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Displaying 241 - 260 of 669
PIPS Search Results
PIP Number Active Substance Sort descending Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published
MHRA-100303-PIP01-21-M01 (update)
  • DARUNAVIR
  • COBICISTAT
  • EMTRICITABINE
  • TENOFOVIR ALAFENAMIDE
  • Treatment of human immunodeficiency virus type-1 (HIV-1) infection
  • Symtuza
  • Symtuza
  • Symtuza
  • Symtuza
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 29/07/2022
MHRA-100300-PIP01-21-M01 (update)
  • DARUNAVIR
  • COBICISTAT
  • Treatment of HIV-1 Infection
  • REZOLSTA
  • REZOLSTA
  • REZOLSTA
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 02/11/2022
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-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-100677-PIP01-22-M01 (update)
  • COBICISTAT
  • Treatment of human immunodeficiency virus type-1 (HIV-1) infection
  • Tybost
  • Tybost
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 24/08/2023
MHRA-100669-PIP01-22-M01 (update)
  • EMTRICITABINE
  • RILPIVIRINE
  • TENOFOVIR ALAFENAMIDE FUMARATE
  • Treatment of Human immunodeficiency virus (HIV-1) infection
  • Odefsey
  • Odefsey
  • Odefsey
  • Odefsey
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 25/05/2023
MHRA-100676-PIP01-22-M01 (update)
  • EMTRICITABINE
  • TENOFOVIR ALAFENAMIDE FUMARATE
  • Treatment of human immunodeficiency virus (HIV-1) infection.
  • Descovy
  • Descovy
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 24/08/2023
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-100336-PIP01-21-M01 (update)
  • soticlestat
  • Treatment of Dravet Syndrome
  • Lennox-Gastaut Syndrome
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 29/07/2022
MHRA-100349-PIP01-21-M01 (update)
  • Rezafungin acetate
  • Treatment of invasive candidiasis
  • Rezafungin 200 mg powder for concentrate for solution for infusion
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 29/07/2022
MHRA-100349-PIP01-21-M02 (update)
  • Rezafungin acetate
  • Treatment of invasive candidiasis
  • Rezzayo 200 mg powder for concentrate for solution for infusion
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/06/2023
MHRA-100428-PIP01-22-M01 (update)
  • Lenacapavir
  • Treatment of human immunodeficiency virus (HIV-1) infection
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 29/07/2022
MHRA-100727-PIP01-22-M01 (update)
  • ALPELISIB
  • Treatment of PIK3CA related overgrowth spectrum
  • Vijoice
  • Piqray
  • Vijoice
  • Other: Congenital, Hereditary, Neonatal Disease and Abnormalities
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/06/2023
MHRA-100806-PIP01-22
  • ALPELISIB
  • Treatment of ovarian cancer (excluding rhabdomyosarcoma and germ cell tumours)
  • Treatment of Fallopian cancer (excluding rhabdomyosarcoma and germ cell tumours)
  • Treatment of Peritoneal cancer (excluding blastomas and sarcomas).
  • Piqray
  • Piqray
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 24/08/2023
MHRA-100494-PIP01-22-M01 (update)
  • NIVOLUMAB
  • Malignant neoplasms of lymphoid tissue
  • Malignant neoplasms of the central nervous system
  • OPDIVO
  • OPDIVO
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 29/07/2022
MHRA-100761-PIP01-22-M01 (update)
  • NIVOLUMAB
  • relatlimab
  • Treatment of melanoma
  • Opdualag
  • Opdualag
  • Opdualag
  • Opdualag
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 25/05/2023
MHRA-100122-PIP01-21
  • olpasiran
  • Prevention of cardiovascular events
  • Cardiovascular Diseases
W: decision granting a waiver in all age groups for the listed condition(s). No 29/07/2022
MHRA-100190-PIP01-21
  • Ordesekimab
  • Treatment of coeliac disease
  • Gastroenterology-Hepatology
  • Immunology -Rheumatology-Transplantation
W: decision granting a waiver in all age groups for the listed condition(s). No 29/07/2022
MHRA-100525-PIP01-22-M01 (update)
  • TILDRAKIZUMAB
  • Treatment of psoriasis
  • Ilumetri 100 mg solution for injection in pre-filled syringe
  • Ilumetri 100 mg solution for injection in pre-filled syringe
  • ILUMYA
  • ILUMYA
  • ILUMYA
  • Ilumetri 100 mg solution for injection in pre-filled syringe
  • Ilumetri
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 29/07/2022
MHRA-100409-PIP01-21
  • autologous dendritic cells pulsed with autologous tumour cell lysate
  • Treatment of high grade glioma
  • Oncology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 27/09/2022