SUKL Bulletin 2/2010

SUKL Bulletin 2/2010 was published 15. 2. 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 January 2010
  • List of guidelines valid as of February 1, 2010
  • Outline of notifications on the use of non-authorised medicinal products in the month of January 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 January 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
  • Overview of data on applications submitted in the fourth quarter of 2009 – department of clinical trials
  • Overview of data on basic activities of the Section of Pharmacy and Distribution Controlin the fourth quarter of 2009
  • Overview of data on basic activities of the Inspection Section in the fourth quarter of 2009
  • Overview of data on activities of the Surveillance Branch in the area of medical devicesin the fourth quarter of 2009
  • List of manufacturers and distributors of pharmaceuticals in the CR approved in the month of January 2010
  • List of medicinal products whose marketing authorisation will expire in April 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 January 31, 2010
  • Revocations of marketing authorisations in the period from November 26, 2009 to December 16, 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 January 1, 2010 to January 31, 2010