Pylobactell

RSS

13C-urea

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach its recommendations on how to use the medicine.

If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the scientific discussion (also part of the EPAR).

This EPAR was last updated on 27/09/2019

Authorisation details

Product details
Name
Pylobactell
Agency product number
EMEA/H/C/000151
Active substance
13C-urea
International non-proprietary name (INN) or common name
13C-urea
Therapeutic area (MeSH)
  • Breath Tests
  • Helicobacter Infections
Anatomical therapeutic chemical (ATC) code
V04CX
Publication details
Marketing-authorisation holder
Torbet Laboratories Ireland Limited
Revision
10
Date of issue of marketing authorisation valid throughout the European Union
07/05/1998
Contact address

20 Holles Street
Dublin 2
Ireland

Product information

06/09/2019 Pylobactell - EMEA/H/C/000151 - T/0016

Contents

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

DIAGNOSTIC AGENTS

Therapeutic indication

This medicinal product is for diagnostic use only.

For in vivo diagnosis of gastroduodenal Helicobacter pylori (H. pylori) infection.

Assessment history

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