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EMA, MHRA to review Vertex' Kaftrio for children with CF
pharmatimes
May 21, 2021
The European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA) have validated Vertex' applications to expand the scope of its cystic fibrosis (CF) treatment Kaftrio (ivacaftor/tezacaftor/elexacaftor).
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MHRA approves label extension for Vertex’s Kaftrio combo
pharmatimes
May 12, 2021
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved a label extension for Vertex’s cystic fibrosis (CF) treatment Kaftrio in combination with ivacaftor.
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Triple combo cystic fibrosis therapy Kaftrio scores EU label expansion
pharmatimes
April 30, 2021
The European Commission (EC) has approved a label extension for Vertex’s triple combination cystic fibrosis (CF) treatment Kaftrio, extending its use for the ‘majority’ of patients aged 12 years and older in Europe.
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Vertex’s Kaftrio approved for use in Europe and made accessible on the NHS
europeanpharmaceuticalreview
August 27, 2020
The European Commission and European Medicines Agency have approved the triple combination Kaftrio for use in certain cystic fibrosis patients, triggering the drug to be accessible on the UK’s National Health Service.
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EC approves Vertex’s Kaftrio plus ivacaftor for cystic fibrosis patients
pharmaceutical-technology
August 25, 2020
Vertex Pharmaceuticals has secured approval from the European Commission (EC) for the use of Kaftrio (ivacaftor / tezacaftor / elexacaftor) in combination with ivacaftor for the treatment of cystic fibrosis (CF).
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EU nod for Vertex CF therapy Kaftrio
pharmatimes
August 24, 2020
Vertex Pharmaceuticals' Kaftrio (ivacaftor/tezacaftor/elexacaftor) has been approved by the European Commission for use in combination with ivacaftor to treat people aged 12 years and older with certain forms of cystic fibrosis.
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Vertex and NHS Wales agree on Kaftrio reimbursement
pharmatimes
July 23, 2020
People with cystic fibrosis (CF) living in Wales should get speedy access to Vertex' new therapy following its approval by Europe regulators.
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CHMP recommends cystic fibrosis treatment Kaftrio is granted marketing authorisation
europeanpharmaceuticalreview
July 03, 2020
The European Medicines Agency’s human medicines committee (CHMP) said the treatment would offer a therapeutic option for certain cystic fibrosis phenotypes that are currently untreatable.