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Displaying 681 - 700 of 828
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
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
MHRA-100557-PIP01-22-M01 (update)
  • Hepatitis B (rDNA) surface antigen adjuvanted
  • Prevention of hepatitis B virus infection
  • HEPLISAV B
  • HEPLISAV-B
  • HEPLISAV-B
  • HEPLISAV B
  • Vaccines
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100501-PIP01-22-M01 (update)
  • INOTUZUMAB OZOGAMICIN
  • Treatment of B cell acute lymphoblastic leukaemia
  • Besponsa
  • Besponsa
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100028-PIP01-21-M01 (update)
  • TIXAGEVIMAB
  • CILGAVIMAB
  • Prevention of Coronavirus Disease 2019 (COVID-19)
  • Treatment of COVID-19
  • Evusheld
  • Evusheld
  • Evusheld
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100511-PIP01-22-M01 (update)
  • GUSELKUMAB
  • Treatment of Crohn's disease
  • TREMFYA
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100476-PIP01-22
  • Anti-(alpha-synuclein) human monoclonal antibody
  • Treatment of Multiple System Atrophy
  • Treatment of Parkinson's Disease
  • Neurology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100481-PIP01-22
  • TUCATINIB
  • Treatment of solid tumours
  • Tukysa
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100404-PIP01-21
  • insulin icodec
  • SEMAGLUTIDE
  • Treatment of type 2 diabetes mellitus
  • Endocrinology-Gynaecology-Fertility-metabolism
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100365-PIP01-21
  • Batiraxcept
  • Treatment of Ovarian cancer
  • Treatment of Fallopian tube cancer
  • Treatment of Primary peritoneal cancer
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100395-PIP01-21
  • TALAZOPARIB TOSYLATE
  • Treatment of breast malignant neoplasms
  • Treatment of prostate malignant neoplasms
  • Talzenna
  • Talzenna
  • Talzenna
  • Talzenna
  • Talzenna
  • Talzenna
  • Psychiatry
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100366-PIP01-21
  • Cevostamab
  • Treatment of multiple myeloma
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100383-PIP01-21
  • TRASTUZUMAB DERUXTECAN
  • Treatment of lung cancer
  • Enhertu
  • Enhertu
  • Enhertu
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100441-PIP01-22-M01 (update)
  • Delandistrogene moxeparvovec
  • Treatment of Duchenne Muscular Dystrophy (DMD)
  • Elevidys
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100408-PIP01-21-M01 (update)
  • Hepatitis B (rDNA) surface antigen adjuvanted
  • Prevention of hepatitis B virus infection
  • HEPLISAV B
  • Vaccines
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100333-PIP01-21-M01 (update)
  • MIRABEGRON
  • Treatment of neurogenic detrusor overactivity
  • BETMIGA
  • BETMIGA
  • MYRBETRIQ / MYRBETRIQ GRANULES
  • Uro-Nephrology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100329-PIP01-21-M01 (update)
  • EDOXABAN TOSYLATE
  • Treatment of venous thromboembolism
  • Prevention of arterial thromboembolism
  • Prevention of Venous thromboembolism
  • Lixiana film-coated tablets
  • Lixiana
  • Cardiovascular Diseases
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100302-PIP01-21-M01 (update)
  • CRIZANLIZUMAB
  • Treatment of sickle cell disease
  • Adakveo® 10 mg/ml concentrate for solution for infusion
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100296-PIP01-21-M01 (update)
  • palovarotene
  • Treatment of fibrodysplasia ossificans progressiva
  • SOHONOS
  • Other: Musculo-skeletal
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100211-PIP01-21-M01 (update)
  • VOLANESORSEN SODIUM
  • Treatment of familial chylomicronemia syndrome
  • WAYLIVRA
  • WAYLIVRA
  • Gastroenterology-Hepatology
  • Cardiovascular Diseases
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100401-PIP01-21
  • Humanised IgG2k Fc-modified bispecific antibody against CD3 and BCMA (PF-06863135)
  • Treatment of multiple myeloma
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No