Displaying 81 - 100 of 907
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
MHRA-101388-PIP01-24-M03 (update)
  • DARIDOREXANT HYDROCHLORIDE
  • Treatment of insomnia
  • QUVIVIQ
  • Psychiatry
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100291-PIP01-21-M02 (update)
  • imetelstat
  • Treatment of acute myeloid leukaemia (AML)
  • Treatment of myelodysplastic syndromes (MDS), including juvenile myelomonocytic leukaemia (JMML)
  • RYTELO
  • RYTELO
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100123-PIP01-21-M03 (update)
  • SARILUMAB
  • Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, spondylarthritis, psoriatic arthritis and juvenile idiopathic arthritis)
  • Kevzara
  • Kevzara
  • Kevzara
  • Kevzara
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100342-PIP01-21-M02 (update)
  • arimoclomol citrate
  • Treatment of Niemann-Pick disease type C
  • MIPLYFFA
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101812-PIP01-25
  • BICTEGRAVIR
  • LENACAPAVIR SODIUM
  • Treatment of Human Immunodeficiency virus type 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-101758-PIP01-24
  • deuruxolitinib
  • Treatment of alopecia areata
  • LEQSELVI
  • LEQSELVI
  • Other: immunosuppressant
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes
MHRA-101181-PIP01-23-M01 (update)
  • Amlitelimab
  • Treatment of atopic dermatitis
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100601-PIP01-22-M04 (update)
  • Elasomeran, davesomeran, andusomeran, mRNA-1273.167
  • imelasomeran
  • Prevention of Coronavirus Disease 2019 (COVID-2019)
  • Vaccines
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101769-PIP01-24
  • Olorofim
  • Treatment of invasive aspergillosis
  • Treatment of non-Aspergillus invasive mould infections
  • Infectious diseases
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101439-PIP01-24-M02 (update)
  • Tolebrutinib
  • Treatment of Multiple Sclerosis
  • Neurology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100075-PIP01-21-M03 (update)
  • leniolisib
  • Treatment of activated phosphoinositide 3-kinase delta (δ) syndrome (APDS)
  • Joenja
  • Joenja
  • Joenja
  • Joenja
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101915-PIP01-25
  • Patritumab deruxtecan
  • Treatment of breast malignant neoplasms
  • Not available at present
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101897-PIP01-25
  • doxecitine
  • doxribtimine
  • Treatment of thymidine kinase 2 deficiency
  • KYGEVVI
  • Endocrinology-Gynaecology-Fertility-metabolism
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes
MHRA-101881-PIP01-25
  • opevesostat
  • Treatment of prostate malignant neoplasms
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101844-PIP01-25
  • SEMAGLUTIDE
  • Prevention of peripheral arterial disease
  • Ozempic
  • Ozempic
  • Ozempic
  • Ozempic
  • Cardiovascular Diseases
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101825-PIP01-25
  • AZD6793
  • Treatment of chronic obstructive pulmonary disease (COPD)
  • Pneumology - Allergology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101816-PIP01-25
  • Nipocalimab
  • Prevention of foetal and neonatal alloimmune thrombocytopenia
  • Immunology -Rheumatology-Transplantation
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101800-PIP01-25
  • OMEPRAZOLE MAGNESIUM
  • AMOXICILLIN TRIHYDRATE
  • RIFABUTIN
  • Treatment of Helicobacter spp. infection
  • Talicia
  • Talicia
  • Talicia
  • Gastroenterology-Hepatology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101794-PIP01-25
  • evenamide
  • Treatment of schizophrenia
  • Psychiatry
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101785-PIP01-25
  • (R)-3-(1-cyclopropyl-3-(2-fluoro-4-(trifluoromethoxy)benzyl)ureido)piperidine-1-carboxamide (JNT- 517)
  • Treatment of hyperphenylalaninemia
  • Endocrinology-Gynaecology-Fertility-metabolism
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No