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Displaying 841 - 860 of 1015
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
MHRA-100151-PIP01-21
  • CANNABIDIOL
  • Treatment of epilepsy with myoclonic-atonic seizures (EMAS)
  • Epidyolex
  • Epidyolex
  • Epidyolex
  • Epidiolex
  • Epidyolex
  • Epidyolex
  • Epidiolex
  • Neurology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-100105-PIP01-21
  • ALPRAZOLAM
  • Treatment of epileptic seizures
  • Neurology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-100115-PIP01-21
  • Dersimelagon
  • Treatment of erythropoietic protoporphyria
  • Treatment of X-linked protoporphyria
  • Not available at present
  • Dermatology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
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
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
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
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
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
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
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
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
MHRA-100294-PIP01-21-M01 (update)
  • BENRALIZUMAB
  • Treatment of asthma
  • FASENRA
  • FASENRA
  • FASENRA
  • FASENRA
  • FASENRA
  • FASENRA PEN
  • FASENRA
  • Pneumology - Allergology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100308-PIP01-21-M01 (update)
  • AZILSARTAN MEDOXOMIL
  • Treatment of hypertension
  • Edarbi
  • Edarbi
  • Cardiovascular Diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No
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
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
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
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
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
MHRA-100221-PIP01-21-M01 (update)
  • BARICITINIB
  • Treatment of atopic dermatitis
  • Olumiant
  • Olumiant
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
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