SUKL Bulletin 12/2010

SUKL Bulletin 12/2010 was published 16. 12. 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 November 2010
  • List of guidelines valid as of December 1, 2010
  • Announcement of texts of the European Pharmacopoeia being recognized as official standards
  • Decision on a result of the competition for the lowest price – ref. group 1/3
  • Decision on a result of the competition for the lowest price – ref. group 87/1
  • Decision on a result of the competition for the lowest price – ref. group 25/3
  • Decision on a result of the competition for the lowest price – ref. group 4/2
  • Outline of notifications on the use of non-authorised medicinal products in the month of November 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 November 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 (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 November 2010
  • List of medicinal products whose marketing authorisation will expire in February 2011
  • List of medicinal products with expired marketing authorisation
  • List of medicinal products for which maximum price applies in the same amount as proposed by the applicant as of November 30, 2010
  • Revocations of marketing authorisations in the period from September 23, 2010 to October 20, 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 November 1, 2010 to November 30, 2010