Fortacin
lidocaine / prilocaine
Table of contents
Overview
Fortacin is used to treat men with primary (lifelong) premature ejaculation (when ejaculation regularly occurs before, or too early during, penetration).
Fortacin contains the active substances lidocaine and prilocaine.
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List item
Fortacin : EPAR - Medicine overview (PDF/120.28 KB)
First published: 25/11/2013
Last updated: 19/10/2020
EMA/414001/2020 -
List item
Fortacin : EPAR - Risk-management-plan summary (PDF/60.74 KB)
First published: 19/10/2020
Authorisation details
Product details | |
---|---|
Name |
Fortacin
|
Agency product number |
EMEA/H/C/002693
|
Active substance |
|
International non-proprietary name (INN) or common name |
|
Therapeutic area (MeSH) |
Sexual Dysfunction, Physiological
|
Anatomical therapeutic chemical (ATC) code |
N01BB20
|
Publication details | |
---|---|
Marketing-authorisation holder |
Recordati Ireland Ltd.
|
Revision |
12
|
Date of issue of marketing authorisation valid throughout the European Union |
15/11/2013
|
Contact address |
Raheens East |
Product information
15/09/2023 Fortacin - EMEA/H/C/002693 - R/0038
This medicine’s product information is available in all official EU languages.
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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
Anesthetics
Therapeutic indication
Treatment of primary premature ejaculation in adult men.