SUKL Bulletin 12/2009

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 products
  • List of guidelines valid as of December 1, 2009
  • Team of authors: Drug consumption in the Czech Republic in the 3th quarter of the year 2009
  • Update on reported adverse drug reactions after administration of pandemic vaccine Pandemrixand medicines for treatment of the pandemic influenza H1N1 in the Czech Republic
  • Announcement on cancellation of the competition for the lowest price
  • Outline of notifications on the use of non-authorised medicinal products in the month of November 2009
  • List of authorised medicinal products where placing on the market of individual batches with the labellingin a foreign language was approved in the month of November 2009
  • Information on Czech standards relating to medical devices published in the Bulletin of the COSMT
  • Information on documents issued by the European Medicines Agency
  • 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 2009
  • List of medicinal products whose marketing authorisation will expire in February 2010
  • List of medicinal products with expired marketing authorisation
  • List of medicinal products for which maximum price applies in the same amount as proposedby the applicant as of November 30, 2009
  • Revocations of marketing authorisations in the period from September 24, 2009 to October 21, 2009
  • Authorised medicinal products and variations to marketing authorisations approved in the year 2009
  • Medicinal products authorised under the EU centralised procedure and enteredin SUKL database in the year 2009
  • List of specific therapeutic programmes approved in the period from November 1, 2009 to November 30, 2009