Displaying 141 - 160 of 1085
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
MHRA-100580-PIP01-22-M02 (update)
  • CEMIPLIMAB
  • Treatment of all conditions included in the category of malignant neoplasms (except haematopoietic and lymphoid tissue)
  • Libtayo
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100573-PIP01-22
  • Vorasidenib
  • Treatment of glioma
  • Oncology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes Full Compliance Check Granted
MHRA-100567-PIP01-22-M02 (update)
  • DINUTUXIMAB BETA
  • Treatment of neuroblastoma.
  • Qarziba
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100564-PIP01-22-M03 (update)
  • TEDIZOLID PHOSPHATE
  • Treatment of acute bacterial skin and skin structure infections
  • Sivextro
  • Sivextro
  • Sivextro
  • Sivextro
  • Sivextro
  • Sivextro
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100550-PIP01-22-M01 (update)
  • BELIMUMAB
  • Treatment of systemic lupus erythematosus
  • Benlysta
  • Benlysta
  • Benlysta
  • Benlysta
  • Benlysta
  • Benlysta
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100547-PIP01-22-M02 (update)
  • PEGINTERFERON BETA-1A
  • Treatment of multiple sclerosis.
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100543-PIP01-22-M03 (update)
  • DOLUTEGRAVIR
  • LAMIVUDINE
  • Treatment of Human Immunodeficiency virus type 1 (HIV-1) Infection
  • Dovato
  • Dovato
  • Dovato
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100532-PIP01-22-M02 (update)
  • BUROSUMAB
  • Treatment of X-linked Hypophosphataemia
  • Crysvita
  • Crysvita
  • Crysvita
  • Crysvita
  • Crysvita
  • Crysvita
  • Crysvita
  • Crysvita
  • Crysvita
  • Crysvita
  • Crysvita
  • Crysvita
  • Crysvita
  • Crysvita
  • Crysvita
  • Crysvita
  • Crysvita
  • Crysvita
  • Crysvita
  • Crysvita
  • Crysvita
  • Crysvita
  • Crysvita
  • Crysvita
  • Other: musculoskeletal disorder; osteology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-101671-PIP01-24
  • PEGCETACOPLAN
  • Treatment of glomerulonephritis and nephrotic syndrome
  • ASPAVELI
  • ASPAVELI
  • 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-100524-PIP01-22-M04 (update)
  • gadopiclenol
  • Detection and visualisation of areas with disruption of the blood brain barrier and/or abnormal vascularity for diagnostic purposes
  • Elucirem
  • Elucirem
  • Elucirem
  • Elucirem
  • Elucirem
  • Diagnostic
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100523-PIP01-22-M04 (update)
  • gadopiclenol
  • Detection and visualisation of areas with disruption of the blood brain barrier and/or abnormal vascularity for diagnostic purposes.
  • Elucirem
  • Elucirem
  • Elucirem
  • Elucirem
  • Elucirem
  • Diagnostic
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100507-PIP01-22-M03 (update)
  • BREXPIPRAZOLE
  • Treatment of schizophrenia
  • RXULTI
  • RXULTI
  • Psychiatry
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted
MHRA-100502-PIP01-22-M03 (update)
  • Recombinant Influenza Hemagglutinin-strain A (H1N1 subtype)
  • Recombinant Influenza Hemagglutinin-strain A (H3N2 subtype)
  • Recombinant Influenza Hemagglutinin-strain B (Victoria lineage)
  • Recombinant Influenza Hemagglutinin-strain B (Yamagata lineage)
  • Prevention of influenza disease
  • Supemtek
  • Vaccines
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100499-PIP01-22-M01 (update)
  • Giroctocogene Fitelparvovec
  • Treatment of haemophilia A
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted
MHRA-100494-PIP01-22-M02 (update)
  • NIVOLUMAB
  • Treatment of malignant neoplasms of lymphoid tissue
  • Treatment of malignant neoplasms of the central nervous system
  • OPDIVO
  • OPDIVO
  • OPDIVO
  • OPDIVO
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100492-PIP01-22-M02 (update)
  • MOLGRAMOSTIM
  • Treatment of pulmonary alveolar proteinosis
  • MOLBREEVI
  • Pneumology - Allergology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted
MHRA-100490-PIP01-22-M01 (update)
  • nirsevimab (MEDI8897)
  • Prevention of lower respiratory tract infection caused by respiratory syncytial virus (RSV).
  • Beyfortus
  • Vaccines
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100475-PIP01-22-M02 (update)
  • Neisseria meningitidis serogroup A polysaccharide conjugated to tetanus toxoid
  • Neisseria meningitidis serogroup C polysaccharide conjugated to tetanus toxoid
  • Neisseria meningitidis serogroup Y polysaccharide conjugated to tetanus toxoid
  • Neisseria meningitidis serogroup W polysaccharide conjugated to tetanus toxoid
  • Prevention of invasive meningococcal disease
  • MenQuadfi
  • MenQuadfi
  • MenQuadfi
  • Vaccines
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100465-PIP01-22-M02 (update)
  • efanesoctocog alfa
  • Treatment of congenital haemophilia A
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100463-PIP01-22-M01 (update)
  • spesolimab
  • Treatment of Generalised Pustular Psoriasis
  • Prevention of Generalised Pustular Psoriasis
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted