Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Tolucombi   
Auth. number : EU/1/13/821
Active substance : 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. Tolucombi fixed dose combination (40 mg telmisartan/12.5 mg hydrochlorothiazide) is indicated in adults whose blood pressure is not adequately controlled on telmisartan alone.
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
Updated with Decision(2014)6392 of 04/09/2014
27/01/2014 Centralised - Variation EMEA/H/C/2549/IAin/3
Updated with Decision(2014)6392 of 04/09/2014
14/02/2014 Centralised - Variation EMEA/H/C/2549/IB/4/G
Updated with Decision(2014)6392 of 04/09/2014
22/05/2014 Centralised - Variation EMEA/H/C/2549/IB/5/G
Updated with Decision(2014)6392 of 04/09/2014
08/09/2014 Referral EMEA/H/C/2549/A-31/1370 (2014)6392 of 04/09/2014
08/04/2015 Centralised - Variation EMEA/H/C/2549/IB/10/G
Updated with Decision(2015)3654 of 27/05/2015
29/05/2015 Centralised - Yearly update (2015)3654 of 27/05/2015
17/02/2016 Centralised - Variation EMEA/H/C/2549/IAin/13
Updated with Decision(2017)798 of 06/02/2017
09/02/2017 Centralised - Yearly update (2017)798 of 06/02/2017
15/06/2017 Centralised - Notification EMEA/H/C/2549/N/19
Updated with Decision(2018)130 of 08/01/2018
22/06/2017 Corrigendum
10/01/2018 Centralised - Renewal EMEA/H/C/2549/R/20 (2018)130 of 08/01/2018
14/02/2018 Centralised - Variation EMEA/H/C/2549/IB/21