prevention of influenza disease
  • Supemtek
  • Vaccines
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes 28/10/2024
MHRA-101496-PIP01-24
  • zirconium (89Zr) girentuximab senvedoxam
  • Diagnostic evaluation of indeterminate renal masses detected by conventional imaging
  • Not available at present
  • Uro-Nephrology
  • Diagnostic
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 28/10/2024
MHRA-100891-PIP01-23
  • MODIFIED MESSENGER RIBONUCLEIC ACID ENCODING HUMAN PROPIONYL-COENZYME A CARBOXYLASE ALPHA AND BETA SUBUNITS ENCAPSULATED INTO LIPID NANOPARTICLES
  • Treatment of propionic acidaemia
  • Endocrinology-Gynaecology-Fertility-metabolism
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 28/10/2024
MHRA-100798-PIP01-22
  • CX-000359 mRNA encoding the UL128 protein in the CMV glycoprotein complex pentamer / CX- 000594 mRNA encoding the gL protein in the CMV glycoprotein complex pentamer / CX- 000712 mRNA encoding the UL130 protein in the CMV glycoprotein complex pentamer / CX-005128 mRNA encoding the UL131A protein in the CMV glycoprotein complex pentamer / CX-005282 m-RNA encoding the gH protein in the CMV glycoprotein complex pentamer / CX-000667 mRNA encoding CMV gB (mRNA- 1647).
  • Prevention of cytomegalovirus (CMV) infection
  • Vaccines
  • Other: mRNA-vaccine
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 28/10/2024
MHRA-100635-PIP02-24
  • CEDAZURIDINE
  • DECITABINE
  • Treatment of myelodysplastic syndromes, including juvenile myelomonocytic leukaemia
  • INAQOVI
  • INQOVI
  • INQOVI
  • Inqovi 35/100
  • Haematology-Hemostaseology
  • Oncology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 28/10/2024
MHRA-100324-PIP01-21-M01 (update)
  • Loncastuximab tesirine
  • Treatment of mature B-cell neoplasms
  • Zynlonta
  • Zynlonta
  • Zynlonta
  • Zynlonta
  • Zynlonta
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 28/10/2024
MHRA-100614-PIP01-22-M03 (update)
  • VONICOG ALFA
  • Treatment of von Willebrand Disease
  • veyvondi
  • veyvondi
  • Vonvendi
  • veyvondi
  • Vonvendi
  • veyvondi
  • Vonvendi
  • veyvondi
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 28/10/2024
MHRA-101495-PIP01-24
  • Split influenza virus, inactivated containing antigens equivalent to the A/H1N1-like strain
  • Split influenza virus, inactivated containing antigens equivalent to the A/H3N2-like strain
  • Split influenza virus, inactivated containing antigens equivalent to B-like strain
  • Prevention of influenza disease
  • not available
  • Vaccines
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes 28/10/2024
MHRA-101454-PIP01-24
  • Donidalorsen
  • Treatment of hereditary angioedema
  • Pneumology - Allergology
  • Haematology-Hemostaseology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 28/10/2024
MHRA-101407-PIP01-24
  • chikungunya virus virus-like particle
  • Prevention of chikungunya virus disease
  • Infectious diseases
  • Vaccines
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes 28/10/2024
MHRA-101395-PIP01-24
  • Zanidatamab
  • Treatment of biliary tract cancer (BTC).
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 28/10/2024
MHRA-101410-PIP01-24
  • ISATUXIMAB
  • Treatment of malignant neoplasms of the haematopoietic and lymphoid tissue
  • Sarclisa
  • Sarclisa
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 28/10/2024
MHRA-101356-PIP01-24
  • inebilizumab
  • Treatment of myasthenia gravis
  • Uplizna
  • Neurology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 28/10/2024
MHRA-101334-PIP01-24
  • Insulin Efsitora Alfa (LY3209590)
  • Treatment of type 1 diabetes mellitus
  • Treatment of type 2 diabetes mellitus
  • Endocrinology-Gynaecology-Fertility-metabolism
W: decision granting a waiver in all age groups for the listed condition(s). No 28/10/2024