Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Helicobacter Test INFAI   

   This product is authorized under a different brandname in the EU in the folowing languages:
   - Helicobacter test INFAI (CS)
   - Helicobacter INFAI test (ET)
   - Test INFAI Helicobacter (LV)
   - Test INFAI Helicobacter (PL)
   - Test Helicobacter INFAI (SL)
Auth. number : EU/1/97/045
INN : ¹³C - urea
ATC: Anatomical main group: V - Various
Therapeutic subgroup: V04 - Diagnostic agents
Pharmacological subgroup: V04C - Other diagnostic agents
Chemical subgroup: V04CX - Other diagnostic agents
Chemical substance: V04CX - Other diagnostic agents
(See WHO ATC Index)
Indication: Helicobacter Test INFAI may be used for in vivo diagnosis of gastroduodenal Helicobacter pylori infection in:- adults,- adolescents, who are likely to have peptic ulcer disease.This medicinal product is for diagnostic use only.
Marketing Authorisation Holder: INFAI, Institut für biomedizinische Analytik und NMR-Imaging GmbH
Universitätsstraße 142, D-44799 Bochum, Deutschland

  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
16/08/1997 Centralised - Authorisation EMEA/H/C/140 (97)2734 of 14/08/1997
20/07/1998 Centralised - Variation EMEA/H/C/140/N/1 (1998)2083 of 17/07/1998
21/06/1999 Centralised - Variation EMEA/H/C/140/N/2 (1999)1609 of 11/06/1999
14/04/2000 Centralised - Variation EMEA/H/C/140/I/4
26/05/2000 Centralised - Variation EMEA/H/C/140/N/3 (2000)1282 of 24/05/2000
20/07/2000 Centralised - Variation EMEA/H/C/140/N/5 (2000)1788 of 11/07/2000
22/04/2002 Centralised - Variation EMEA/H/C/140/II/6 (2002)1588 of 22/05/2002
06/05/2002 Centralised - Variation EMEA/H/C/140/II/7 (2002)1838 of 02/05/2002
15/10/2002 Centralised - Variation EMEA/H/C/140/X/8 (2002)3961 of 10/10/2002
05/11/2002 Centralised - Renewal EMEA/H/C/140/R/9 (2002)4385 of 29/10/2002
27/02/2004 Centralised - Variation EMEA/H/C/140/IB/10
Updated with Decision(2005)385 of 14/02/2005
16/02/2005 Centralised - Variation EMEA/H/C/140 (2005)385 of 14/02/2005
13/03/2008 Centralised - Renewal EMEA/H/C/140/R/11 (2008)1062 of 11/03/2008
26/06/2009 Centralised - Variation EMEA/H/C/140/N/12
Updated with Decision(2012)7715 of 25/10/2012
28/04/2010 Centralised - Variation EMEA/H/C/140/N/13
Updated with Decision(2012)7715 of 25/10/2012
03/02/2011 Centralised - Variation EMEA/H/C/140/IA/14
16/05/2011 Centralised - Variation EMEA/H/C/140/IA/15
Updated with Decision(2012)7715 of 25/10/2012
29/10/2012 Centralised - Variation (2012)7715 of 25/10/2012
20/12/2012 Centralised - Variation EMEA/H/C/140/N/16
09/10/2013 Centralised - Variation EMEA/H/C/140/N/17