News

Reassessment of ATC-groups C01, C04 and C05

At its meeting on 19 September 2006, the Reimbursement Committee had its first discussion of the reimbursement status of the following ATC groups.

Reassessment of reimbursement status

This summer, the Danish Medicines Agency will begin the periodic reassessment of reimbursement status of medicinal products. Over a 5-year period, the reimbursement status of all medicinal products will be reassessed to ensure that the medicinal products having been granted general reimbursement still meet the required criteria and that medicinal products which have not been granted general reimbursement do not meet the criteria.

Reassessment of reimbursement status for medicinal products for hypertension

In March 2006, the Danish Medicines Agency contacted a number of scientific societies to clarify certain aspects of the treatment of hypertension in Denmark.

The European Commission publishes Volume 10 – clinical trials

The European Commission has gathered all relevant guidances, guidelines, legislaten, frequently asked questions, etc. concerning clinical trials in a Volume 10 in Eudralex.

Steps towards improved consumer safety

Every year, mistakes and unintended incidents within the healthcare system, hereunder incorrect medication, cause patients and society great human and economic costs.

The Danish Medicines Agency, the National Board of Health and the Danish Environmental Protection Agency makes a statement about tooth whitening products

Joint statement from the Danish Medicines Agency, the National Board of Health and the Danish Environmental Protection Agency about tooth whitening and tooth whitening products.

Chinese products containing tadalafil, sildenafil and sibutramine

The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) has found four products containing the active substances tadalafil, sildenafil or sibutramine without this appearing on the packets.

Investigation of the safety of MRI contrast medium Omniscan®

It has come to the attention of the Danish Medicines Agency that over a four year period 20 patients in Denmark and 5 patients in Austria have developed a very rare disease called 'Nephrogenic Fibrosing Dermopathy' or 'Nephrogenic Systemic Fibrosis' after the administration of Omniscan®.

Reassessment of subgroups in ATC group C

The Danish Medicines Agency is just beginning to reassess the subgroups in ATC group C, medicinal products for the cardiovascular system, and for the first three months of 2006 the agency expects to be working with the following six subgroups.

Warning: Illegal copies of medicinal products with the active substance rimonabant sold on the internet

Illegally copied medicinal products, which apparently contain the active substance rimonabant, are sold at several websites. Rimonabant has been developed for treatment of obesity, but it has not yet been authorised for sale.

First adverse drug reaction report about Therma Power

In March, the Danish Medicines Agency warned about the sale of illegal diet pills with a risk of serious adverse drug reactions, please see the fact box to the right.

Warning on adverse reactions from Coleus Forskolii Briq

The Italian pharmaceutical authority has discovered that specific products containing the substance Foskolin may cause adverse reactions. The adverse reactions are similar to those arising from treatment with atropine.

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