SUKL Bulletin 5/2010

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 April 2010
  • List of guidelines valid as of May 1, 2010
  • Outcomes of projects finished by the Laboratory Control Section
  • Announcement of texts of the European Pharmacopoeia being recognizedas official standards - a quick procedure
  • Outline of notifications on the use of non-authorised medicinal products in the month of April 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 April 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 first quarter of 2010 – clinical trials
  • Overview of data on basic activities of the Section of Pharmacy and Distribution Controlin the first quarter of 2010
  • Overview of data on basic activities of the Inspection Section in the first quarter of 2010
  • Overview of data on activities of the Surveillance Branch in the area of medical devicesin the first quarter of 2010
  • List of manufacturers and distributors of pharmaceuticals in the CR approved in the month of April 2010
  • List of medicinal products whose marketing authorisation will expire in July 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 April 30, 2010
  • Revocations of marketing authorisations in the period from February 25, 2009 to March 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 April 1, 2010 to April 30, 2010