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Displaying 1 - 20 of 1015
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
MHRA-101006-PIP01-23-M02 (update)
  • IMLIFIDASE
  • Prevention of graft rejection following solid organ transplantation
  • Idefirix
  • Idefirix
  • Idefirix
  • Idefirix
  • Idefirix
  • Idefirix
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100118-PIP01-21-M03 (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. No
MHRA-101044-PIP01-23-M02 (update)
  • INCLISIRAN SODIUM
  • Treatment of elevated cholesterol
  • Leqvio
  • Leqvio
  • Endocrinology-Gynaecology-Fertility-metabolism
  • Other: chemically synthesized small interfering RNA (siRNA)
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101707-PIP01-24
  • AMG 193
  • Treatment of non-small cell lung cancer
  • Not available at present
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101729-PIP01-24
  • Ifinatamab deruxtecan
  • Treatment of prostate malignant neoplasms
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101730-PIP01-24
  • Ifinatamab deruxtecan
  • Treatment of oesophageal cancer
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100297-PIP01-21-M04 (update)
  • Human, recombinant, non-fucosylated IgG1k monoclonal antibody targeting OX-40 receptor on activated T cells (rocatinlimab)
  • Treatment of atopic dermatitis
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101660-PIP01-24
  • RUXOLITINIB PHOSPHATE
  • Treatment of prurigo nodularis
  • OPZELURA
  • OPZELURA
  • OPZELURA
  • OPZELURA
  • Dermatology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101412-PIP01-24
  • Pridopidine hydrochloride
  • Treatment of amyotrophic lateral sclerosis (ALS)
  • Nurzigma
  • Neurology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101413-PIP01-24
  • BLINATUMOMAB
  • Treatment of acute lymphoblastic leukaemia
  • BLINCYTO
  • Oncology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101770-PIP01-24
  • SEMAGLUTIDE
  • Treatment of Chronic Kidney Disease
  • Ozempic
  • Ozempic
  • Ozempic
  • Ozempic
  • Ozempic
  • Uro-Nephrology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100910-PIP01-23-M03 (update)
  • ABEMACICLIB
  • Treatment of glioma
  • Verzenios
  • Verzenios
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100156-PIP01-21-M02 (update)
  • FLUOCINOLONE ACETONIDE
  • Treatment of non-infectious uveitis
  • Secondary prevention of non-infectious uveitis
  • ILUVIEN 190 micrograms intravitreal implant in applicator
  • ILUVIEN 190 micrograms intravitreal implant in applicator
  • ILUVIEN 190 Mikrogramm intravitreales Implantat im Applikator
  • ILUVIEN 190 microgrammes, implant intravitréen avec applicateur
  • ILUVIEN 190 mikrogramů intravitreální implantát v aplikátoru
  • ILUVIEN
  • Iluvien 190 mikrogrammaa, implantaatti silmän lasiaiseen, asetin
  • ILUVIEN 190 microgrammes, implant intravitréen avec applicateur
  • ILUVIEN 190 Mikrogramm intravitreales Implantat im Applikator
  • ILUVIEN 190 microgrammi impianto intravitreale in applicatore
  • ILUVIEN 190 microgrammes, implant intravitréen avec applicateur
  • ILUVIEN 190 microgram, intravitreaal implant in applicator
  • Iluvien 190 mikrogram intravitrealt implantat i applikator
  • ILUVIEN, 190 mikrogramów, implant do ciałka szklistego w aplikatorze
  • ILUVIEN 190 microgramas implante intravítreo em aplicador
  • ILUVIEN 190 microgramos implante intravítreo en aplicador
  • Iluvien 190 mikrogram intravitrealt implantat i applikator
  • ILUVIEN 190 micrograms intravitreal implant in applicator
  • Ophthamology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100093-PIP01-21-M05 (update)
  • UPADACITINIB
  • Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, psoriatic arthritis, spondyloarthritis and juvenile idiopathic arthritis).
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100579-PIP01-22-M04 (update)
  • Maribavir
  • Treatment of cytomegalovirus (CMV)
  • Livtencity
  • Livtencity
  • Livtencity
  • Livtencity
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101671-PIP01-24
  • PEGCETACOPLAN
  • Treatment of glomerulonephritis and nephrotic syndrome
  • ASPAVELI
  • ASPAVELI
  • Uro-Nephrology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-100325-PIP01-21-M02 (update)
  • NALDEMEDINE
  • Treatment of opioid induced constipation
  • Rizmoic
  • Rizmoic
  • SYMPROIC
  • SYMPROIC
  • SYMPROIC
  • Symproic 
  • Symproic 
  • Gastroenterology-Hepatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100209-PIP01-21-M02 (update)
  • survodutide
  • Treatment of obesity
  • Not available at present
  • Gastroenterology-Hepatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101489-PIP01-24-M01 (update)
  • Enlicitide (decanoate)
  • Treatment of hypercholesterolemia
  • Cardiovascular Diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101739-PIP01-24-M01 (update)
  • ASCORBIC ACID
  • MACROGOL 3350
  • POTASSIUM CHLORIDE
  • SODIUM ASCORBATE
  • SODIUM CHLORIDE
  • SODIUM SULPHATE
  • Bowel cleansing prior to clinical procedures
  • PLENVU
  • PLENVU® powder for oral solution
  • PLEINVUE™ Pulver zur Herstellung einer Lösung zum Einnehmen
  • PLENVU® powder for oral solution
  • PLENVU® powder for oral solution
  • Plenvu prašak za oralnu otopinu
  • PLENVU
  • PLENVU® powder for oral solution
  • PLENVU® powder for oral solution
  • PLENVU, poudre pour solution buvable
  • PLENVU® powder for oral solution
  • PLENVU por belsőleges oldathoz
  • PLENVU® powder for oral solution
  • PLENVU® powder for oral solution
  • PLENVU® powder for oral solution
  • PLENVU
  • Pleinvue™ powder for oral solution
  • PLENVU
  • PLENVU® powder for oral solution
  • PLENVU
  • PLENVU® powder for oral solution
  • Plenvu pulbere pentru soluție orală
  • PLENVU
  • Plenvu prašek za peroralno raztopino
  • PLENVU Powder
  • Pleinvue polvo para solución oral
  • PLENVU
  • Plenvu, Pulver
  • PLENVU
  • PLENVU® powder for oral solution
  • PLENVU
  • PLENVU Powder for oral solution
  • PLENVU Powder for oral solution
  • PLENVU, POLVO PARA SOLUCIÓN ORAL
  • PLENVU, POLVO PARA SOLUCIÓN ORAL
  • PLENVU, POLVO PARA SOLUCIÓN ORAL
  • PLENVU POLVO PARA SOLUCIÓN ORAL
  • PLENVU, POLVO PARA SOLUCIÓN ORAL
  • PLENVU, POLVO PARA SOLUCIÓN ORAL
  • PLENVU, powder for oral solution
  • PLENVU
  • Gastroenterology-Hepatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No