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18 June 2013 /Authorisation and supervision
Import of active substances from third countries after 2 July 2013
Importers can now apply to the Danish Health and Medicines Authority, requesting it to waive the requirement to obtain a written confirmation from the authorities in third-country in connection with import of active substances. The requirement for a written confirmation enters into force on 2 July 2013.
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17 June 2013 /News - miscellaneous
Danish Pharmacovigilance Update, 23 May 2013
In this issue of Danish Pharmacovigilance Update: Cases of necrotising fasciitis associated with the use of bevacizumab (Avastin®).
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10 June 2013 /News - miscellaneous
DKMAnet and indlaegsseddel.dk will be unavailable from 14 June at 13:00 to 18 June at 7:00
During the above period, we will be updating a number of systems, which means it will not be possible to log in or use any of the DKMAnet services or indlaegsseddel.dk.
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03 June 2013 /Authorisation and supervision
EMA recommends restrictions in the use of Trobalt
The Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) recommends restricting the use of the epilepsy medicine Trobalt® (retigabine) to only those patients for whom other anti-epileptic medicines have proved inadequate or have not been tolerated.
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29 May 2013 /News - miscellaneous
Danish Pharmacovigilance Update, 25 April 2013
In this issue of Danish Pharmacovigilance Update: Cerebral haemorrhage in association with the use of methylphenidate (Ritalin® etc.).
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28 May 2013 /News - miscellaneous
Painkillers to be prescription only in Denmark from 30 September 2013
The Danish Health and Medicines Authority has decided that large packs of mild painkillers will be prescription-only in Denmark from 30 September 2013. From this date, it will only be possible to buy small packs of mild painkillers over the counter. There will be no changes to dispensing status of the medicines that can be bought over the counter after 30 September.
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18 May 2013 /Side effects and trials
The benefits of acne treatment (Diane® Mite, etc.) still outweigh risks in specific patients
The European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) has investigated the safety of medicines containing cyproterone acetate and ethinylestradiol, which are used in the treatment of acne (Diane® Mite, etc.). The Committee concludes that the benefits of this type of medicine outweigh the risks, provided it is used in specific patients and measures are taken to minimise the risk of blood clots.
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15 May 2013 /News - miscellaneous
Information about biosimilar medicines
The European Commission has published a document about biosimilar medicines titled 'What you need to know about Biosimilar Medicinal Products – A consensus information document.'
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03 May 2013 /Side effects and trials
New version of the guidance document Voluntary Harmonisation Procedure for clinical trials
April saw the release of version 3 of the Voluntary Harmonisation Procedure (VHP), a voluntary procedure which makes it possible to obtain a coordinated assessment of an application for a clinical trial that is to take place in several European countries.
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03 May 2013 /Authorisation and supervision
Application for parallel import from Croatia
On 1 July 2013, Croatia joins the EU after which it will be possible to apply for parallel import with Croatia as import country.
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30 April 2013 /Side effects and trials
New European list of medicines under additional monitoring
The European Medicines Agency (EMA) has published a list of medicines that are subject to additional monitoring. From the autumn of 2013, these medicines will display an inverted black triangle in their package leaflet and the summary of product characteristics with information for patients and healthcare professionals.
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29 April 2013 /Side effects and trials
Adverse reactions from non-interventional studies to be reported as 'report from study'
The Danish Health and Medicines Authority advises that adverse reactions from non-interventional studies published in the scientific literature should be reported as 'reports from study'. Also, they should only be reported to us if either the authors of the literature article or the marketing authorisation holder (or both) asses that there is a causal relationship between the drug and the adverse drug reaction.
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25 April 2013 /News - miscellaneous
Danish Pharmacovigilance Update, 21 March 2013
In this issue of Danish Pharmacovigilance Update: Depressive and suicidal thoughts following discontinuation of varenicline (Champix®).
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25 April 2013 /News - miscellaneous
Danish Pharmacovigilance Update, 21 February 2013
In this issue of Danish Pharmacovigilance Update: Cardiovascular monitoring when initiating and re-initiating treatment with fingolimod (Gilenya®).
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08 April 2013 /News - miscellaneous
Painkillers to be prescription only in Denmark
In Denmark, it will soon only be possible to buy large packs of mild painkillers when prescribed by a doctor. The aim is to reduce poisoning incidents and the need for liver transplants.
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05 April 2013 /Authorisation and supervision
Updating of summary of product characteristics prompted by changed ATC codes for 2013
We advise marketing authorisation holders of veterinary medicinal products authorised under the decentralised procedure and the mutual recognition procedure that some ATC codes have changed in 2013.
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05 April 2013 /Authorisation and supervision
Amendment of Danish executive order on euphoriant substances 5 April 2013
As of 5 April 2013, new substances have been included in annex 1 of executive order no. 557 of 31 May 2011 on euphoriant substances issued by the Danish Ministry of Health.
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03 April 2013 /Authorisation and supervision
Text on reporting of adverse reactions in SPC and PL
In connection with the pharmacovigilance legislation from 2011, which entered into force in the summer 2012, a requirement was introduced for the summary of product characteristics and the package leaflet of human medicinal products to include a text encouraging the reporting of suspected adverse reactions in compliance with the applicable national reporting system. In regard to the text in the package leaflet, the Danish Health and Medicines Authority is planning an amendment of the Danish executive order on labelling to extend the deadline for implementation of the executive order's section 35(3) for medicinal products authorised on or before 20 July 2012.
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26 March 2013 /News - miscellaneous
Danish Pharmacovigilance Update, 17 January 2013
In this issue of Danish Pharmacovigilance Update: The Pharmacovigilance Risk Assessment Committee, PRAC, finds that the risks outweigh the benefits from the use of Tredaptive®
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18 March 2013 /Prices and reimbursement
Preliminary data on Medicine Prices available to all subscribers of Medicine Prices for Companies
As of 1 March 2013, anyone who subscribes to Medicine Prices for companies has access to preliminary data on Medicine Prices. Preliminary data will be made available 11 and 10 days prior to the effective date of a new medicine price period. This follows from an amendment to the Danish executive order no. 59 of 29 January 2009 on medicine prices and supply conditions.
