Displaying 1 - 20 of 1112
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
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-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-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-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-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-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
MHRA-102026-PIP01-25
  • DB-OTO
  • Treatment of otoferlin gene-mediated hearing loss
  • Other: Audiology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-102444-PIP01-26
  • MOMELOTINIB DIHYDROCHLORIDE MONOHYDRATE
  • Treatment of myelodysplastic syndrome
  • Omjjara
  • Ojjara
  • Omjjara
  • Omjjara
  • Omjjara
  • Omjjara
  • Omjjara
  • Omjjara
  • OJJAARA
  • Omjjara
  • Omjjara
  • Omjjara
  • Omjjara
  • Omjjara
  • Omjjara
  • Ojjara
  • Omjjaara
  • Omjjara
  • Omjjara
  • Omjjara
  • Omjjara 100mg Film coated tablet PLGB 19494/0318
  • Omjjara 150mg Film coated tablet PLGB 19494/0322
  • Omjjara 200mg Film coated tablet PLGB 19494/0323
  • Other: Congenital, familial and genetic disorders, neoplasms benign, malignant and unspecified (including cysts and polyps)
W: decision granting a waiver in all age groups for the listed condition(s). No
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