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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-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
MHRA-100779-PIP01-22-M03 (update)
  • GUSELKUMAB
  • Treatment of chronic idiopathic arthritis (inc. rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and juvenile idiopathic arthritis).
  • TREMFYA
  • TREMFYA
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  • TREMFYA
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  • TREMFYA
  • TREMFYA
  • TREMFYA
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  • TREMFYA
  • TREMFYA
  • TREMFYA
  • TREMFYA
  • TREMFYA
  • Immunology -Rheumatology-Transplantation
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100099-PIP01-21-M06 (update)
  • BRIVARACETAM
  • Treatment of paediatric epilepsy syndromes
  • Treatment of neonatal seizures.
  • Briviact
  • Neurology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101521-PIP01-24-M01 (update)
  • Derivative of 6-(piperidine-1-carbonyl)pyridin-3-ol
  • Treatment of glomerulonephritis and nephrotic syndrome
  • Uro-Nephrology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101189-PIP01-23-M01 (update)
  • Zasocitinib
  • Treatment of psoriasis
  • Dermatology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100230-PIP01-21 -M02 (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-102037-PIP01-25
  • Coramitug
  • Treatment of transthyretin amyloidosis
  • Cardiovascular Diseases
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100258-PIP01-21-M03 (update)
  • Clesrovimab
  • Prevention of lower respiratory tract infection caused by respiratory syncytial virus
  • Infectious diseases
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100046-PIP01-21-M06 (update)
  • cenobamate
  • Treatment of epilepsy
  • Ontozry
  • Ontozry
  • Neurology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-102228-PIP01-25
  • Opevesostat tosilate
  • Treatment of Ovarian cancer
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-102203-PIP01-25
  • Opevesostat tosilate
  • Treatment of breast cancer
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-102191-PIP01-25
  • Opevesostat tosilate
  • Treatment of endometrial cancer
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-102041-PIP01-25
  • Daraxonrasib
  • Treatment of pancreatic cancer
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101643-PIP01-24
  • Trivalent mRNA vaccine encoding for NoV VP1 (mRNA-1403)
  • Prevention of acute norovirus gastroenteritis.
  • Vaccines
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101413-PIP01-24-M01 (update)
  • BLINATUMOMAB
  • Treatment of acute lymphoblastic leukaemia
  • BLINCYTO
  • Oncology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-102029-PIP01-25
  • Encaleret
  • Treatment of hypoparathyroidism
  • Endocrinology-Gynaecology-Fertility-metabolism
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-100901-PIP01-23-M03 (update)
  • CABOTEGRAVIR
  • Treatment of human immunodeficiency virus (HIV-1) infection
  • Vocabria
  • Vocabria
  • Vocabria
  • Vocabria / Cabenuva
  • Vocabria
  • Vocabria
  • Vocabria
  • Vocabria
  • Vocabria
  • Vocabria / Cabenuva
  • Vocabria / Cabenuva
  • Vocabria
  • Infectious diseases
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
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