Tolucombi
telmisartan / hydrochlorothiazide
Table of contents
Overview
This is a summary of the European public assessment report (EPAR) for Tolucombi. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Tolucombi.
For practical information about using Tolucombi, patients should read the package leaflet or contact their doctor or pharmacist.
Authorisation details
| Product details | |
|---|---|
| Name |
Tolucombi
|
| Agency product number |
EMEA/H/C/002549
|
| Active substance |
|
| International non-proprietary name (INN) or common name |
|
| Therapeutic area (MeSH) |
Hypertension
|
| Anatomical therapeutic chemical (ATC) code |
C09DA07
|
Generic |
This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines. |
| Publication details | |
|---|---|
| Marketing-authorisation holder |
Krka, d.d., Novo mesto
|
| Revision |
10
|
| Date of issue of marketing authorisation valid throughout the European Union |
13/03/2013
|
| Contact address |
Šmarješka cesta 6 |
Product information
14/02/2022 Tolucombi - EMEA/H/C/002549 - IB/0029
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
Therapeutic indication
Tolucombi fixed-dose combination (80 mg telmisartan/25 mg hydrochlorothiazide) is indicated in adults whose blood pressure is not adequately controlled on Tolucombi 80 mg/12.5 mg (80 mg telmisartan/12.5 mg hydrochlorothiazide) or adults who have been previously stabilised on telmisartan and hydrochlorothiazide given separately.