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Displaying 141 - 160 of 426
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
MHRA-100805-PIP01-22-M01 (update)
  • ATIDARSAGENE AUTOTEMCEL
  • Treatment of metachromatic leukodystrophy (MLD)
  • Libmeldy
  • Libmeldy
  • Libmeldy
  • Other: Lysosomal storage Disorder
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/06/2023
MHRA-100802-PIP01-22-M01 (update)
  • roxadustat
  • Treatment of anaemia due to chronic disorders
  • EVRENZO
  • EVRENZO
  • EVRENZO
  • EVRENZO
  • EVRENZO
  • EVRENZO
  • EVRENZO
  • EVRENZO
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/06/2023
MHRA-100727-PIP01-22-M01 (update)
  • ALPELISIB
  • Treatment of PIK3CA related overgrowth spectrum
  • Vijoice
  • Piqray
  • Vijoice
  • Other: Congenital, Hereditary, Neonatal Disease and Abnormalities
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/06/2023
MHRA-100716-PIP01-22-M01 (update)
  • RUXOLITINIB PHOSPHATE
  • Treatment of chronic Graft versus Host Disease
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 30/06/2023
MHRA-100544-PIP01-22-M01 (update)
  • sebetralstat
  • Treatment of hereditary angioedema
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/06/2023
MHRA-100515-PIP01-22-M01 (update)
  • VORTIOXETINE
  • Treatment of Major Depressive Disorder
  • Brintellix
  • Brintellix
  • Brintellix
  • Psychiatry
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes 30/06/2023
MHRA-100392-PIP01-21-M03 (update)
  • TOZINAMERAN
  • TOZINAMERAN/ FAMTOZINAMERAN
  • Prevention of coronavirus disease 2019 (COVID-19)
  • Comirnaty
  • Comirnaty concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
  • concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty concentrate for dispersion for injection; COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty concentrate for dispersion for injection; COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty concentrate for dispersion for injection; COVID-19 mRNA Vaccine (nucleoside modified)
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/06/2023
MHRA-100580-PIP01-22-M01 (update)
  • CEMIPLIMAB
  • Treatment of all conditions included in the category of malignant neoplasms (except haematopoietic and lymphoid tissue)
  • Libtayo
  • Cemiplimab
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/06/2023
MHRA-100195-PIP01-21-M02 (update)
  • BALOXAVIR MARBOXIL
  • Treatment of Influenza
  • Prevention of Influenza
  • Xofluza
  • Xofluza
  • Xofluza
  • Xofluza
  • Xofluza
  • Xofluza
  • Xofluza
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/06/2023
MHRA-100681-PIP01-22
  • Lomitapide
  • Treatment of (heterozygous or homozygous) familial hypercholesterolaemia
  • Lojuxta hard capsule
  • Other: Hypercholesterolaemia (HoFH)
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/06/2023
MHRA-100845-PIP01-23-M02 (update)
  • CABOTEGRAVIR
  • Prevention of human immunodeficiency virus (HIV-1) infection
  • N/A
  • VOCABRIA AND APRETUDE
  • Apretude
  • N/A
  • N/A
  • N/A
  • Apretude
  • Apretude
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted 20/06/2023
MHRA-100845-PIP01-23-M01 (update)
  • CABOTEGRAVIR
  • Prevention of human immunodeficiency virus (HIV-1) infection
  • VOCABRIA and CABENUVA
  • Apretude
  • APRETUDE
  • Apretude
  • VOCABRIA/APRETUDE
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 20/06/2023
MHRA-100567-PIP01-22-M01 (update)
  • Dinutuximab beta
  • Treatment of neuroblastoma
  • Qarziba
  • Qarziba
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 25/05/2023
MHRA-100312-PIP01-21-M01 (update)
  • Ritlecitinib
  • Treatment of alopecia areata
  • Litfulo
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 25/05/2023
MHRA-100283-PIP01-21-M02 (update)
  • USTEKINUMAB
  • Treatment of Crohn's disease
  • Stelara
  • Gastroenterology-Hepatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 25/05/2023
MHRA-100884-PIP01-23-M01 (update)
  • SACUBITRIL
  • VALSARTAN
  • Treatment of Heart failure
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Neparvis
  • Neparvis
  • Neparvis
  • Neparvis
  • Neparvis
  • Neparvis
  • Neparvis
  • Neparvis
  • Neparvis
  • Neparvis
  • Neparvis
  • Neparvis
  • Neparvis
  • Neparvis
  • Neparvis
  • Neparvis
  • Neparvis
  • Cardiovascular Diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted 25/05/2023
MHRA-100817-PIP01-22-M01 (update)
  • SIPONIMOD
  • Treatment of Multiple Sclerosis
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 25/05/2023
MHRA-100815-PIP01-22-M01 (update)
  • SIPONIMOD
  • Treatment of Multiple Sclerosis
  • Mayzent
  • Mayzent
  • Mayzent
  • Mayzent
  • Mayzent
  • Mayzent
  • Mayzent
  • Mayzent
  • Mayzent
  • Mayzent
  • Mayzent
  • Mayzent
  • Mayzent
  • Mayzent
  • Kiendra
  • Mayzent
  • Mayzent
  • Mayzent
  • Kiendra
  • Mayzent
  • Kiendra
  • Mayzent
  • Mayzent
  • Mayzent
  • Mayzent
  • Mayzent
  • Mayzent
  • Kiendra
  • Mayzent
  • Mayzent
  • Mayzent
  • Mayzent
  • Mayzent
  • Mayzent
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 25/05/2023
MHRA-100711-PIP01-22-M01 (update)
  • TISAGENLECLEUCEL
  • Treatment of B cell acute lymphoblastic leukaemia/lymphoblastic lymphoma
  • Kymriah 1.2 x 10^6 – 6 x 10^8 cells dispersion for infusion
  • Kymriah
  • Kymriah 1.2 x 106 – 6 x 108 cells dispersion for infusion
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 25/05/2023
MHRA-100361-PIP01-21-M02 (update)
  • GOLIMUMAB
  • Treatment of ulcerative colitis
  • Simponi
  • Gastroenterology-Hepatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 25/05/2023