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PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published
MHRA-100614-PIP01-22-M04 (update)
  • VONICOG ALFA
  • Treatment of von Willebrand Disease
  • veyvondi
  • Vonvendi
  • veyvondi
  • veyvondi
  • Vonvendi
  • veyvondi
  • Vonvendi
  • Haematology-Hemostaseology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-102362-PIP01-26
  • Telisotuzumab adizutecan
  • Treatment of all conditions included in the category of malignant neoplasms.
  • Oncology
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101362-PIP01-24-M02 (update)
  • ZANAMIVIR
  • Treatment of Influenza
  • Prevention of Influenza
  • Dectova
  • Dectova
  • Infectious diseases
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-102117-PIP01-25
  • Efimosfermin alfa
  • Treatment of metabolic dysfunction-associated steatohepatitis
  • Gastroenterology-Hepatology
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-100468-PIP01-22-M04 (update)
  • EPTINEZUMAB
  • Prevention of migraine headaches
  • Vyepti
  • VYEPTI 100 mg concentrate for solution for infusion
  • VYEPTI 300 mg concentrate for solution for infusion
  • Neurology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100348-PIP01-21-M02 (update)
  • botaretigene sparoparvovec
  • Treatment of retinitis pigmentosa
  • Ophthamology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
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-102502-PIP01-26
  • Cemacabtagene ansegedleucel (cema-cel)
  • Treatment of non-Hodgkin B-cell lymphomas.
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-102207-PIP01-25-M01 (update)
  • Dazukibart
  • Treatment of idiopathic inflammatory myopathy
  • Other: Musculoskeletal and connective tissue disorders, Skin and subcutaneous tissue disorders
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100232-PIP01-21-M01 (update)
  • ALECTINIB HYDROCHLORIDE
  • All conditions included in the category of malignant neoplasms (except haematopoietic and lymphoid tissue neoplasms)
  • Alecensa
  • Oncology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100325-PIP01-21-M03 (update)
  • NALDEMEDINE
  • Treatment of opioid-induced constipation
  • Rizmoic
  • Rizmoic
  • SYMPROIC
  • SYMPROIC
  • SYMPROIC
  • SYMPROIC
  • SYMPROIC
  • Gastroenterology-Hepatology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101980-PIP01-25
  • Group B Streptococcus 6-valent polysaccharide conjugate vaccine (GBS6)
  • Prevention of Group B Streptococcus invasive disease via maternal immunisation.
  • Not available at present
  • Vaccines
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101827-PIP01-25
  • Apazunersen
  • Treatment of Angelman syndrome
  • Not available at present
  • Neurology
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-102346-PIP01-26
  • Sonrotoclax
  • Treatment of mantle cell lymphoma (MCL)
  • Treatment of chronic lymphocytic leukaemia (CLL) / small lymphocytic lymphoma (SLL)
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-102405-PIP01-26
  • BIIB122 (proposed INN: liradasertib)
  • Treatment of Parkinson's disease
  • Neurology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100982-PIP01-23-M02 (update)
  • pegunigalsidase alfa
  • Treatment of Fabry disease
  • Elfabrio
  • Elfabrio
  • Elfabrio
  • Elfabrio
  • Elfabrio
  • Elfabrio
  • Elfabrio
  • Elfabrio
  • Elfabrio
  • Elfabrio
  • Elfabrio
  • Elfabrio
  • Elfabrio
  • Elfabrio
  • Endocrinology-Gynaecology-Fertility-metabolism
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
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
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