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SUKL Bulletin 9/2012

SUKL Bulletin 9/2012 was published 25. 9. 2012  

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


  • Information about quality defects or adverse reactions to medicinal products, counterfeit products,illegal products and medical devices in the month of August 2012
  • List of guidelines valid as of September 1, 2012
  • Specification of properties of OTC medicinal products
  • Outline of notifications on the use of non-authorised medicinal products in the month of August 2012
  • List of medicinal products whose authorisation for parallel import was granted in the monthof August 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 August 2012
  • List of medicinal products whose marketing authorisation will expire in November 2012
  • List of medicinal products with expired marketing authorisation
  • List of medicinal products and foods for special medical purposes without determinedreimbursement, for which maximum price applies in the same amount as proposedby the applicant as of August 31, 2012
  • Revocations of marketing authorisations in the period from July 1, 2012 to July 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 databasein the year 2012