Camcevi

RSS

leuprorelin

Authorised
This medicine is authorised for use in the European Union.

Overview

Camcevi is a medicine used in adult men for the treatment of advanced prostate cancer that is ‘hormone-dependent’, meaning that it responds to treatments that lower the level of the hormone testosterone. Camcevi is also used in combination with radiotherapy to treat locally advanced hormone-dependent prostate cancer and high-risk localised prostate cancer (this means that the cancer is likely to spread beyond the prostate gland to nearby tissues and become ‘locally advanced’). 

Camcevi is a ‘hybrid medicine’. This means that it is similar to a ‘reference medicine’ containing the same active substance but has a different formulation. The reference medicine for Camcevi is Eligard. Camcevi is available as a ready-to-use medicine in contrast with Eligard, which requires pre-mixing before it can be given to the patient.

The active substance in Camcevi is leuprorelin.

This EPAR was last updated on 20/06/2022

Authorisation details

Product details
Name
Camcevi
Agency product number
EMEA/H/C/005034
Active substance
leuprorelin mesilate
International non-proprietary name (INN) or common name
leuprorelin
Therapeutic area (MeSH)
Prostatic Neoplasms
Publication details
Marketing-authorisation holder
Accord Healthcare S.L.U.
Date of issue of marketing authorisation valid throughout the European Union
24/05/2022
Contact address

World Trade Center
Moll de Barcelona
s/n, Edifici Est 6ª planta
08039 Barcelona
Spain

Product information

24/05/2022 Camcevi - EMEA/H/C/005034 -

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Endocrine therapy

Therapeutic indication

Camcevi is indicated for the treatment of hormone dependent advanced prostate cancer and for the treatment of high-risk localised and locally advanced hormone dependent prostate cancer in combination with radiotherapy.

Assessment history

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