Search Filters:

The items contained in the list are being used to filter the search results. Click them to remove them from the search filter.
Displaying 421 - 440 of 478
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort descending
MHRA-100123-PIP01-21-M02 (update)
  • SARILUMAB
  • Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, spondylarthritis, psoriatic arthritis and juvenile idiopathic arthritis)
  • Kevzara
  • Kevzara
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 30/01/2024
MHRA-101131-PIP01-23-M01 (update)
  • BLINATUMOMAB
  • Treatment of acute lymphoblastic leukaemia
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCTYO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted 30/01/2024
MHRA-100840-PIP01-23-M01 (update)
  • Odronextamab
  • Treatment of mature B cell malignancies
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/01/2024
MHRA-101053-PIP01-23-M01 (update)
  • DOLUTEGRAVIR
  • ABACAVIR
  • LAMIVUDINE
  • Treatment of human immunodeficiency virus (HIV-1) infection
  • TRIUMEQ
  • TRIUMEQ
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted 30/01/2024
MHRA-100544-PIP01-22-M02 (update)
  • sebetralstat
  • Treatment of hereditary angioedema
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/01/2024
MHRA-101003-PIP01-23-M01 (update)
  • garadacimab
  • Prevention of hereditary angioedema
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 06/03/2024
MHRA-100562-PIP01-22
  • strontium-82 chloride/ rubidium-82 chloride
  • Visualisation of myocardial perfusion for diagnostic purposes
  • Ruby-Fill
  • Ruby-Fill
  • Ruby-Fill
  • Cardiovascular Diseases
  • Diagnostic
PM: decision on the application for modification of an agreed paediatric investigation plan. 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