SUKL Bulletin 11/2009

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 October 2009
  • List of guidelines valid as of November 1, 2009
  • Announcement on prices offered within the competition for the lowest price
  • Outline of notifications on the use of non-authorised medicinal products in the month of October 2009
  • 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 October 2009
  • Information on Czech standards relating to medical devices published in the Bulletin of the COSMT
  • Information on documents issued by the European Medicines Agency
  • Data on applications submitted to SUKL – marketing authorisations and variations thereto
  • Overview of data on applications submitted in the third quarter of 2009
  • Overview of data on basic activities of the Section of Pharmacyand Distribution Control in the third quarter of 2009
  • Overview of data on basic activities of the Inspection Section in the third quarter of 2009
  • Overview of data on activities of the Surveillance Branch in the area of medical devicesin the third quarter of 2009
  • List of manufacturers and distributors of pharmaceuticals in the CR approved in the month of October 2009
  • List of medicinal products whose marketing authorisation will expire in January 2010
  • 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 October 31, 2009
  • Revocations of marketing authorisations in the period from August 27, 2009 to September 23, 2009
  • Authorised medicinal products and variations to marketing authorisations approved in the year 2009
  • Medicinal products authorised under the EU centralised procedure and enteredin SUKL database in the year 2009
  • List of specific therapeutic programmes approved in the period from October 1, 2009 to October 31, 2009