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Displaying 81 - 100 of 108
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
MHRA-100846-PIP01-23-M01 (update)
  • ENALAPRIL MALEATE
  • Treatment of heart failure
  • Cardiovascular Diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes
MHRA-100553-PIP01-22-M01 (update)
  • REMIMAZOLAM BESYLATE
  • Sedation
  • General Anaesthesia
  • Byfavo 20mg
  • Anerem
  • Byfavo
  • Byfavo
  • Byfavo
  • Anaesthesiology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted
MHRA-100716-PIP01-22-M01 (update)
  • RUXOLITINIB PHOSPHATE
  • Treatment of chronic Graft versus Host Disease
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted
MHRA-100515-PIP01-22-M01 (update)
  • VORTIOXETINE
  • Treatment of Major Depressive Disorder
  • Brintellix
  • Brintellix
  • Brintellix
  • Psychiatry
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes
MHRA-100706-PIP01-22
  • METHYLPHENIDATE HYDROCHLORIDE
  • Treatment of attention-deficit hyperactivity disorder
  • Not available at present
  • Methylphenidate hydrochloride
  • Methylphenidate hydrochloride
  • Methylphenidate hydrochloride
  • Methylphenidate hydrochloride
  • Neurology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes
MHRA-100845-PIP01-23-M02 (update)
  • CABOTEGRAVIR
  • Prevention of human immunodeficiency virus (HIV-1) infection
  • N/A
  • VOCABRIA AND APRETUDE
  • Apretude
  • N/A
  • N/A
  • N/A
  • Apretude
  • Apretude
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100884-PIP01-23-M01 (update)
  • SACUBITRIL
  • VALSARTAN
  • Treatment of Heart failure
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Neparvis
  • Neparvis
  • Neparvis
  • Neparvis
  • Neparvis
  • Neparvis
  • Neparvis
  • Neparvis
  • Neparvis
  • Neparvis
  • Neparvis
  • Neparvis
  • Neparvis
  • Neparvis
  • Neparvis
  • Neparvis
  • Neparvis
  • Cardiovascular Diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100816-PIP01-22-M01 (update)
  • crovalimab
  • Treatment of paroxysmal nocturnal haemoglobinuria
  • Treatment of atypical haemolytic uremic syndrome
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes
MHRA-100855-PIP01-23-M01 (update)
  • DOPAMINE HYDROCHLORIDE
  • Treatment of vascular hypotensive disorders
  • Neoatricon
  • Cardiovascular Diseases
  • Neonatology - Paediatric Intensive Care
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100610-PIP01-22-M01 (update)
  • ECULIZUMAB
  • Treatment of myasthenia gravis
  • SOLIRIS
  • SOLIRIS
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes
MHRA-100224-PIP01-21-M01 (update)
  • Etrasimod L-arginine
  • Treatment of ulcerative colitis
  • Gastroenterology-Hepatology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted
MHRA-100552-PIP01-22-M01 (update)
  • RILPIVIRINE HYDROCHLORIDE
  • Treatment of human immunodeficiency virus (HIV-1) infection
  • edurant
  • edurant
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes
MHRA-100496-PIP01-22-M01 (update)
  • RUXOLITINIB PHOSPHATE
  • Treatment of acute Graft versus Host Disease (aGvHD)
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted
MHRA-100605-PIP01-22
  • sparsentan
  • Treatment of immunoglobulin A nephropathy
  • Not available at present
  • Uro-Nephrology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes Partial Compliance Check Granted
MHRA-100271-PIP01-21-M01 (update)
  • LINAGLIPTIN
  • Treatment of Type 2 Diabetes Mellitus
  • Trajenta
  • Trajenta
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes
MHRA-100272-PIP01-21-M01 (update)
  • EMPAGLIFLOZIN
  • Treatment of Type 2 Diabetes Mellitus
  • Jardiance
  • Jardiance
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes
MHRA-100608-PIP01-22-M01 (update)
  • mitapivat
  • Treatment of pyruvate kinase deficiency
  • PYRUKYND
  • PYRUKYND
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted
MHRA-100522-PIP01-22-M01 (update)
  • CABOZANTINIB
  • Treatment of malignant solid tumours
  • Cometriq
  • Cabometyx
  • Cabometyx
  • Cometriq
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted
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
MHRA-100175-PIP01-21-M01 (update)
  • AGOMELATINE
  • Treatment of major depressive episodes
  • Valdoxan
  • Valdoxan
  • Psychiatry
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes