SUKL Bulletin 12/2011

SUKL Bulletin 12/2011 was published 20. 12. 2011  

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 productsin the month of November 2011
  • List of guidelines valid as of December 1, 2011
  • Resolution on discontinuation of price competition – reference group 18/1
  • Bisphosphonates and atypical femoral fractures – procedure for submission of Risk Management Plan
  • Progress report of projects co-financed by the European Social Fund
  • Outline of notifications on the use of non-authorised medicinal products in the monthof November 2011
  • List of medicinal products whose authorisation for parallel import was granted in the monthof November 2011
  • 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 monthof November 2011
  • List of medicinal products whose marketing authorisation will expire in February 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 November 30, 2011
  • Revocations of marketing authorisations in the period from September 15, 2011 to October 19, 2011
  • Authorised medicinal products and variations to marketing authorisations approved in the year 2011
  • Medicinal products authorised under the EU centralised procedure and enteredin SUKL database in the year 2011