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05 July 2012 /Authorisation and supervision
Suspension of Certificate of Suitability for the active substance Leflunomide
EDQM, the European Directorate for the Quality of Medicines and Healthcare, has suspended the following Certificate of Suitability (CEP): CEP 2009-035/Leflunomide.
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05 July 2012 /Authorisation and supervision
Withdrawal of Certificates of Suitability for the active substances Chlorhexidine digluconate solution and Calcium dobesilate monohydrate
EDQM, the European Directorate for the Quality of Medicines and Healthcare, has withdrawn the following Certificates of Suitability (CEP): CEP 2005-076-Rev 01/Chlorhexidine digluconate solution and CEP 2010-209-Rev 00/Calcium dobesilate monohydrate.
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05 July 2012 /Side effects and trials
Monthly report from the EU Pharmacovigilance Working Party, PhVWP – June 2012
The EU Pharmacovigilance Working Party (PhVWP) convened on 18-20 June 2012.
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07 June 2012 | Updated 04 July 2012 /About us
New opening hours from 2 July 2012
As part of the merger announced earlier this year, the Danish Health and Medicines Authority introduced new opening hours as of 2 July 2012.
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04 July 2012 /News - miscellaneous
Danish Pharmacovigilance Update, 19 April 2012
Among the topics covered in this issue of Danish Pharmacovigilance Update are: Split and crushed tablets containing finasteride may pose a risk for pregnant and fertile women.
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03 July 2012 /Side effects and trials
New study on treatment with HES (hydroxyethyl starch) in patients with severe sepsis
A new Danish study published in the New England Journal of Medicine has investigated HES used as a plasma substitute in patients with severe sepsis. The study followed 800 patients from intensive care units in Denmark, Iceland, Norway and Finland over a two-year period. The conclusions of the study suggest that HES has a less favourable safety profile than Ringer's acetate used as plasma substitutes in patients with severe sepsis.
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29 May 2012 | Updated 27 June 2012 /Legislation
New European legislation improves the monitoring of adverse reactions and strengthens patient safety
In July 2012, new pharmacovigilance legislation comes into effect across the EU. The purpose of the new legislation is to strengthen patient safety by improving the present system used for monitoring safety of medicines in Europe.
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25 June 2012 /Legislation
Publication of EU Implementing Regulation on the performance of pharmacovigilance activities
On 20 June 2012, the European Commission's Implementing Regulation (EU) No 520/2012 of 19 June 2012 on the performance of pharmacovigilance activities provided for in Regulation (EC) No 726/2004 of the European Parliament and of the Council and Directive 2001/83/EC of the European Parliament and of the Council was published in the Official Journal of the European Union.
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22 June 2012 /Authorisation and supervision
Suspension of Certificates of Suitability for several active substances from the manufacturer Amoli Organics PVT Ltd
EDQM, the European Directorate for the Quality of Medicines and Healthcare, has suspended a number of Certificates of Suitability (CEP):
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22 June 2012 /Authorisation and supervision
Suspension of Certificate of Suitability for the active substance Povidone iodicated
EDQM, the European Directorate for the Quality of Medicines and Healthcare, has suspended the following Certificates of Suitability (CEP): CEP 2009-166 / Povidone iodicated ...
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22 June 2012 /Authorisation and supervision
Danish translation of the PhVWP's revised recommendation for the product information of fluoroquinolones
The European Pharmacovigilance Working Party, PhVWP, has prepared a revised recommendation for the wording of the product information for fluoroquinolones. The Danish Health and Medicines Authority has now translated this recommendation into Danish.
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20 June 2012 /Product areas
NHS publishes final report into the safety of PIP implants
An expert group under the National Health Service (NHS) in Britain has published a thorough report on PIP implants. The exhaustive worldwide testing of the PIP gel has not revealed anything that could cause a long-term threat to human health. The implants are not toxic and do not cause cancer. But the risk that the PIP implants may rupture is around two times higher than it is for other brands of implants - around 6-12% after 5 years, and 15-30% after 10 years, whereas the risk associated with other brands is 10-14% after 10 years. The contents of the PIP implants are therefore not harmful, and the gel has not been shown to contain any toxic substances, but the poorer mechanical durability makes the PIP implants a substandard product.
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19 June 2012 /Side effects and trials
European Medicines Agency assesses risk of the arthritis medicine diclofenac
In response to recent days' debate about the safety of the arthritis medicine diclofenac, the Danish Health and Medicines Authority urges doctors to carefully follow the restrictions and precautions for use that are already described in the medicine's summary of product characteristics and on the Danish website medicin.dk.
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19 June 2012 /News - miscellaneous
Danish Pharmacovigilance Update, 15 March 2012
Among the topics covered in this issue of Danish Pharmacovigilance Update are: A new registry study has investigated the frequency of malformations in newborns after treating the mother with antidepressants (SSRI) during the pregnancy.
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18 June 2012 /Authorisation and supervision
Assessment times for authorisation of medicines for the first three months of 2012
We have published our assessment times for authorisation of medicines for the first three months of 2012.
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14 June 2012 /Side effects and trials
Low oestrogen dose in contraceptive pills reduces risk of blood clots
The risk of forming blood clots in brain and heart from the use of contraceptive pills has become smaller as the dose of oestrogen contained in contraceptive pills has been lowered. Moreover, blood clots in brain and heart are generally less frequent than blood clots in legs and lungs, so shows a new Danish study on a cohort of 1.6 million Danish women aged between 15 and 49.
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08 June 2012 | Updated 13 June 2012 /Authorisation and supervision
Certificates of Suitability for the active substances Oxytetracycline dihydrate and Oxytetracycline hydrochloride have been withdrawn
Updated: The following Certificates of Suitability (CEPs) have been withdrawn at the request of the manufacturer. CEP 2004-177-Rev 00/ Oxytetracycline dihydrate CEP 2008-165-Rev 00/ Oxytetracycline hydrochloride
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17 April 2012 | Updated 12 June 2012 /Authorisation and supervision
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08 June 2012 /About us
Reception for Jytte Lyngvig
At the end of June, Director Jytte Lyngvig will be retiring from her position at the Danish Health and Medicines Authority. We invite you to a reception in her honour on Thursday 28 June 2012 from 14:00 to 16:00 at the Danish Health and Medicines Authority.
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08 June 2012 /Authorisation and supervision
Danish translation of the PhVWP's recommendation for the product information of SSRIs
The European Pharmacovigilance Working Party, PhVWP, has prepared a recommendation for the wording of the product information for SSRIs (fluvoxamine, citalopram, escitalopram, fluoxetine, sertraline and paroxetine). The Danish Health and Medicines Authority has now translated this recommendation into Danish.
