SUKL Bulletin 4/2010

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 March 2010
  • List of guidelines valid as of April 1, 2010
  • Announcement for pharmacies´ operators
  • Information for wholesalers and pharmacies
  • Information on electronic publications of SUKL
  • Outline of notifications on the use of non-authorised medicinal products in the month of March 2010
  • List of authorised medicinal products where placing on the market of individual batches with the labellingin a foreign language was approved in the month of March 2010
  • Information on Czech standards relating to medical devices published in the Bulletin of the COSMT
  • Information on documents issued by the European Medicines Agency (EMEA)
  • Data on applications submitted to SUKL – marketing authorisations and variations thereto
  • List of new pharmacies and separate departments for dispensing pharmaceuticalsand medical devices approved by SUKL in the first quarter of 2010
  • List of manufacturers and distributors of pharmaceuticals in the CR approved in the month of March 2010
  • List of medicinal products whose marketing authorisation will expire in June 2010
  • List of medicinal products with expired marketing authorisation
  • List of medicinal products which are again subject to price regulation as of April 15, 2010
  • List of medicinal products for which maximum price applies in the same amount as proposedby the applicant as of March 31, 2010
  • Revocations of marketing authorisations in the period from January 28, 2010 to February 24, 2010
  • Authorised medicinal products and variations to marketing authorisations approved in the year 2010
  • Medicinal products authorised under the EU centralised procedure and enteredin SUKL database in the year 2010
  • List of specific therapeutic programmes approved in the period from March 1, 2010 to March 31, 2010