SUKL Bulletin 12/2007

Contents of SUKL Bulletin 12/2007  

 

  • Contents
  • Front page news
    • Measures taken in the case of quality defects or adverse reactions to medicinal products in the month of November 2007
  • Information on drug consumption
    • Team of authors: Drug consumption in the Czech Republic in the 3rd quarter of the year 2007 Comparison with the situation in the previous period is given.       Figures are expressed in number of packages, Czech crowns and Defined       Daily Doses.
  • Information
    • Information on seminars held by SUKL in the 1st half of 2008 The overview of seminars and the application form are included.
    • Outline of notifications on the use of non-authorised medicinal products in the month of November 2007 The information on evaluated notifications in the month of November 2007, in particular numbers of notifications, patients, health care facilities and used medicinal products is published.
    • List of authorised medicinal products where placing on the market of individual batches with the labelling in a foreign language was approved in the month of November 2007
    • 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) A list of new documents issued by the EMEA in October 2007 is published. Documents are available in SUKL library.
    • Data on applications submitted to SUKL Data on numbers of various types of applications submitted monthly to SUKL.
    • List of manufacturers and distributors of pharmaceuticals in the CR approved in the month of November 2007
    • List of medicinal products whose marketing authorisation will expire in February 2008 The validity of marketing authorisations of the listed products will expire during February 2008 and the products will be marked in SUKL database by "Z" and published in Věstník SÚKL.
    • List of medicinal products with expired marketing authorisation The listed       products are marked by "Z" in SUKL database as of November 30, 2007.
  • Information on authorised  medicinal products and approved specific therapeutic programmes
    • Authorised medicinal products and variations to marketing authorisations approved in the period from October 25, 2007 to November 21, 2007
    • Medicinal products authorised under the EU centralised procedure in the period from November 1, 2007 to November 30, 2007
    • List of specific therapeutic programmes approved in the period from November 1, 2007 to November 30, 2007