Displaying 41 - 60 of 773
Download
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published
MHRA-100332-PIP01-21-M01 (update)
  • sotatercept
  • Treatment of pulmonary arterial hypertension
  • Not available at present
  • Cardiovascular Diseases
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes 24/08/2023
MHRA-100844-PIP01-23-M01 (update)
  • IVACAFTOR
  • Treatment of cystic fibrosis.
  • Kalydeco
  • Kalydeco
  • Kalydeco
  • Kalydeco
  • Kalydeco
  • Kalydeco
  • Kalydeco
  • Other: Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted 24/08/2023
MHRA-100177-PIP01-21-M02 (update)
  • INFLUENZA A/ (H1N1)-LIKE VIRUS ANTIGEN
  • INFLUENZA A/ (H3N2)-LIKE VIRUS ANTIGEN
  • INFLUENZA B/VICTORIA/2/87-LIKE VIRUS ANTIGEN
  • INFLUENZA B/YAMAGATA/16/88-LIKE VIRUS ANTIGEN
  • Prevention of Influenza
  • FLUCELVAX TETRA
  • Cell-based Quadrivalent Influenza Vaccine (Surface Antigen, Inactivated) Seqirus suspension for injection in pre-filled syringe
  • FLUCELVAX TETRA
  • Vaccines
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 24/08/2023
MHRA-100775-PIP01-22-M02 (update)
  • (4R,5R)-1-[[4-[[4-[3,3-Dibutyl-7-(dimethylamino)-2,3,4,5-4-hydroxy-1,1-dioxido-1-benzothiepin-5-yl] phenoxy] methyl] phenyl] methyl]-4-aza-1-azoniabicyclo[2.2.2]octane Chloride
  • Maralixibat chloride
  • Treatment of Alagille Syndrome (ALGS)
  • Livmarli (maralixibat chloride)
  • LIVMARLI
  • Gastroenterology-Hepatology
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted 01/08/2023
MHRA-100775-PIP01-22-M01 (update)
  • (4R,5R)-1-[[4-[[4-[3,3-Dibutyl-7-(dimethylamino)-2,3,4,5-4- hydroxy-1,1-dioxido-1-benzothiepin-5-yl] phenoxy] methyl] phenyl] methyl]-4-aza-1-azoniabicyclo[2.2.2]octane Chloride
  • Maralixibat chloride
  • Treatment of Alagille Syndrome (ALGS)
  • maralixibat chloride
  • Gastroenterology-Hepatology
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 01/08/2023
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 30/06/2023
MHRA-100959-PIP01-23-M01 (update)
  • DOSTARLIMAB
  • Treatment of all conditions included in the category of malignant neoplasms (except haematopoietic and lymphoid malignancies).
  • Jemperli
  • Jemperli
  • Jemperli
  • Oncology
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 30/06/2023
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 30/06/2023
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 30/06/2023
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 30/06/2023
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 30/06/2023
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 20/06/2023
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 25/05/2023
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 25/05/2023
MHRA-100811-PIP01-22-M01 (update)
  • Vamorolone
  • Treatment of Duchenne muscular dystrophy
  • Other: Neuromuscular Diseases
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 25/05/2023
MHRA-100718-PIP01-22-M01 (update)
  • deucravacitinib
  • Treatment of psoriasis
  • SOTYKTU
  • Dermatology
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 25/05/2023
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 25/05/2023
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 25/05/2023
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 25/05/2023
MHRA-100630-PIP01-22-M01 (update)
  • PATIROMER SORBITEX CALCIUM
  • Treatment of hyperkalaemia
  • Veltassa
  • Other: Nephrology/Metabolism
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 25/05/2023
Download XLSX