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26 October 2012 /Authorisation and supervision
New, higher-strength insulin on the way
The European Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) recommended last week that a new analogue insulin can be marketed in the strengths of 100 units/ml and 200 units/ml. The strength of 100 units/ml has for many years been the only strength available for all insulin products. But from the beginning of 2013, it is expected that the new, higher-strength version will be marketed in Europe, and other insulin products of strengths higher than 100 units/ml are expected to be on the way as well.
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15 October 2012 /Authorisation and supervision
Danish translation of the PhVWP's recommendation for the product information of dopamine agonists, levodopa and COMT inhibitors
The European Pharmacovigilance Working Party, PhVWP, has prepared a recommendation for the wording of the product information for dopamine agonists, levodopa and COMT inhibitors. The Danish Health and Medicines Authority has now translated this recommendation into Danish.
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02 October 2012 /Authorisation and supervision
Amendment of executive order on euphoriant substances of 30 September 2012
On 30 September 2012, a new substance was included in annex 1 of the executive order no. 557 of 31 May 2011 on euphoriant substances.
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24 September 2012 /Authorisation and supervision
Important notice to marketing authorisation holders/representatives of medicines containing cephalosporins
Four Chinese companies have been found to have used waste gutter oil in the manufacturing of 7-aminocephalosporanic acid (7-ACA).
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21 September 2012 /Authorisation and supervision
Danish translation of the CMDh's recommendation for the product information of gabapentin
The CMDh has prepared a recommendation for the wording of the product information for gabapentin-containing medicines. The Danish Health and Medicines Authority has now translated this recommendation into Danish.
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21 September 2012 /Authorisation and supervision
Danish translation of the PhVWP's recommendation for the product information of allopurinol
The European Pharmacovigilance Working Party, PhVWP, has prepared a recommendation for the wording of the product information for allopurinol.
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21 September 2012 /Authorisation and supervision
Danish translation of the PhVWP's recommendation for the product information of risedronate
The European Pharmacovigilance Working Party, PhVWP, has prepared a recommendation for the wording of the product information for risedronate. The Danish Health and Medicines Authority has now translated this recommendation into Danish.
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21 September 2012 /Authorisation and supervision
Danish translation of the PhVWP's recommendation for the product information of tramadol
The European Pharmacovigilance Working Party, PhVWP, has prepared a recommendation for the wording of the product information for tramadol-containing medicines. The Danish Health and Medicines Authority has now translated this recommendation into Danish.
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20 September 2012 /Authorisation and supervision
Time slots for marketing authorisation applications through the decentralised procedure in 2013
From 1 October 2012 to 31 October 2012 (both days included) it will be possible to request time slots for January, February and March 2013 for submission of marketing authorisation applications.
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03 September 2012 /Authorisation and supervision
Company authorisations issued without expiry date
As of 1 September 2012, the Danish Health and Medicines Authority implements a new practice by which company authorisations are no longer issued with an expiry date. The company authorisations issued in future will therefore only bear an effective date, implying that the authorisation is valid until it is changed or terminated.
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28 August 2012 /Authorisation and supervision
Danish translation of PhVWP's recommendation for the product information - oxcarbazepine (Trileptal)
The European Pharmacovigilance Working Party, PhVWP, has prepared a recommendation for the wording of the product information for oxcarbazepine.
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28 August 2012 /Authorisation and supervision
Danish translation of the PhVWP's recommendation for the product information - carbamazepine
The European Pharmacovigilance Working Party, PhVWP, has prepared a recommendation for the wording of the product information for carbamazepine.
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21 August 2012 /Authorisation and supervision
Tests of glycerol used in magistral formulations and marketed medicinal products
Supplementing the enhanced control of active substances (the API project), the Danish Health and Medicines Authority has recently put increased focus on further testing of excipients. The Danish Health and Medicines Authority's laboratory has analysed the excipients glycerol and glycerol 85%. Samples of the excipient have been submitted by pharmacies that perform magistral formulations and by companies with marketed medicinal products. Analyses have been performed on glycerol batches from seven pharmacies and five companies.
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10 August 2012 /Authorisation and supervision
Closer attention to guidelines on submission of electronic applications for marketing authorisations
Our guidelines on submission of electronic applications to the Danish Health and Medicines Authority have been available on our website for some time, but we wish to draw attention to them once again As we have received a number of incorrect submissions.
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12 July 2012 /Authorisation and supervision
Assessment times for authorisation of medicines for the first six months of 2012
We have published our assessment times for authorisation of medicines for the first six months of 2012.
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05 July 2012 /Authorisation and supervision
Suspension of Certificate of Suitability for the active substance Leflunomide
EDQM, the European Directorate for the Quality of Medicines and Healthcare, has suspended the following Certificate of Suitability (CEP): CEP 2009-035/Leflunomide.
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05 July 2012 /Authorisation and supervision
Withdrawal of Certificates of Suitability for the active substances Chlorhexidine digluconate solution and Calcium dobesilate monohydrate
EDQM, the European Directorate for the Quality of Medicines and Healthcare, has withdrawn the following Certificates of Suitability (CEP): CEP 2005-076-Rev 01/Chlorhexidine digluconate solution and CEP 2010-209-Rev 00/Calcium dobesilate monohydrate.
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22 June 2012 /Authorisation and supervision
Suspension of Certificates of Suitability for several active substances from the manufacturer Amoli Organics PVT Ltd
EDQM, the European Directorate for the Quality of Medicines and Healthcare, has suspended a number of Certificates of Suitability (CEP):
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22 June 2012 /Authorisation and supervision
Suspension of Certificate of Suitability for the active substance Povidone iodicated
EDQM, the European Directorate for the Quality of Medicines and Healthcare, has suspended the following Certificates of Suitability (CEP): CEP 2009-166 / Povidone iodicated ...
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22 June 2012 /Authorisation and supervision
Danish translation of the PhVWP's revised recommendation for the product information of fluoroquinolones
The European Pharmacovigilance Working Party, PhVWP, has prepared a revised recommendation for the wording of the product information for fluoroquinolones. The Danish Health and Medicines Authority has now translated this recommendation into Danish.
