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PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published
MHRA-102132-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
  • (AZD5004)
  • Treatment of obesity
  • Endocrinology-Gynaecology-Fertility-metabolism
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-100141-PIP01-21-M02 (update)
  • BENRALIZUMAB
  • Treatment of Eosinophilic granulomatosis with polyangiitis (EGPA)
  • FASENRA
  • FASENRA
  • FASENRA
  • FASENRA
  • FASENRA
  • FASENRA
  • FASENRA
  • FASENRA PEN
  • FASENRA
  • FASENRA PEN
  • FASENRA
  • FASENRA
  • Other: Respiratory, thoracic and mediastinal disorders, Immune system disorders
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100230-PIP01-21 -M03 (update)
  • Nerandomilast
  • Treatment of fibrosing interstitial lung disease
  • Pneumology - Allergology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-102136-PIP01-25
  • Human amylin analogue, amylin receptor selective, long-acting, N-terminally lipidated (AZD6234)
  • Treatment of obesity
  • Endocrinology-Gynaecology-Fertility-metabolism
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-100019-PIP01-21-M02 (update)
  • BELUMOSUDIL MESYLATE
  • Treatment of chronic Graft versus Host Disease (cGVHD)
  • Rezurock
  • Rezurock
  • Rholistiq
  • Rholistiq
  • Rezurock
  • Rezurock
  • Rezurock
  • Rezurock
  • Rezurock
  • Rezurock
  • Rezurock
  • Rezurock
  • Rezurock
  • Rezurock
  • Rezurock
  • Rezurock
  • Rezurock
  • Rezurock
  • Rezurock
  • Rezurock
  • Immunology -Rheumatology-Transplantation
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100678-PIP01-22-M02 (update)
  • Vamikibart
  • Treatment of uveitic macular oedema
  • Ophthamology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-102273-PIP01-25
  • EZETIMIBE
  • ATORVASTATIN
  • Treatment of hypercholesterolaemia
  • Prevention of cardiovascular events
  • Ezetimibe/Atorvastatin 10mg/10mg Film-coated Tablets
  • Ezetimibe/Atorvastatin 10mg/20mg Film-coated Tablets
  • Ezetimibe/Atorvastatin 10mg/40mg Film-coated Tablets
  • Ezetimibe/Atorvastatin 10mg/80mg Film-coated Tablets
  • Cardiovascular Diseases
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-102153-PIP01-25
  • Human IgG1 monoclonal antibody against folate receptor alfa conjugated to samrotecan
  • Treatment of ovarian cancer, fallopian tube cancer and peritoneal cancer.
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-102137-PIP01-25
  • izalontamab brengitecan
  • Treatment of lung cancer
  • Treatment of breast cancer
  • Treatment of urothelial carcinoma
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
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-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-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-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-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
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