Displaying 1 - 20 of 1030
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
MHRA-100623-PIP01-22-M03 (update)
  • NIRAPARIB TOSYLATE MONOHYDRATE
  • Treatment of all conditions included in the category of malignant neoplasms (except haematopoetic and lymphoid malignancies)
  • Zejula
  • Zejula
  • Zejula
  • Zejula
  • Zejula
  • Zejula
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100618-PIP01-22-M01 (update)
  • AVIBACTAM
  • CEFTAZIDIME
  • Treatment of intra-abdominal infections
  • Treatment of urinary tract infections
  • Treatment of pneumonia
  • Treatment of infections due aerobic Gram-negative organisms.
  • Zavicefta
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100614-PIP01-22-M03 (update)
  • VONICOG ALFA
  • Treatment of von Willebrand Disease
  • veyvondi
  • veyvondi
  • Vonvendi
  • veyvondi
  • Vonvendi
  • veyvondi
  • Vonvendi
  • veyvondi
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted
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 Full Compliance Check Granted
MHRA-100609-PIP01-22-M01 (update)
  • LENVATINIB MESILATE
  • Treatment of papillary thyroid cancer and follicular thyroid cancer
  • Treatment of osteosarcoma
  • Lenvima
  • Kisplyx
  • Lenvima
  • Kisplyx
  • Lenvima
  • Kisplyx
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100604-PIP01-22-M02 (update)
  • REMDESIVIR
  • Treatment of coronavirus disease 2019 (COVID-19)
  • VEKLURY
  • VEKLURY
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100586-PIP01-22-M02 (update)
  • DUPILUMAB
  • Treatment of asthma
  • Dupixent
  • Dupixent
  • Dupixent
  • Dupixent
  • Dupixent
  • Dupixent
  • Dupixent
  • Dupixent
  • Dupixent
  • Dupixent
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted
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