Health Canada grants market authorisation for Kalydeco (ivacaftor) for eligible children with cystic fibrosis ages 2 months and older

29 November 2023 - Vertex Pharmaceuticals today announced that Health Canada has granted market authorisation for the expanded use of ...

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Health Canada grants market authorisation for Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) in children with cystic fibrosis ages 2 to 5 years with at least one F508del mutation

17 October 2023 - Approximately 330 children with cystic fibrosis ages 2-5 years are now eligible for a medicine that ...

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Health Canada approves new antibody drug to help prevent serious RSV in babies

22 April 2023 - Health Canada has approved a new antibody drug to help protect babies from serious illness caused ...

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Vertex announces Health Canada market authorisation for Orkambi (lumacaftor/ivacaftor) in children with cystic fibrosis ages 1 to <2 years

10 April 2023 - With this approval, approximately 30 children with two copies of the F508del mutation are eligible for ...

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Koselugo approved in Canada for paediatric patients with neurofibromatosis type 1 plexiform neurofibromas

3 April 2023 - First and only therapy approved to treat this rare and debilitating genetic condition. ...

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Health Canada authorises Moderna's Omicron targeting bivalent COVID-19 vaccine in children & adolescents (6-17 years)

17 February 2023 - The recommendation is based on clinical data for Moderna's bivalent Omicron targeting COVID-19 vaccine, mRNA.1273.214. ...

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Health Canada approves Adtralza (tralokinumab) for the treatment of adolescents aged 12 to 17 with moderate to severe atopic dermatitis

8 February 2023 - Adtralza is the first treatment for adolescents with moderate to severe atopic dermatitis specifically targeting the ...

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Health Canada accepts nirsevimab regulatory submission for infant RSV

18 January 2023 - Nirsevimab is the first investigational long-acting antibody designed for all infants to help protect against respiratory syncytial ...

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Health Canada authorises the Pfizer-BioNTech Omicron BA.4/BA.5 bivalent adapted COVID-19 booster for children 5 to 11 years of age

9 December 2022 - Today, Health Canada authorised the Pfizer-BioNTech Comirnaty Omicron BA.4/BA.5 bivalent adapted booster for use in children 5 ...

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Novavax Nuvaxovid COVID-19 vaccine approved in Canada for use as a primary series in adolescents

7 December 2022 - Novavax today announced that Health Canada has approved a supplement to a new drug submission for Nuvaxovid ...

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Health Canada approves Pfizer-BioNTech COVID-19 vaccine for kids under 5

9 September 2022 - Health Canada approves Pfizer-BioNTech COVID-19 vaccine for kids under 5. ...

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Health Canada approves COVID-19 booster dose for kids 5 to 11

19 August 2022 - The 10 mcg dose can be given at least 6 months after primary series is completed. ...

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Health Canada authorises use of Moderna COVID-19 vaccine in children 6 months to 5 years of age

14 July 2022 - Today, Health Canada authorised the use of the Moderna Spikevax COVID-19 vaccine in children 6 months to ...

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Maviret (glecaprevir/pibrentasvir) approved by Health Canada for paediatric patients with chronic hepatitis C

22 June 2022 - This approval is supported by 98.4 per cent cure rate across this group of patients who ...

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Health Canada OKs Pfizer COVID-19 booster shot for teens ages 16 and 17

1 June 2022 - Canada on Wednesday authorised a single booster shot of Pfizer and partner BioNTech’s COVID-19 vaccine for ...

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