SUKL Bulletin 8/2011

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 products in the month of July 2011
  • List of guidelines valid as of August 1, 2011
  • Drug distribution and dispensing in the Czech Republic in the 1st quarter of the year 2011
  • Information for Marketing Authorisation Holders
  • Information of SUKL for patients and healthcare professionals
  • Outline of notifications on the use of non-authorised medicinal products in the month of July 2011
  • List of medicinal products whose authorisation for parallel import was granted in the month of July 2011
  • 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
  • Overview of data on applications submitted in the second quarter of 2011 – clinical trials
  • Overview of data on basic activities of the Section of Pharmacy and Distribution Controlin the second quarter of 2011
  • Overview of data on basic activities of the Inspection Section in the second quarter of 2011
  • Overview of data on activities of the Surveillance Branch in the area of medical devicesin the second quarter of 2011
  • List of manufacturers and distributors of pharmaceuticals in the CR approved in the month of July 2011
  • List of medicinal products whose marketing authorisation will expire in October 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 July 31, 2011
  • Revocations of marketing authorisations in the period from May 26, 2011 to June 15, 2011
  • Authorised medicinal products and variations to marketing authorisations approved in the year 2011
  • Medicinal products authorised under the EU centralised procedure and entered in SUKL database in the year 2011