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Displaying 21 - 40 of 159
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
MHRA-100796-PIP01-22
  • Single-stranded 5' capped mRNA encoding the Respiratory syncytial virus glycoprotein F stabilized in the prefusion conformation
  • Prevention of lower respiratory tract illness (LRTI) caused by respiratory syncytial virus (RSV)
  • Not available at present
  • Vaccines
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 19/12/2023
MHRA-100573-PIP01-22
  • Vorasidenib
  • Treatment of glioma
  • Oncology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 19/12/2023
MHRA-100673-PIP01-22
  • Fidrisertib
  • Treatment of fibrodysplasia ossificans progressiva
  • Other: Musculoskeletal
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 19/12/2023
MHRA-100731-PIP01-22
  • deucravacitinib
  • Treatment of systemic lupus erythematosus
  • SOTYKTU
  • SOTYKTU
  • SOTYKTU
  • SOTYKTU
  • Immunology -Rheumatology-Transplantation
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 19/12/2023
MHRA-100741-PIP01-22
  • CRISANTASPASE
  • Treatment of acute lymphoblastic leukaemia
  • Treatment of lymphoblastic lymphoma
  • Enrylaze
  • Rylaze
  • Oncology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes Full Compliance Check Granted 19/12/2023
MHRA-100679-PIP01-22
  • Talazoparib
  • Treatment of Ewing Sarcoma
  • Talzenna
  • Talzenna
  • Talzenna
  • Talzenna
  • Talzenna
  • Talzenna
  • Talzenna
  • Talzenna
  • Talzenna
  • Oncology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 03/10/2023
MHRA-100824-PIP01-22
  • perflubutane
  • Diagnostic evaluation of focal hepatic lesions
  • Sonazoid
  • Sonazoid
  • Sonazoid
  • Sonazoid
  • Sonazoid
  • Sonazoid
  • Sonazoid
  • Diagnostic
  • Oncology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 24/08/2023
MHRA-100820-PIP01-22
  • Tirzepatide
  • Treatment of obesity
  • Mounjaro
  • Other: Obesity, Overweight
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 24/08/2023
MHRA-100670-PIP01-22
  • Ibrexafungerp citrate
  • Treatment of invasive candidiasis
  • Brexafemme
  • Infectious diseases
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 24/08/2023
MHRA-100430-PIP01-22
  • ±3,4-methylenedioxymethamphetamine hydrochloride (MDMA)
  • Treatment of post-traumatic stress disorder
  • Not available at present
  • Psychiatry
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 24/08/2023
MHRA-100612-PIP01-22
  • Fosmanogepix
  • Treatment of invasive fungal infections
  • Infectious diseases
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 24/08/2023
MHRA-100118-PIP02-22
  • OCRELIZUMAB
  • Treatment of Multiple Sclerosis
  • Ocrevus
  • Ocrevus
  • Ocrevus
  • Neurology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 24/08/2023
MHRA-100788-PIP01-22
  • favezelimab
  • PEMBROLIZUMAB
  • Treatment of Hodgkin lymphoma
  • Not availble at present
  • Oncology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 24/08/2023
MHRA-100513-PIP01-22
  • efgartigimod alfa
  • Treatment of dermatomyositis
  • Treatment of immune-mediated necrotizing myopathy
  • Treatment of polymyositis (including antisynthetase syndrome)
  • Immunology -Rheumatology-Transplantation
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 24/08/2023
MHRA-100721-PIP01-22
  • Recombinant fusion protein linking iduronate 2-sulfatase to engineered Fc with binding site for transferrin receptor (DNL310)
  • Treatment of mucopolysaccharidosis II (Hunter syndrome)
  • Endocrinology-Gynaecology-Fertility-metabolism
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 24/08/2023
MHRA-100424-PIP01-22
  • zilebesiran sodium
  • Treatment of hypertension
  • Cardiovascular Diseases
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 24/08/2023
MHRA-100966-PIP01-23
  • COVID-19 Vaccine (recombinant, adjuvanted)
  • Prevention of coronavirus disease 2019 (COVID-19)
  • Not available at present
  • Vaccines
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 24/08/2023
MHRA-100578-PIP01-22
  • Cagrilintide
  • SEMAGLUTIDE
  • Treatment of obesity
  • Not available at present
  • Endocrinology-Gynaecology-Fertility-metabolism
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 24/08/2023
MHRA-100719-PIP01-22
  • LUTETIUM (177LU) OXODOTREOTIDE
  • Treatment of gastroenteropancreatic neuroendocrine tumours
  • Lutathera 370 MBq/mL solution for infusion
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Oncology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 30/06/2023
MHRA-100110-PIP02-22
  • Yellow fever virus, strain vYF-247
  • Prevention of yellow fever disease
  • Vaccines
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 30/06/2023