Displaying 101 - 120 of 1121
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
MHRA-101495-PIP01-24
  • Split influenza virus, inactivated containing antigens equivalent to the A/H1N1-like strain
  • Split influenza virus, inactivated containing antigens equivalent to the A/H3N2-like strain
  • Split influenza virus, inactivated containing antigens equivalent to B-like strain
  • Prevention of influenza disease
  • not available
  • Vaccines
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes Full Compliance Check Granted
MHRA-101489-PIP01-24-M02 (update)
  • Enlicitide (decanoate)
  • Treatment of lipid disorders
  • Cardiovascular Diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted
MHRA-101454-PIP01-24-M01 (update)
  • Donidalorsen
  • Treatment of hereditary angioedema
  • Pneumology - Allergology
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted
MHRA-101400-PIP01-24
  • nirogacestat hydrobromide
  • Treatment of soft tissue sarcoma
  • Not yet available in the United Kingdom (Ogsiveo in the United States and European Union).
  • Ogsiveo
  • Oncology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes Partial Compliance Check Granted
MHRA-101360-PIP01-24-M01 (update)
  • Purified Rabies virus, WISTAR PM/WI 38-1503-3M strain (inactivated)
  • Prevention of rabies viral infection
  • Vaccines
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-101357-PIP01-24-M01 (update)
  • inebilizumab
  • Treatment of immunoglobulin G4-related disease (IgG4-RD)
  • Uplizna
  • Uplizna
  • Uplizna
  • Uplizna
  • Xinyue
  • Uplizna
  • Uplizna
  • Uplizna
  • Uplizna
  • Uplizna
  • Uplizna
  • Uplizna
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted
MHRA-101356-PIP01-24-M01 (update)
  • inebilizumab
  • Treatment of myasthenia gravis
  • Uplizna
  • Uplizna
  • Uplizna
  • Uplizna
  • Uplizna
  • Xinyue
  • Uplizna
  • Uplizna
  • Uplizna
  • Uplizna
  • Uplizna
  • Uplizna
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted
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