SUKL Bulletin 12/2012

SUKL Bulletin 12/2012 was published 18. 12. 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 November 2012
  • List of guidelines valid as of December 1, 2012
  • Drug distribution and dispensing in the Czech Republic in the 3rd quarter of the year 2012
  • Progress report of projects co-financed by the European Structural funds
  • Outline of notifications on the use of non-authorised medicinal products in the month of November 2012
  • List of medicinal products whose authorisation for parallel import was granted in the month of November 2012
  • Information on Czech standards relating to medical devices published in the Bulletin of the COSMT
  • Information on documents issued by the European Medicines Agency (EMA)
  • Data on applications submitted to SUKL – marketing authorisations and variations thereto
  • List of manufacturers and distributors of pharmaceuticals in the CR approved in the month of November 2012
  • List of medicinal products whose marketing authorisation will expire in February 2013
  • List of medicinal products and foods for special medical purposes without determined reimbursement, for which maximum price applies in the same amount as proposed by the applicant as of November 30, 2012
  • Revocations of marketing authorisations in the period from October 1, 2012 to October 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 database in the year 2012