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Displaying 1 - 20 of 864
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
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-102550-PIP01-26
  • Humanised IgG1 (LALA) monoclonal antibody against folate receptor alfa, conjugated with exatecan
  • Treatment of peritoneal cancer.
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-102549-PIP01-26
  • Humanised IgG1 (LALA) monoclonal antibody against folate receptor alfa, conjugated with exatecan
  • Treatment of ovarian cancer.
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-102548-PIP01-26
  • Humanised IgG1 (LALA) monoclonal antibody against folate receptor alfa, conjugated with exatecan
  • Treatment of fallopian tube cancer.
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-102360-PIP01-26
  • olezarsen sodium
  • Treatment of Hypertriglyceridemia
  • Tryngolza
  • Tryngolza
  • Tryngolza
  • Tryngolza
  • Tryngolza
  • Tryngolza
  • Cardiovascular Diseases
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100786-PIP01-22-M03 (update)
  • TOFACITINIB CITRATE
  • Treatment of ulcerative colitis
  • XELJANZ
  • Gastroenterology-Hepatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-102485-PIP01-26
  • Povorcitinib
  • Treatment of hidradenitis suppurativa
  • Dermatology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-102390-PIP01-26
  • empasiprubart
  • Treatment of Chronic Inflammatory Demyelinating Polyneuropathy
  • Not available at present
  • Neurology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100606-PIP01-22-M03 (update)
  • SPARSENTAN
  • Treatment of focal segmental glomerulosclerosis
  • Other: Nephrology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-102207-PIP01-25
  • Dazukibart
  • Treatment of idiopathic inflammatory myopathy
  • Immunology -Rheumatology-Transplantation
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-102442-PIP01-26
  • Gocatamig
  • Neuroendocrine carcinomas (excluding Neuroblastoma)
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-102427-PIP01-26
  • BRIMONIDINE TARTRATE
  • CARBACHOL
  • Treatment of presbyopia
  • YUVEZZI
  • YUVEZZI
  • Ophthamology
W: decision granting a waiver in all age groups for the listed condition(s). No