SUKL Bulletin 10/2011

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

Contents:

  • Measures taken in the case of quality defects or adverse reactions to medicinal productsin the month of September 2011
  • List of guidelines valid as of October 1, 2011
  • Drug distribution and dispensing in the Czech Republic in the 2nd quarter of the year 2011
  • Announcement on commencement of competition for the lowest price – ref. group 18/1
  • Outline of notifications on the use of non-authorised medicinal products in the monthof September 2011
  • List of medicinal products whose authorisation for parallel import was granted in the month ofSeptember 2011
  • 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 2011
  • List of medicinal products whose marketing authorisation will expire in December 2011
  • List of medicinal products with expired marketing authorisation
  • List of medicinal products for which maximum price applies in the same amount as proposed by theapplicant as of September 30, 2011
  • Revocations of marketing authorisations in the period from July 27, 2011 to August 10, 2011
  • Authorised medicinal products and variations to marketing authorisations approved in the year 2011
  • Medicinal products authorised under the EU centralised procedure and enteredin SUKL database in the year 2011