Share
News
-
22 December 2009 /Product information
Warning against the potency-enhancing product Rock Hard Weekend
The Danish Medicines Agency strongly warns against using the potency-enhancing product Rock Hard Weekend after the FDA (U.S. Food and Drug Administration) has notified the Danish Medicines Agency that Rock Hard Weekend contains an undeclared active substance and that the product has been exported from the USA to Denmark.
-
18 December 2009 /Side effects and trials
Side effects from Pandemrix® from 5 to 11 December 2009
In the period from 5 to 11 December, the Danish Medicines Agency received 68 new side effect reports covering a total of 173 suspected side effects (adverse reactions).
-
17 December 2009 /Prices and reimbursement
Consultation on the Reimbursement Committee's recommendation concerning the reimbursement status of medicinal products in ATC group A02 (drugs for acid related disorders)
At the request of the Danish Medicines Agency, the Reimbursement Committee has reassessed the reimbursement status of medicinal products in ATC group A02 (drugs for acid related disorders).
-
14 December 2009 /Side effects and trials
Side effects from Pandemrix® from 28 November to 4 December 2009
In the period from 28 November to 4 December, the Danish Medicines Agency received 77 new side effect reports covering a total of 224 suspected side effects (adverse reactions).
-
09 December 2009 /Product information
Warning against the weight-loss product Super Slim
The Danish Medicines Agency strongly warns against using the weight-loss product Super Slim. We do so based on a warning from the Swedish Medical Products Agency against Super Slim, which is sold on the internet.
-
08 December 2009 /News - miscellaneous
Alternative practitioners must know regulations on health foods
If your company sells food supplements and/or medicines or if you import them from abroad, the products and your company must be registered with or authorised by the Danish authorities -
-
05 December 2009 /Side effects and trials
Young children develop good protection from influenza A vaccine - but may have fever
New data show that one single vaccine dose againts influenza A (H1N1) given to children aged from six months to three years provides a good immune response, but that the second vaccine does presumably provides even better protection against the influenza.
-
04 December 2009 /Side effects and trials
Side effects from Pandemrix® from 21 to 27 November 2009
In the period from 21 to 27 November, the Danish Medicines Agency received 150 new side effect reports covering a total of 475 suspected side effects
-
03 December 2009 /Side effects and trials
The National Board of Health adjusts recommendations on vaccination for influenza A (H1N1)
New data from the European Medicines Agency (EMEA) have shown that it is sufficient to give one dose of vaccine for influenza A (H1N1) for persons with a functional immune system.
-
02 December 2009 /Authorisation and supervision
Public access to EMA's community database EudraGMP
On 30 July 2009, EMA made it community database EudraGMP available to the public. With time, the database will contain all manufacturing and import authorisations (MIAs) for medicinal products issued to pharmaceutical companies within the EEA
-
01 December 2009 /Prices and reimbursement
Decision on future reimbursement status of medicinal products in ATC groups A04 and A03FA
On 25 November 2009, the Danish Medicines Agency made a decision on the future reimbursement status of medicinal products in ATC group A04 (antiemetics and antinauseants) and medical products in ATC group A03FA (propulsives)
-
27 November 2009 /Side effects and trials
Side effects from Pandemrix® from 17 to 20 November 2009
In the period from 17 to 20 November, the Danish Medicines Agency received 87 new side effect reports covering a total of 310 suspected side effects (adverse reactions).
-
23 November 2009 /Side effects and trials
EMEA: H1N1 vaccine is safe and efficient
The European Medicines Agency (EMEA) has issued a press release stating that a new review of data on Pandemrix® and other vaccines against H1N1 shows that it is sufficient to use a single dose of vaccine for adults, elderly people and children aged 10 and older.
-
23 November 2009 /Side effects and trials
European Medicines Agency makes recommendations to minimise risk of nephrogenic systemic fibrosis with gadolinium-containing contrast agents
The European Medicines Agency (EMEA) has adopted a set of recommendations aimed at minimising the risk of neophrogenic systemic fibrosis (NSF) with gadolinium-containing contrast agents in patients at risk of developing the condition.
-
23 November 2009 /Side effects and trials
Gadolinium and nephrogenic systemic fibrosis: New recommendations from the European Medicines Agency
The European Medicines Agency (EMEA) has adopted new recommendations for the use of gadolinium-containing contrast agents to minimise the risk of a rare adverese reaction, neophrogenic systemic fibrosis (NSF)
-
23 November 2009 /Retail and online sale
Global operation against illegal medicines takes down more than 70 websites
A global operation against illegal medicine has taken down more than 70 illegal websites,and a total of 22 individuals are currently under investigation for a range of offenses.
-
20 November 2009 /Side effects and trials
Side effects from Pandemrix® from 11 to 16 November 2009
In the period of 11 - 16 November, the Danish Medicines Agency received 73 new side effect reports related to the Pandemrix® vaccine against influenza.
-
23 November 2009 | Updated 19 November 2009 /Side effects and trials
Tamiflu® for prevention and treatment during an influenza epidemic
Earlier this year, the European Medicines Agency updated the product information for Tamiflu® to ensure that as many people as possible can benefit from the medicine in connection with an influenza epidemic.
-
12 November 2009 /Side effects and trials
Side effects from Pandemrix® from 4 to 10 November 2009
The Danish Medicines Agency has received the first side effect reports related to the Pandemrix® vaccine against influenza.
-
10 November 2009 /Authorisation and supervision
Information about variation applications from 1 January 2010
In a new regulation, the European Commission has established new rules that regulate variations of authorisations granted according to the Centralised Procedure, Decentralised Procedure (DCP) and the Mutual Recognition Procedure (MRP).
