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Displaying 41 - 60 of 1047
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
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
MHRA-101185-PIP01-23
  • gefurulimab
  • Treatment of myasthenia gravis
  • Neurology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101430-PIP01-24
  • RAVULIZUMAB
  • Treatment in haematopoietic stem cell transplant
  • Ultomiris
  • Ultomiris
  • Ultomiris
  • Ultomiris
  • Ultomiris
  • Uro-Nephrology
  • Haematology-Hemostaseology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101417-PIP01-24
  • Plozasiran (USAN)(synthetic double-stranded siRNA oligonucleotide directed against apolipoprotein C-III mRNA and covalently linked to a ligand containing three N-acetylgalactosamine residues)
  • Familial chylomicronaemia syndrome (FCS)
  • Redemplo
  • Cardiovascular Diseases
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-100734-PIP01-22
  • tideglusib
  • Treatment of myotonic dystrophy
  • Neurology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-100851-PIP01-23 -M01 (update)
  • NEISSERIA MENINGITIDIS GROUP C POLYSACCHARIDE CONJUGATED TO TETANUS TOXOID CARRIER PROTEIN
  • NEISSERIA MENINGITIDIS GROUP A POLYSACCHARIDE CONJUGATED TO TETANUS TOXOID CARRIER PROTEIN
  • NEISSERIA MENINGITIDIS GROUP W-135 POLYSACCHARIDE CONJUGATED TO TETANUS TOXOID CARRIER PROTEIN
  • NEISSERIA MENINGITIDIS GROUP Y POLYSACCHARIDE CONJUGATED TO TETANUS TOXOID CARRIER PROTEIN
  • Recombinant Neisseria meningitidis serogroup B protein 1
  • Recombinant Neisseria meningitidis serogroup B protein 2
  • Recombinant Neisseria meningitidis serogroup B Protein-based active substance
  • Recombinant Neisseria meningitidis serogroup B protein 3
  • Prevention of meningococcal disease (serogroups A, B, C, W and Y)
  • Vaccines
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100129-PIP01-21-M02 (update)
  • Cipaglucosidase alfa
  • Treatment of glycogen storage disease Type II (Pompe's disease)
  • Pombiliti
  • Pombilti
  • Pombiliti
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101694-PIP01-24
  • Human IgG1 monoclonal antibody targeting amyloid transthyretin
  • Treatment of transthyretin-mediated amyloidosis
  • Neurology
  • Cardiovascular Diseases
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100823-PIP01-22-M03 (update)
  • Recombinant Human A Disintegrin and Metalloprotease with Thrombospondin Type-1 Motifs 13 (rADAMTS13)
  • Treatment of thrombotic thrombocytopenic purpura
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. No