Displaying 1 - 20 of 950
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
MHRA-102165-PIP01-25
  • adeno-associated viral vector serotype Anc80 containing the 5' portion of human OTOF gene
  • adeno-associated viral vector serotype Anc80 containing the 3' portion of human OTOF gene
  • Treatment of otoferlin gene-mediated hearing loss
  • Oto-Rhino-Laryngology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes
MHRA-102170-PIP01-25-M01 (update)
  • asciminib hydrochloride
  • Treatment of chronic myeloid leukaemia.
  • Scemblix
  • Haematology-Hemostaseology
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100865-PIP01-23-M02 (update)
  • RILPIVIRINE
  • Treatment of human immunodeficiency virus (HIV-1) infection
  • REKAMBYS
  • REKAMBYS
  • REKAMBYS
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100355-PIP02-22-M01 (update)
  • Fenebrutinib
  • Treatment of Multiple Sclerosis
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100140-PIP01-21-M01 (update)
  • BENRALIZUMAB
  • Treatment of Hypereosinophilic syndrome (HES)
  • FASENRA
  • FASENRA PEN
  • FASENRA
  • FASENRA
  • FASENRA
  • FASENRA PEN
  • FASENRA
  • FASENRA
  • FASENRA
  • FASENRA
  • FASENRA
  • FASENRA
  • Other: Respiratory, thoracic and mediastinal disorders, Immune system disorders
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-102113-PIP01-25
  • aglatimagene besadenovec
  • Treatment of prostate cancer
  • Treatment of Non-small cell lung cancer
  • Treatment of Pancreatic cancer
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-102051-PIP01-25
  • Veligrotug
  • Treatment of thyroid eye disease
  • Endocrinology-Gynaecology-Fertility-metabolism
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-102031-PIP01-25
  • resmetirom
  • Treatment of metabolic dysfunction-associated steatohepatitis
  • Rezdiffra
  • Rezdiffra
  • Gastroenterology-Hepatology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes Partial Compliance Check Granted
MHRA-101982-PIP01-25
  • obicetrapib
  • Treatment of elevated cholesterol
  • Ubeslo
  • Cardiovascular Diseases
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101519-PIP01-24
  • Mezagitamab
  • Treatment of Immune thrombocytopenia
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
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