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Displaying 141 - 160 of 295
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Sort descending Compliance outcome Date Published
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-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-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
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-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-100472-PIP01-22
  • Tarlatamab
  • Treatment of small cell lung cancer (SCLC)
  • Treatment of prostate malignant neoplasms.
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 02/02/2023
MHRA-100634-PIP01-22
  • Ceralasertib
  • Treatment of lung carcinoma (small cell and non-small cell carcinoma)
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 02/02/2023
MHRA-100287-PIP01-21
  • SEMAGLUTIDE
  • Treatment of obesity
  • Not available at present
  • Rybelsus
  • Rybelsus
  • Rybelsus
  • Rybelsus
  • Rybelsus
  • Rybelsus
  • Rybelsus
  • Rybelsus
  • Rybelsus
  • Rybelsus
  • Rybelsus
  • Rybelsus
  • Rybelsus
  • Endocrinology-Gynaecology-Fertility-metabolism
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 25/05/2023
MHRA-100209-PIP01-21
  • Peptide derivative of glucagon-like-peptide 1 and glucagon with fatty acid side chain
  • Treatment of obesity
  • Gastroenterology-Hepatology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 25/05/2023
MHRA-100585-PIP01-22
  • Adintrevimab
  • Treatment of coronavirus disease 2019 (COVID-19)
  • Prevention of Coronavirus Disease 2019 (COVID-19)
  • Bredaygio
  • Infectious diseases
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 25/05/2023
MHRA-100503-PIP01-22
  • efavaleukin alfa
  • Treatment of ulcerative colitis
  • Not available at present
  • Other: Inflammatory Bowel Disease
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 25/05/2023
MHRA-100514-PIP01-22
  • Gliadin Protease
  • Treatment of coeliac disease
  • Gastroenterology-Hepatology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 25/05/2023
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-100345-PIP01-21
  • Magrolimab
  • Treatment of myelodysplastic syndromes (including juvenile myelomonocytic leukaemia)
  • Treatment of acute myeloid leukaemia
  • Oncology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 25/05/2023