Displaying 261 - 280 of 692
PIPS Search Results
PIP Number Active Substance Sort descending Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published
MHRA-100188-PIP01-21-M01 (update)
  • lebrikizumab
  • Treatment of atopic dermatitis
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 29/07/2022
MHRA-100250-PIP01-21-M01 (update)
  • VERICIGUAT
  • Treatment of left ventricular failure
  • Verquvo
  • Verquvo
  • Verquvo
  • Verquvo
  • Cardiovascular Diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 29/07/2022
MHRA-100250-PIP01-21-M02 (update)
  • VERICIGUAT
  • Treatment of left ventricular failure
  • Verquvo
  • Verquvo
  • Verquvo
  • Verquvo
  • Cardiovascular Diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/06/2023
MHRA-100252-PIP01-21-M01 (update)
  • GEMTUZUMAB OZOGAMICIN
  • Treatment of acute myeloid leukaemia
  • Mylotarg
  • Mylotarg
  • 16/06/2019
  • Mylotarg
  • Mylotarg
  • Mylotarg
  • Mylotarg
  • Mylotarg
  • Mylotarg
  • Mylotarg
  • Mylotarg
  • Mylotarg
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 29/07/2022
MHRA-100259-PIP01-21-M01 (update)
  • DULAGLUTIDE
  • Treatment of Type 2 Diabetes Mellitus
  • Trulicity
  • Trulicity
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. No 29/07/2022
MHRA-100289-PIP01-21-M01 (update)
  • GALCANEZUMAB
  • Prevention of migraine headaches
  • Emgality
  • Emgality
  • Emgality
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 29/07/2022
MHRA-100289-PIP01-21-M02 (update)
  • GALCANEZUMAB
  • Prevention of migraine headache
  • Emgality
  • Emgality
  • Emgality
  • Emgality
  • Emgality
  • Emgality
  • Emgality
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 02/02/2023
MHRA-100289-PIP01-21-M03 (update)
  • GALCANEZUMAB
  • Prevention of migraine headache
  • Emgality
  • Emgality
  • Emgality
  • Emgality
  • Emgality
  • Emgality
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
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-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