Published: 18 January 2022

COVID-19

Approval status of COVID-19 treatment applications received by Medsafe

A Medsafe approval is one step in the process for accessing a COVID-19 treatment. In addition to Medsafe assessment of applications for regulatory approval, PHARMAC is working with pharmaceutical companies to negotiate supply for New Zealand patients. For more information, please see the website Ministry of Health and PHARMAC websites or see a description of the Medsafe approval process for COVID-19 treatments. More information about medicine applications and approvals can also be found using our Product/Application Search.

Dexmethsone
Dexamethasone 0.3 mg tablet
Healthcare Logistics


Status
Extension of indications to include treatment of severe COVID-19 approved under section 24 of the Medicines Act 1981 on 16 November 2020.

Approved indication
Dexamethasone is indicated in the treatment of coronavirus disease 2019 (COVID-19) in adult and adolescent patients (aged 12 years and older with body weight at least 40 kg) who require supplemental oxygen therapy.

Documents

Ronapreve
Casirivimab/imdevimab 120 mg/mL solution for injection
Roche Products (NZ) Ltd


Approval pathway
New medicine application

Status
Approved under section 20 of the Medicines Act on 21 December 2021

Approved indications

Treatment
Treatment Ronapreve is indicated for the treatment of COVID-19 in adults and adolescents (aged 12 years and older and weighing at least 40 kg) who do not require supplemental oxygen for COVID-19 and who are at increased risk of progressing to severe COVID-19.

Post-exposure prophylaxis
Ronapreve is indicated for the prevention of COVID-19 in adults and adolescents (aged 12 years and older and weighing at least 40 kg) who have been exposed to SARS-CoV-2 AND who either:

  •  have a medical condition making them unlikely to respond to or be protected by vaccination, or
  • are not vaccinated against COVID-19.

Ronapreve is not intended to be used as a substitute for vaccination against COVID-19.

Documents

Veklury
Remdesivir 100 mg powder for injection
Gilead Sciences (NZ)


Approval pathway
Abbreviated new medicine application

Status
The initial assessment of this application is currently ongoing.

Proposed indication
Veklury is indicated for the treatment of coronavirus disease 2019 (COVID-19) in adults and adolescents (aged 12 years and older weighing at least 40 kg) with pneumonia, requiring supplemental oxygen.

Paxlovid
PF-07321332 150 mg film coated tablet + ritonavir 100 mg film coated tablet
Pfizer New Zealand Limited


Approval pathway
Rolling new medicine application

Status
Pfizer has provided some data to Medsafe for the rolling assessment but still needs to provide further data as it becomes available. Timing for completing the assessment is dependent on when Medsafe receives all the data, the completeness of the information provided, and the time taken by Pfizer to respond to any requests for further information that may be required.

Proposeded indications
Paxlovid is indicated for:

  • the treatment of adult patients with symptomatic confirmed SARS-CoV-2 infection, and
  • the post-exposure prophylaxis of potential SARS-CoV-2 infection (e.g. close contacts).

Molnupiravir
Merck Sharp & Dohme (New Zealand) Limited


Approval pathway
TBC

Status
Medsafe has been in correspondence with the sponsor Merck Sharp & Dohme but is yet to receive an application.

Proposed indications
TBC

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