Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Tolucombi   
Auth. number : EU/1/13/821
INN : telmisartan/hydrochlorothiazide
ATC: Anatomical main group: C - Cardiovascular system
Therapeutic subgroup: C09 - Agents acting on the renin-angiotensin system
Pharmacological subgroup: C09D - Angiotensin II antagonists, combinations
Chemical subgroup: C09DA - Angiotensin II antagonists and diuretics
Chemical substance: C09DA07 - Telmisartan and diuretics
(See WHO ATC Index)
Indication: Treatment of essential hypertension.fixed dose combination (40 mg telmisartan/12.5 mg hydrochlorothiazide) is indicated in adults whose blood pressure is not adequately controlled on telmisartan alone.
fixed dose combination (80 mg telmisartan/12.5 mg hydrochlorothiazide) is indicated in adults whose blood pressure is not adequately controlled on telmisartan alone.
fixed dose combination (80 mg telmisartan/25 mg hydrochlorothiazide) is indicated in adults whose blood pressure is not adequately controlled on 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.
Marketing Authorisation Holder: Krka, d. d., Novo Mesto
Šmarješka cesta 6, 8501 Novo mesto, Slovenija

  EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

 

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
15/03/2013 Centralised - Authorisation EMEA/H/C/2549 (2013)1644 of 13/03/2013
23/09/2013 Centralised - Variation EMEA/H/C/2549/IB/1/G
27/01/2014 Centralised - Variation EMEA/H/C/2549/IAin/3
14/02/2014 Centralised - Variation EMEA/H/C/2549/IB/4/G
22/05/2014 Centralised - Variation EMEA/H/C/2549/IB/5/G