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PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published
MHRA-100604-PIP01-22-M01 (update)
  • REMDESIVIR
  • Treatment of coronavirus disease 2019 (COVID-19)
  • VEKLURY
  • VEKLURY
  • VEKLURY
  • Infectious diseases
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes 02/02/2023
MHRA-100272-PIP01-21-M01 (update)
  • EMPAGLIFLOZIN
  • Treatment of Type 2 Diabetes Mellitus
  • Jardiance
  • Jardiance
  • Endocrinology-Gynaecology-Fertility-metabolism
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes 02/02/2023
MHRA-100406-PIP01-21-M01 (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 02/02/2023
MHRA-100471-PIP01-22-M01 (update)
  • SETMELANOTIDE
  • Treatment of appetite and general nutrition disorders
  • IMCIVREE
  • IMCIVREE
  • IMCIVREE
  • IMCIVREE
  • Nutrition
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 02/02/2023
MHRA-100118-PIP01-21-M02 (update)
  • OCRELIZUMAB
  • Treatment of Multiple Sclerosis
  • Ocrevus
  • Ocrevus
  • Neurology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 02/02/2023
MHRA-100093-PIP01-21-M02 (update)
  • UPADACITINIB
  • Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, psoriatic arthritis, spondyloarthritis and juvenile idiopathic arthritis)
  • Immunology -Rheumatology-Transplantation
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 02/02/2023
MHRA-100579-PIP01-22-M02 (update)
  • Maribavir
  • Treatment of cytomegalovius (CMV) infection
  • Livtencity
  • Livtencity
  • Infectious diseases
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 02/02/2023
MHRA-100579-PIP01-22-M01 (update)
  • Maribavir
  • Treatment of cytomegalovius (CMV) infection
  • Livtencity
  • Livtencity
  • Infectious diseases
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 02/02/2023
MHRA-100695-PIP01-22-M01 (update)
  • Etranacogene dezaparvovec
  • Treatment of haemophilia B
  • Hemgenix
  • Haematology-Hemostaseology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 02/02/2023
MHRA-100418-PIP01-22-M01 (update)
  • axicabtagene ciloleucel
  • Treatment of mature B-cell neoplasms
  • Yescarta
  • Yescarta
  • Yescarta
  • Yescarta
  • Yescarta
  • Yescarta
  • Yescarta
  • Yescarta
  • Oncology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 02/02/2023
MHRA-100087-PIP01-21-M02 (update)
  • LACOSAMIDE
  • Treatment of generalised epilepsy and epileptic syndromes.
  • Neurology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 02/02/2023
MHRA-100297-PIP01-21
  • Human, recombinant, non-fucosylated IgG1k monoclonal antibody targeting OX-40 receptor on activated T cells (AMG 451)
  • Treatment of atopic dermatitis
  • Dermatology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 02/02/2023
MHRA-100376-PIP01-21-M01 (update)
  • VEDOLIZUMAB
  • Treatment of Crohn's disease
  • Treatment of Ulcerative colitis
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Gastroenterology-Hepatology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 22/12/2022
MHRA-100254-PIP01-21-M01 (update)
  • epcoritamab
  • Treatment of mature B-cell malignancies
  • Not available at present
  • Oncology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 07/12/2022
MHRA-100053-PIP01-21 -M02 (update)
  • IMDEVIMAB
  • Treatment of coronavirus disease 2019 (COVID-19)
  • Prevention of Coronavirus Disease 2019 (COVID-19)
  • Ronapreve
  • Ronapreve
  • Ronapreve
  • Ronapreve
  • Ronapreve
  • Infectious diseases
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 07/12/2022
MHRA-100052-PIP01-21-M02 (update)
  • CASIRIVIMAB
  • Treatment of coronavirus disease 2019 (COVID-19)
  • Prevention of coronavirus disease 2019 (COVID-19)
  • Ronapreve
  • Ronapreve
  • Ronapreve
  • Ronapreve
  • Ronapreve
  • Infectious diseases
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 07/12/2022
MHRA-100507-PIP01-22-M02 (update)
  • BREXPIPRAZOLE
  • Treatment of schizophrenia
  • RXULTI
  • RXULTI
  • Psychiatry
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 07/12/2022
MHRA-100600-PIP01-22-M01 (update)
  • Modified Vaccinia Ankara - Bavarian Nordic virus (smallpox)
  • Prevention of smallpox, monkeypox, related orthopoxvirus infection and disease
  • Imvanex
  • Imvamune
  • Jynneos
  • Vaccines
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 07/12/2022
MHRA-100623-PIP01-22-M01 (update)
  • NIRAPARIB TOSYLATE MONOHYDRATE
  • Treatment of all conditions included in the category of malignant neoplasms (except haematopoietic and lymphoid malignancies).
  • Zejula
  • Zejula
  • Zejula
  • Zejula
  • Oncology
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 07/12/2022
MHRA-100608-PIP01-22-M01 (update)
  • mitapivat
  • Treatment of pyruvate kinase deficiency
  • PYRUKYND
  • PYRUKYND
  • Haematology-Hemostaseology
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 07/12/2022
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