SUKL Bulletin 6/2010

SUKL Bulletin 6/2010 was published 18. 6. 2010  

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 productsin the month of May 2010
  • List of guidelines valid as of June 1, 2010
  • Drug consumption in the Czech Republic in the 1st quarter of the year 2010
  • Information on controls made in healthcare facilities in the year 2009
  • Outline of notifications on the use of non-authorised medicinal products in the month of May 2010
  • 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 May 2010
  • List of medicinal products whose authorisation for parallel import was granted in the month of May 2010
  • 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 May 2010
  • List of medicinal products whose marketing authorisation will expire in August 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 May 31, 2010
  • Revocations of marketing authorisations in the period from March 25, 2010 to April 28, 2010
  • Authorised medicinal products and variations to marketing authorisations approved in the year 2010
  • Medicinal products authorised under the EU centralised procedure and enteredin SUKL database in the year 2010
  • List of specific therapeutic programmes approved in the period from May 1, 2010 to May 31, 2010