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21 December 2010 /Retail and online sale
The Danish Medicines Agency warns against illegal version of Pregnyl
The pharmaceutical company Missionpharma A/S has alerted the Danish Medicines Agency that an illegal version of the medicine Pregnyl is in circulation.
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21 December 2010 /News - medical devices
Danish Medicines Agency sends out acknowledgement letters and decisions electronically
The Danish Medicines Agency will be sending out acknowledgement letters and decisions to companies, researchers, etc. electronically, in so far as we have a registered email address for the person(s) that we primarily correspond with
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20 December 2010 /Product areas
Check your Mini Crosser el-scooter if it is more than four years old
Older versions of el-scooters (Model T and Model Nordic) could have problems with the electronics and therefore need to be adjusted.
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17 December 2010 /Authorisation and supervision
The EDQM has suspended the Certificate of Suitability for the active substance pyrazinamide
The European Directorate for the Quality of Medicines and Healthcare, EDQM, has suspended the following Certificate og Suitability. CEP R1-1998-070-Rev02 Pyrazinamide
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17 December 2010 /News - miscellaneous
Recommendation for doctors and dialysis patients in connection with peritoneal dialysis solutions from Baxter A/S
The European Medicines Agency (EMA) recommends that all batches of Baxter's peritoneal dialysis solutions, Extraneal®, Nutrineal® and Dianeal® be replaced.
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16 December 2010 /News - miscellaneous
Moderate catch in fitness centres
The Danish Veterinary and Food Administration and the Danish Medicines Agency only found a small number of violations of the Danish Food Act and the Danish Medicines Act during a joint on-site inspection of some 30 fitness centres and clubs in autumn 2010.
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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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13 December 2010 /Side effects and trials
Exercise particular caution when using Extraneal Viaflex® and Nutrineal Viaflex® peritoneal dialysis solution
A number of units of Baxter’s peritoneal dialysis solution of the brands Extraneal® and Nutrineal® manufactured in Ireland are suspected of containing a too high content of endotoxin. A too high content of endotoxin may pose a risk of aseptic peritonitis (infection of abdominal fluid).
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10 December 2010 /Side effects and trials
Update of validation rules for electronic reporting of adverse reactions
We are updating the validation rules in connection with the implementation of the Danish Medicines Agency's new adverse reaction database. The changes, which entered into force on 6 December 2010, are.
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02 July 2010 | Updated 10 December 2010 /Retail and online sale
OTC medicines and release for sale outside pharmacies
In consultation with the Licensing Committee, the Danish Medicines Agency has adopted a new practice, describing when an over-the-counter (OTC) medicine is released for sale outside pharmacies.
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06 December 2010 /About us
Danish Medicines Agency sends out acknowledgement letters and decisions electronically
The Danish Medicines Agency will be sending out acknowledgement letters and decisions to companies, researchers, etc. electronically, in so far as we have registered email address for the person(s) that we primarily correspond with.
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29 November 2010 /Side effects and trials
Delay in acknowledgements for adverse reactions submitted from 1 December to 6 December 2010
Companies submitting electronic adverse reaction reports to the Danish Medicines Agency in the period from 1 Dece´mber up to and including 6 December are advised that the electronic acknowledgement will be delayed.
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16 November 2010 /Authorisation and supervision
The EDQM has suspended the Certificate of Suitability for the active substance rifampicin
The European Directorate for the Quality of Medicines and Healthcare, EDQM, has suspended the Certificate of Suitability (CEP) for the active substance rifampicin
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16 November 2010 /Authorisation and supervision
The EDQM has suspended the Certificates of Suitability for the active substances oxytetracycline HCl and phenoxymethylpenicillin potassium
The European Directorate for the Quality of Medicines and Healthcare, EDQM, has suspended the Certificates of Suitability (CEP) for the active substances Oxytetracycline HCl (CEP 1999-162) abd Phenoxymethylpenicillin pottassium (CEP 2006-019)
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16 November 2010 /Authorisation and supervision
The EDQM has suspended the Certificates of Suitability for the active substances metronidazole and caffeine
The European Directorate for the Quality of Medicines and Healthcare, EDQM, has suspended the Certificates of Suitability (CEP) for the active substances metronidazole (R1-CEP 2002-119-Rev 00) and caffeine (R0-CEP 2005-116-Rev 01)
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12 November 2010 /News - miscellaneous
Heads of Medicines Agencies adopts new strategy
The Heads of Medicines Agencies (HMA) has adopted a new strategy for 2011-2015 at the HMA meeting in Antwerp on 25 October 2010. The key themes of the strategy are.
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10 November 2010 /Side effects and trials
Pregnancy and use of over-the-counter painkillers
A new Danish study has shown that the use of paracetamol during pregnancy may be associated with an increased risk of cryptorchidism in baby boys at birth1. Cryptorchidism is a condition where the testicles have not descended into the scrotum at birth.
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29 October 2010 /Side effects and trials
Assessment of safety of methylphenidate in ADHD treatment
The Danish Medicines Agency has reviewed the data on consumption and side effects of methylphenidate-containing medicine, which is authorised for the treatment of ADHD and narcolepsy.
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29 October 2010 /Side effects and trials
Implementation of MedDRA version 13.1
MedDRA (Medical Dictionary for Regulatory Activities) is a code book of medical terminology developed by ICH (International Conference on Harmonisation).
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25 October 2010 /Side effects and trials
Adjustment of new validation rules for electronic exchange of adverse reaction data
On 11 October, the Danish Medicines Agency, implemented the updated validation rules for electronic exchange of E2B files ((ICH E2B (R2)) EV7 Release 1.
