SUKL Bulletin 7/2010

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 June 2010
  • List of guidelines valid as of July 1, 2010
  • Information on amendment of Decree on the marketing authorisation of medicinal products (No 13/2010 Coll.)
  • Outline of notifications on the use of non-authorised medicinal products in the month of June 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 June 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 new pharmacies and separate departments for dispensing pharmaceuticals and medical devicesapproved by SUKL in the second quarter of 2010
  • List of manufacturers and distributors of pharmaceuticals in the CR approved in the month of June 2010
  • List of medicinal products whose marketing authorisation will expire in September 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 June 30, 2010
  • Revocations of marketing authorisations in the period from April 29, 2010 to June 2, 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 June 1, 2010 to June 30, 2010