Displaying 261 - 280 of 692
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Sort descending Decision Type Compliance Check Compliance outcome Date Published
MHRA-100264-PIP01-21-M01 (update)
  • spesolimab
  • Treatment of Generalised Pustular Psoriasis
  • Prevention of Generalised Pustular Psoriasis
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 17/05/2022
MHRA-100426-PIP01-22-M01 (update)
  • ligelizumab
  • Treatment of chronic spontaneous urticaria
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 17/05/2022
MHRA-100100-PIP01-21
  • Human Immunoglobulin G1 Constant Region – Human Ectodysplasin-A1 Receptor-binding Domain Fusion Protein
  • Treatment of X-linked hypohidrotic ectodermal dysplasia (XLHED)
  • Dermatology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 29/07/2022
MHRA-100199-PIP01-21
  • efgartigimod alfa
  • Treatment of Pemphigus
  • Dermatology
W: decision granting a waiver in all age groups for the listed condition(s). No 29/07/2022
MHRA-100312-PIP01-21
  • Ritlectinib
  • Treatment of alopecia areata
  • Dermatology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes Partial Compliance Check Granted 29/07/2022
MHRA-100448-PIP01-22
  • RUXOLITINIB PHOSPHATE
  • Treatment of vitiligo
  • OPZELURA
  • Dermatology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 29/07/2022
MHRA-100188-PIP01-21-M01 (update)
  • lebrikizumab
  • Treatment of atopic dermatitis
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 29/07/2022
MHRA-100221-PIP01-21-M01 (update)
  • BARICITINIB
  • Treatment of atopic dermatitis
  • Olumiant
  • Olumiant
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 29/07/2022
MHRA-100525-PIP01-22-M01 (update)
  • TILDRAKIZUMAB
  • Treatment of psoriasis
  • Ilumetri 100 mg solution for injection in pre-filled syringe
  • Ilumetri 100 mg solution for injection in pre-filled syringe
  • ILUMYA
  • ILUMYA
  • ILUMYA
  • Ilumetri 100 mg solution for injection in pre-filled syringe
  • Ilumetri
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 29/07/2022
MHRA-100115-PIP01-21
  • Dersimelagon
  • Treatment of erythropoietic protoporphyria
  • Treatment of X-linked protoporphyria
  • Not available at present
  • Dermatology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 27/09/2022
MHRA-100218-PIP01-21
  • DUPILUMAB
  • Treatment of chronic spontaneous urticaria
  • Dupixent
  • Dupixent
  • Dermatology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 27/09/2022
MHRA-100216-PIP01-21-M02 (update)
  • TRALOKINUMAB
  • Treatment of atopic dermatitis
  • Adtralza
  • Adtralza
  • Adtralza
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 07/12/2022
MHRA-100297-PIP01-21
  • Human, recombinant, non-fucosylated IgG1k monoclonal antibody targeting OX-40 receptor on activated T cells (AMG 451)
  • Treatment of atopic dermatitis
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 02/02/2023
MHRA-100469-PIP01-22
  • delgocitinib
  • Treatment of chronic hand eczema
  • no invented name yet
  • Dermatology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 02/02/2023
MHRA-100023-PIP01-21-M02 (update)
  • bimekizumab
  • Treatment of psoriasis
  • Bimzelx
  • Bimzelx
  • Bimzelx
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 02/02/2023
MHRA-100251-PIP01-21
  • DUPILUMAB
  • Chronic pruritus of unknown origin
  • Dupixent
  • Dupixent
  • Dupixent
  • Dupixent
  • Dupixent
  • Dermatology
W: decision granting a waiver in all age groups for the listed condition(s). No 02/02/2023
MHRA-100508-PIP01-22
  • tezepelumab
  • Treatment of chronic spontaneous urticaria
  • Not available at present
  • TEZSPIRE
  • Dermatology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 25/05/2023
MHRA-100463-PIP01-22-M01 (update)
  • spesolimab
  • Treatment of Generalised Pustular Psoriasis
  • Prevention of Generalised Pustular Psoriasis
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 25/05/2023
MHRA-100586-PIP01-22-M01 (update)
  • DUPILUMAB
  • Treatment of asthma
  • Dupixent
  • Dupixent
  • Dupixent
  • Dupixent
  • Dupixent
  • Dupixent
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 25/05/2023
MHRA-100718-PIP01-22-M01 (update)
  • deucravacitinib
  • Treatment of psoriasis
  • SOTYKTU
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 25/05/2023