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Displaying 81 - 100 of 107
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
MHRA-100190-PIP01-21
  • Ordesekimab
  • Treatment of coeliac disease
  • Gastroenterology-Hepatology
  • Immunology -Rheumatology-Transplantation
W: decision granting a waiver in all age groups for the listed condition(s). No 29/07/2022
MHRA-100122-PIP01-21
  • olpasiran
  • Prevention of cardiovascular events
  • Cardiovascular Diseases
W: decision granting a waiver in all age groups for the listed condition(s). No 29/07/2022
MHRA-100316-PIP01-21
  • latozinemab
  • Treatment of clinically symptomatic or pre-symptomatic frontotemporal dementia (FTD)
  • Neurology
W: decision granting a waiver in all age groups for the listed condition(s). No 29/07/2022
MHRA-100396-PIP01-21
  • sugemalimab
  • Treatment of non-small cell lung cancer (NSCLC)
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(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-100301-PIP01-21
  • Anti-neonatal Fc receptor human monoclonal antibody(Nipocalimab )
  • Treatment of chronic inflammatory demyelinating polyradiculoneuropathy
  • Neurology
W: decision granting a waiver in all age groups for the listed condition(s). No 19/05/2022
MHRA-100309-PIP01-21
  • gantenerumab
  • Prevention of Alzheimer's disease
  • Not available at present
  • Neurology
W: decision granting a waiver in all age groups for the listed condition(s). No 19/05/2022
MHRA-100206-PIP01-21
  • EMPAGLIFLOZIN
  • Treatment of ischaemic heart disease
  • Jardiance
  • Jardiance
  • Endocrinology-Gynaecology-Fertility-metabolism
W: decision granting a waiver in all age groups for the listed condition(s). No 19/05/2022
MHRA-100194-PIP01-21
  • sivopixant
  • Treatment of unexplained or refractory chronic cough
  • Pneumology - Allergology
W: decision granting a waiver in all age groups for the listed condition(s). No 19/05/2022
MHRA-100204-PIP01-21
  • verdiperstat
  • Treatment of Amyotrophic lateral sclerosis
  • Dazluma
  • Neurology
W: decision granting a waiver in all age groups for the listed condition(s). No 19/05/2022
MHRA-100184-PIP01-21
  • BENRALIZUMAB
  • Non-cystic fibrosis bronchiectasis with an eosinophilic phenotype
  • FASENRA
  • FASENRA
  • FASENRA
  • FASENRA
  • FASENRA
  • FASENRA
  • Pneumology - Allergology
W: decision granting a waiver in all age groups for the listed condition(s). No 17/05/2022
MHRA-100135-PIP01-21
  • anti-CD40L humanized monoclonal antibody (SAR441344)
  • Treatment of Sjogren's Syndrome
  • Immunology -Rheumatology-Transplantation
W: decision granting a waiver in all age groups for the listed condition(s). No 17/05/2022
MHRA-100368-PIP01-21
  • aumolertinib
  • Treatment of lung cancer
  • Ameile
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 17/05/2022
MHRA-100279-PIP01-21
  • Humanized monoclonal antibody of IgG1 sub-type targeting the human SEMA3A polypeptide
  • Diabetic retinopathy
  • Ophthamology
W: decision granting a waiver in all age groups for the listed condition(s). No 04/05/2022
MHRA-100163-PIP01-21
  • Vupanorsen (PF-07285557)
  • Treatment of Hypertriglyceridemia
  • Prevention of cardiovascular events
  • Not available at present
  • Cardiovascular Diseases
W: decision granting a waiver in all age groups for the listed condition(s). No 18/03/2022
MHRA-100155-PIP01-21
  • efgartigimod alfa
  • Treatment of Chronic Inflammatory Demyelinating Polyneuropathy
  • Neurology
W: decision granting a waiver in all age groups for the listed condition(s). No 18/03/2022
MHRA-100107-PIP01-21
  • 1-(3-methylbutanoyl)-l-aspartyl-l-threonyl-l-histidyl-l-phenylalanyl-l-prolyl-(l-cystinyl-l-isoleucyl-[(n6-(s)-4-carboxy-4-palmitamidobutanoyl)-l-lysinyl]-l-phenylalanyl-l-glutamyl-l-prolyl-l-arginyl-l-serinyl-l-lysinyl-l-glycinyl-l-cystinyl)-l-lysinamide, disulfide, acetate
  • Treatment of polycythaemia vera
  • Haematology-Hemostaseology
W: decision granting a waiver in all age groups for the listed condition(s). No 18/03/2022
MHRA-100112-PIP01-21
  • savolitinib
  • Treatment of renal neoplasms
  • Not available
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 18/03/2022
MHRA-100080-PIP01-21
  • Anti-C1s Humanized IgG4 Monoclonal Antibody
  • Treatment of Immune Thrombocytopenic Purpura
  • Neurology
  • Immunology -Rheumatology-Transplantation
  • Haematology-Hemostaseology
W: decision granting a waiver in all age groups for the listed condition(s). No 17/12/2021
MHRA-100142-PIP01-21
  • Synthetic Hypericin
  • Treatment of cutaneous T-cell lymphoma
  • HyBryte
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 17/12/2021