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Displaying 61 - 80 of 1088
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
MHRA-101342-PIP01-24-M02 (update)
  • ESKETAMINE HYDROCHLORIDE
  • Treatment of Major Depressive Disorder
  • Spravato
  • Spravato
  • Spravato
  • Spravato
  • Spravato
  • Spravato
  • Psychiatry
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted
MHRA-101335-PIP01-24-M01 (update)
  • LANDIOLOL HYDROCHLORIDE
  • Treatment of supraventricular arrhythmias.
  • Rapibloc
  • Rapibloc
  • Rapibloc
  • Cardiovascular Diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-101289-PIP01-23-M01 (update)
  • Remibrutinib
  • Treatment of chronic spontaneous urticaria.
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted
MHRA-101151-PIP01-23-M01 (update)
  • OBETICHOLIC ACID
  • Treatment of primary biliary cirrhosis
  • Treatment of biliary atresia
  • Ocaliva
  • Ocaliva
  • Ocaliva
  • Ocaliva
  • Ocaliva
  • Ocaliva
  • Ocaliva
  • Ocaliva
  • Ocaliva
  • Ocaliva
  • Ocaliva
  • Ocaliva
  • Ocaliva
  • Ocaliva
  • Ocaliva
  • Ocaliva
  • Ocaliva
  • Gastroenterology-Hepatology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted
MHRA-101141-PIP01-23-M01 (update)
  • mavacamten
  • Treatment of hypertrophic cardiomyopathy
  • CAMZYOS
  • CAMZYOS
  • CAMZYOS
  • CAMZYOS
  • CAMZYOS
  • CAMZYOS
  • CAMZYOS
  • CAMZYOS
  • CAMZYOS
  • CAMZYOS
  • CAMZYOS
  • CAMZYOS
  • Cardiovascular Diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted
MHRA-101123-PIP01-23-M02 (update)
  • BREXUCABTAGENE AUTOLEUCEL
  • Treatment of acute lymphoblastic leukaemia.
  • Tecartus
  • Brexucabtagene autoleucel
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-101071-PIP01-23-M01 (update)
  • pegzilarginase
  • Treatment of hyperargininaemia
  • Loargys
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-101024-PIP01-23-M01 (update)
  • gadoquatrane
  • Diagnosis by evaluation of any known or suspected clinical condition with contrast enhanced magnetic resonance imaging
  • Diagnostic
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100991-PIP01-23-M01 (update)
  • Maralixibat chloride
  • Progressive familial intrahepatic cholestasis (PFIC)
  • LIVMARLI
  • LIVMARLI
  • LIVMARLI
  • LIVMARLI
  • LIVMARLI
  • LIVMARLI
  • LIVMARLI
  • LIVMARLI
  • LIVMARLI
  • LIVMARLI
  • Gastroenterology-Hepatology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100989-PIP01-23-M01 (update)
  • DERMATOPHAGOIDES FARINAE
  • DERMATOPHAGOIDES PTERONYSSINUS
  • Treatment of asthma
  • Treatment of allergic rhinitis
  • ACARIZAX and associated names
  • ACARIZAX
  • ACARIZAX
  • ACARIZAX
  • ACARIZAX
  • AMITEND
  • ACARIZAX
  • AITARO
  • ACARIZAX
  • ACARIZAX
  • ACARIZAX
  • ACARIZAX
  • ACARIZAX
  • ACARIZAX
  • ACARIZAX
  • ACARIZAX
  • ACARIZAX
  • ACARIZAX
  • ACARIZAX
  • ACARIZAX
  • ACARIZAX
  • ACARIZAX
  • ACCARIZAX
  • Pneumology - Allergology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100986-PIP01-23-M01 (update)
  • ENCORAFENIB
  • Treatment of melanoma
  • Braftovi
  • Braftovi
  • Bravtovi
  • Braftovi
  • Braftovi
  • Braftovi
  • Braftovi
  • Braftovi
  • Braftovi
  • Braftovi
  • Braftovi
  • Braftovi
  • Braftovi
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100985-PIP01-23-M01 (update)
  • BINIMETINIB
  • Treatment of melanoma
  • Mektovi
  • Mektovi
  • Mektovi
  • Mektovi
  • Mektovi
  • Mektovi
  • Mektovi
  • Mektovi
  • Mektovi
  • Mektovi
  • Mektovi
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100966-PIP01-23-M02 (update)
  • SARS-CoV-2 virus recombinant spike (S) protein receptor binding domain (RBD) fusion homodimer - Omicron LP.8.1-LP.8.1 variant
  • selvacovatein
  • damlecovatein
  • Prevention of coronavirus disease 2019 (COVID-19)
  • BIMERVAX, BIMERVAX XBB.1.16, BIMERVAX LP.8.1
  • Bimervax
  • Bimervax
  • BIMERVAX
  • BIMERVAX
  • BIMERVAX XBB.1.16
  • BIMERVAX XBB.1.16
  • BIMERVAX XBB.1.16
  • BIMERVAX LP.8.1
  • BIMERVAX LP.8.1
  • BIMERVAX LP.8.1
  • Bimervax
  • BIMERVAX XBB.1.16
  • BIMERVAX LP.8.1
  • Vaccines
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted
MHRA-100959-PIP01-23-M03 (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 Full Compliance Check Granted
MHRA-100934-PIP01-23-M02 (update)
  • CARFILZOMIB
  • Treatment of acute lymphoblastic leukemia
  • Kyprolis
  • Kyprolis
  • Kyprolis
  • Kyprolis
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100921-PIP01-23-M04 (update)
  • AVATROMBOPAG MALEATE
  • Treatment of Idiopathic Thrombocytopenia Purpura
  • Treatment of Thrombocytopenic Purpura Secondary to Liver Disease
  • Doptelet
  • Doptelet
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100909-PIP01-23-M02 (update)
  • ABEMACICLIB
  • Treatment of Ewing's sarcoma
  • Verzenios
  • Verzenios
  • Verzenios
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100907-PIP01-23-M02 (update)
  • CEFTOLOZANE
  • TAZOBACTAM
  • Treatment of pneumonia
  • ZERBAXA
  • ZERBAXA
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100866-PIP01-23
  • obecabtagene autoleucel
  • Treatment of acute lymphoblastic leukaemia (ALL)
  • Oncology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes Partial Compliance Check Granted
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 Full Compliance Check Granted