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Displaying 61 - 80 of 104
PIPS Search Results
PIP Number Active Substance Sort descending Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published
MHRA-100442-PIP01-22-M02 (update)
  • TALIMOGENE LAHERPAREPVEC
  • Treatment of melanoma
  • Imlygic
  • Imlygic
  • Imlygic
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted 30/04/2024
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 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-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 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
MHRA-101053-PIP01-23-M01 (update)
  • DOLUTEGRAVIR
  • ABACAVIR
  • LAMIVUDINE
  • Treatment of human immunodeficiency virus (HIV-1) infection
  • TRIUMEQ
  • TRIUMEQ
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted 30/01/2024
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-100865-PIP01-23-M01 (update)
  • RILPIVIRINE
  • Treatment of human immunodeficiency virus (HIV-1) infection
  • REKAMBYS
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 19/12/2023
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-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-100642-PIP01-22-M02 (update)
  • Tremelimumab
  • Treatment of all conditions included in the category of malignant neoplasms (except central nervous system, haematopoietic and lymphoid tissue).
  • IMJUDO
  • Tremelimumab AstraZeneca
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted 19/12/2023
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-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-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-100901-PIP01-23-M02 (update)
  • CABOTEGRAVIR
  • Treatment of human immunodeficiency virus (HIV-1) infection
  • Vocabria
  • Vocabria / Cabenuva
  • Vocabria
  • Vocabria
  • Vocabria
  • Vocabria
  • Vocabria
  • Vocabria
  • Vocabria
  • Vocabria / Cabenuva
  • Vocabria / Cabenuva
  • Vocabria
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 19/12/2023
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-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-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-100720-PIP01-22-M02 (update)
  • Gepotidacin
  • Treatment of uncomplicated urinary tract infection
  • Not available at present
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 24/08/2023
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