Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Pylobactell   
Auth. number : EU/1/98/064
Active substance : 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: This medicinal product is for diagnostic use only. For in vivo diagnosis of gastroduodenal Helicobacter pylori (H. pylori) infection.
Marketing Authorisation Holder: Torbet Laboratories Limited
Unit 1 Chestnut Drive, Wymondham, Norfolk, NR18 9SB, United Kingdom
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
08/05/1998 Centralised - Authorisation EMEA/H/C/151 (1998)1280 of 07/05/1998
04/01/1999 Centralised - Variation EMEA/H/C/151/I/1 (1998)4500 of 17/12/1998
12/05/2000 Centralised - Variation (no change in Commission Decision) EMEA/H/C/151/I/3
06/11/2000 Centralised - Variation (no change in Commission Decision) EMEA/H/C/151/I/4
07/03/2001 Centralised - Variation EMEA/H/C/151/I/5, 6 (2001)310 of 05/03/2001
03/10/2001 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/151/T/7 (2001)2203 of 17/09/2001
07/10/2002 Centralised - Variation EMEA/H/C/151/I/8 (2002)3720 of 03/10/2002
13/06/2003 Centralised - Renewal EMEA/H/C/151/R/9 (2003)1895 of 11/06/2003
24/01/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/151/IA/10
25/01/2005 Centralised - Variation EMEA/H/C/151/IB/11
Updated with Decision(2005)3491 of 08/09/2005
13/09/2005 Centralised - Variation EMEA/H/C/151 (2005)3491 of 08/09/2005
01/08/2008 Centralised - Renewal EMEA/H/C/151/R/12 (2008)4202 of 29/07/2008
04/04/2012 Centralised - Variation EMEA/H/C/151/IAin/13/G
Updated with Decision(2012)7214 of 10/10/2012
12/10/2012 Centralised - Variation (2012)7214 of 10/10/2012
03/03/2017 Centralised - Variation EMEA/H/C/151/IAin/14