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06 July 2010 /Side effects and trials
New validation rules for electronic exchange of adverse reaction data via E2B from 15 September 2010
Companies that report adverse reaction data to the Danish Medicines Agency are advised that new validation rules for electronic exchange of E2B files soon enter into force.
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05 July 2010 /Authorisation and supervision
Notification to medicines manufacturers about reduced testing of raw materials
The Danish Medicines Agency has become aware that there is some uncertainty about the possibility of using reduced testing of raw materials, including active pharmaceutical ingredients (API).
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05 July 2010 /Side effects and trials
Side effects from Eltroxin® - status July 2010
In 2009, the Danish Medicines Agency recorded a rise in the number of reported side effects (adverse reactions) from Eltroxin® after the manufacturer changed the excipients contained in Eltroxin®.
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16 June 2010 /About us
Danish Chair of European group of experts
Anja Holm, Veterinarian at the Danish Medicines Agency, is elected Chair of the European Commission's Committee for Medicinal Products for Veterinary Use (CVMP).
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15 June 2010 /Authorisation and supervision
Implementation of Braille (raised dots for the blind and partially sighted) on medicine packages
Please be advised that the name and strength in Braille (raised dots for the blind and partially sighted people) must appear on the outer packaging of medicine packages in Denmark, cf. section 12 of the Danish executive order on labelling
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14 June 2010 /Prices and reimbursement
Change of the reimbursement for certain cardiovascular products as of 15 November 2010
The Reimbursement Committee and the Danish Medicines Agency have reviewed some of the medicinal products used for the treatment of cardiovascular disease (antihypertensives) in order to assess whether they meet the criteria for public reimbursement. The medicinal products concerned are the so-called angiotensin II antagonists and renin inhibitors.
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14 June 2010 /Prices and reimbursement
Changes in reimbursements for anti-ulcer medicines
The Reimbursement Committee and the Danish Medicines Agency have reviewed medicinal products for the treatment of heartburns, sour eructations and ulcers ('acid-related disorders') in order to assess whether they meet the criteria for public reimbursement.
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03 June 2010 /Prices and reimbursement
Consultation responses on the Reimbursement Committee’s recommendation concerning the reimbursement status of medicinal products in ATC groups C09C, C09D and C09X (angiotensin II antagonists and renin inhibitors)
The Reimbursement Committee’s recommendation concerning the future reimbursement status of medicinal products in ATC groups C09C, C09D and C09X (angiotensin II antagonists and renin inhibitors) was open for consultation until 7 May 2010.
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01 June 2010 /Side effects and trials
Campaign at Danish pharmacies: ”Help us make medicine better for all”
”Help us make medicine better for all” is the message of a new campaign from the Danish Medicines Agency. Via Danish pharmacies, it focuses on how medicine users can report side effects from their medicine.
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10 May 2010 /Side effects and trials
Side effects from Pandemrix® from 23 January to 18 April 2010
In the period from 23 January to 18 April 2010, the Danish Medicines Agency received 35 new side effect reports covering a total of 97 suspected side effects (adverse reactions).
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04 May 2010 /Side effects and trials
Upgrade of the Danish Medicines Agency’s system for electronic transmission of adverse reaction reports via Eudravigilance gateway
On 5 May 2010, the Danish Medicines Agency will perform an upgrade of the system for transmission of adverse reaction reports between the European Medicines Agency and the pharmaceutical companies (Cyklone to Axway version 5.2.2)
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21 April 2010 /Authorisation and supervision
The Danish Medicines Agency resumes the allocation of time slots for the second half of 2011
From 3 May 2010 to 31 May 2010 (both days included) the Danish Medicines Agency resumes the allocation of time slots for the second half of 2011.
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21 April 2010 /Prices and reimbursement
Decision on future reimbursement status of losartan-containing medicines (C09CA01 and C09DA01) - angiotensin II antagonists
On 16 April 2010, the Danish Medicines Agency decided on the future reimbursement status of some of the losartan-containing medicines in ATC groups C09C and C09D, making these products eligible for general reimbursement as of 19 April 2010.
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09 April 2010 /Prices and reimbursement
Consultation responses on the Reimbursement Committee’s recommendation concerning the reimbursement status of medicinal products in ATC group A02 (drugs for acid related disorders)
The Reimbursement Committee’s recommendation concerning the future reimbursement status of medicinal products in ATC group A02 (drugs for acid related disorders) was open for consultation until 15 March 2010.
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09 April 2010 /Product areas
The Danish Medicines Agency warns against the use of silicone breast implants manufactured by Poly Implant Prothèse, France
The Danish Medicines Agency warns against the use of silicone gel filled breast implants marked IMGHC-TX, IMGHC-MX or IMGHC-LS manufactured by the French company Poly Implant Prothèse
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31 March 2010 /Prices and reimbursement
Consultation on the Reimbursement Committee's recommendation concerning the reimbursement status of medicinal products in ATC groups C09C, C09D and C09X (angiotensin II antagonists and renin inhibitors)
At the Danish Medicines Agency's request, the Reimbursement Committee has reassessed the reimbursement status of medicinal products in ATC groups C09C, C09D and C09X (angiotensin II antagonists and renin inhibitors).
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26 March 2010 /Product information
EMA recommends recall of clopidogrel products from Acino Pharma GmbH
The Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) has been made aware of quality problems with the manufacturing process at the factory which supplies the active substance for the manufacturing of eight clopidrogel-containing products.
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25 March 2010 /News - miscellaneous
Danish Medicines Agency co-organises biosimulation workshop on 11 March 2010
The Danish Medicines Agency co-organises a workshop on biosimulation taking place on Thursdag 11 March 2010 in the city of Lund in Sweden.
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24 March 2010 /Prices and reimbursement
The Danish Medicines Agency begins ad hoc reassessment of reimbursement status of medicines in ATC groups C09C, C09D and C09X
On 8 March 2010, a number of pharmaceutical companies put generic copies of the angiotensin II antagonist losartan on the market at prices comparable to those of the cheapest ACE inhibitors.
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22 March 2010 /Side effects and trials
EMA updates warning on clopidogrel-containing medicines
In May 2009, the European Medicines Agency (EMA) raised concern about a possible risk of interaction between proton pump inhibitors (PPI) and clopidogrel-containing medicines.
