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SUKL Bulletin 6/2015

SUKL Bulletin 6/2015 was published 10. 6. 2015  


  • Information about quality defects or adverse reactions to medicinal products, counterfeit products, illegal products and medical devices in the month of March 2015 
  • List of guidelines valid as of June 1, 2015
  • Outline of notifications on the use of non-authorised medicinal products in the month of May 2015
  • List of medicinal products whose authorisation for parallel import was granted in the month of May 2015
  • 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 May 2015
  • List of medicinal products and foods for special medical purposes without determined reimbursement, for which maximum price applies in the same amount as proposed by the applicant as of May 31, 2015
  • Authorised medicinal products and variations to marketing authorisations approved in the year 2015
  • Medicinal products authorised under the EU centralised procedure and entered in SUKL database in the year 2015
  • Revocations of marketing authorisations in the year 2015