Verquvo

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Authorised

This medicine is authorised for use in the European Union

vericiguat
Medicine Human Authorised
  • Application under evaluation
  • CHMP opinion
  • European Commission decision

Overview

Verquvo is a medicine used to treat adults with long-term heart failure with reduced ejection fraction who recently received treatment given intravenously (into a vein) because their symptoms had worsened. Heart failure with reduced ejection fraction is when the heart does not pump blood as well as it should, especially when the amount of blood being pumped out of the heart is less than the body needs. Some common symptoms of heart failure are shortness of breath, tiredness, or swelling caused by a build-up of fluid.

Verquvo contains the active substance vericiguat.

Verquvo can only be obtained with a prescription. It is given in combination with other treatments for heart failure and is available as tablets. The recommended starting dose is 5 mg once a day. The doctor may lower the starting dose to 2.5 mg if the patient has symptomatic hypotension (low blood pressure with symptoms such as light-headedness).

The dose should be doubled approximately every 2 weeks to reach the target maintenance dose of 10 mg once a day, if tolerated. The dose should be lowered or treatment should be stopped if the patient does not tolerate the medicine well.

For more information about using Verquvo, see the package leaflet or contact your doctor or pharmacist.

The active substance in Verquvo, vericiguat, stimulates an enzyme (a type of protein) called soluble guanylate cyclase (sGC) in the blood vessels, which causes them to relax and widen, making it easier for the heart to pump blood out.

Verquvo has been shown to be effective in treating heart failure in one main study involving over 5,000 patients with long-term heart failure and reduced ejection fraction who had been recently

treated for an increase in their symptoms. In the study, which lasted around one year, patients were given either Verquvo or placebo (a dummy treatment) in combination with other medicines for heart failure.

In the group treated with Verquvo, 35.5% of patients (897 out of 2,526) either died as a result of heart and circulation problems or were admitted to hospital with heart failure, compared to 38.5% (972 out of 2,524) of patients given placebo.

For the full list of side effects and restrictions of Verquvo, see the package leaflet.

The most common side effect with Verquvo (which may affect more than 1 in 10 people) is hypotension (low blood pressure).

Verquvo must not be used together with other sGC stimulators, such as riociguat.

The main study found that Verquvo reduced deaths from heart and circulation problems or hospital admissions for heart failure. Although the effect compared to placebo was modest, it was considered significant considering that the patients included in the study were at high risk of hospitalisation or death. The safety of Verquvo was considered acceptable and the medicine well-tolerated. The European Medicines Agency therefore decided that Verquvo’s benefits are greater than its risks and it can be authorised for use in the EU.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Verquvo have been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Verquvo are continuously monitored. Suspected side effects reported with Verquvo are carefully evaluated and any necessary action taken to protect patients.

Verquvo received a marketing authorisation valid throughout the EU on 16 July 2021.

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Product information

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Latest procedure affecting product information:VR/0000257213
24/10/2025
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This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.

 

Product information documents contain:

  • summary of product characteristics (annex I);
  • manufacturing authorisation holder responsible for batch release (annex IIA);
  • conditions of the marketing authorisation (annex IIB);
  • labelling (annex IIIA);
  • package leaflet (annex IIIB).

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Product details

Name of medicine
Verquvo
Active substance
vericiguat
International non-proprietary name (INN) or common name
vericiguat
Therapeutic area (MeSH)
Heart Failure
Anatomical therapeutic chemical (ATC) code
C01

Pharmacotherapeutic group

Cardiac therapy

Therapeutic indication

Treatment of symptomatic chronic heart failure

Authorisation details

EMA product number
EMEA/H/C/005319

Additional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Marketing authorisation holder
Bayer AG

51368 Leverkusen
Germany

Opinion adopted
20/05/2021
Marketing authorisation issued
16/07/2021
Revision
1

Assessment history

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