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20 November 2008 /Authorisation and supervision
Control of Eprex®
The Danish Medicines Agency has determined the activity of seven different batches of Eprex®. Eprex® is used for the treatment of anaemia in case of chronic renal failure.
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10 November 2008 /Authorisation and supervision
Sale or delivery of advanced therapy medicinal products on 30 December 2008
The regulation on advanced therapy medicinal products (Regulation (EC) no. 1394/2007 of 13 November 2007), which enters into force on 30 December 2008, contains a transitional provision for medicinal products sold or delivered legally in the EU on this date.
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10 November 2008 /Authorisation and supervision
Control of medicinal product labelling (fall 2008)
The Danish Medicines Agency has controlled different elements of the labelling in the below medicinal products, due to, among other things, complaints and reports submitted to the Danish Patient Safety Database.
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31 October 2008 /Authorisation and supervision
Control of streptokinase-containing medicinal products
The Danish Medicines Agency's laboratory has tested five different products that contain the active substance streptokinase, which is used for the treatment of blood clots.
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31 October 2008 /Authorisation and supervision
Control of oral suspensions
The Danish Medicines Agency's laboratory has analysed six different oral suspensions. The control was carried out in response to a complaint about microbiological contamination in one of the products after opening.
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12 September 2008 /Authorisation and supervision
The Danish Medicines Agency's work with tissues and cells in 2007 and 2008
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.
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14 July 2008 /Authorisation and supervision
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04 June 2008 /Authorisation and supervision
Updating of Danish QRD templates for summaries of product characteristics and package leaflets
On the EMA website, you can find the QRD templates that the industry must use to draw up summaries of product characteristics and package leaflets.
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15 May 2008 /Authorisation and supervision
Warning about unauthorised distribution of donated sperm from the sperm bank A.I. Sædbank
The Danish Medicines Agency has previously warned againts the sperm bank A.I. Sædbank, which unlawfully sells donated sperm from its website.
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11 April 2008 /Authorisation and supervision
Control of medicinal product labelling (spring 2008)
The Danish Medicines Agency has examined the medicinal products shown in this text to see whether the labelling complied with section 7 of the Executive Order on Labelling which stipulates that the labelling of a medicinal product must not be misleading or give rise to mix-ups between medicinal products, pharmaceutical forms or strengths.
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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.
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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.
