Share
News
-
30 January 2008 /News - miscellaneous
Nordic Market for Medicinal Products
Availability of medicinal products in small markets is an issue that has been repeatedly on the agenda of EEA countries. A Nordic working group has therefore been formed to explore the possibilities of a common Nordic market for medicinal products.
-
30 January 2008 /Product information
The Danish Medicines Agency and the Danish Veterinary and Food Administration warn against the weight loss product Therma Power
The Danish Medicines Agency strongly warns against Therma Power and products with a similar content and characteristics. Therma Power contains ephedrine or synephrine and is illegal in Denmark.
-
29 January 2008 /Side effects and trials
Treatment of haemangioma with interferon
Over recent days, the Danish Media has drawn attention to several incidents where interferon treatment of haemangioma (strawberry marks) in children is suspected to have caused spastic paralysis affecting the legs in children.
-
24 January 2008 /Side effects and trials
Statement from EMEA regarding the safety of Gardasil®
The European Medicines Agency (EMEA) has received reports of deaths in women who had previously received Gardasil®, including two reports concerning the sudden and unexpected deaths of two young women in EU.
-
11 January 2008 /Side effects and trials
Use of waivers in connection with the inclusion of trial subjects/patients in clinical trials
The EMEA GCP Inspectors Working Group has prepared a document with a common European position on the use of waivers in connection with the inclusion of trial subjects/patients in clinical trials.
-
11 January 2008 /Side effects and trials
Reflection paper from EMEA's GCP Inspectors Working Group on expectations for electronic source documents used in clinical trials
The EMEA GCP Inspectors Working Group has prepared a reflection paper on the handling of electronic documents in connection with clinical trials.
-
10 January 2008 /Authorisation and supervision
New rules governing advanced therapy medicinal products
The proposed regulation on advanced therapy medicinal products, including tissue engineered products, was announced on the Danish Medicines Agency's website on 12 June 2007.
-
10 January 2008 /Authorisation and supervision
General principles of the regulation on advanced therapy medicinal products
Regulation (EC) No 1394/2007 on advanced therapy medicinal products specifically governs gene therapy medicinal products, somatic cell therapy medicinal products and tissue engineered products.
-
09 January 2008 /Side effects and trials
Safety regarding use of corticosteroids
Synthetic corticosteroids are used to treat a variety of disesaes. For some reason, some patient cannot produce the vital corticosteroid hormone (cortisol) naturally, and they therefore need to be given this hormone.
