Displaying 1 - 20 of 891
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
MHRA-101985-PIP01-25
  • obicetrapib
  • EZETIMIBE
  • Treatment of mixed dyslipidaemia
  • Cardiovascular Diseases
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101808-PIP01-25-M01 (update)
  • DARVADSTROCEL
  • Treatment of perianal fistula
  • Alofisel
  • Gastroenterology-Hepatology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101467-PIP01-24-M01 (update)
  • apitegromab
  • Treatment of spinal muscular atrophy
  • Isembyld
  • Other: Neuromuscular disorders
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100369-PIP01-21-M03 (update)
  • MIGALASTAT HYDROCHLORIDE
  • Treatment of Fabry disease
  • Galafold
  • Galafold
  • Galafold
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101592-PIP01-24
  • Afimkibart
  • Treatment of Crohn's disease
  • Human IgG1 kappa monoclonal antibody against tumor necrosis factor-like ligand 1A
  • Gastroenterology-Hepatology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101549-PIP01-24
  • Afimkibart
  • Treatment of ulcerative colitis
  • Gastroenterology-Hepatology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101454-PIP01-24-M01 (update)
  • Donidalorsen
  • Treatment of hereditary angioedema
  • Pneumology - Allergology
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes
MHRA-100635-PIP01-22-M03 (update)
  • CEDAZURIDINE
  • DECITABINE
  • Treatment of acute myeloid leukaemia
  • INAQOVI
  • INAQOVI
  • INQOVI
  • INQOVI
  • Inqovi 35/100
  • Haematology-Hemostaseology
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100182-PIP01-21-M02 (update)
  • Avalglucosidase alfa
  • Treatment of Pompe disease.
  • Nexviadyme
  • Nexviadyme
  • Nexviadyme
  • Nexviadyme
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100149-PIP01-21-M04 (update)
  • NVX-CoV2373
  • Prevention of coronavirus disease 2019 (COVID-19)
  • Nuvaxovid dispersion for injection, COVID-19 Vaccine (recombinant, adjuvanted)
  • Nuvaxovid
  • Nuvaxovid
  • Vaccines
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100118-PIP01-21-M04 (update)
  • OCRELIZUMAB
  • Treatment of Multiple Sclerosis
  • Ocrevus
  • Ocrevus
  • Ocrevus
  • Ocrevus
  • Ocrevus
  • Ocrevus
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes
MHRA-101983-PIP01-25
  • obicetrapib
  • Treatment of mixed dyslipidaemia
  • Cardiovascular Diseases
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-102020-PIP01-25-M01 (update)
  • tezepelumab
  • Treatment of asthma
  • TEZSPIRE
  • TEZSPIRE
  • Pneumology - Allergology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101923-PIP01-25
  • Pimicotinib hydrochloride hydrate
  • Treatment of tenosynovial giant cell tumours
  • Oncology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes Partial Compliance Check Granted
MHRA-100092-PIP01-21-M04 (update)
  • VENETOCLAX
  • Treatment of malignant neoplasms of the haematopoietic and lymphoid tissue
  • Treatment of solid malignant tumours
  • Venclyxto
  • Venclyxto
  • Venclyxto
  • Venclyxto
  • Venclyxto
  • Venclyxto
  • Venclyxto
  • Venclyxto
  • Haematology-Hemostaseology
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-102064-PIP01-25-M01 (update)
  • MERCAPTAMINE HYDROCHLORIDE
  • Treatment of cystinosis.
  • Cystadrop
  • Cystadrops
  • Cystadrops
  • Cystadrops
  • Ophthamology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-101905-PIP01-25
  • FUROSEMIDE
  • Treatment of fluid retention
  • Cardiovascular Diseases
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes Full Compliance Check Granted
MHRA-100130-PIP01-21-M03 (update)
  • BUPIVACAINE
  • Postsurgical analgesia
  • EXPAREL liposomal
  • EXPAREL
  • EXPAREL
  • EXPAREL
  • EXPAREL
  • EXPAREL
  • EXPAREL
  • Pain
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101953-PIP01-25-M01 (update)
  • Nipocalimab
  • Treatment of myasthenia gravis
  • Not available at present
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100216-PIP01-21-M05 (update)
  • TRALOKINUMAB
  • Treatment of atopic dermatitis.
  • Adtralza
  • Adtralza
  • Adbry
  • Adtralza
  • Adtralza
  • Adtralza
  • Adtralza
  • Adtralza
  • Adtralza
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No