News

22 April 2011 /Retail and online sale

Warning against sundeled.dk – the scam company Helse Danmark A/S

Thousands have been deceived into purchasing glucosamine illegally from the website sundeled.dk. In addition to the risk of a DKK 2,500 fine for purchasing illegal medicines, several Danes have been threatened with debt collection by the company behind the website.

20 April 2011 /Prices and reimbursement

Review concluded regarding general reimbursement for Grazax®

The Danish Medicines Agency has completed its review of an application for general reimbursement for Grazax®. The product is eligible for general conditional reimbursement from 2 May 2011.

19 April 2011 /News - miscellaneous

Special edition of Indication about Per Helboe

This issue of the newsletter is a special edition about Senior Director of Division Per Helboe in honour of his retirement in April, this year.

18 April 2011 /Side effects and trials

Bisphosphonates may cause atypical fractures

Treatment with bisphosphonates may cause atypical fractures of the femur – especially in patients who have received long-term treatment for osteoporosis; concludes the European Medicines Agency, EMA, on the basis of a review it recently completed.

11 April 2011 | Updated 18 April 2011 /Side effects and trials

Report side effects from medicines, herbal medicines and food supplements

At the Danish Medicines Agency, we receive reports of side effects from doctors, medicine users and relatives. You can report side effects from any type of medicines and herbal medicines, and it is of no importance whether you bought the product over the counter or on prescription.

15 April 2011 /News - miscellaneous

Indication, march 2011

In this issue of Indication you can read about The Danish Medicines Agency's new strategy, how companies and scientists can save resources by applying for approval of a clinical trial through the European Voluntary Harmonisation Procedure, the daily work of evaluating serious side effects, and whether the differences between men and women should be reflected in the development of new medicines.

15 April 2011 /Side effects and trials

EMA recommends interim changes to the summary of product characteristics of Pandemrix®

The European Medicines Agency, EMA, recommends that the product information for the influenza vaccine Pandemrix® should be amended to advise prescribers to weigh the benefits against the risks when considering the medicine for a child or adolescent.

15 April 2011 /Authorisation and supervision

The EDQM has suspended the Certificates of Suitability for the active substances buprenorphine hydrochloride, fentanyl, buprenorphine and naltrexone hydrochloride

The European Directorate for the Quality of Medicines and Healthcare (EDQM) has suspended the following Certificates of Suitability (CEP): buprenorphine hydrochloride, fentanyl, buprenorphine og naltrexone hydrochloride

14 April 2011 /Authorisation and supervision

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.

05 April 2011 | Updated 14 April 2011 /Side effects and trials

Danish hospitals are stepping up side effect reporting

As a result of the Danish Medicines Agency’s campaign “React when serious and unexpected side effects occur”, hospital doctors have more than ever contributed with information and thus given us a better basis to regularly assess the safety of the medicine on the market: Hospital doctors have put more focus on identifying and reporting side effects, and the number of reports submitted by hospitals across Denmark has increased on average.

14 April 2011 /Prices and reimbursement

Use the conditional reimbursement scheme correctly – the opposite is misuse of society’s money and puts patient safety at risk

The Danish Medical Association and the Danish Medicines Agency urge doctors to use the conditional reimbursement scheme correctly - the opposite is misuse of society’s money and puts patient safety at risk

12 April 2011 /Product areas

More reports of medical device incidents in 2010 in Denmark

In 2010, the Danish Medicines Agency experienced a 23 percent increase in the number of reported serious incidents with medical devices, from 1128 in 2009 to 1383 in 2010.

12 April 2011 /Side effects and trials

Implementation of MedDRA version 14.0

MedDRA is updated every six months, and on 1 March 2011, MedDRA version 14.0 was released. Therefore, MedDRA version 14.0 will be implemented the night before Monday 2 May 2011.

12 April 2011 /Authorisation and supervision

Digital processing of application for company authorisation

In future, the Danish Medicines Agency will prefer to receive applications for company authorisations electronically as a signed, scanned PDF file. Not least, because we have migrated to digital processing, and consequently we scan all incoming post, which is then distributed electronically internally.

08 April 2011 /News - miscellaneous

No increase in neither suicide attempts nor poisonings with paracetamol in Sweden

Neither the number of poisonings nor suicide attempts with the active substance paracetamol has increased in Sweden, despite the fact that it has become easier to buy paracetamol in Sweden. This is the findings of a study published yesterday by the Swedish Medical Products Agency.

07 April 2011 /About us

The Shared Medication Record wins digitisation award

The Shared Medication Record was one of the two winners when the Digitisation Award 2011 was given out at the conference Digitise Denmark yesterday 6 April 2011 in Århus.

05 April 2011 /Side effects and trials

Cases of narcolepsy in adolescents after vaccination with Pandemrix® in France

The French medicines agency (Afssaps) has announced that they have received more reports of the sleep disorder narcolepsy than expected, among adolescents aged 10 to 15 who have received the influenza vaccine Pandemrix®. The French health authorities consider it to be a slight signal of possible problems with Pandemrix®, which is still watched closely.

05 April 2011 /About us

Perspectives and challenges 2011-2016

We have just published the Danish Medicines Agency's strategy Perspectives and challenges 2011-2016.

04 April 2011 /Retail and online sale

Danish pharmacies now accept foreign prescriptions

From 1 April 2011, Danish pharmacies accept prescriptions issued by a physician or dentist in another EU country, Norway or Iceland.

01 April 2011 /Side effects and trials

Companies' (MAH) handling of adverse reaction reports received via E2B from the Danish Medicines Agency

When the Danish Medicines Agency sends adverse reaction reports via E2B to marketing authorisation holders (MAHs), it sometimes happens that an MAH returns the adverse reaction report to Danish Medicines Agency via E2B.