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Displaying 41 - 60 of 599
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
MHRA-100985-PIP01-23-M01 (update)
  • BINIMETINIB
  • Treatment of melanoma
  • Mektovi
  • Mektovi
  • Mektovi
  • Mektovi
  • Mektovi
  • Mektovi
  • Mektovi
  • Mektovi
  • Mektovi
  • Mektovi
  • Mektovi
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-100093-PIP01-21-M03 (update)
  • UPADACITINIB
  • Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, psoriatic arthritis, spondyloarthritis and juvenile idiopathic arthritis)
  • Rinvoq
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-100406-PIP01-21-M02 (update)
  • Marstacimab
  • Treatment of congenital haemophilia A
  • Treatment of congenital haemophilia B
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-100249-PIP01-21-M02 (update)
  • BUDESONIDE
  • GLYCOPYRRONIUM BROMIDE
  • FORMOTEROL FUMARATE DIHYDRATE
  • Treatment of asthma
  • Trixeo Aerosphere
  • Trixeo Aerosphere
  • Trixeo Aerosphere
  • BREZTRI AEROSPHERE
  • Pneumology - Allergology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-100921-PIP01-23-M01 (update)
  • AVATROMBOPAG
  • Treatment of Idiopathic Thrombocytopenia Purpura
  • Treatment of Thrombocytopenic Purpura Secondary to Liver Disease
  • Doptelet
  • Avatrombopag
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-100934-PIP01-23-M01 (update)
  • CARFILZOMIB
  • Treatment of acute lymphoblastic leukaemia
  • Kyprolis
  • Kyprolis
  • Kyprolis
  • Kyprolis
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-100951-PIP01-23-M02 (update)
  • FOSTEMSAVIR TROMETHAMINE
  • Treatment of human immunodeficiency virus (HIV-1) infection
  • RUKOBIA
  • RUKOBIA
  • RUKOBIA
  • RUKOBIA
  • RUKOBIA
  • RUKOBIA
  • RUKOBIA
  • Rukobia 600 mg prolonged-release tablets
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-100951-PIP01-23-M01 (update)
  • FOSTEMSAVIR TROMETHAMINE
  • Treatment of human immunodeficiency virus (HIV-1) infection
  • RUKOBIA
  • RUKOBIA
  • RUKOBIA
  • RUKOBIA
  • Rukobia 600 mg prolonged-release tablets
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-100625-PIP01-22-M01 (update)
  • RISANKIZUMAB
  • Treatment of psoriasis
  • Skyrizi
  • Skyrizi
  • Skyrizi
  • Skyrizi
  • Gastroenterology-Hepatology
  • Immunology -Rheumatology-Transplantation
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-100303-PIP01-21-M02 (update)
  • DARUNAVIR
  • COBICISTAT
  • EMTRICITABINE
  • TENOFOVIR ALAFENAMIDE
  • Treatment of human immunodeficiency virus type-1 (HIV-1) infection
  • Symtuza
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-100409-PIP01-21-M01 (update)
  • autologous dendritic cells pulsed with autologous tumour cell lysate
  • Treatment of high grade glioma
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-100327-PIP01-21-M02 (update)
  • SELPERCATINIB
  • Treatment of all conditions included in the category of malignant neoplasms (except haematopoietic and lymphoid tissue neoplasms).
  • Retsevmo
  • Retsevmo
  • Retevmo
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-100222-PIP01-21-M02 (update)
  • romosozumab
  • Treatment of osteoporosis
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-101006-PIP01-23-M01 (update)
  • IMLIFIDASE
  • Prevention of graft rejection following solid organ transplantation
  • Idefirix
  • Idefirix
  • Idefirix
  • Idefirix
  • Idefirix
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-100079-PIP01-21-M02 (update)
  • GILTERITINIB FUMARATE
  • Treatment of acute myeloid leukemia
  • Xospata
  • Xospata
  • Haematology-Hemostaseology
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-100901-PIP01-23-M01 (update)
  • CABOTEGRAVIR
  • Treatment of human immunodeficiency virus (HIV-1) infection
  • Vocabria
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-100993-PIP01-23-M01 (update)
  • QUIZARTINIB DIHYDROCHLORIDE
  • Treatment of acute myeloid leukaemia (AML)
  • VANFLYTA
  • VANFLYTA
  • VANFLYTA
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-100288-PIP01-21-M02 (update)
  • DENOSUMAB
  • Treatment of osteoporosis
  • Prolia
  • Prolia
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-100469-PIP01-22-M01 (update)
  • delgocitinib
  • Treatment of chronic hand eczema
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-100909-PIP01-23-M01 (update)
  • ABEMACICLIB
  • Treatment of Ewing's sarcoma.
  • Verzenios
  • Verzenios
  • Verzenios
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023