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PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published
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-100237-PIP01-21-M01 (update)
  • Split influenza virus, inactivated containing antigens equivalent to the A/H1N1-like strain
  • Split influenza virus, inactivated containing antigens equivalent to the A/H3N2-like strain
  • Split influenza virus, inactivated containing antigens equivalent to the B-like strain (Victoria lineage)
  • Split influenza virus, inactivated containing antigens equivalent to the B-like strain (Yamagata lineage)
  • Prevention of influenza infection
  • Split influenza virus, inactivated containing antigens equivalent to the A/H1N1-like strain
  • Quadrivalent Influenza Vaccine (Split Virion, Inactivated) High-Dose (called Efluelda throughout rest of Europe)
  • Efluelda
  • Efluelda
  • Efluelda
  • Efluelda
  • Efluelda
  • Efluelda
  • Efluelda
  • Efluelda
  • Efluelda
  • Efluelda
  • Efluelda
  • Efluelda
  • Efluelda
  • Efluelda
  • Efluelda
  • Efluelda
  • Efluelda
  • Efluelda
  • Efluelda
  • Efluelda
  • Efluelda
  • Efluelda
  • Efluelda
  • Efluelda
  • Quadrivalent Influenza Vaccine (Split Virion, Inactivated) High Dose
  • Vaccines
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes 29/07/2022
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-100450-PIP01-22-M01 (update)
  • ALPELISIB
  • PIK3CA Related Overgrowth Spectrum (PROS)
  • Piqray
  • Piqray
  • Other: Congenital, Hereditary, Neonatal Disease and Abnormalities
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 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-100521-PIP01-22-M01 (update)
  • Evinacumab
  • Treatment of elevated cholesterol
  • Evkeeza
  • Evkeeza
  • Evkeeza
  • Endocrinology-Gynaecology-Fertility-metabolism
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 29/07/2022
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