Advanced Accelerator Applications announces Health Canada approval for Lutathera, a treatment for gastro-enteropancreatic neuroendocrine tumours

7 February 2019 - First ever approved peptide receptor radionuclide therapy in Canada. ...

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Health Canada grants market authorisation for Kalydeco (ivacaftor) in children ages 12 to <24 months with certain mutations in the CFTR gene

28 January 2019 - Kalydeco is the first and only approved medicine in Canada to treat the underlying cause of ...

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Sandoz Canada receives Health Canada approval for Erelzi (etanercept) in the treatment of psoriatic arthritis in adult patients

21 January 2019 - Erelzi is the only etanercept biosimilar to be indicated for reducing the signs and symptoms of psoriatic ...

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Valeo Pharma and Zambon announce the approval of Onstryv (safinamide) for Canada

15 January 2019 - New treatment option for estimated 100,000 Canadians living with Parkinson's disease. ...

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Health Canada approves Xtandi (enzalutamide) - the first and only oral treatment for men with non-metastatic and metastatic castration-resistant prostate cancer

14 January 2019 - Astellas today announced that Health Canada approved an expanded indication for enzalutamide, an androgen receptor inhibitor for ...

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Bausch & Lomb announces Health Canada approval of Vyzulta (latanoprostene bunod ophthalmic solution, 0.024%) for the treatment of glaucoma

3 January 2019 - Bausch & Lomb today announced that on 27 December 2018, Health Canada issued the notice of compliance ...

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Emergent BioSolutions receives Health Canada approval of BioThrax (anthrax vaccine adsorbed)

17 December 2018 - Emergent BioSolutions today announced that Health Canada has approved the company’s new drug submission for its anthrax ...

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Health Canada grants market authorisation for Orkambi (lumacaftor/ivacaftor) for children with cystic fibrosis aged 2 to 5 years old with most common form of the disease

13 December 2018 - Orkambi is the first medicine in Canada to treat the underlying cause of cystic fibrosis in young ...

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Zaxine (rifaximin) - now indicated in Canada for patients with irritable bowel syndrome with diarrhoea

6 December 2018 - Lupin Pharma Canada is pleased to announce the approval from Health Canada for Zaxine 550 mg (rifaximin) ...

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Ultragenyx and Kyowa Kirin announce Health Canada approval of Crysvita (burosumab injection) for the treatment of X–linked hypophosphataemia in adults and children

6 December 2018 - First approved treatment for XLH in Canada that targets the underlying cause of this rare, hereditary, lifelong ...

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Alimera Sciences announces Canadian regulatory approval for Iluvien

26 November 2018 - Alimera Sciences today announced that Health Canada has approved Iluvien for the treatment of diabetic macular oedema.  ...

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Health Canada has now authorised Adynovate [anti-haemophilic factor (recombinant), PEGylated] in paediatrics for treatment of children under 12 with haemophilia A

26 November 2018 - Canadian children now have access to Adynovate, which offers a twice-weekly prophylaxis dosing schedule and on-demand control ...

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Indivior announces Health Canada approval of Sublocade (buprenorphine extended release) injection for patients with moderate to severe opioid use disorder

23 November 2018 - Sublocade is the first and only once-monthly injectable buprenorphine formulation approved in Canada for the management of ...

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Inclusion of data on treatment discontinuation in the Tasigna product monograph approved by Health Canada for CML patients who achieve a sustained molecular response

13 November 2018 - Approval is based on two studies showing more than half of patients remained in remission after stopping ...

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Servier receives Health Canada approval of Folotyn for the treatment of relapsed or refractory peripheral T-cell lymphoma

1 November 2018 - Servier Canada announced that Health Canada granted a Notice of Compliance with conditions for Folotyn (pralatrexate) for ...

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