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22 October 2010 /Product information
Important information for diabetics: GlucaGen® Hypokit 1 mg for injection recalled in Denmark
Novo Nordisk A/S in Denmark is recalling a defective batch of GlucaGen® Hypokit, which is used to treat severe hypoglycaemia (low blood sugar) in diabetes.
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20 October 2010 /Prices and reimbursement
General reimbursement for medicines containing losartan in combination with hydrochlorothiazide
Patients can now receive general reimbursement for all medicines containing losartan in combination with hydrochlorothiazide. This also includes medicines containing a combination of losartan 100 mg and hydrochlorothiazide 12.5 mg
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18 October 2010 /News - miscellaneous
Expiry of transitional arrangement for traditional herbal medicinal products and natural medicinal products
Since 2005, it has been possible in Denmark to have traditional herbal medicinal products registered as an alternative way of bringing herbal medicines onto the Danish market.
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14 October 2010 /Retail and online sale
Global operation targeting illegal and counterfeit medicines
More than 40 countries have taken part in an international week of action targeting the online sale of counterfeit and illegal medicines to raise awareness of the associated health risks, resulting in arrests across the globe and the seizure of thousands of potentially harmful medicines.
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06 October 2010 /Side effects and trials
Implementation of new validation rules for electronic exchange of adverse reaction data
Companies which report adverse reaction data to the Danish Medicines Agency are advised that on Monday 11 October 2010, we will be implementing the updated (ICH E2B (R2)) validation rules for the exchange of E2B files, which entered into force on 1 June 2010.
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29 September 2010 /Product areas
Problems with breast implants
On 8 April 2010, the Danish Medicines Agency warned against the use of breast implants pre-filled with silicone based gel labelled IMGHC-TX, IMGHC-MX or IMGHC-LS manufactured by the French company Poly Implant Prothèse.
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24 September 2010 /Side effects and trials
EMA recommends suspension of rosiglitazone-containing medicines (Avandia®, Avandamet® and Avaglim®)
The Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) has reviewed the benefits and risks of rosiglitazone-containing medicines (Avandia, Avandamet and Avaglim) used in diabetes care.
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23 September 2010 /About us
Focus on cooperation with Chinese authorities
A business visit to Shanghai and Beijing in September has strengthened collaboration between the Danish Medicins Agency and its Chinese counterpart, SFDA.
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22 September 2010 /Side effects and trials
Octagam® recalled by the Danish Medicines Agency
Based on increased reports of blood clots from the use of Octagam® 50 mg/ml in 2010, the Danish Medicines Agency has decided to recall Octagam® in Denmark. Octagam® is available in two strengths (50 mg/ml and 100 mg/ml) both of which are recalled.
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15 September 2010 /Side effects and trials
React to serious and unexpected side effects
In week 37 the Danish Medicines Agency launches a nationwide campaign, setting out to encourage hospital doctors to be more active in reporting serious and unexpected side effects from medicine. The Danish Medicines Agency runs this campaign because it estimates that whenever one side effect is reported by a hospital doctor another 50 serious or unexpected side effects go unreported.
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15 September 2010 /News - miscellaneous
Danish authorities focus efforts on fitness centres
Illegal medicines under the counter, unauthorised sale of food supplements in the back? Next week, the Danish Veterinary and Food Administration and the Danish Medicines Agency concentrate their efforts to combat the distribution of illegal food supplements and medicines in fitness centres and fitness clubs across Denmark.
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02 September 2010 /Product areas
Much debated dental crowns pose no health risk
On 29 August, DR TV (Danish Broadcasting Corporation) broadcast a story on the Danish company Oversea Labs about gold dental crowns.
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31 August 2010 /Product areas
About gold dental crowns from Oversea Labs: Experts assess there to be no health risk associated with the dental crowns
On 29 August, DR TV (Danish Broadcasting Corportaion) broadcast a story on the Danish company Oversea Labs, revealing that the company's gold dental crowns according to DR's analysis of five teeth did not contain as much gold as they were supposed to.
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26 August 2010 /Side effects and trials
Evaluation of possible link between Pandemrix® and narcolepsy
The Medical Products Agency in Sweden is evaluating a possible link between the H1N1 vaccine, Pandemrix®, and the neurological disorder narcolepsy.
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09 August 2010 /News - miscellaneous
Danish authorities assess risk of calcium supplements
Do calcium supplements increase the risk of blood clots? Are changes to the official recommendations required? These questions are now being discussed by the Danish Veterinary and Food Administration and the Danish Medicines Agency, etc. after an article in the British Medical Journal (BMJ) suspected calcium supplements of increasing the risk of heart attacks.
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27 July 2010 /About us
Conclusions and recommendations from the Pharmaceutical Forum
The High Level Pharmaceutical Forum was officially concluded in October 2008 with the adoption of a number of recommendations and conclusions within three themes explored by the Forum.
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26 July 2010 /Product information
EMA reassesses cardiovascular safety of rosiglitazone-containing medicines (Avandia, Avandamet and Avaglim)
In July, the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) once again initiated a review of the benefit-risk profile of rosiglitazone-containing medicines, which in Denmark are used to a very limited degree for the treatment of type 2 diabetes.
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22 July 2010 /Product information
Updated monographs for Heparin calcium (0332) and Heparin sodium (0333) for implementation in the European Pharmacopoeia (Ph. Eur.) as of 1 August 2010
As a follow-up on the work on improving the analysis methods for potentially contaminated heparin preparations, the European Pharmacopoeia Commission has adopted two revised monographs for Heparin calcium (0332) and Heparin sodium (0333) which will be implemented in the European Pharmacopoeia (Ph. Eur.) from 1 August 2010.
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13 July 2010 /News - miscellaneous
Consultation on the Heads of Medicines Agencies’ Strategy Paper for 2011-2015
The Heads of Medicines Agencies (HMA) has drawn up a draft strategy document for the period 2011-2015. As part of the strategy development process, the HMA now gives its key stakeholder groups an opportunity to comment on the strategy's content.
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09 July 2010 /Authorisation and supervision
Licensing of medicines – prioritisation and forecast processing times for the second half of 2010
We still find it important to maintain a high level of participation as rapporteur/co-rapporteur in applications under the centralised procedure as well as a high level of engagement in providing scientific advice to the EMA.
