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19 October 2012 /Side effects and trials
Benefits of NSAIDs still outweigh risks - but diclofenac may be associated with a small increased risk of side effects
In October 2011, the Committee for Medicinal Products for Human Use (CHMP) decided to review the newest data on cardiovascular side effects from analgesics (painkillers) of the NSAID type. The conclusions are now available, and they confirm the previous conclusions from 2005 and 2006 that the benefits of NSAIDs still outweigh the risks.
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17 October 2012 /News - miscellaneous
Danish Pharmacovigilance Update, 20 September 2012
Among the topics covered in this issue of Danish Pharmacovigilance Update are: New definition of adverse reactions due to new European legislation on pharmacovigilance.
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16 October 2012 /News - medical devices
European Commission proposes two new regulations on medical devices and in vitro diagnostic devices
The European Commission has proposed two new regulations on medical devices and in vitro diagnostic devices. This launches the European Union's (EU) legislative decision-making process
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15 October 2012 /Side effects and trials
The Danish Health and Medicines Authority still recommends influenza vaccine
The Danish Health and Medicines Authority still recommends using the Fluarix® seasonal flu vaccine for people who are in a risk group.
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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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10 October 2012 /News - miscellaneous
Contaminated medication possibly linked to several meningitis outbreaks in the USA
The health authorities in the USA are presently investigating the cause of a large number of meningitis outbreaks caused by the fungus Aspergillus. In the USA, only those who received the medication in question have been infected, and there have been no reports of transmission from persons to person.
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05 October 2012 /News - miscellaneous
Warning against illegal potency enhancers
The Danish Health and Medicines Authority warns against widespread sale of illegal potency enhancers. Over the first nine months of 2012, the Danish Health and Medicines Authority was made aware of 54 illegal potency-enhancing products found to contain active pharmaceutical ingredients not declared anywhere on the package or in the product information. The findings are a result of international cooperation.
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04 October 2012 /News - miscellaneous
INTERPOL-coordinated operation against illegal internet sale of medicines
Last week, the Danish Health and Medicines Authority took place in a global operation code-named PANGEA V against illegal online trading of medicines together with the Danish tax and customs authorities (SKAT), the Danish Police and the Danish Veterinary and Food Administration. The operation was joined by more than 190 authorities from 100 countries all over the world.
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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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28 September 2012 /Side effects and trials
Doctors in Denmark follow new recommendations for contraceptive pills
In early 2012, the Danish Health and Medicines Authority recommended doctors to generally prescribe the older type of contraceptive pills (2nd generation pills) because these pills pose the lowest risk of blood clots. In a follow-up report, the Danish Health and Medicines Authority has now reviewed the latest scientific articles as well as the consumption trends and reported side effects for contraceptive pills prescribed in Denmark.
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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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11 September 2012 /Retail and online sale
Repeated warning against the scam company Helse Danmark
Many Danes use glucosamine for joint pain, but thousands are tricked into buying glucosamine illegally from Helse Danmark, which operates the website sundeled.dk and other websites. Consumers who buy illegal medicines risk getting a fine of DKK 2,500. In this specific case, several Danes report that they have also been threatened with debt collection when they tried to return the illegal medicine to Helse Danmark.
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06 September 2012 /News - miscellaneous
Danish Pharmacovigilance Update, 16 August 2012
Among the topics covered in this issue of Danish Pharmacovigilance Update are: Maximum single dose of intravenous ondansetron (Zofran® and others) now restricted to 16 mg.
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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.
