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SUKL Bulletin 4/2013

SUKL Bulletin 4/2013 was published 23. 4. 2013  

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 March 2013
  • List of guidelines valid as of April 1, 2013
  • Evaluation of deliveries of distributed medicinal products in the year 2012
  • Outline of notifications on the use of non-authorised medicinal products in the month of March 2013
  • List of medicinal products whose authorisation for parallel import was granted in the monthof March 2013
  • 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 of March 2013
  • List of medicinal products whose marketing authorisation will expire as of January 2, 2014
  • List of medicinal products whose marketing authorisation will expire from January 3,2014 to March 31, 2014
  • 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 March 31, 2013
  • Revocations of marketing authorisations in the period from February 1, 2013 to February 28, 2013
  • Authorised medicinal products and variations to marketing authorisations approved in the year 2013
  • Medicinal products authorised under the EU centralised procedure and entered in SUKL databasein the year 2013