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Displaying 61 - 80 of 295
PIPS Search Results
PIP Number Active Substance Sort descending Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published
MHRA-100291-PIP01-21
  • imetelstat
  • Treatment of acute myeloid leukaemia
  • Treatment of Myelodysplastic Syndromes (MDS), including JMML
  • Oncology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 17/05/2022
MHRA-100254-PIP01-21
  • epcoritamab
  • Treatment of mature B-cell malignancies
  • Not available at present
  • Oncology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 17/05/2022
MHRA-100230-PIP01-21
  • Thienopyrimidine Derivative
  • Treatment of fibrosing interstitial lung disease
  • Pneumology - Allergology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 17/05/2022
MHRA-100208-PIP01-21
  • Peptide derivative of glucagon-like-peptide 1 and glucagon with fatty acid side chain
  • Treatment of non-alcoholic steatohepatitis
  • Gastroenterology-Hepatology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 17/05/2022
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-100275-PIP01-21
  • SEMAGLUTIDE
  • Treatment of non-alcoholic steatohepatitis (NASH)
  • Ozempic
  • OZEMPIC 0.5 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN
  • Ozempic
  • Ozempic
  • Ozempic
  • Ozempic
  • OZEMPIC 0.25 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN
  • OZEMPIC 1 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN
  • Gastroenterology-Hepatology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 17/05/2022
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-101270-PIP01-23
  • SEMAGLUTIDE
  • Prevention of cardiovascular events in patients with atherosclerosis
  • Wegovy
  • Wegovy
  • Wegovy
  • Wegovy
  • Wegovy
  • Wegovy
  • Wegovy
  • Wegovy
  • Wegovy
  • Wegovy
  • Wegovy
  • Wegovy
  • Wegovy
  • Wegovy
  • Wegovy
  • Wegovy
  • Wegovy
  • Wegovy
  • Wegovy
  • Wegovy
  • Wegovy
  • Wegovy
  • Wegovy
  • Wegovy
  • Endocrinology-Gynaecology-Fertility-metabolism
W: decision granting a waiver in all age groups for the listed condition(s). No 30/04/2024
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-100381-PIP01-21
  • Regdanvimab
  • Treatment of coronavirus disease 2019 (COVID-19)
  • Regkirona
  • Regkirona Inj.
  • Infectious diseases
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 17/05/2022
MHRA-100324-PIP01-21
  • Loncastuximab tesirine
  • Treatment of mature B-cell neoplasms
  • Zynlonta
  • Zynlonta
  • Oncology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 17/05/2022
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-100382-PIP01-21
  • RAVULIZUMAB
  • Treatment of myasthenia gravis
  • Ultomiris
  • Ultomiris
  • Ultomiris
  • Ultomiris
  • Neurology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 27/09/2022
MHRA-100445-PIP01-22
  • RAVULIZUMAB
  • Treatment of Neuromyelitis Optica Spectrum Disorder
  • Ultomiris
  • Ultomiris
  • Ultomiris
  • Ultomiris
  • Neurology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes 07/12/2022
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-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-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-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-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-100027-PIP01-21
  • benzylamine derivative of benzofuran
  • Treatment of paroxysmal nocturnal haemoglobinuria (PNH)
  • Haematology-Hemostaseology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 29/07/2022