SUKL Bulletin 9/2011

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 products in the month of August 2011
  • List of guidelines valid as of September 1, 2011
  • Information on reimbursement of medicinal products from group 82/2 – anti-Parkinson drugs
  • Medicinal herbal teas – microbiological compliance
  • Outline of notifications on the use of non-authorised medicinal products in the month of August 2011
  • List of medicinal products whose authorisation for parallel import was granted in the monthof August 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 month of August 2011
  • List of medicinal products whose marketing authorisation will expire in November 2011
  • List of medicinal products with expired marketing authorisation
  • List of medicinal products for which maximum price applies in the same amount as proposedby the applicant as of August 31, 2011
  • Revocations of marketing authorisations in the period from June 16, 2011 to July 7, 2011
  • Authorised medicinal products and variations to marketing authorisations approved in the year 2011
  • Medicinal products authorised under the EU centralised procedure and entered in SUKL database in the year 2011