30 September 2008 /Side effects and trials
From 1 October 2008 and two years onwards, the Danish Medicines Agency implements special monitoring of side effects (adverse reactions) fron the Gardasil® cervical cancer vaccine.
26 September 2008 /Side effects and trials
The EMEA's Committee for Medicinal Products for Human Use (CHMP) has recommended that the product information for the sclerosis medicine Tysabri® (natalizumab) be updated.
26 September 2008 /Prices and reimbursement
From 1 January 2009, all changes to prices and product range must be reported electronically at DKMAnet – Prices & Packages
From 1 January 2009 changes in prices and product range for medicinal products can no longer be sent by fax. In future, notifications must be sent electronically at DKMAnet - Prices & Packages.
19 September 2008 /Product information
On 12 September 2008, the Danish Medicines Agency hosted a national meeting about the Pharmaceutical Forum held by the Danish Ministry of Health and Prevention and the Danish Medicines Agency.
12 September 2008 /Authorisation and supervision
The use of human tissues and cells is expanding, and since the implementation of the Danish Issue Act in 2007, the Danish Medicines Agency performs an increasing number of tasks within this field.
12 September 2008 /Product information
2care4 has, in cooperation with the Danish Medicines Agency, chosen to withdraw Oxis Turbohaler® with batch no. IA763-3 from Danish pharmacies. The company has chosen to do so because of the risk that packages in this batch may contain turbohalers with the wrong dose relative to the strength stated on the package.
10 September 2008 /Side effects and trials
08 September 2008 /Prices and reimbursement
Reassessment of reimbursement status of medicinal products for cardiovascular diseases – additional recommendation from the Reimbursement Committee
The Danish Medicines Agency has asked the Reimbursement Committee to reassess the reimbursement status of medicinal products authorised for marketing in Denmark in the ATC groups C02 (antihypertensives), C03 (diuretics), C07 (beta blocking agents), C08 (calcium channel blockers) and C09 (ACE inhibitors, angiotensin II antagonists and renin inhibitors).