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News about licensing of medicines
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25 January 2012
Danish translation of the PhVWP's recommendation for the product information of Strattera (atomoxetine)
The European Pharmacovigilance Working Party, PhVWP, has prepared a recommendation for the wording of the product information for Strattera (atomoxetine). The Danish Medicines Agency has now translated this recommendation into Danish.
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20 January 2012
Updating of summaries of product characteristics prompted by changed ATC codes for 2012
Marketing authorisation holders of medicinal products authorised under the Decentralised Procedure and the Mutual Recognition Procedure should be aware that some ATC codes have been changed in 2012.
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10 January 2012
Danish Medicines Agency resumes allocation of DCP time slots for the period July-October 2012
From 16 January until 6 February 2012, the Danish Medicines Agency accepts request for DCP time slots with Denmark as reference member state (RMS) for the period July-October 2012.
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07 December 2011
Danish translation of the PhVWP's recommendation for the product information of citalopram
The European Pharmacovigilance Working Party, PhVWP, has prepared a recommendation for the wording of the product information for citalopram. The Danish Medicines Agency has now translated this recommendation into Danish. The text is used to prepare new product information. Furthermore, marketing authorisation holders of citalopram must implement the new text by submitting variation applications for all relevant products.
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07 December 2011
Translation of the PhVWP's recommendation for product information concerning use of antipsychotics during pregnancy
The European Pharmacovigilance Working Party, PhVWP, has prepared a recommendation for the wording of the product information for antipsychotics. The Danish Medicines Agency has now translated this recommendation into Danish. The text is used to prepare new product information. Marketing authorisation holders of antipsychotics must implement the new text by submitting variation applications for all relevant products.
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25 November 2011
Difference between the EU and the USA in authorisation of Avastin® (bevacizumab) for metastatic breast cancer
The U.S. Food and Drug Administration (FDA) has revoked the authorisation of Avastin® for use in treating metastatic breast cancer. In the EU, Avastin® is still authorised for treatment of metastatic breast cancer in combination with paclitaxel and in combination with gemcitabine.
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15 November 2011
Available time slots for DCP procedures with Denmark as Reference Member State (RMS)
The Danish Medicines Agency announces that some DCP procedure time slots have become available in November and December 2011.
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11 November 2011
Translation of the PhVWP's recommendation for product information on Stevens-Johnson syndrome and toxic epidermal necrolysis
The European Pharmacovigilance Working Party, PhVWP, has drawn up a recommendation for the wording of the product information concerning Stevens-Johnson syndrome and toxic epidermal necrolysis for high risk medicines.
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26 October 2011
Assessment times for authorisation of medicines for the first six months of 2011
We have just published our assessment times for authorisation of medicines for the first six months of 2011.
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26 August 2011
Danish translation of the PhVWP's recommendation for hydrochlorothiazide product information
The European Pharmacovigilance Working Party, PhVWP, has prepared a recommendation for the wording of the product information for hydrochlorothiazide. The Danish Medicines Agency has now translated this recommendation into Danish. The text is to be used when preparing new product information for medicines containing hydrochlorothiazide.
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29 July 2011
New guidelines on submittable formats for applications for marketing authorisation, variations, etc.
The Danish Medicines Agency has formulated new guidelines on submittable formats for applications for marketing authorisation, variations, update prior to MRP, renewal, follow-up and referral to CMD. In addition, the guidelines on submission of paper applications have been revised. The new guidelines are intended to make it easier for companies to submit applications electronically and to ease our electronic processing of applications.
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26 July 2011
New labelling order effective on 28 July 2011
A new executive order no. 869 of 21 July 2011 on the labelling etc. of medicinal products (labelling order) enters into force on 28 July 2011. Most provisions of the new labelling order are unaltered compared to executive order no. 1210 of 7 December 2005 on labelling etc. of medicinal products.
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14 July 2011
Licensing of medicines prioritisation and forecast processing times for the second half of 2011
Every six months, we prioritise and forecast processing times for the authorisation of medicines. Our forecast for the second half of 2011 and status on the first half of 2011 are now ready.
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13 July 2011
Danish translations of the PhVWP recommendations for the wording of product information are now available on our website
The Danish Medicines Agency has translated a series of recommendations for the wording of summaries of product characteristics and package leaflets, prepared by the European Pharmacovigilance Working Party, PhVWP. The Danish translations are now available on our website.
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13 July 2011
Generic substitution terminated for oral medicines containing cyclosporine or tacrolimus
With regard to generic medicines for oral use that contain cyclosporine or tacrolimus, it has so far been possible to label these as generically substitutable if the medicines were assessed to be therapeutically interchangeable. Provided, however, that bioequivalence between the generic version and the original product is established based on stringent criteria. Following a reassessment, the Danish Medicines Agency now considers that generic substitution should no longer be possible for these to active substances.
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12 May 2011
Entry into force of extended deadline for implementation of changes to labelling and package leaflets
The new 12-month deadline for implementation of changes to labelling and package leaflets enters into force on 16 May 2011. As part of the implementation of the new deadline, a new Danish executive order on submission of package leaflets to the Danish Medicines Agency has been issued. Equally, the 'Guideline on variations to marketing authorisations for medicinal products' (the variation guideline) has been updated.
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03 May 2011 | Updated 05 May 2011
Antidepressants for treatment of children and adolescents
In continuation of a report on Danish television in ‘DR 21’ on Sunday 1 May 2011 on the risk of suicide from using SSRIs to treat children and adolescents, the Danish Medicines Agency has the following comments.
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14 April 2011
EMA recommends resuming marketing of Octagam®
The European Medicines Agency (EMA) recommends resuming marketing of both strengths of the medicine Octagam®, 50 mg/ml and 100 mg/ml. Octagam® was recalled in autumn 2010 due to an unexpected increase in side effect reports of blood clots. The recommendation to resume marketing is based on a number of improvements in the manufacturing process.
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01 April 2011
Requests for DCP time slots for the first half of 2012 now possible
Until 30 April 2011 , the Danish Medicines Agency is open for requests for DCP time slots for the first half of 2012.
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03 March 2011
DCP time slots for the first half of 2012
From 1 April 2011 to 30 April 2011, the Danish Medicines Agency resumes the allocation of DCP time slots for the first half of 2012.
