SUKL Bulletin 3/2012

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

Contents:

  • Information about quality defects or adverse reactions to medicinal products,counterfeit products, illegal products and medical devices in the month of February 2012
  • List of guidelines valid as of March 1, 2012
  • Outline of notifications on the use of non-authorised medicinal products in the month of February 2012
  • List of medicinal products whose authorisation for parallel import was grantedin the month of February 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 approvedin the month of February 2012
  • List of medicinal products whose marketing authorisation will expire in May 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 proposed bythe applicant as of February 29, 2012
  • Revocations of marketing authorisations in the period from January 1, 2012 to January 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