News | Danish Health and Medicines Authority

23 December 2011 /Side effects and trials

EMA to review benefits and risks of blood pressure medicines containing aliskiren

Yesterday, the European Medicines Agency (EMA) started reviewing the benefits and risks of blood pressure medicines that contain aliskiren. Based on the present knowledge, the Danish Medicines Agency does not find that there is cause to review the patients’ treatment urgently.

21 December 2011 /Product areas

Patients treated with Visco Supreme may claim compensation via the Danish Patient Insurance Association

The Danish Medicines Agency has received 44 reports on cases of infection of the interior of the eye (endophthalmitis) following treatment with Visco Supreme (batch nos.11A03 and 11D04) from CLR Medicals International Inc. A total of 93 treatments were made with the products in question.

21 December 2011 /Side effects and trials

EMA confirms a positive benefit-risk balance of medicines containing growth hormone (somatropin)

After completing a review of all available data on medicines containing growth hormone (somatropin), the European Medicines Agency (EMA) confirms that the benefits of these medicines still outweigh their risks.

21 December 2011 /Authorisation and supervision

Recall of Vistide® deliveries causes no supply issues

The European Medicines Agency (EMA) has found that quality issues may have arisen in the production of the medicine Vistide® from the US company Ben Venue. EMA has therefore recommended that the company recall all affected deliveries (batches) of Vistide® until the quality can be assured.

12 December 2011 /Prices and reimbursement

Changed practice for single reimbursement for hyaluronic acid

In collaboration with the Reimbursement Committee, the Danish Medicines Agency has decided to change the practice for granting single reimbursement for hyaluronic acid. As of 15 January 2012, we will only grant single reimbursement for hyaluronic acid in exceptional circumstances and not, as we have done thus far, to all patients with osteoarthritis of the knee. In the period up until 15 January 2012, we will introduce a time limit on single reimbursement grants for hyaluronic acid to patients with knee osteoarthritis. In Denmark, hyaluronic acid is available as the two medicines Hyalgan® and Artz®, and they are used for patients with knee osteoarthritis for alleviating pain and improving the function of the knee joint.

12 December 2011 /Authorisation and supervision

No supply problems caused by recall of batches of Luminity® and Ecalta®

The European Medicines Agency (EMA) has found that a quality problem may have occurred during the manufacturing of the two medicines Luminity® and Ecalta® from the US-based company Ben Venue.

07 December 2011 /Authorisation and supervision

Danish translation of the PhVWP's recommendation for the product information of citalopram

The European Pharmacovigilance Working Party, PhVWP, has prepared a recommendation for the wording of the product information for citalopram. The Danish Medicines Agency has now translated this recommendation into Danish. The text is used to prepare new product information. Furthermore, marketing authorisation holders of citalopram must implement the new text by submitting variation applications for all relevant products.

07 December 2011 /Side effects and trials

Improved guidance on the definition of a clinical trial of medicinal products

The Danish Medicines Agency acknowledges that it is often difficult to find out whether or not a trial is to be classified as a clinical trial of medicinal products. We have therefore updated chapter 1 of our Guideline for applications for authorisation of clinical trials of medicinal products in humans and have also included some examples of what is not a clinical trial. Along with the update, we have published information that can help researchers find out whether a trial is a clinical trial of medicinal products or possibly a non-interventional study.

07 December 2011 /Authorisation and supervision

Translation of the PhVWP's recommendation for product information concerning use of antipsychotics during pregnancy

The European Pharmacovigilance Working Party, PhVWP, has prepared a recommendation for the wording of the product information for antipsychotics. The Danish Medicines Agency has now translated this recommendation into Danish. The text is used to prepare new product information. Marketing authorisation holders of antipsychotics must implement the new text by submitting variation applications for all relevant products.

01 December 2011 /News - miscellaneous

Danish Pharmacovigilance Update, 17 November 2011

In this issue of Danish Pharmacovigilance Update, you can read about domperidone (Motilium® etc.) and potential risk of cardiac disorders, about the European Medicines Agency's recommendation on a lower dose of the antidepressant citalopram as well as about more interesting aspects of pharmacovigilance.

25 November 2011 /Side effects and trials

Atomoxetine (Strattera®) and risk of increased blood pressure and heart rate

In November 2011, the European Pharmacovigilance Working Party (PhVWP) concluded that new knowledge should be communicated about the known risk of increased blood pressure and heart rate associated with the use of atomoxetine, which is authorised for the treatment of ADHD (Attention-Deficit/Hyperactivity Disorder).

25 November 2011 /Side effects and trials

Tibolone and potential risk of venous thromboembolism, myocardial infarction, breast cancer and ovarian cancer

The European Pharmacovigilance Working Party (PhVWP) has looked at new data from various epidemiological studies on the connection between the use of tibolone, which is authorised for the treatment of symptoms of oestrogen deficiency due to menopause and for the prevention of osteoporosis, and the risk of thromboembolism, myocardial infarction, breast cancer and ovarian cancer.

25 November 2011 /Side effects and trials

Strengthened suspicion about risk of foetal malformations from use of the antiepileptic topiramate (Topimax® etc.)

It is well-known that use of antiepileptics during pregnancy can cause malformations in the foetus. A recent review of data from two birth registers has reinforced the suspicion concerning the antiepileptic topiramate. The review showed that use of topiramate during the first trimester of pregnancy may cause increased risk of cleft lip and palate, hypospadias and malformations in other parts of the body.

25 November 2011 | Updated 25 November 2011 /Side effects and trials

New recommendations for escitalopram announced by EMA

In October 2011, the European Pharmacovigilance Working Party, PhVWP, decided that the summaries of product characteristics and package leaflets of medicine containing the antidepressant citalopram must be updated with information on a lower maximum dose. EMA has also reviewed the antidepressant escitalopram and has concluded that the maximum dose of escitalopram should also be reduced.

25 November 2011 /Authorisation and supervision

Difference between the EU and the USA in authorisation of Avastin® (bevacizumab) for metastatic breast cancer

The U.S. Food and Drug Administration (FDA) has revoked the authorisation of Avastin® for use in treating metastatic breast cancer. In the EU, Avastin® is still authorised for treatment of metastatic breast cancer in combination with paclitaxel and in combination with gemcitabine.

23 November 2011 /Authorisation and supervision

The use of Caelyx® should be limited due to quality issue

The European Medicines Agency (EMA) recommends doctors to limit the use of the medicine Caelyx® due to a potential quality issue during the manufacturing process at the US-based company Ben Venue.

23 November 2011 /Authorisation and supervision

No supply problems caused by recall of batches of Busilvex®, Velcade® and Vidaza®

The European Medicines Agency has found that a quality problem may have occurred during the manufacturing of three medicines Busilvex®, Velcade® and Vidaza® at the US-based company Ben Venue. EMA has therefore recommended that the company recall all affected batches of the three medicines until the required quality assurance has been established.

23 November 2011 /Product areas

Eye surgical solution recalled due to risk of inflammation within the eyeball

The Danish Medicines Agency has received reports of at least five cases of inflammation within the eyeball (endophthalmitis) caused by the use of a specific consignment of the product Visco Supreme from CLR Medicals International Inc. (lot no.11A03).

21 November 2011 /About us

More digital services on DKMAnet: company authorisations, clinical trials and follow-up on adverse reaction reports

We are pleased to announce the expansion of the Danish Medicines Agency's extranet, DKMAnet, which offers electronic self-service solutions for companies. DKMAnet is expanded today, 21 November, with three new areas: company authorisations, clinical trials of medicines for human use, and follow-up on adverse reaction reports.

21 November 2011 /Authorisation and supervision

Withdrawal of a medicine due to possible counterfeiting

The pharmaceutical company Orifarm has – in consultation with the Danish Medicines Agency – decided to withdraw the medicine Truvada®. The withdrawal is caused by a potential presence of counterfeit packs on the market.

18 November 2011 /Side effects and trials

Pradaxa (dabigatran etexilate) – remember to assess renal function

At a meeting held 17-20 October 2011, the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA), strengthened the instructions for doctors' use of dabigatran etexilate with particular focus on patients with impaired renal function.

15 November 2011 /Authorisation and supervision

Available time slots for DCP procedures with Denmark as Reference Member State (RMS)

The Danish Medicines Agency announces that some DCP procedure time slots have become available in November and December 2011.

15 November 2011 /Prices and reimbursement

Review concluded regarding general reimbursement for Adepend®

The Danish Medicines Agency has completed its review of an application for general reimbursement for Adepend®. The product is neither eligible for general nor general conditional reimbursement. Adepend® is used as part of treatment of alcoholism. When we compare treatment with Adepend® with treatment with Antabuse, we assess that the price of the medicine is not reasonable relative to its therapeutic value.

11 November 2011 /Authorisation and supervision

Translation of the PhVWP's recommendation for product information on Stevens-Johnson syndrome and toxic epidermal necrolysis

The European Pharmacovigilance Working Party, PhVWP, has drawn up a recommendation for the wording of the product information concerning Stevens-Johnson syndrome and toxic epidermal necrolysis for high risk medicines.

11 November 2011 /Prices and reimbursement

Review concluded regarding general reimbursement for Xiapex®

The Danish Medicines Agency has completed its review of an application for general reimbursement for Xiapex®. The product is neither eligible for general nor general conditional reimbursement. Xiapex® is indicated for the treatment of Dupuytren's contracture.

01 November 2011 | Updated 09 November 2011 /Side effects and trials

Monthly report from the EU Pharmacovigilance Working Party, PhVWP – October 2011

The EU Pharmacovigilance Working Party (PhVWP) convened on 17-19 October 2011. On the meeting's agenda was antiepileptics, citalopram and domperidone.

09 November 2011 /News - miscellaneous

Danish Pharmacovigilance Update, 20 October 2011

In this edition of Danish Pharmacovigilance Update, you can read about: Use of medicines involving a risk of serious and life-threatening skin reactions, the European Medicines Agency to investigate the possible connection between orlistat and rare cases of severe liver toxicity, and the EMA’s review of peritoneal dialysis solutions from Baxter A/S.

09 November 2011 /Authorisation and supervision

Requirement for raised dots led to recalls after spot checks

In June 2010, the Danish Medicines Agency announced that packs of medicine are required to have the medicine's name and strength printed in Braille writing (raised dots) on the outer packaging no later than 30 October 2010 when the medicine is supplied to a wholesaler. The Danish Medicines Agency has carried out spot checks to follow up on the implementation of the requirement on Braille writing. 10 in 518 packs were deficient.

08 November 2011 /Retail and online sale

Still more types of illegal medicine sold in creative packages online

Over the past six months, the Danish Medicines Agency has withheld an increasing number of different products in customs. Many of them appear to be common food products or food supplements, but in fact they contain medicine, and this is not written on the package. For example, it can be sachets with powder that can be added to juice or milkshakes – or coffee with medicine in it.

04 November 2011 /Authorisation and supervision

Warning on illegal sale of donor sperm from saedbank.com

The Danish Medicines Agency has twice before warned against the sperm bank A. I. Sædbank, which yet again sells donor sperm illegally from the website www.saedbank.com. The website has been inactive for a period, but is now active again. According to the information on the website, the sperm bank supplies donor sperm for persons in the former Aarhus County.

04 November 2011 /Authorisation and supervision

The EDQM has suspended the Certificate of Suitability for the active substance protamine sulphate

EDQM, the European Directorate for the Quality of Medicines and Healthcare, has suspended the CEP for the active substance protamine sulphate.

04 November 2011 /Prices and reimbursement

Comments received on the reassessment of reimbursement status of strong analgesics (opioids)

The Danish Medicines Agency has received a number of comments for the Reimbursement Committee's discussion of reimbursement status of strong analgesics (opioids). These comments were presented to the Reimbursement Committee at its meeting on 27 September 2011. The Reimbursement Committee is currently processing a recommendation.

02 November 2011 /Side effects and trials

Electronic reporting of SUSARs from other EU countries now possible

The Danish Medicines Agency can now receive electronic reports of suspected unexpected serious adverse reactions, also known as SUSARs, from trials in other EU countries. SUSARs that occur in other EU/EEA countries must be reported to the Danish Medicines Agency if the trials have the same protocol (EudraCT number) as in Denmark. The new opportunity of electronic submission applies to precisely these SUSARs.

01 November 2011 /Authorisation and supervision

Recall of medicines from patients: Truxal® 15 mg tablets with batch number 2282853

The Danish Medicines Agency has been informed that an error has occurred in the manufacturing of Truxal®, an antipsychotic medicine from Lundbeck. All users of Truxal® must therefore check the batch number on their packages. If the batch number is 2282853, the package must be returned to a pharmacy.

01 November 2011 /Authorisation and supervision

Amendment of executive order on euphoriant substances

As of 27 October 2011, the substances 4-MEC, MPPP and N-ethylbuphedrone are comprised by the Danish executive order on euphoriant substances.

01 November 2011 /Prices and reimbursement

Decision on general reimbursement for Adenuric®

The Danish Medicines Agency has completed its review of an application for general reimbursement for Adenuric®. The product is neither eligible for general nor general conditional reimbursement. Adenuric® is used for treatment of chronic hyperuricaemia (primarily gout).

31 October 2011 /News - miscellaneous

FDA seminar on IVD/Medical Device Regulation and Management

On 15 to 16 November, the Danish embassy in Washington D.C. hosts a seminar in collaboration with the U.S. Food and Drug Administration (FDA) and Beaufort Advisors.

28 October 2011 /Side effects and trials

European Medicines Agency recommends lower dose of citalopram

In October 2011, the European Pharmacovigilance Working Party has concluded to reduce the maximum dose of the antidepressant medicine citalopram. The recommendation follows from a drug trial and adverse reactions showing that citalopram may affect the heart rhythm, especially when given in high doses.

28 October 2011 /Authorisation and supervision

Annual report on human tissues and cells shows continued rise in tissue establishment activity

The annual report on human tissues and cells is now available in English. It shows, among other things, that there were altogether 56 tissue establishments and 40 gynaecology clinics authorised to handle human tissues and cells in Denmark.

27 October 2011 /Authorisation and supervision

Spot checks reveal insufficient information about antidepressants for pregnant and breast-feeding women

The Danish Medicines Agency has reported a number of companies to the police for having failed to update the package leaflet regarding pregnant and breast-feeding women's use of antidepressants of the SSRI type (selective serotonin reuptake inhibitors). At the same time, the Danish Medicines Agency has instructed the companies to withdraw any SSRIs with inadequate warnings.

26 October 2011 /Authorisation and supervision

No cause for concern about influenza vaccination

A single batch of the influenza vaccine Preflucel has been withdrawn from the Danish market. 14 vaccines have been used in Denmark, and all other unused vaccines have been withdrawn from the market. There have been no reports of side effects in Denmark.

26 October 2011 /Authorisation and supervision

Assessment times for authorisation of medicines for the first six months of 2011

We have just published our assessment times for authorisation of medicines for the first six months of 2011.

25 October 2011 /Side effects and trials

Number of suspected adverse reactions reported to the Danish Medicines Agency for articaine

In 2006, the Danish Medicines Agency examined the risk of nerve damage from the anaesthetics that dentists use for local anaesthesia. The examination was initiated due to a suspicion raised in Denmark that one of the active substances, articaine, caused a greater risk of nerve damage than other substances. We have followed the development since then, and we have decided to review the safety again.

24 October 2011 /Side effects and trials

Adverse reaction reports on antidepressants and pregnancy – June to October 2011

On 20 September 2011, the Danish Medicines Agency published an overview report (in Danish) on antidepressants of the SSRI type, the main focus being on safety and the risk of adverse reactions in foetuses and newborns whose mothers had taken an SSRI. In the subsequent period from 14 June 2011 to 9 October 2011, the Danish Medicines Agency has received 12 reports concerning 21 suspected adverse reactions in children/foetuses whose mothers had taken an SSRI.

24 October 2011 /Authorisation and supervision

Statement from EMA about Advagraf® and cardiovascular medicine

The European Medicines Agency, EMA, has decided to immediately recall some batches of Advagraf® (tacrolimus) 0.5 mg prolonged-release hard capsules from pharmacies and wholesalers from a number of countries across the EU. EMA has also looked into the possible link between the use of blood pressure lowering medicines of the type angiotensin II receptor antagonists and the occurrence of new incidences of cancer. EMA found that the evidence does not suggest any link with cancer.

21 October 2011 /Prices and reimbursement

Decision on general reimbursement for Cholestagel®

The Danish Medicines Agency has completed its review of an application for general reimbursement for Cholestagel®. The product is neither eligible for general nor general conditional reimbursement. Cholestagel® is used for treatment of elevated blood cholesterol levels.

12 October 2011 /Prices and reimbursement

Review concluded regarding general reimbursement for Bydureon

The Danish Medicines Agency has completed its review of an application for general reimbursement for Bydureon®. The product has been granted general reimbursement. Bydureon® is used for the treatment of type 2 diabetes in adults.

12 October 2011 /Side effects and trials

Focus on medicines most frequently involved in serious adverse drug events can improve patient safety

A new study carried out by a working group associated with the Danish Medicines Agency's network "Prevention of Medication Errors" has shown that it is more or less the same groups of medicines that have been involved in the so-called adverse events from the 1970s and up until today. Based on the study, we have drawn up two lists of medicines that appear in high-risk situations – sorted by active substance and medicine group. The Danish Medicines Agency and the working group behind the study hope that these lists can become an important tool in the daily work with risks in the medication process in the health sector.

07 October 2011 /Authorisation and supervision

The EDQM has suspended the Certificate of Suitability for the active substance oxytetracycline

The European Directorate for the Quality of Medicines and Healthcare, has suspended the Certificate of Suitability for oxytetracycline.

07 October 2011 /Prices and reimbursement

Changed reimbursement for medicines for depression and anxiety as of 5 March 2012

With effect from 5 March 2012, the reimbursement is changed for certain medicinal products for treatment of depression and anxiety (antidepressants and anxiolytics). Based on the Reimbursement Committee's recommendation, the Danish Medicines Agency has decided that in future the general rule is that treatment with inexpensive medicines (e.g. sertraline and citalopram) must be attempted before reimbursement can be granted for more expensive medicines (e.g. escitalopram, duloxetine, pregabalin and agomelatine).

04 October 2011 /Prices and reimbursement

The reimbursement for glucosamine is removed on 28 November 2011

The Reimbursement Committee and the Danish Medicines Agency have reassessed the reimbursement status of glucosamine-containing medicines. We have decided to remove the reimbursement for these over-the-counter medicines on 28 November 2011. Glucosamine is used for the alleviation of painful osteoarthritis.

04 October 2011 /Side effects and trials

Monthly report from the EU Pharmacovigilance Working Party, PhVWP – September 2011

The EU Pharmacovigilance Working Party (PhVWP) convened on 19-21 September. On the meeting's agenda was: active substances with a known risk of Stevens-Johnson syndrome and toxic epidermal necrolysis.

04 October 2011 /Side effects and trials

Monthly reports from the EU Pharmacovigilance Working Party, PhVWP – June and July 2011

The EU Pharmacovigilance Working Party (PhVWP) convened on 20-22 June and 18- 20 July 2011.

03 October 2011 /Authorisation and supervision

Changed practice for authorisations for wholesale distribution of medicines within the EU/EEA

The Danish Medicines Agency has changed its practice with respect to the format of authorisations for wholesale distribution of medicines within the EU/EEA. The change concerns the application form's Annex A.1 in which applicants are now only to indicate activities that the company carries out at its own address. Likewise, Annex A.1 of the wholesale dealer's authorisation will only list the activities performed at the company's own address.

30 September 2011 /Authorisation and supervision

New guidelines on applications for company authorisations

The Danish Medicines Agency has prepared a number of new guidelines on applications for company authorisations.

30 September 2011 /Retail and online sale

Global operation strikes at online sale of illegal and counterfeit medicines - "Operation PANGEA IV"

In the past week, more than 165 regulatory authorities from 81 countries took part in "Operation PANGEA IV", a global action against online trading of counterfeit and illegal drugs. The operation sets out to raise awareness about the risks associated with buying medicines on the internet and through joint efforts to bring these offences to justice.

30 September 2011 /Product information

Dangerous sex pills on the market

A control and awareness-raising campaign organised jointly by the Danish Veterinary and Food Administration and the Danish Medicines Agency has found that several erotic shops in Copenhagen sell sex pills containing herbal ingredients that could damage the liver and nervous system or could have other harmful effects.

06 May 2011 | Updated 30 September 2011 /Authorisation and supervision

Errors found at more than one in five alternative practitioners

More than one in five alternative practitioners visited by the Danish Veterinary and Food Administration and the Danish Medicines Agency in a series of joint on-site inspections last year were unfamiliar with the regulations for the food supplements and medicines on their shelves. This is the result of a report based on more than 50 on-site inspections at alternative practitioners across Denmark.

27 September 2011 /Side effects and trials

Danish report on treatment with SSRI antidepressants

Based on a debate about the safety of treatment with SSRI antidepressants, the Danish Medicines Agency has drawn up an overview report. The report aims to provide healthcare professionals and others involved in SSRI treatment with an overview of our current knowledge about the consumption of SSRIs and the safety of this type of medicine. The main focus of the report is on the safety of SSRIs and the risk of adverse reactions in foetuses and newborns of mothers who have used SSRI antidepressants.

26 September 2011 /News - miscellaneous

Danish Pharmacovigilance Update, 15 September 2011

In this issue of Danish Pharmacovigilance Update, read about a significant increase in off-label use of AeroBec® in children under the age of five, and much more.

23 September 2011 /Side effects and trials

The European Medicines Agency recommends restricted use of Multaq®

The European Medicines Agency, EMA, recommends limited use of the medicine Multaq®, which is used for cardiac arrhythmia. This is the result of an overall review of the risks and benefits of this medicine carried out by the Committee for Medicinal Products for Human Use, CHMP. The review was initiated in January 2011 due to reports of serious liver damage in patients who had been treated with Multaq®.

21 September 2011 /Prices and reimbursement

Review concluded regarding general reimbursement for Trajenta®

The Danish Medicines Agency has completed its review of an application for general reimbursement for Trajenta®. The product has been granted general reimbursement.

14 September 2011 | Updated 21 September 2011 /About us

Biological Assessor for the Licensing Division in the Danish Medicines Agency

Do you hold a scientific degree in pharmacy or other biological science degree, and are you interested in working with the licensing of medicines? Then, maybe you are our new colleague in the PharmaBiotech Department in the Licensing Division of the Danish Medicines Agency.

20 September 2011 /Prices and reimbursement

Consultation responses on the Reimbursement Committee’s recommendation concerning the reimbursement status of glucosamine-containing medicines

The Reimbursement Committee’s recommendation on the future reimbursement status of glucosamine-containing medicines was open for consultation until 8 August 2011. The Danish Medicines Agency received 4 consultation responses.

20 September 2011 /Prices and reimbursement

Consultation responses on the Reimbursement Committee’s recommendation concerning the reimbursement status of medicines for treatment of depression and anxiety (ACT group N06A, etc.)

The Reimbursement Committee’s recommendation on the future reimbursement status of medicines in ATC group N06A, antidepressants, as well as certain medicines in ATC groups N03A, N05A and N05B was open for consultation until 15 August 2011. The Danish Medicines Agency received 9 consultation responses.

20 September 2011 /Authorisation and supervision

The EDQM has suspended the Certificate of Suitability for the active substance theophylline

The European Directorate for the Quality of Medicines and Healthcare (EDQM) has suspended Theophylline.

20 September 2011 /Authorisation and supervision

The EDQM has suspended the Certificates of Suitability for the active substances ribavirin and tiamulin

The European Directorate for the Quality of Medicines and Healthcare (EDQM) has suspended Tiamulin Hydrogen for veterinary use and Ribavirin.

16 September 2011 /Product information

Warning against the product "Weight Loss Coffee"

If you have bought Weight Loss Coffee, please do not drink it. It may be dangerous to your health, as it contains an active substance which can cause side effects.

13 September 2011 /Side effects and trials

Citalopram and the risk of cardiac arrhythmia

The U.S. Food and Drug Administration (FDA) recently issued a warning against using large doses of the antidepressant citalopram. The FDA has reviewed data which shows that doses of citalopram of 60 mg a day may be linked with changes in the heart rate (QT interval prolongation).

12 September 2011 /About us

Dr. Christian Schneider joins the Danish Medicines Agency as Senior Medical Officer

As of 1 October 2011, Dr. Christian Schneider will be filling the position as Senior Medical Officer in the Licensing Division of the Danish Medicines Agency.

09 September 2011 /News - miscellaneous

Danish Pharmacovigilance Update, 18 August 2011

Among the topics covered in this issue are Vimpat® 15mg/ml syrup (lacosamide) for treatment of epilepsy, which is recalled due to a quality defect and Nplate® (romiplostim), which could increase the risk of disease progression in patients with myelodysplastic syndrome (MDS).

08 September 2011 /Side effects and trials

New English e-form for reporting of adverse reactions in clinical trials (SUSARs)

The Danish Medicines Agency now launches an e-form in English for reporting suspected unexpected serious adverse reactions in clinical trials (SUSARs). The e-form specifically targets researchers and small and medium-sized enterprises that for some reason cannot report via EudraVigilance.

26 August 2011 /Prices and reimbursement

Reassessment of reimbursement status of strong analgesics (opioids) – methadone and codeine

On 15 August 2011, the Danish Medicines Agency announced that we would begin reassessing the reimbursement status of medicines in ATC group N02A, opioids. The Reimbursement Committee opened its preliminary discussions at its meeting on 23 August 2011 and recommended to include the opioids methadone (N07BC02) and codeine (R05DA04), also used in pain management, in the reassessment of reimbursement status of medicinal products in ATC group N02A.

26 August 2011 /Authorisation and supervision

Danish translation of the PhVWP's recommendation for hydrochlorothiazide product information

The European Pharmacovigilance Working Party, PhVWP, has prepared a recommendation for the wording of the product information for hydrochlorothiazide. The Danish Medicines Agency has now translated this recommendation into Danish. The text is to be used when preparing new product information for medicines containing hydrochlorothiazide.

23 August 2011 /Side effects and trials

Commission guidance on adverse reactions from clinical trials (CT3) has been changed

The EU Commission has updated its guidance on adverse reactions arising from clinical trials, known as CT3. In future, CT3 will also include the previous Eudravigilance guidance - clinical trial module (CT4) - as well as the Q&A document regarding adverse reaction reports in clinical trials.

22 August 2011 /News - miscellaneous

Indication, 30 June 2011

In the June issue, catch up on the amendments to the Danish Medicines Act and more.

19 August 2011 /News - miscellaneous

Continued fall in lice medicines sales in Denmark

In Denmark, August marks the prime time for head lice infestation when kids meet up at school after their holidays. But despite the increase in head lice attacks, sales of head lice medicines are headed opposite, as revealed by declining sales of the authorised medicines (Nix® and Prioderm®). And so, last year's falling trend continues.

15 August 2011 /Prices and reimbursement

Reassessment of reimbursement status of strong analgesics (opioids)

On 22 December 2009, the Danish Medicines Agency announced that it would begin reassessing the reimbursement status of medicines in ATC group N (nervous system) starting with the ATC subgroup N06A (antidepressants) and then N02A (opioids). The Reimbursement Committee is having the initial discussions of the opioids at its meeting on 23 August 2011.

12 August 2011 /News - miscellaneous

Report on the blood product area in 2010

In 2010, 337,000 blood collections were made in Denmark. This is approximately 21,000 collections less than the previous year.

12 August 2011 /Prices and reimbursement

Review concluded regarding general reimbursement for Pradaxa®

The Danish Medicines Agency has completed its review of an application for continued general reimbursement for Pradaxa®. The product maintains general reimbursement. Pradaxa® is now also authorised for prevention of apoplexy (stroke) and systemic embolism in patients with atrial fibrillation.

11 August 2011 /Side effects and trials

Danish Drug Interaction Database expanded significantly

The Danish website interaktionsdatabasen.dk, where you can find information about interactions between various medicines, has been improved significantly. The Drug Interaction Database is in Danish only. Among the improvements is a general overview of how two different categories of medicinal product groups interact (class effect), the hospital pharmacies' SAD products have been included, and finally, you can search on both active substance and product names for herbal remedies as well as vitamins.

29 July 2011 /Authorisation and supervision

New guidelines on submittable formats for applications for marketing authorisation, variations, etc.

The Danish Medicines Agency has formulated new guidelines on submittable formats for applications for marketing authorisation, variations, update prior to MRP, renewal, follow-up and referral to CMD. In addition, the guidelines on submission of paper applications have been revised. The new guidelines are intended to make it easier for companies to submit applications electronically and to ease our electronic processing of applications.

27 July 2011 /Product information

Limited availability of Thyrogen® (thyrotropin alfa) expected to continue in 2011 and 2012

In March 2011, the Danish Medicines Agency together with the manufacturer of Thyrogen® announced that Thyrogen® would be in limited supply until July 2011. However, it is now estimated that the limited supply of Thyrogen® will persist throughout 2011 and in 2012 due to unexpected delays in the release of three lots destined for global markets.

26 July 2011 /Authorisation and supervision

New labelling order effective on 28 July 2011

A new executive order no. 869 of 21 July 2011 on the labelling etc. of medicinal products (labelling order) enters into force on 28 July 2011. Most provisions of the new labelling order are unaltered compared to executive order no. 1210 of 7 December 2005 on labelling etc. of medicinal products.

22 July 2011 /Authorisation and supervision

Annual report 2010 of the Danish Medicines Agency's laboratory control activities

The Danish Medicines Agency's Laboratory has published an annual report for 2010 that describes our activities within the European network called the Official Medicines Control Laboratories (OMCL).

21 July 2011 /Side effects and trials

Update on Pandemrix® and narcolepsy

As mentioned in the announcement from 30 June, the case about Pandemrix® and narcolepsy was to be re-evaluated by the member states' experts at the meeting in the European Medicines Agency (EMA), this week. The latest evaluation has resulted in the following recommendation: Pandemrix® should not be used in persons under the age of 20 unless there is no seasonal flu vaccine that protects against influenza H1N1. In Denmark, the seasonal flu vaccine will protect against influenza H1N1.

21 July 2011 /Side effects and trials

EMA recommends to restrict the use of a particular diabetes medicine

The European Medicines Agency EMA reacts to information stating that diabetics who are treated with the medicine pioglitazone have a slightly increased risk of bladder cancer.

21 July 2011 /Side effects and trials

EMA concludes benefits of the smoking cessation product Champix® (varenicline) still outweigh risks

The Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) has assessed a new study that suggests that the smoking cessation product Champix® (varenicline) may be associated with a risk of cardiovascular events.

18 July 2011 /Authorisation and supervision

Update for tissue establishments about the West Nile Virus and quarantine

In cooperation with the Danish National Board of Health, the Danish Medicines Agency wishes to inform tissue establishments in Denmark about the risk of exposure to the West Nile Virus.

18 July 2011 /Retail and online sale

Scam company behind sundeled.dk still makes empty threats of debt collection

Since our warning in April against the scam company behind the website sundeled.dk, calling itself Helse Danmark A/S, the number of seized packages of glucosamine sent to Denmark illegally from the scam company in Singapore has dropped to almost none. Helse Danmark A/S is not registered in Denmark. The Danish Medicines Agency considers the company to be fake and has reported sundeled.dk to the police for illegal sale of medicines.

14 July 2011 /Authorisation and supervision

Licensing of medicines prioritisation and forecast processing times for the second half of 2011

Every six months, we prioritise and forecast processing times for the authorisation of medicines. Our forecast for the second half of 2011 and status on the first half of 2011 are now ready.

13 July 2011 /Authorisation and supervision

Danish translations of the PhVWP recommendations for the wording of product information are now available on our website

The Danish Medicines Agency has translated a series of recommendations for the wording of summaries of product characteristics and package leaflets, prepared by the European Pharmacovigilance Working Party, PhVWP. The Danish translations are now available on our website.

13 July 2011 | Updated 13 July 2011 /About us

Problem receiving emails now solved

The problems we experienced earlier today with sending and receiving emails have now been solved. There is no indication that emails are lost.

13 July 2011 /Authorisation and supervision

Generic substitution terminated for oral medicines containing cyclosporine or tacrolimus

With regard to generic medicines for oral use that contain cyclosporine or tacrolimus, it has so far been possible to label these as generically substitutable if the medicines were assessed to be therapeutically interchangeable. Provided, however, that bioequivalence between the generic version and the original product is established based on stringent criteria. Following a reassessment, the Danish Medicines Agency now considers that generic substitution should no longer be possible for these to active substances.

11 July 2011 /Side effects and trials

Electronic clinical trial applications do not meet format requirements

A month ago, the Danish Medicines Agency announced that it is possible to submit clinical trial applications electronically, and we are happy to see that many have taken advantage of this possibility. Unfortunately, quite many of the applications do not comply with the requested format.

11 July 2011 /Side effects and trials

New list clarifies requirements for amendments to clinical trials

The Danish Medicines Agency receives many questions regarding which amendments to clinical trials are to be notified to the Danish Medicines Agency, in particular because the European guideline CT 1 has been revised.

11 July 2011 /Side effects and trials

Acne product isotretinoin not to be used during pregnancy

Women of child-bearing age must not use the acne product isotretinoin, unless a number of criteria are met. This contraindication has been in force since 2003 and applies to all medicines with the active substance isotretinoin. Even so, it still occurs that women fall pregnant even though they are treated with isotretinoin. A recent European report shows that since 2003, the European database of side effects has received reports of more than 80 pregnancies involving the original isotretinoin product (Roaccutan®, no longer marketed in Denmark) and several hundreds of pregnancies involving all isotretinoin products (Roaccutan® as well as generic versions).

07 July 2011 /Side effects and trials

Risk of the rare but serious adverse reaction methemoglobinemia from the use of benzocaine-containing products used to relieve teething pain

Following a review of data, the U.S. Food and Drug Administration (FDA) has warned against the use of medicines containing the local anesthetic benzocaine in children less than two years of age. The reason is the risk of the rare but potentially serious adverse reaction, methemoglobinemia.

06 July 2011 /Side effects and trials

Recent study suggests risk of cardiac events associated with the smoking cessation product Champix® (varenicline)

The Danish Medicines Agency is aware of a new study that suggests that the smoking cessation product Champix® (varenicline) may be associated with a risk of cardiac events.

05 July 2011 /Prices and reimbursement

Consultation on the Reimbursement Committee’s recommendation concerning the reimbursement status of medicines in ATC group C01 (cardiac therapy)

At the request of the Danish Medicines Agency, the Reimbursement Committee has reassessed the reimbursement status of medicines in ATC group C01 – cardiac therapy. These medicines are used for the treatment of cardiac arrhythmia (e.g. atrial fibrillation) and heart cramps (angina pectoris).