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Displaying 1 - 20 of 274
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
MHRA-101748-PIP01-24
  • Influenza virus surface antigens (haemagglutinin and neuraminidase), inactivated, of the strains: A/(H1N1)-Like Virus Antigen A/(H3N2)-Like Virus Antigen B/-Like Virus Antigen
  • Prevention of influenza
  • Cell-based Trivalent Influenza Vaccine Seqirus suspension for injection in pre-filled syringe
  • FLUCELVAX
  • FLUCELVAX
  • FLUCELVAX
  • Vaccines
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes Full Compliance Check Granted
MHRA-101408-PIP01-24
  • Human, recombinant, non-fucosylated IgG1k monoclonal antibody targeting OX-40 receptor on activated T cells (rocatinlimab)
  • Treatment of asthma
  • Pneumology - Allergology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
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) No
MHRA-101661-PIP01-24
  • RUXOLITINIB PHOSPHATE
  • Treatment of atopic dermatitis
  • OPZELURA
  • OPZELURA
  • OPZELURA
  • OPZELURA
  • OPZELURA
  • Dermatology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101579-PIP01-24
  • AZD0780
  • Treatment of elevated cholesterol
  • Treatment of mixed dyslipidaemia
  • AZD0780
  • Cardiovascular Diseases
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101731-PIP01-24
  • Pridopidine hydrochloride
  • Treatment of Huntington disease (HD)
  • Nurzigma
  • Neurology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101550-PIP01-24
  • Troriluzole Hydrochloride
  • Treatment of hereditary spinocerebellar ataxia
  • Neurology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
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
MHRA-101413-PIP01-24
  • BLINATUMOMAB
  • Treatment of acute lymphoblastic leukaemia
  • BLINCYTO
  • Oncology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101671-PIP01-24
  • PEGCETACOPLAN
  • Treatment of glomerulonephritis and nephrotic syndrome
  • ASPAVELI
  • ASPAVELI
  • Uro-Nephrology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101185-PIP01-23
  • gefurulimab
  • Treatment of myasthenia gravis
  • Neurology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101430-PIP01-24
  • RAVULIZUMAB
  • Treatment in haematopoietic stem cell transplant
  • Ultomiris
  • Ultomiris
  • Ultomiris
  • Ultomiris
  • Ultomiris
  • Uro-Nephrology
  • Haematology-Hemostaseology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101417-PIP01-24
  • Plozasiran (USAN)(synthetic double-stranded siRNA oligonucleotide directed against apolipoprotein C-III mRNA and covalently linked to a ligand containing three N-acetylgalactosamine residues)
  • Familial chylomicronaemia syndrome (FCS)
  • Redemplo
  • Cardiovascular Diseases
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-100734-PIP01-22
  • tideglusib
  • Treatment of myotonic dystrophy
  • Neurology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101542-PIP01-24
  • lutikizumab
  • Treatment of hidradenitis suppurativa
  • Dermatology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101595-PIP01-24
  • efinopegdutide
  • 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-101488-PIP01-24
  • etavopivat
  • Treatment of sickle cell disease
  • Not available at present
  • Haematology-Hemostaseology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101435-PIP01-24
  • Hemopexin, human
  • Treatment of sickle cell disease
  • Haematology-Hemostaseology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101314-PIP01-23
  • Venglustat
  • Treatment of Gaucher Disease Type 2
  • Treatment of Gaucher Disease type 3
  • Endocrinology-Gynaecology-Fertility-metabolism
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101350-PIP01-24
  • DECITABINE
  • Tetrahydrouridine
  • Treatment of sickle cell disease (SCD)
  • Not available at present
  • Haematology-Hemostaseology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No