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PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published
MHRA-100556-PIP02-25
  • Riliprubart
  • Treatment of rejection of a transplanted kidney
  • Neurology
  • Immunology -Rheumatology-Transplantation
  • Haematology-Hemostaseology
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-100993-PIP01-23-M03 (update)
  • QUIZARTINIB DIHYDROCHLORIDE
  • Treatment of acute myeloid leukaemia
  • VANFLYTA
  • VANFLYTA
  • Oncology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-102046-PIP01-25
  • Pegozafermin
  • Treatment of metabolic dysfunction-associated steatohepatitis (MASH).
  • Gastroenterology-Hepatology
  • Endocrinology-Gynaecology-Fertility-metabolism
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101705-PIP01-24
  • Elamipretide
  • Treatment of Barth syndrome
  • Not available at present
  • Endocrinology-Gynaecology-Fertility-metabolism
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-100069-PIP01-21-M01 (update)
  • RIBOCICLIB SUCCINATE
  • Treatment of neuroblastoma
  • KISQALI
  • KISQALI
  • Oncology
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes
MHRA-102050-PIP01-25
  • Aficamten
  • Treatment of hypertrophic cardiomyopathy
  • Cardiovascular Diseases
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes
MHRA-100957-PIP01-23-M01 (update)
  • deucravacitinib
  • Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis & juvenile idiopathic arthritis)
  • SOTYKTU
  • SOTYKTU
  • SOTYKTU
  • SOTYKTU
  • SOTYKTU
  • SOTYKTU
  • SOTYKTU
  • SOTYKTU
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101901-PIP01-25
  • Golcadomide
  • Treatment of mature B cell neoplasms
  • Haematology-Hemostaseology
  • Oncology
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101094-PIP01-23-M02 (update)
  • GIVINOSTAT HYDROCHLORIDE MONOHYDRATE
  • Treatment of Duchenne muscular dystrophy
  • Duvyzat
  • Duvyzat 8.86 mg/ml oral suspension
  • Neurology
  • Other: Other drugs for disorders of the musculo-skeletal system
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100059-PIP01-21-M02 (update)
  • roxadustat
  • Treatment of anaemia due to chronic disorders
  • EVRENZO
  • EVRENZO
  • EVRENZO
  • EVRENZO
  • Ivrenzo
  • EVRENZO
  • EVRENZO
  • Evrenzo Tablets
  • EVRENZO
  • EVRENZO
  • Haematology-Hemostaseology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100811-PIP01-22-M04 (update)
  • Vamorolone
  • Treatment of Duchenne muscular dystrophy
  • AGAMREE
  • AGAMREE
  • AGAMREE
  • AGAMREE
  • AGAMREE
  • AGAMREE
  • AGAMREE
  • AGAMREE
  • Neurology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101846-PIP01-25
  • budigalimab
  • Treatment of all conditions inc. in the category of malignant neoplasms except melanoma, CNS neoplasms, haematopoietic and lymphoid tissues neoplasms
  • Not available at present
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100129-PIP01-21-M03 (update)
  • Cipaglucosidase alfa
  • Treatment of glycogen storage disease Type II (Pompe's disease)
  • Pombiliti
  • Pombiliti
  • Pombilti
  • Pomiliti
  • Pombiliti
  • Pombiliti
  • Endocrinology-Gynaecology-Fertility-metabolism
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-102204-PIP01-25
  • pasritamig
  • Treatment of prostate malignant neoplasms
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100949-PIP01-23-M03 (update)
  • delandistrogene moxeparvovec
  • Treatment of Duchenne Muscular Dystrophy.
  • Neurology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-102297-PIP01-25
  • imlunestrant
  • Treatment of breast malignant neoplasms
  • Inluriyo
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-102102-PIP01-25
  • 3-(1-(2-((S)-2-(3-Cyclopropyl-4-fluorophenyl)-3-(3-(4-fluoro-1-methyl-1H-indazol-5-yl)-2-oxo-2,3-dihydro-1H-imidazol-1-yl)-4-methyl-4,5,6,7-tetrahydro-2H-pyrazolo[4,3-c]pyridine-5-carbonyl)-7-((S)-2,2-dimethyltetrahydro-2Hpyran-4-yl)indolizin-3-yl)cyclopropyl)-1,2,4-oxadiazol-5(4H)-one
  • DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE
  • Treatment of Type 2 Diabetes Mellitus
  • Endocrinology-Gynaecology-Fertility-metabolism
  • Nutrition
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-102028-PIP01-25
  • Humanised IgG1 monoclonal antibody against B7H4 receptor conjugated to N-((2R,10S)-10-benzyl-2-cyclopropyl-1- (((1S,9S)-9-ethyl-5-fluoro-9-hydroxy-4-methyl-10,13-dioxo- 2,3,9,10,13,15-hexahydro-1H,12H- benzo[de]pyrano[3',4':6,7]indolizino[1,2-b]quinolin-1- yl)amino)-1,6,9,12,15-pentaoxo-3-oxa-5,8,11,14- tetraazahexadecan-16-yl)-6-(2,5-dioxo-2,5-dihydro-1H-pyrrol- 1-yl)hexanamide
  • Treatment of endometrial cancer
  • Not available at present
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-102027-PIP01-25
  • Humanised IgG1 monoclonal antibody against B7H4 receptor conjugated to N-((2R,10S)-10-benzyl-2-cyclopropyl-1-(((1S,9S)-9-ethyl-5-fluoro-9-hydroxy-4-methyl-10,13-dioxo- 2,3,9,10,13,15-hexahydro-1H,12H- benzo[de]pyrano[3',4':6,7]indolizino[1,2-b]quinolin-1- yl)amino)-1,6,9,12,15-pentaoxo-3-oxa-5,8,11,14- tetraazahexadecan-16-yl)-6-(2,5-dioxo-2,5-dihydro-1H-pyrrol- 1-yl)hexanamide
  • Treatment of ovarian cancer, treatment of fallopian tube cancer or treatment of primary peritoneal cancer
  • Not available at present
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-102127-PIP01-25
  • BI 1584862
  • Treatment of age-related macular degeneration
  • Ophthamology
 W: decision granting a waiver in all age groups for the listed condition(s). No
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