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Displaying 81 - 100 of 669
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Sort descending Decision Type Compliance Check Compliance outcome Date Published
MHRA-100303-PIP01-21-M02 (update)
  • DARUNAVIR
  • COBICISTAT
  • EMTRICITABINE
  • TENOFOVIR ALAFENAMIDE
  • Treatment of human immunodeficiency virus type-1 (HIV-1) infection
  • Symtuza
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-100951-PIP01-23-M01 (update)
  • FOSTEMSAVIR TROMETHAMINE
  • Treatment of human immunodeficiency virus (HIV-1) infection
  • RUKOBIA
  • RUKOBIA
  • RUKOBIA
  • RUKOBIA
  • Rukobia 600 mg prolonged-release tablets
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-100951-PIP01-23-M02 (update)
  • FOSTEMSAVIR TROMETHAMINE
  • Treatment of human immunodeficiency virus (HIV-1) infection
  • RUKOBIA
  • RUKOBIA
  • RUKOBIA
  • RUKOBIA
  • RUKOBIA
  • RUKOBIA
  • RUKOBIA
  • Rukobia 600 mg prolonged-release tablets
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-100235-PIP01-21-M02 (update)
  • Sotrovimab
  • Treatment of coronavirus disease 2019 (COVID-19)
  • Xevudy
  • Xevudy
  • Xevudy
  • Xevudy
  • Xevudy
  • Xevudy
  • Xevudy
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-100440-PIP01-22-M02 (update)
  • EMTRICITABINE
  • TENOFOVIR ALAFENAMIDE
  • BICTEGRAVIR
  • Treatment of Human immunodeficiency virus (HIV) infection
  • Biktarvy
  • Biktarvy
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/01/2024
MHRA-100669-PIP01-22-M02 (update)
  • RILPIVIRINE
  • EMTRICITABINE
  • TENOFOVIR ALAFENAMIDE
  • Treatment of human immunodeficiency virus (HIV-1) infection
  • Odefsey
  • Odefsey
  • Odefsey
  • Infectious diseases
W: decision granting a waiver in all age groups for the listed condition(s). No 30/01/2024
MHRA-100971-PIP01-23
  • Sipavibart (AZD3152)
  • Prevention of coronavirus disease 2019 (COVID-19)
  • Infectious diseases
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 30/04/2024
MHRA-100913-PIP01-23
  • mRNA that encodes for the NTD and RBD epitopes of the spike glycoprotein of SARS-CoV-2 (mRNA-1283)
  • Prevention of coronavirus disease 2019 (COVID-19)
  • Not available at present
  • Infectious diseases
  • Vaccines
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-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-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-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-100143-PIP01-21-M02 (update)
  • TENOFOVIR ALAFENAMIDE FUMARATE
  • Treatment of chronic viral hepatitis B
  • Vemlidy
  • Vemlidy
  • Vemlidy
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/04/2024
MHRA-100164-PIP01-21-M03 (update)
  • Nirmatrelvir
  • RITONAVIR
  • Treatment of coronavirus disease 2019 (COVID-19)
  • Prevention of coronavirus disease 2019 (COVID-19)
  • Paxlovid
  • Paxlovid
  • Paxlovid
  • Paxlovid
  • Paxlovid
  • Paxlovid
  • Paxlovid
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/04/2024
MHRA-100564-PIP01-22-M03 (update)
  • TEDIZOLID PHOSPHATE
  • Treatment of acute bacterial skin and skin structure infections
  • Sivextro
  • Sivextro
  • Sivextro
  • Sivextro
  • Sivextro
  • Sivextro
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 01/05/2024
MHRA-100083-PIP01-21-M01 (update)
  • Human Fibrinogen (INN) / Human Thrombin (INN)
  • HUMAN THROMBIN
  • HUMAN FIBRINOGEN
  • Treatment of: haemorrhage from a surgical procedure
  • CSF leakage from a neurosurgical procedure
  • EVICEL, Solution for sealant
  • EVARREST, Sealant matrix (withdrawn EU MAA)
  • EVICEL
  • EVICEL
  • EVICEL
  • Other: blood-derived topical haemostats
PM: decision on the application for modification of an agreed paediatric investigation plan. No 15/11/2021
MHRA-100081-PIP01-21
  • Zibotentan
  • DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE
  • Treatment of Chronic Kidney Disease
  • Not available at present
  • Other: Renal Disease
W: decision granting a waiver in all age groups for the listed condition(s). No 17/12/2021
MHRA-100060-PIP01-21
  • 2'-O-(2-methoxyethyl) phosphorothioate antisense oligonucleotide targeting CD49d RNA
  • Treatment of Duchenne muscular dystrophy
  • Other: Neuromuscular
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 17/03/2022
MHRA-100330-PIP01-21
  • Autologous CD34+ hematopoietic stem and progenitor cells (HSPCs) genetically modified with the lentiviral vector IDUA LVV, encoding for the human α-L-iduronidase (IDUA) gene (OTL-203)
  • Treatment of Mucopolysaccharidosis type I, Hurler syndrome (MPS-IH)
  • Other: Metabolic disorders
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 29/07/2022