Displaying 81 - 100 of 773
PIPS Search Results
PIP Number Active Substance Sort ascending Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published
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-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-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-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-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-100079-PIP01-21-M03 (update)
  • GILTERITINIB FUMARATE
  • Treatment of acute myeloid leukaemia (AML)
  • Xospata
  • Xospata
  • Haematology-Hemostaseology
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/04/2024
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-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-100910-PIP01-23-M01 (update)
  • ABEMACICLIB
  • Treatment of glioma
  • Treatment of neuroblastoma
  • Verzenios
  • Verzenios
  • Verzenios
  • Oncology
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
MHRA-100066-PIP01-21-M01 (update)
  • efgartigimod alfa
  • Treatment of myasthenia gravis
  • Vyvgart
  • Vyvgart
  • Vyvgart
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-100818-PIP01-22-M01 (update)
  • BEMPEDOIC ACID
  • Treatment of elevated cholesterol
  • Nilemdo® (bempedoic acid) tablets
  • Nilemdo® (bempedoic acid) film-coated tablets
  • Nilemdo® (bempedoic acid) film-coated tablets
  • Nexletol® (bempedoic acid) tablets
  • Nilemdo®
  • Nilemdo®
  • Nilemdo®
  • Nexletol®
  • Nilemdo®
  • Cardiovascular Diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-100907-PIP01-23-M01 (update)
  • CEFTOLOZANE
  • TAZOBACTAM
  • Treatment of pneumonia
  • ZERBAXA
  • ZERBAXA
  • ZERBAXA
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-101079-PIP01-23-M01 (update)
  • ZANUBRUTINIB
  • Treatment of lymphoplasmacytic lymphoma
  •  Treatment of mature B-cell neoplasms (excluding lymphoplasmacytic lymphoma)
  • Brukinsa
  • Brukinsa
  • Brukinsa
  • Brukinsa
  • Brukinsa
  • Brukinsa
  • Brukinsa
  • Brukinsa
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 19/12/2023
MHRA-100931-PIP01-23-M01 (update)
  • mirikizumab
  • Treatment of ulcerative colitis
  • Treatment of Crohn's disease
  • Gastroenterology-Hepatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-100758-PIP01-22-M01 (update)
  • BEZLOTOXUMAB
  • Prevention of recurrence of Clostridioides difficile infection
  • ZINPLAVA
  • ZINPLAVA
  • ZINPLAVA
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-101023-PIP01-23-M01 (update)
  • ganaxolone
  • Treatment of cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder
  • ZTALMY
  • ZTALMY
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-101023-PIP01-23-M02 (update)
  • ganaxolone
  • Treatment of cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 19/12/2023