Search Filters:

The items contained in the list are being used to filter the search results. Click them to remove them from the search filter.
Displaying 21 - 40 of 838
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
MHRA-101021-PIP01-23-M04 (update)
  • FILGOTINIB MALEATE
  • Chronic idiopathic arthritis
  • Jyseleca
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-102520-PIP01-26
  • 2'-methoxyethyl antisense gapmer oligonucleotide against MAPT mRNA
  • Treatment of progressive supranuclear palsy.
  • Neurology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-102389-PIP01-26
  • Humanised IgG4 monoclonal antibody against S100A4
  • Treatment of idiopathic pulmonary fibrosis
  • Not available at present
  • Pneumology - Allergology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-102112-PIP01-25
  • Retatrutide
  • Obesity
  • Other: Obesity, Overweight
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-102435-PIP01-26
  • MK-8748/EYE201
  • Treatment of diabetic macular oedema
  • Ophthamology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101094-PIP01-23-M03 (update)
  • GIVINOSTAT HYDROCHLORIDE MONOHYDRATE
  • Treatment of Duchenne muscular dystrophy
  • Duvyzat
  • Duvyzat 8.86 mg/ml oral suspension
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100115-PIP01-21-M01 (update)
  • Dersimelagon
  • Treatment of erythropoetic protoporphyria
  • Treatment of X-linked protoporphyria
  • Not available at present
  • Dermatology
  • Other: Genetic medicine
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100689-PIP01-22
  • Dersimelagon
  • Treatment of systemic sclerosis
  • Other: Autoimmune and immune dysfunction diseases
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101855-PIP01-25
  • unasnemab
  • Treatment of Amyotrophic lateral sclerosis
  • Neurology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100055-PIP01-21
  • Edaravone
  • Treatment of Amyotrophic lateral sclerosis
  • Radicava
  • Radicut
  • Radicut
  • Radicut
  • Neurology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100268-PIP01-21-M05 (update)
  • inotuzumab-ozogamicin
  • Treatment of B cell acute lymphoblastic leukaemia
  • Besponsa
  • Besponsa
  • Haematology-Hemostaseology
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101324-PIP01-23-M03 (update)
  • REGADENOSON
  • Diagnosis of myocardial perfusion disturbances
  • Rapiscan
  • Rapiscan
  • Cardiovascular Diseases
  • Diagnostic
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-102436-PIP01-26
  • Caveolin-1 scaffold protein-derived 7-amino acid peptide (LTI-03)
  • Treatment of idiopathic pulmonary fibrosis
  • Pneumology - Allergology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-102400-PIP01-26-M03 (update)
  • ODEVIXIBAT SESQUIHYDRATE
  • Treatment of Alagille Syndrome (ALGS)
  • Bylvay
  • Gastroenterology-Hepatology
  • Other: Hepatobiliary disorders
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-102305-PIP01-26
  • VICADROSTAT
  • EMPAGLIFLOZIN
  • Prevention of heart failure
  • Cardiovascular Diseases
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101389-PIP01-24-M02 (update)
  • omaveloxolone
  • Treatment of Friedreich's ataxia
  • Skyclarys
  • Skyclarys 50mg Hard capsules
  • Skyclarys 50mg Hard capsules
  • Skyclarys 50mg Hard capsules
  • Other: Neuromuscular
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-102134-PIP01-25
  • Enicepatide
  • 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-102357-PIP01-26
  • LAROPROVSTAT
  • ROSUVASTATIN CALCIUM
  • Treatment of mixed dyslipidaemia
  • Cardiovascular Diseases
  • Endocrinology-Gynaecology-Fertility-metabolism
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-102355-PIP01-26
  • LAROPROVSTAT
  • ROSUVASTATIN CALCIUM
  • Treatment of elevated cholesterol
  • Cardiovascular Diseases
  • Endocrinology-Gynaecology-Fertility-metabolism
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-102299-PIP01-26
  • CRB-701
  • Treatment of cervical cancer
  • Treatment of head and neck epithelial malignant neoplasms
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No