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PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published
MHRA-100601-PIP01-22-M01 (update)
  • elasomeran
  • imelasomeran
  • Prevention of coronavirus disease 2019 (COVID-19)
  • Spikevax bivalent Original / Omicron
  • Spikevax
  • Infectious diseases
  • Vaccines
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 07/12/2022
MHRA-100075-PIP01-21-M01 (update)
  • leniolisib
  • Treatment of activated phosphoinositide 3-kinase delta (δ) syndrome (APDS)
  • Joenja
  • Immunology -Rheumatology-Transplantation
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 07/12/2022
MHRA-100608-PIP01-22-M01 (update)
  • mitapivat
  • Treatment of pyruvate kinase deficiency
  • PYRUKYND
  • PYRUKYND
  • Haematology-Hemostaseology
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 07/12/2022
MHRA-100623-PIP01-22-M01 (update)
  • NIRAPARIB TOSYLATE MONOHYDRATE
  • Treatment of all conditions included in the category of malignant neoplasms (except haematopoietic and lymphoid malignancies).
  • Zejula
  • Zejula
  • Zejula
  • Zejula
  • Oncology
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 07/12/2022
MHRA-100600-PIP01-22-M01 (update)
  • Modified Vaccinia Ankara - Bavarian Nordic virus (smallpox)
  • Prevention of smallpox, monkeypox, related orthopoxvirus infection and disease
  • Imvanex
  • Imvamune
  • Jynneos
  • Vaccines
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 07/12/2022
MHRA-100507-PIP01-22-M02 (update)
  • BREXPIPRAZOLE
  • Treatment of schizophrenia
  • RXULTI
  • RXULTI
  • Psychiatry
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 07/12/2022
MHRA-100052-PIP01-21-M02 (update)
  • CASIRIVIMAB
  • Treatment of coronavirus disease 2019 (COVID-19)
  • Prevention of coronavirus disease 2019 (COVID-19)
  • Ronapreve
  • Ronapreve
  • Ronapreve
  • Ronapreve
  • Ronapreve
  • Infectious diseases
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 07/12/2022
MHRA-100053-PIP01-21 -M02 (update)
  • IMDEVIMAB
  • Treatment of coronavirus disease 2019 (COVID-19)
  • Prevention of Coronavirus Disease 2019 (COVID-19)
  • Ronapreve
  • Ronapreve
  • Ronapreve
  • Ronapreve
  • Ronapreve
  • Infectious diseases
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 07/12/2022
MHRA-100254-PIP01-21-M01 (update)
  • epcoritamab
  • Treatment of mature B-cell malignancies
  • Not available at present
  • Oncology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 07/12/2022
MHRA-100135-PIP02-22
  • anti-CD40L humanised monoclonal antibody (SAR441344)
  • Treatment of progressive Multiple Sclerosis
  • Neurology
 W: decision granting a waiver in all age groups for the listed condition(s). No 07/12/2022
MHRA-100458-PIP01-22
  • Modakafusp alfa
  • Treatment of multiple myeloma
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No 07/12/2022
MHRA-100556-PIP01-22
  • Anti-C1s Humanized IgG4 Monoclonal Antibody
  • Treatment of chronic inflammatory demyelinating polyradiculoneuropathy
  • Neurology
  • Immunology -Rheumatology-Transplantation
  • Haematology-Hemostaseology
 W: decision granting a waiver in all age groups for the listed condition(s). No 07/12/2022
MHRA-100376-PIP01-21-M01 (update)
  • VEDOLIZUMAB
  • Treatment of Crohn's disease
  • Treatment of Ulcerative colitis
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Gastroenterology-Hepatology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 22/12/2022
MHRA-100574-PIP01-22
  • lixmabegagene relduparvovec
  • Treatment of GM1 gangliosidosis
  • Neurology
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 02/02/2023
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-100482-PIP01-22
  • acetyl-L-leucine ((s)-(acetylamino)-4-methylpentanoic acid)
  • Treatment of Niemann-Pick Disease type C (NPC)
  • Neurology
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 02/02/2023
MHRA-100572-PIP01-22
  • autologous bone marrow-derived mononuclear cell enriched white blood cells
  • Treatment of chronic limb-threatening ischemia
  • Cardiovascular Diseases
 W: decision granting a waiver in all age groups for the listed condition(s). No 02/02/2023
MHRA-100519-PIP01-22
  • RSV preF protein
  • Prevention of lower respiratory tract disease caused by Respiratory syncytial virus (RSV)
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 02/02/2023
MHRA-100421-PIP01-22
  • efavaleukin alfa
  • Treatment of systemic lupus erythematosus (SLE)
  • Not available at present
  • Immunology -Rheumatology-Transplantation
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 02/02/2023
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