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Displaying 121 - 140 of 961
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
MHRA-100623-PIP01-22-M02 (update)
  • NIRAPARIB TOSYLATE MONOHYDRATE
  • Treatment of all conditions included in the category of malignant neoplasms (except haematopoietic and lymphoid malignancies)
  • Zejula
  • Zejula
  • Zejula
  • Zejula
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 29/10/2024
MHRA-100448-PIP01-22-M01 (update)
  • RUXOLITINIB PHOSPHATE
  • Vitiligo
  • OPZELURA
  • OPZELURA
  • OPZELURA
  • OPZELURA
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 29/10/2024
MHRA-100183-PIP01-21-M03 (update)
  • AZILSARTAN MEDOXOMIL
  • Treatment of hypertension
  • Edarbi
  • Edarbi
  • Edarbi
  • Cardiovascular Diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 29/10/2024
MHRA-100623-PIP01-22-M02 (update)
  • NIRAPARIB TOSYLATE MONOHYDRATE
  • Treatment of all conditions included in the category of malignant neoplasms (except haematopoietic and lymphoid malignancies)
  • Zejula
  • Zejula
  • Zejula
  • Zejula
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 29/10/2024
MHRA-100993-PIP01-23-M02 (update)
  • QUIZARTINIB DIHYDROCHLORIDE
  • Treatment of acute myeloid leukaemia
  • VANFLYTA
  • VANFLYTA
  • VANFLYTA
  • VANFLYTA
  • VANFLYTA
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 28/10/2024
MHRA-101021-PIP01-23-M02 (update)
  • FILGOTINIB MALEATE
  • Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, ankylosing spondylarthritis, psoriatic arthritis, and juvenile idiopathic arthritis).
  • Jyseleca
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. No 28/10/2024
MHRA-100111-PIP01-21-M01 (update)
  • Islatravir
  • DORAVIRINE
  • Treatment of human immunodeficiency virus-1 (HIV-1) infection
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 28/10/2024
MHRA-101493-PIP01-24
  • anti-alpha-synuclein recombinant humanised monoclonal antibody (Company code UCB7853)
  • Treatment of Parkinson's disease
  • Neurology
W: decision granting a waiver in all age groups for the listed condition(s). No 28/10/2024
MHRA-100482-PIP01-22-M02 (update)
  • acetyl-L-leucine ((s)-(acetylamino)-4-methylpentanoic acid)
  • Treatment of Niemann-Pick Disease Type C (NPC)
  • Aqneursa
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 28/10/2024
MHRA-101630-PIP01-24-M01 (update)
  • LISOCABTAGENE MARALEUCEL
  • Treatment of B-lymphoblastic leukaemia/lymphoma
  • Treatment of mature B-cell neoplasm
  • Breyanzi
  • Breyanzi
  • Breyanzi
  • Breyanzi
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 28/10/2024
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-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-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