Pylori-Chek

Withdrawn

This medicine's authorisation has been withdrawn

13C-urea

Overview

On 15 June 1998, the European Commission issued a Marketing Authorisation valid throughout the European Union for the medicinal product Pylori-Chek, which contains ¹³C-urea. The pharmaceutical company responsible for this medicinal product is Alimenterics B V.

On 17 April 2000, the Marketing Authorisation holder notified the European Commission about the Marketing Authorisation holder’s decision to withdraw the Marketing Authorisation for Pylori-Chek.

On 5 July 2000, the European Commission has adopted the decision withdrawing the Marketing Authorisation for the medicinal product for human use “PYLORI-CHEK - ¹³C-urea”. Pursuant to this decision the European Public Assessment Report for Pylori-Chek has been removed from this website.

For information, it should be noted that at present there are still two Community Marketing Authorisations valid throughout the European Union for medicinal products containing ¹³C-urea, i.e. Pylobactell (BSIA Ltd.) and Helicobacter Test INFAI (INFAI, Institut für biomedizinische Analytik und NMR Imaging GmbH), in addition to nationally-authorised products.

Product information

Product details

• Name of medicine:
  Pylori-Chek
• Active substance:
  urea (13C)
• International non-proprietary name (INN) or common name:
  13C-urea
• Therapeutic area (MeSH):
  • Breath Tests
  • Helicobacter Infections
• Anatomical therapeutic chemical (ATC) code:
  V04CX

Pharmacotherapeutic group

Diagnostic agents

Therapeutic indication

Pylori-Chek may be used for in vivo diagnosis of gastroduodenal Helicobacter pylori infection.

Authorisation details

• EMA product number:
  EMEA/H/C/000182
• Marketing authorisation holder:
  Alimenterics B.V.

  Paul-Ehrlich-Strasse 32 H8; D-63322 Roedermark; Germany

• Marketing authorisation issued:
  15/06/1998
• Withdrawal of marketing authorisation:
  05/07/2000