SUKL Bulletin 10/2012

SUKL Bulletin 10/2012 was published 19. 10. 2012  

Since 2009 SUKL Bulletin is published in electronic form. Full version is available on the czech webpage.

Contents:

  • Information about quality defects or adverse reactions to medicinal products, counterfeit products,illegal products and medical devices in the month of September 2012
  • List of guidelines valid as of October 1, 2012
  • Drug distribution and dispensing in the Czech Republic in the 2st quarter of the year 2012
  • Outline of notifications on the use of non-authorised medicinal products in the month of September 2012
  • List of medicinal products whose authorisation for parallel import was granted in the monthof September 2012
  • Information on Czech standards relating to medical devices published in the Bulletin of the COSMT
  • Data on applications submitted to SUKL – marketing authorisations and variations thereto
  • List of manufacturers and distributors of pharmaceuticals in the CR approved in the monthof September 2012
  • List of medicinal products whose marketing authorisation will expire in December 2012
  • List of medicinal products with expired marketing authorisation
  • List of medicinal products and foods for special medical purposes without determinedreimbursement, for which maximum price applies in the same amount as proposedby the applicant as of September 30, 2012
  • Revocations of marketing authorisations in the period from August 1, 2012 to August 31, 2012
  • Authorised medicinal products and variations to marketing authorisations approved in the year 2012
  • Medicinal products authorised under the EU centralised procedure and entered in SUKL databasein the year 2012