Displaying 21 - 40 of 907
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
MHRA-101903-PIP01-25
  • Ifinatamab deruxtecan
  • 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-101112-PIP01-23-M02 (update)
  • Icotrokinra
  • Treatment of psoriasis.
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted
MHRA-100605-PIP01-22-M01 (update)
  • SPARSENTAN
  • Treatment of immunoglobulin A nephropathy
  • Filspari
  • Filspari
  • Filspari
  • Filspari
  • Other: Nephrology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100567-PIP01-22-M02 (update)
  • DINUTUXIMAB BETA
  • Treatment of neuroblastoma.
  • Qarziba
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes
MHRA-101945-PIP01-25
  • Hafnium Oxide
  • Treatment of lung cancer
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101939-PIP01-25
  • Hafnium Oxide
  • Treatment of head and neck epithelial malignant neoplasms
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101917-PIP01-25
  • BOTULINUM TOXIN TYPE A
  • Treatment of skin wrinkling.
  • Dermatology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101283-PIP01-23-M03 (update)
  • Fitusiran
  • Treatment of haemophilia A
  • Treatment of Haemophilia B
  • Fitusiran
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100797-PIP02-24
  • mRNA encoding Influenza A, H1N1 strain, hemagglutinin glycoprotein, mRNA encoding Influenza A, H3N2 strain, hemagglutinin glycoprotein, mRNA encoding Influenza B/Victoria, hemagglutinin glycoprotein
  • Prevention of influenza disease
  • Vaccines
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101985-PIP01-25
  • obicetrapib
  • EZETIMIBE
  • Treatment of mixed dyslipidaemia
  • Cardiovascular Diseases
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101808-PIP01-25-M01 (update)
  • DARVADSTROCEL
  • Treatment of perianal fistula
  • Alofisel
  • Gastroenterology-Hepatology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101467-PIP01-24-M01 (update)
  • apitegromab
  • Treatment of spinal muscular atrophy
  • Isembyld
  • Other: Neuromuscular disorders
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100369-PIP01-21-M03 (update)
  • MIGALASTAT HYDROCHLORIDE
  • Treatment of Fabry disease
  • Galafold
  • Galafold
  • Galafold
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101592-PIP01-24
  • Afimkibart
  • Treatment of Crohn's disease
  • Human IgG1 kappa monoclonal antibody against tumor necrosis factor-like ligand 1A
  • Gastroenterology-Hepatology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101549-PIP01-24
  • Afimkibart
  • Treatment of ulcerative colitis
  • Gastroenterology-Hepatology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101454-PIP01-24-M01 (update)
  • Donidalorsen
  • Treatment of hereditary angioedema
  • Pneumology - Allergology
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes
MHRA-100635-PIP01-22-M03 (update)
  • CEDAZURIDINE
  • DECITABINE
  • Treatment of acute myeloid leukaemia
  • INAQOVI
  • INAQOVI
  • INQOVI
  • INQOVI
  • Inqovi 35/100
  • Haematology-Hemostaseology
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100182-PIP01-21-M02 (update)
  • Avalglucosidase alfa
  • Treatment of Pompe disease.
  • Nexviadyme
  • Nexviadyme
  • Nexviadyme
  • Nexviadyme
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100149-PIP01-21-M04 (update)
  • NVX-CoV2373
  • Prevention of coronavirus disease 2019 (COVID-19)
  • Nuvaxovid dispersion for injection, COVID-19 Vaccine (recombinant, adjuvanted)
  • Nuvaxovid
  • Nuvaxovid
  • Vaccines
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100118-PIP01-21-M04 (update)
  • OCRELIZUMAB
  • Treatment of Multiple Sclerosis
  • Ocrevus
  • Ocrevus
  • Ocrevus
  • Ocrevus
  • Ocrevus
  • Ocrevus
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes