Displaying 21 - 40 of 887
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
MHRA-100991-PIP01-23-M01 (update)
  • Maralixibat chloride
  • Progressive familial intrahepatic cholestasis (PFIC)
  • LIVMARLI
  • LIVMARLI
  • LIVMARLI
  • LIVMARLI
  • LIVMARLI
  • LIVMARLI
  • LIVMARLI
  • LIVMARLI
  • LIVMARLI
  • LIVMARLI
  • Gastroenterology-Hepatology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes 15/08/2024
MHRA-100262-PIP01-21-M02 (update)
  • DALBAVANCIN HYDROCHLORIDE
  • Treatment of acute bacterial skin and skin structure infections (ABSSSI)
  • Xydalba
  • Xydalba
  • Xydalba
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 15/08/2024
MHRA-100701-PIP01-22-M02 (update)
  • Recombinant Neisseria meningitis group B Protein 936-741
  • Meningococcal group W-135 oligosaccharides conjugated to Corynebacterium diptheriae CRM197 protein
  • Meningococcal group A oligosaccharides conjugated to Corynebacterium diptheriae CRM197 protein
  • Recombinant Neisseria meningitis group B Protein 287-953
  • Recombinant Neisseria meningitis group B Protein 961c
  • Meningococcal group Y oligosaccharides conjugated to Corynebacterium diptheriae CRM197 protein
  • Outer Membrane Vesicles (OMV) from N. meningitidis Strain NZ 98/254
  • Meningococcal group C oligosaccharides conjugated to Corynebacterium diphtheriae CRM197 protein
  • Prevention of meningococcal meningitis
  • Not available at present
  • Vaccines
PM: decision on the application for modification of an agreed paediatric investigation plan. No 15/08/2024
MHRA-100868-PIP01-23-M02 (update)
  • AFAMELANOTIDE
  • Treatment of erythropoietic protoporphyria (EPP)
  • SCENESSE
  • SCENESSE
  • SCENESSE
  • SCENESSE
  • SCENESSE
  • SCENESSE
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. No 15/08/2024
MHRA-100070-PIP01-21-M01 (update)
  • molnupiravir
  • Treatment of coronavirus disease 2019 (COVID-19)
  • Lagevrio
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 15/08/2024
MHRA-101362-PIP01-24-M01 (update)
  • ZANAMIVIR
  • Prevention of influenza
  • Treatment of influenza
  • Relenza (inhalation powder)
  • Dectova (solution for infusion)
  • Dectova
  • Dectova
  • Relenza
  • Relenza
  • Relenza
  • Relenza
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 15/08/2024
MHRA-101360-PIP01-24-M01 (update)
  • Purified Rabies virus, WISTAR PM/WI 38-1503-3M strain (inactivated)
  • Prevention of rabies viral infection
  • Vaccines
PM: decision on the application for modification of an agreed paediatric investigation plan. No 15/08/2024
MHRA-100218-PIP01-21-M01 (update)
  • DUPILUMAB
  • Chronic spontaneous urticaria
  • Dupixent
  • Dupixent
  • Dupixent
  • Dupixent
  • Dupixent
  • Dupixent
  • Dupixent
  • Dupixent
  • Dupixent
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 15/08/2024
MHRA-101404-PIP01-24
  • TRASTUZUMAB DERUXTECAN
  • Treatment of all conditions in the category of malignant neoplasms (except haematopoietic and lymphoid tissue neoplasms)
  • Enhertu
  • Enhertu
  • Oncology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 15/08/2024
MHRA-100823-PIP01-22-M02 (update)
  • Recombinant Human A Disintegrin and Metalloprotease with Thrombospondin Type-1 Motifs 13 (rADAMTS13)
  • Treatment of thrombotic thrombocytopenic purpura.
  • Not available at present
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 15/08/2024
MHRA-101359-PIP01-24
  • spesolimab
  • Treatment of Netherton syndrome
  • Spevigo
  • Spevigo
  • Spevigo
  • Spevigo
  • Spevigo
  • Spevigo
  • Spevigo
  • Spevigo
  • Spevigo
  • Spevigo
  • Spevigo
  • Spevigo
  • Spevigo
  • Spevigo
  • Spevigo
  • Spevigo
  • Spevigo
  • Dermatology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 15/08/2024
MHRA-101021-PIP01-23-M01 (update)
  • FILGOTINIB
  • Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, ankylosing spondylarthritis, psoriatic arthritis, and juvenile idiopathic arthritis)
  • Jyseleca
  • Jyseleca
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. No 15/08/2024
MHRA-100273-PIP03-24
  • Derivative of 6-[2-(pyridin-2- yl)phenoxy]methyl}- 1,2,3,4-tetrahydroisoquinoline
  • Treatment of portal hypertension
  • Not available at present
  • Gastroenterology-Hepatology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 15/08/2024
MHRA-101342-PIP01-24-M01 (update)
  • ESKETAMINE HYDROCHLORIDE
  • Treatment of major depressive disorder (MDD)
  • Spravato
  • Spravato
  • Psychiatry
PM: decision on the application for modification of an agreed paediatric investigation plan. No 15/08/2024
MHRA-101379-PIP01-24
  • Broadly neutralizing anti-HIV human monoclonal antibody (VH3810109)
  • Treatment of human immunodeficiency virus (HIV-1) infection
  • Not available at present
  • Infectious diseases
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 15/08/2024
MHRA-101385-PIP01-24
  • Valemetostat tosilate
  • Treatment of mature T-cell neoplasms
  • EZHARMIA
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 15/08/2024
MHRA-100543-PIP01-22-M03 (update)
  • DOLUTEGRAVIR
  • LAMIVUDINE
  • Treatment of Human Immunodeficiency virus type 1 (HIV-1) Infection
  • Dovato
  • Dovato
  • Dovato
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 15/08/2024
MHRA-101073-PIP01-23-M02 (update)
  • MIRABEGRON
  • Treatment of idiopathic overactive bladder.
  • BETMIGA
  • BETMIGA
  • Uro-Nephrology
W: decision granting a waiver in all age groups for the listed condition(s). No 15/08/2024
MHRA-101004-PIP01-23-M02 (update)
  • APIXABAN
  • Treatment of venous thromboembolism
  • Eliquis
  • Eliquis
  • Eliquis
  • Eliquis
  • Cardiovascular Diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 15/08/2024
MHRA-101123-PIP01-23-M02 (update)
  • BREXUCABTAGENE AUTOLEUCEL
  • Treatment of acute lymphoblastic leukaemia.
  • Tecartus
  • Brexucabtagene autoleucel
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 15/08/2024