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Displaying 541 - 560 of 669
PIPS Search Results
PIP Number Active Substance Sort descending Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published
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-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-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-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-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-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-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-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-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-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-100807-PIP01-22-M02 (update)
  • RIMEGEPANT SULFATE
  • Treatment of migraine headaches
  • Vydura
  • Vydura
  • Vydura
  • Vydura
  • Vydura
  • Nurtec ODT
  • Nurtec ODT
  • Nurtec ODT
  • Nurtec ODT
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/04/2024
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-100690-PIP01-22-M01 (update)
  • IMIPENEM MONOHYDRATE
  • CILASTATIN SODIUM
  • RELEBACTAM MONOHYDRATE
  • Treatment of infections caused by gram-negative organisms.
  • RECARBRIO
  • RECARBRIO
  • RECARBRIO
  • RECARBRIO
  • RECARBRIO
  • RECARBRIO
  • RECARBRIO
  • RECARBRIO
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 24/08/2023
MHRA-100301-PIP02-22
  • Nipocalimab
  • Treatment of Bullous Pemphigoid
  • Dermatology
W: decision granting a waiver in all age groups for the listed condition(s). No 24/08/2023
MHRA-100301-PIP03-23
  • Nipocalimab
  • Treatment of Sjögren’s syndrome
  • Immunology -Rheumatology-Transplantation
W: decision granting a waiver in all age groups for the listed condition(s). No 19/12/2023
MHRA-100301-PIP04-23
  • Nipocalimab
  • Treatment of chronic inflammatory demyelinating polyradiculoneuropathy
  • Neurology
W: decision granting a waiver in all age groups for the listed condition(s). No 19/12/2023
MHRA-100801-PIP01-22
  • eplontersen
  • Treatment of transthyretin-mediated amyloidosis
  • Not available at present
  • Neurology
W: decision granting a waiver in all age groups for the listed condition(s). No 24/08/2023
MHRA-100776-PIP01-22-M01 (update)
  • Nemolizumab
  • Treatment of atopic dermatitis.
  • Not yet defined
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 24/08/2023
MHRA-100212-PIP01-21-M02 (update)
  • FINERENONE
  • Treatment of Chronic Kidney Disease
  • Kerendia
  • Kerendia
  • Uro-Nephrology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 24/08/2023
MHRA-100786-PIP01-22-M01 (update)
  • TOFACITINIB CITRATE
  • Treatment of ulcerative colitis
  • XELJANZ
  • XELJANZ
  • XELJANZ
  • XELJANZ
  • XELJANZ
  • XELJANZ
  • XELJANZ
  • XELJANZ
  • XELJANZ
  • XELJANZ
  • XELJANZ
  • Gastroenterology-Hepatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 24/08/2023