Displaying 161 - 180 of 692
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
MHRA-100268-PIP01-21-M02 (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 24/08/2023
MHRA-100844-PIP01-23-M01 (update)
  • IVACAFTOR
  • Treatment of cystic fibrosis.
  • Kalydeco
  • Kalydeco
  • Kalydeco
  • Kalydeco
  • Kalydeco
  • Kalydeco
  • Kalydeco
  • Other: Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted 24/08/2023
MHRA-100750-PIP01-22-M01 (update)
  • setrusumab
  • Treatment of osteogenesis imperfecta
  • Other: Skeletal
PM: decision on the application for modification of an agreed paediatric investigation plan. No 24/08/2023
MHRA-100276-PIP01-21-M02 (update)
  • BRODALUMAB
  • Treatment of psoriasis
  • Kyntheum
  • Lumicef
  • Siliq
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 24/08/2023
MHRA-100177-PIP01-21-M02 (update)
  • INFLUENZA A/ (H1N1)-LIKE VIRUS ANTIGEN
  • INFLUENZA A/ (H3N2)-LIKE VIRUS ANTIGEN
  • INFLUENZA B/VICTORIA/2/87-LIKE VIRUS ANTIGEN
  • INFLUENZA B/YAMAGATA/16/88-LIKE VIRUS ANTIGEN
  • Prevention of Influenza
  • FLUCELVAX TETRA
  • Cell-based Quadrivalent Influenza Vaccine (Surface Antigen, Inactivated) Seqirus suspension for injection in pre-filled syringe
  • FLUCELVAX TETRA
  • Vaccines
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 24/08/2023
MHRA-100807-PIP01-22-M01 (update)
  • RIMEGEPANT SULFATE
  • Treatment of migraine headaches
  • Vydura
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 24/08/2023
MHRA-100687-PIP01-22-M01 (update)
  • OBINUTUZUMAB
  • Treatment of systemic lupus erythematosus
  • Gazyvaro
  • Gazyvaro
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 24/08/2023
MHRA-100297-PIP01-21-M01 (update)
  • Human, recombinant, non-fucosylated IgG1k monoclonal antibody targeting OX-40 receptor on activated T cells (rocatinlimab)
  • Treatment of atopic dermatitis
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 24/08/2023
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-100738-PIP01-22
  • PEMIGATINIB
  • Treatment of myeloid/lymphoid neoplasms with eosinophilia and gene rearrangement
  • Pemazyre
  • Pemazyre
  • Pemazyre
  • Pemazyre
  • Pemazyre
  • Pemazyre
  • Pemazyre
  • Pemazyre
  • Pemazyre
  • Pemazyre
  • Pemazyre
  • Pemazyre
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(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