MedPath
EMA Approval

Veoza

G02CX06

fezolinetant

Other gynecologicals

Basic Information

G02CX06

fezolinetant

Other gynecologicals

Therapeutic indication

Veoza is indicated for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause.

Overview Summary

Veoza is a medicine used to treat moderate to severe vasomotor symptoms (also referred to as hot flushes or night sweats) associated with menopause.

Veoza contains the active substance fezolinetant.

Authorisations (1)

EMEA/H/C/005851

Astellas Pharma Europe B.V.,Sylviusweg 62,2333 BE Leiden,The Netherlands

Authorised

December 7, 2023

Active Substances (2)

fezolinetant

fezolinetant

Documents (11)

Veoza : EPAR - Procedural steps taken and scientific information after the authorisation

February 19, 2024

CHANGES_SINCE_INITIAL_AUTHORISATION

Veoza : EPAR - Public assessment report

December 20, 2023

INITIAL_MARKETING_AUTHORISATION_DOCUMENTS

Veoza : EPAR - Product information

December 20, 2023

DRUG_PRODUCT_INFORMATION

CHMP summary of positive opinion for Veoza

October 13, 2023

INITIAL_MARKETING_AUTHORISATION_DOCUMENTS

Veoza : EPAR - Medicine overview

December 20, 2023

OVERVIEW_DOCUMENT

Veoza : EPAR - All authorised presentations

December 20, 2023

AUTHORISED_PRESENTATIONS

Veoza : EPAR - Public assessment report

December 20, 2023

CHANGES_SINCE_INITIAL_AUTHORISATION

CHMP summary of positive opinion for Veoza

October 13, 2023

CHANGES_SINCE_INITIAL_AUTHORISATION

Veoza : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)

February 14, 2025

CHANGES_SINCE_INITIAL_AUTHORISATION

Veoza : EPAR - Procedural steps taken and scientific information after the authorisation

March 21, 2025

CHANGES_SINCE_INITIAL_AUTHORISATION

Veoza : EPAR - Procedural steps taken and scientific information after the authorisation (archive)

February 19, 2024

CHANGES_SINCE_INITIAL_AUTHORISATION

Overview Q&A (7)

Question

How is Veoza used?

Answer

Veoza is available as tablets to be taken by mouth once a day. The medicine can only be obtained with a prescription.

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

Question

How does Veoza work?

Answer

Before menopause, there is a balance between oestrogen hormones and a protein called neurokinin B which regulates the brain’s temperature control centre. As the body goes through menopause, oestrogen levels decline and this balance is disrupted, which can lead to vasomotor symptoms.

The active substance in Veoza, fezolinetant, blocks neurokinin B from attaching to its targets in the brain, thereby reducing the number and intensity of hot flushes and night sweats.

Question

What benefits of Veoza have been shown in studies?

Answer

Two main studies involving over 1,000 women showed that Veoza is effective at reducing the number and severity of hot flushes associated with menopause. After 4 weeks of treatment, the number of moderate to severe daily hot flushes was reduced on average by 53% in women taking Veoza 45 mg, compared with a reduction of 32% in women given placebo (a dummy treatment). After 12 weeks of treatment, the average reduction was 63% for women taking Veoza 45 mg, and 40% for women on placebo. The severity of hot flushes was also reduced in women taking Veoza, compared with women on placebo.

Question

What are the risks associated with Veoza?

Answer

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

The most common side effects with Veoza (which may affect up to 1 in 10 people) include diarrhoea and difficulty sleeping.

Veoza must not be used together with moderate or strong ‘CYP1A2 inhibitor medicines’ as these may reduce the breakdown of Veoza in the body and increase the risk of side effects; it must also not be used during pregnancy or if pregnancy is suspected.

Question

Why is Veoza authorised in the EU?

Answer

Veoza was shown to be effective at reducing the frequency and severity of hot flushes associated with menopause; the medicine is well-tolerated with an acceptable safety profile.

The European Medicines Agency therefore decided that Veoza’s benefits are greater than its risks and it can be authorised for use in the EU.

Question

What measures are being taken to ensure the safe and effective use of Veoza?

Answer

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

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

Question

Other information about Veoza

Answer

Veoza received a marketing authorisation valid throughout the EU on 7 December 2023.

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