Displaying 721 - 740 of 773
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort descending
MHRA-101118-PIP01-23
  • 5’-capped mRNA encoding HPV16 oncoprotein E6 5’-capped mRNA encoding HPV16 oncoprotein E7
  • Treatment of head and neck squamous cell carcinoma
  • Not available at present
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 30/04/2024
MHRA-100301-PIP05-23
  • Nipocalimab
  • Treatment of Idiopathic inflammatory myopathies
  • Immunology -Rheumatology-Transplantation
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 30/04/2024
MHRA-100300-PIP01-21-M03 (update)
  • DARUNAVIR
  • COBICISTAT
  • Treatment of human immunodeficiency virus (HIV-1) infection
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/04/2024
MHRA-101008-PIP01-23-M01 (update)
  • AMBRISENTAN
  • Pulmonary Arterial Hypertension
  • Volibris
  • Volibris
  • Cardiovascular Diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/04/2024
MHRA-101044-PIP01-23-M01 (update)
  • INCLISIRAN SODIUM
  • Treatment of elevated cholesterol
  • Leqvio
  • Leqvio
  • Leqvio
  • Leqvio
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/04/2024
MHRA-100068-PIP01-21-M02 (update)
  • VEDOLIZUMAB
  • Treatment of Pouchitis
  • Entyvio
  • Entyvio
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/04/2024
MHRA-100351-PIP01-21-M02 (update)
  • DOLUTEGRAVIR
  • RILPIVIRINE
  • Treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection.
  • Juluca 50mg/25mg film-coated tablets
  • JULUCA
  • JULUCA
  • JULUCA
  • JULUCA
  • JULUCA
  • JASUPA
  • JULUCA
  • JULUCA
  • JULUCA
  • JULUCA
  • JULUCA
  • JULUCA
  • JULUCA
  • JULUCA
  • JULUCA
  • JULUCA
  • JULUCA
  • JULUCA
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/04/2024
MHRA-100442-PIP01-22-M02 (update)
  • TALIMOGENE LAHERPAREPVEC
  • Treatment of melanoma
  • Imlygic
  • Imlygic
  • Imlygic
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted 30/04/2024
MHRA-100462-PIP01-22-M02 (update)
  • FENFLURAMINE HYDROCHLORIDE
  • Treatment of Dravet Syndrome
  • Fintepla
  • Fintepla
  • Fintepla
  • Fintepla
  • Fintepla
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/04/2024
MHRA-100468-PIP01-22-M02 (update)
  • EPTINEZUMAB
  • Prevention of migraine headaches
  • Vyepti
  • Vyepti
  • Vyepti
  • Vyepti
  • Vyepti
  • Vyepti
  • Vyepti
  • Vyepti
  • Vyepti
  • Vyepti
  • Vyepti
  • Vyepti
  • Vyepti
  • Vyepti
  • Vyepti
  • Vyepti
  • Vyepti
  • Vyepti
  • Vyepti
  • Vyepti
  • Vyepti
  • Vyepti
  • Vyepti
  • Vyepti
  • Vyepti
  • Vyepti
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/04/2024
MHRA-100479-PIP01-22-M02 (update)
  • POSACONAZOLE
  • Prevention of invasive fungal infections
  • Treatment of invasive fungal infections
  • Noxafil
  • Noxafil
  • Noxafil
  • Noxafil
  • Noxafil
  • Noxafil
  • Noxafil
  • Noxafil
  • Noxafil
  • Noxafil
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/04/2024
MHRA-100564-PIP01-22-M02 (update)
  • TEDIZOLID PHOSPHATE
  • Treatment of acute bacterial skin and skin structure infections
  • Sivextro
  • Sivextro
  • Sivextro
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/04/2024
MHRA-100046-PIP01-21-M04 (update)
  • cenobamate
  • Treatment of epilepsy
  • Ontozry
  • Ontozry
  • Xcopri
  • Ontozry
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/04/2024
MHRA-100297-PIP01-21-M03 (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 30/04/2024
MHRA-100485-PIP01-22-M02 (update)
  • AMG 176 (4S,7aR,9aR,10S,11E,14S,15R)-6'-chloro-10-methoxy-14,15-dimethyl-3',4',7a,8,9,9a,10,13,14,15-decahydro-2'H,7H-spiro[1,19-ethenocyclobuta[i][1,4]oxazepino[3,4f][1,2,7]thiadiazacyclohexadecine-4,1'-naphthalen]-18(17H)-one 16,16-dioxide
  • Treatment of acute myeloid leukaemia
  • Tapotoclax
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/04/2024
MHRA-100989-PIP01-23-M01 (update)
  • DERMATOPHAGOIDES FARINAE
  • DERMATOPHAGOIDES PTERONYSSINUS
  • Treatment of asthma
  • Treatment of allergic rhinitis
  • ACARIZAX and associated names
  • ACARIZAX
  • ACARIZAX
  • ACARIZAX
  • ACARIZAX
  • AMITEND
  • ACARIZAX
  • AITARO
  • ACARIZAX
  • ACARIZAX
  • ACARIZAX
  • ACARIZAX
  • ACARIZAX
  • ACARIZAX
  • ACARIZAX
  • ACARIZAX
  • ACARIZAX
  • ACARIZAX
  • ACARIZAX
  • ACARIZAX
  • ACARIZAX
  • ACARIZAX
  • ACCARIZAX
  • Pneumology - Allergology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes 30/04/2024
MHRA-100037-PIP01-21-M02 (update)
  • ponesimod
  • Treatment of Multiple Sclerosis
  • Ponvory
  • Neurology
  • Other: Autoimmune disease/dysfunction
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/04/2024
MHRA-100543-PIP01-22-M02 (update)
  • DOLUTEGRAVIR
  • LAMIVUDINE
  • Treatment of Human Immunodeficiency virus (HIV - 1) Infection
  • Dovato
  • Dovato
  • Dovato
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/04/2024
MHRA-100586-PIP01-22-M02 (update)
  • DUPILUMAB
  • Treatment of asthma
  • Dupixent
  • Dupixent
  • Dupixent
  • Dupixent
  • Dupixent
  • Dupixent
  • Dupixent
  • Dupixent
  • Dupixent
  • Dupixent
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/04/2024
MHRA-101212-PIP01-23-M01 (update)
  • CEFEPIME DIHYDROCHLORIDE MONOHYDRATE
  • enmetazobactam
  • Treatment of infections caused by gram-negative organisms
  • EXBLIFEP
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 30/04/2024