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SUKL Bulletin 9/2009

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


  • Measures taken in the case of quality defects or adverse reactions to medicinal products in the month of August 2009
  • List of guidelines valid as of September 1, 2009
  • Team of authors: Drug consumption in the Czech Republic in the 2nd quarter of the year 2009
  • Information on seminars held by SUKL in the 2nd half of 2009
  • Outline of notifications on the use of non-authorised medicinal products in the month of August 2009
  • List of authorised medicinal products where placing on the market of individual batches with the labelling in a foreign language was approved in the month of August 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 (EMEA)
  • 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 August 2009
  • List of medicinal products whose marketing authorisation will expire in November 2009
  • List of medicinal products with expired marketing authorisation
  • List of medicinal products for which maximum price applies in the same amount as proposed by the applicant as of August 31, 2009
  • Revocations of marketing authorisations in the period from June 18, 2009 to July 8, 2009
  • Authorised medicinal products and variations to marketing authorisations approved in the year 2009
  • Medicinal products authorised under the EU centralised procedure and entered in SUKL database in the year 2009
  • List of specific therapeutic programmes approved in the period from August 1, 2009 to August 31, 2009