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Displaying 1 - 20 of 257
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
MHRA-100376-PIP01-21-M02 (update)
  • VEDOLIZUMAB
  • Treatment of ulcerative colitis
  • Treatment of Crohn's disease
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Gastroenterology-Hepatology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted
MHRA-102590-PIP01-26-M01 (update)
  • Lerodalcibep
  • Treatment of hypercholesterolaemia
  • Treatment of mixed dyslipidaemia
  • LEROCHOL
  • LYROKAUL
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted
MHRA-100258-PIP01-21-M03 (update)
  • Clesrovimab
  • Prevention of lower respiratory tract infection caused by respiratory syncytial virus
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-102249-PIP01-25-M01 (update)
  • ESTETROL MONOHYDRATE
  • DROSPIRENONE
  • Prevention of pregnancy
  • Drovelis
  • Nextstellis
  • Lydisilka
  • Nextstellis
  • Drovelis, Lydisilka
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-101687-PIP01-24-M01 (update)
  • MEPOLIZUMAB
  • Treatment of Hypereosinophilic Syndrome
  • Nucala
  • Nucala
  • Nucala
  • Nucala
  • Nucala
  • Nucala
  • Nucala
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-101488-PIP01-24-M02 (update)
  • Etavopivat
  • Treatment of sickle cell disease
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes
MHRA-102542-PIP01-26-M01 (update)
  • CEFTOBIPROLE MEDOCARIL SODIUM
  • Treatment of pneumonia
  • Zevtera and associated names
  • Zevtera
  • Mabelio
  • Zevtera
  • Zevtera
  • Zevtera
  • Mabelio
  • Mabelio
  • Mabelio
  • Zevtera
  • Zevtera
  • Zevtera
  • Zevtera
  • Adaluzis
  • Zevtera
  • Zevtera
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-102252-PIP01-25
  • mavorixafor
  • Treatment of WHIM (Warts, Hypogammaglobulinaemia, Infections, and Myelokathexis) syndrome
  • Xolremdi
  • Xolremdi
  • Immunology -Rheumatology-Transplantation
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes Partial Compliance Check Granted
MHRA-102342-PIP01-26
  • Sepiapterin
  • Treatment of hyperphenylalaninaemia
  • Sephience
  • Sephience
  • Sephience
  • Sephience
  • Sephience
  • Sephience
  • Sephience
  • Sephience
  • Endocrinology-Gynaecology-Fertility-metabolism
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes
MHRA-101078-PIP01-23-M03 (update)
  • OLAPARIB
  • Treatment of all conditions included in the category of malignant neoplasms (except haematopoietic, and lymphoid tissue).
  • Lynparza
  • Lynparza
  • Lynparza
  • Lynparza
  • Lynparza
  • Lynparza
  • Lynparza
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100062-PIP01-21-M01 (update)
  • VANZACAFTOR CALCIUM DIHYDRATE
  • TEZACAFTOR
  • DEUTIVACAFTOR
  • Treatment of Cystic Fibrosis
  • alyftrek
  • Pneumology - Allergology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes
MHRA-101705-PIP01-24
  • Elamipretide
  • Treatment of Barth syndrome
  • Not available at present
  • Endocrinology-Gynaecology-Fertility-metabolism
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes Partial Compliance Check Granted
MHRA-101278-PIP01-23
  • oveporexton
  • Treatment of narcolepsy.
  • Treatment of idiopathic hypersomnia.
  • Neurology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes Partial Compliance Check Granted
MHRA-100820-PIP01-22-M03 (update)
  • Tirzepatide
  • Treatment of obesity
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro, Zepbound
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro, Zepbound
  • Mounjaro
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted
MHRA-100087-PIP01-21-M03 (update)
  • LACOSAMIDE
  • Treatment of generalised epilepsy and epileptic syndromes.
  • VIMPAT
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100069-PIP01-21-M01 (update)
  • RIBOCICLIB SUCCINATE
  • Treatment of neuroblastoma
  • KISQALI
  • KISQALI
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100075-PIP01-21-M03 (update)
  • leniolisib
  • Treatment of activated phosphoinositide 3-kinase delta (δ) syndrome (APDS)
  • Joenja
  • Joenja
  • Joenja
  • Joenja
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted
MHRA-100447-PIP01-22-M03 (update)
  • Tirzepatide
  • Treatment of Type 2 diabetes mellitus.
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro, Zepbound
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro, Zepbound
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-101678-PIP01-24
  • Mirdametinib
  • Treatment of neurofibromatosis type 1
  • Not available at present
  • Gomeklio
  • Gomeklio
  • Neurology
  • Oncology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes Partial Compliance Check Granted
MHRA-102497-PIP01-26
  • PONATINIB
  • PONATINIB HYDROCHLORIDE
  • Treatment of chronic myeloid leukaemia (CML)
  • Treatment of acute lymphoblastic leukaemia
  • Ponatinib Incyte
  • Iclusig
  • Iclusig
  • Iclusig
  • Iclusig
  • Iclusig
  • Iclusig
  • Iclusig
  • Iclusig
  • Iclusig
  • Iclusig
  • Iclusig
  • Iclusig
  • Iclusig
  • Iclusig
  • Iclusig
  • Iclusig
  • Haematology-Hemostaseology
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted