COVID-19 treatments

Applications for authorisation of COVID-19 treatments are made centrally to the European Medicines Agency (EMA). If the EMA concludes that the benefits of a treatment outweighs its risks in treating COVID-19, it makes a recommendation to the European Commission to grant either a marketing authorisation or a conditional marketing authorisation. Once the European Commission grants a marketing authorisation for a medicine, this is valid and legally binding across all EU Member States, including Ireland.

Ireland, through the HPRA, is an active participant in all EMA reviews. The HPRA contributes directly to the assessment of all new medicines and the monitoring of their safety once in use. This is also the case for COVID-19 treatments.

The EMA website contains further information about the development, evaluation and approval of COVID-19 treatments.

The tables below outlines the current status of a treatment in the EMA approval process and links to product information for approved treatments.

The product information includes the:

  • Summary of product characteristics (SPC) containing information for healthcare professionals

  • Package leaflet containing information for members of the public

Authorised treatments

The following medicines can be used in the EU to treat COVID-19:

 

Treatment

Marketing authorisation holder

Current status

Product information

Veklury (remdesivir)

 

View product overview on EMA website

Gilead Sciences Ireland UC

Conditional marketing authorisation granted: 03/07/2020 - see EMA press release

Veklury product information

SPC: see page 1

Package leaflet: see page 25

Regkirona (regdanvimab)

 

View product overview on EMA website

Celltrion Healthcare Hungary Kft.

Marketing authorisation granted: 12/11/2021 – see EMA press release

Regkirona product information

SPC: see page 1

Package leaflet: see page 133

Ronapreve
(casirivimab / imdevimab)

 

View product overview on EMA website

Roche Registration GmbH

Marketing authorisation granted: 12/11/2021 – see EMA press release

Ronapreve product information

SPC: see page 1

Package leaflet: see page 45

RoActemra (tocilizumab)

 

View product overview on EMA website

Roche Registration GmbH

Marketing authorisation for COVID-19 indication granted: 07/12/2021 – see EMA press release

RoActemra product information

SPC: see page 1

Package leaflet: see page 133

Kineret (anakinra)

 

View product overview on EMA website

Swedish Orphan Biovitrum AB (publ)

Marketing authorisation granted: 17/12/2021 – see EMA press release

Kineret product information

SPC: see page 1

Package leaflet: see page 30

Xevudy (sotrovimab)

 

View product overview on EMA website

GlaxoSmithKline Trading Services Limited

Marketing authorisation granted: 17/12/2021 – see EMA press release

Xevudy product information

SPC: see page 1

Package leaflet: see page 19

Paxlovid (PF07321332/ritonavir)

 

View product overview on EMA website

Pfizer

Conditional marketing authorisation granted: 28/1/2022
 – see EMA press release 

Paxlovid product information

SPC: see page 1

Package leaflet: see page 35

 Evusheld
(tixagevimab/cilgavimab)


 AstraZeneca AB
EMA recommended granting a marketing authorisation:   
 24/3/2022
– see EMA press release 
 
Evusheld product information

SPC: see page 1

Package leaflet: see page 18


Treatments under evaluation 

The EMA is currently evaluating the following COVID-19 treatments

Treatment

Applicant

Current status

Advice on possible use of treatment prior to marketing authorisation*

Olumiant(baricitinib)

Eli Lilly Nederland B.V.

Application for marketing authorisation for COVID-19 indication submitted: 29/4/2021 – see EMA press release

N/A

Lagevrio (molnupiravir)

Merck Sharp & Dohme and Ridgeback Biotherapeutics

Application for marketing authorisation submitted: 23/11/2021 – see EMA press release

EMA Article 5(3) opinion


*The European Medicines Agency (EMA) may review COVID-19 medicines under Article 5(3) of the Regulation establishing the EMA (Regulation (EC) No 726/2004).

This is intended to support national decision-making on the possible use of these medicines before a formal authorisation is issued.