Camcevi
leuprorelin
Table of contents
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.
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List item
Camcevi : EPAR - Medicine overview (PDF/137.22 KB)
First published: 20/06/2022
EMEA/H/C/005034 -
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List item
Camcevi : EPAR - Risk management plan summary (PDF/113.05 KB)
First published: 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 | |
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Marketing-authorisation holder |
Accord Healthcare S.L.U.
|
Revision |
1
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Date of issue of marketing authorisation valid throughout the European Union |
24/05/2022
|
Contact address |
Accord Healthcare S.L.U. |
Product information
11/05/2023 Camcevi - EMEA/H/C/005034 - IB/0001
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).
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.