Displaying 1 - 20 of 943
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
MHRA-101824-PIP01-25
  • AAV8-RK-AIPL1
  • Treatment of Leber congenital amaurosis
  • Not available at present
  • Ophthamology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes Partial Compliance Check Granted
MHRA-100910-PIP01-23-M04 (update)
  • ABEMACICLIB
  • Treatment of glioma
  • Abemaciclib
  • Verzenios
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-102076-PIP01-25
  • EMICIZUMAB
  • Treatment of von Willebrand Disease.
  • Hemlibra
  • Hemlibra
  • Hemlibra
  • Hemlibra
  • Hemlibra
  • Hemlibra
  • Hemlibra
  • Hemlibra
  • Hemlibra
  • Haematology-Hemostaseology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-100885-PIP01-23-M01 (update)
  • IPTACOPAN HYDROCHLORIDE MONOHYDRATE
  • Treatment of paroxysmal nocturnal haemoglobinuria (PNH)
  • Fabhalta
  • Fabhalta
  • Fabhalta
  • Fabhalta
  • Fabhalta
  • Fabhalta
  • Fabhalta
  • Fabhalta
  • Fabhalta
  • Fabhalta
  • Fabhalta
  • Fabhalta
  • Fabhalta
  • Fabhalta
  • Fabhalta
  • Fabhalta
  • Fabhalta
  • Fabhalta
  • Fabhalta
  • Fabhalta
  • Fabhalta
  • Haematology-Hemostaseology
  • Other: Complement inhibitor
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-102164-PIP01-25
  • ZANUBRUTINIB
  • Treatment of lymphoplasmacytic lymphoma
  • Treatment of mature B-Cell neoplasms (excluding lymphoplasmacytic lymphoma)
  • Brukinsa
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101772-PIP01-24
  • Mezagitamab
  • Treatment of primary immunoglobulin A nephropathy
  • Not available at present
  • Haematology-Hemostaseology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101389-PIP01-24-M01 (update)
  • omaveloxolone
  • Treatment of Friedreich’s ataxia
  • Skyclarys 50mg Hard capsules
  • Skyclarys 50mg Hard capsules
  • Skyclarys 50mg Hard capsules
  • Other: Neuromuscular
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101959-PIP01-25-M01 (update)
  • Brincidofovir
  • Treatment of adenovirus infection in immunocompromised patients
  • Not available at present
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-102190-PIP01-25
  • RANIBIZUMAB
  • Treatment of age-related macular degeneration and diabetic macular oedema
  • Susvimo
  • Susvimo
  • Susvimo
  • Susvimo
  • Susvimo
  • Susvimo
  • Susvimo
  • Susvimo
  • Susvimo
  • Ophthamology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100297-PIP01-21-M05 (update)
  • Rocatinlimab
  • Treatment of atopic dermatitis
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes
MHRA-100412-PIP01-22-M04 (update)
  • vadadustat
  • Treatment of anaemia due to chronic disorders.
  • VAFSEO
  • Haematology-Hemostaseology
  • Other: Anti-anaemic preparations
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101996-PIP01-25
  • Trilaciclib
  • Prevention of chemotherapy-induced myelosuppression in small-cell lung cancer
  • Not available at present
  • Cosela®
  • Cosela®
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100238-PIP01-21-M03 (update)
  • AVELUMAB
  • Treatment of malignant neoplasms (except central nervous system tumours, haematopoietic and lymphoid tissue neoplasms)
  • Treatment of malignant neoplasms of the central nervous system
  • Treatment of malignant neoplasms of the lymphoid tissue.
  • Bavencio
  • Bavencio
  • Bavencio
  • Bavencio
  • Bavencio
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101417-PIP01-24-M01 (update)
  • Plozasiran (USAN) (synthetic double-stranded siRNA oligonucleotide directed against apolipoprotein C-III mRNA and covalently linked to a ligand containing three N-acetylgalactosamine residues)
  • Treatment of hypertriglyceridaemia
  • Redemplo
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101758-PIP01-24-M01 (update)
  • deuruxolitinib
  • Treatment of alopecia areata.
  • LEQSELVI
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-102032-PIP01-25-M01 (update)
  • Neisseria meningitidis group B fHBP protein subfamily A
  • Neisseria meningitidis group B fHBP protein subfamily B
  • Prevention of invasive meningococcal disease caused by Neisseira meningitidis serogroup B
  • Trumenba
  • Trumenba
  • Trumenba
  • Vaccines
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes
MHRA-101813-PIP01-25
  • Islatravir
  • LENACAPAVIR SODIUM
  • Treatment of human immunodeficiency virus-1 (HIV-1) infection
  • Infectious diseases
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101712-PIP01-24
  • Tebipenem pivoxil (as the hydrobromide salt)
  • Treatment of urinary tract infection
  • Not available at present
  • Infectious diseases
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101913-PIP01-25
  • antisense oligonucleotide against patatin like phospholipase domain containing protein 3 gene (PNPLA3), conjugated to N-acetylgalactosamine (AZD2693), sodium salt
  • Treatment of metabolic dysfunction-associated steatohepatitis (MASH)
  • Not available at present
  • Gastroenterology-Hepatology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101893-PIP01-25
  • eneboparatide
  • Treatment of hypoparathyroidism
  • Endocrinology-Gynaecology-Fertility-metabolism
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No