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News on product information
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15 January 2013 /Product information
Updating of summary of product characteristics prompted by changed ATC codes for 2013
We advise marketing authorisation holders of medicinal products authorised under the Decentralised Procedure and the Mutual Recognition Procedure that some ATC codes have changed in 2013.
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17 August 2012 /Product information
Do not use Spektramox 50 mg/ml +12.5 mg/ml with batch numbers 96629 and 96630
There is a risk that plastic pieces could be present in Spektramox 50 mg/ml + 12.5 oral solution with batch numbers 96629 and 96630, and consumers in Denmark who, during the past seven days, have received this product should return it to a pharmacy for replacement.
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19 March 2012 /Product information
New contraindications and update of warning for the use of Protelos®
Protelos® is no longer recommended for use in immobilised patients or patients with venous thromboembolism, and the product information will therefore be updated.
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23 January 2012 /Product information
Danes can now look up medicines on their mobiles
In Denmark, people can now check medicines via a new free app for mobile phones. The app is called 'Medicintjek', which literally means medicine check, and it's available for download on iPhone and Android mobiles. It is a service offered free of charge by the Danish Medicines Agency for anyone interested.Through one single entry point, Medicintjek gives access to information in Danish from the websites medicinpriser.dk, medicinkombination.dk, indlaegsseddel.dk and laegemiddelstyrelsen.dk, which are all run by the Danish Medicines Agency.
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13 January 2012 /Product information
Warning against Green Coffee 800
A slimming coffee that could give serious side effects because it contains the active substance sibutramine has been sold from a Danish website, which has now been closed. We warn Danish consumers against using the product due to the risk of side effects.
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12 January 2012 /Product information
Dangerous medicine concealed in weight-loss products
Warning against unauthorised weight-loss medicine in juice, tea, coffee, etc. In the past year, the Danish Medicines Agency has noted an increase in unauthorised products that contain the active substance sibutramine. It is included in a variety of products such as tea, coffee, milkshake and juice. Often, there is no way of telling from the products that they contain sibutramine.
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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.
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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.
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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.
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20 June 2011 /Product information
Warning against the tanning product Melanotan
The Danish Medicines Agency repeats its warning against using the illegal product Melanotan because its effect is not documented and because of the absence of studies of its potential side effects. The Danish Medicines Agency urges everyone who uses Melanotan to stop using it and to contact their doctor if concerned.
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16 June 2011 /Product information
Warning against dangerous arthritis product Beline Capsules
The Danish Medicines Agency warns strongly against taking the arthritis product Beline Capsules based on analyses made by the Danish Medicines Agency and the Medical Products Agency in Sweden.
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24 March 2011 /Product information
Limited availability of Thyrogen® (thyrotropin alfa) until July 2011
The Danish Medicines Agency and the manufacturer of Thyrogen® have advised the European Medicines Agency (EMA) that Thyrogen® will be in limited supply until July 2011.
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24 February 2011 | Updated 07 March 2011 /Product information
Spirocort®/Pulmicort pressurised inhalers 100 µg/dose and 200 µg/dose will disappear from the Danish market
The manufacturer of Spirocort® / Pulmicort ceases production permanently, and it is therefore expected that Spirocort® / Pulmicort pressurised inhalers, 100 µg/dose as well as 200 µg/dose, will be in short supply within a few months.
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14 February 2011 /Product information
Gadolinium-containing MRI contrast agents and risk of nephrogenic systemic fibrosis (NSF)
Following a recent European review, the summaries of product characteristics for gadolinium-containing products are to be updated and harmonised, so that the information is the same throughout the EU.
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31 January 2011 /Product information
Potential contamination of alcohol preparation pads, swabs and swabsticks manufactured by Triad Group in the USA
The Danish Medicines Agency warns about potential contamination of prep pads, swabs and swabsticks with the bacteria ‘Bacillus cereus’.
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14 December 2010 /Product information
Warning against dangerous "natural" potency-enhancing product
The Danish Medicines Agency strongly warns against using the potency-enhancing product marketed as POWERtabs based on information from the Norwegian drug regulatory authorities that a Norwegian man needed treatment after having taken the potency-enhancing product.
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22 October 2010 /Product information
Important information for diabetics: GlucaGen® Hypokit 1 mg for injection recalled in Denmark
Novo Nordisk A/S in Denmark is recalling a defective batch of GlucaGen® Hypokit, which is used to treat severe hypoglycaemia (low blood sugar) in diabetes.
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26 July 2010 /Product information
EMA reassesses cardiovascular safety of rosiglitazone-containing medicines (Avandia, Avandamet and Avaglim)
In July, the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) once again initiated a review of the benefit-risk profile of rosiglitazone-containing medicines, which in Denmark are used to a very limited degree for the treatment of type 2 diabetes.
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22 July 2010 /Product information
Updated monographs for Heparin calcium (0332) and Heparin sodium (0333) for implementation in the European Pharmacopoeia (Ph. Eur.) as of 1 August 2010
As a follow-up on the work on improving the analysis methods for potentially contaminated heparin preparations, the European Pharmacopoeia Commission has adopted two revised monographs for Heparin calcium (0332) and Heparin sodium (0333) which will be implemented in the European Pharmacopoeia (Ph. Eur.) from 1 August 2010.
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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.
