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29 March 2011 /Side effects and trials
Acknowledgement Message (ACK) for receipt of an adverse reaction report
The Danish Medicines Agency's new pharmacovigilance system now dispatches ACKs in batch runs. That is why you will no longer receive an ACK immediately after you have submitted an adverse reaction report to the Danish Medicines Agency.
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29 March 2011 /Side effects and trials
Swedish study increases suspicion about link between Pandemrix® (the pandemic vaccine) and the sleep disorder narcolepsy in children and adolescents
A recently completed Swedish registry study indicates that children and adolescents under the age of 20 have a four times higher risk of developing the sleep disorder narcolepsy if they have received the influenza vaccine Pandemrix® compared to those who are not vaccinated. The results from this study are in line with the results of a similar Finnish study.
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24 March 2011 /News - miscellaneous
Danish Pharmacovigilance Update, 17 March 2011
This month’s issue of Danish Pharmacovigilance Update includes articles about reports of serious side effects in Japan from the childhood vaccines Prevenar (PCV7)® and Act-Hib® and reports of serious side effects in France from the childhood vaccine Prevenar13®.
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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 March 2011 /About us
Leading Danish business magazine honours Head of Unit at the Danish Medicines Agency
In the leading Danish business magazine "Berlingske Nyhedsmagasin", published yesterday, Head of Unit at the Danish Medicines Agency Hanne Cozzari has just been recognised as one of the 100 most talented persons on the Danish labour market in the category "Communications and HR".
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18 March 2011 /News - miscellaneous
No need to take potassium iodide in Denmark
The nuclear crisis in Japan does not cause radiation risk in Denmark, and therefore, there is no reason to take potassium iodide if you stay in Denmark.
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17 March 2011 /About us
No access to e-forms on Thursday 24 March from 1 to 4 am
A number of the Danish Medicines Agency’s e-forms cannot be accessed on Thursday 24 March from 1 to 4 am.
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16 March 2011 /Side effects and trials
Solutions to problems with EudraCT version 8
After the upgrade to EudraCT version 8, the Danish Medicines Agency has received increasing reports of problems with making changes to already saved XML files. Please find solutions to the problems here.
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16 March 2011 /Authorisation and supervision
Changes to authorisation to manufacture and import medicines and intermediates
The EMA has changed its practice on how import activities must be registered in the format for Manufacturer's and Importer's Authorisations (MIA). Import covers import of medicines and intermediates from a country outside the EU/EEA (third country).
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14 March 2011 | Updated 14 March 2011 /Side effects and trials
Reports of serious side effects in Japan from the childhood vaccines Prevenar (PCV7)® and Act-Hib®
The marketing authorisations for the vaccines Prevenar (PCV7)® and Act-Hib® have been temporarily suspended in Japan after four deaths among children. None of the lots/batches of the vaccines (Prevenar (PCV7)® or Act-Hib®) used in Japan have been used in Denmark. The Danish Medicines Agency assesses that no further actions are required in Denmark, but will be watching the situation in Japan closely.
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14 March 2011 /Side effects and trials
Reports of serious side effects in France from the childhood vaccine Prevenar13®
The French drug regulatory authorities report of three cases of crib death after vaccination with Prevenar13®. There are no reports of deaths in Denmark that can be related to Prevenar13®. The Danish Medicines Agency assesses that no further actions are required in Denmark, but it will be watching the situation in France closely.
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14 March 2011 /Prices and reimbursement
Review concluded regarding general reimbursement for Brilique®
The Danish Medicines Agency has completed its review of an application for general reimbursement for Brilique®. The product has been granted general reimbursement.
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14 March 2011 /Side effects and trials
Data on deaths or serious side effects in newborns from use of antidepressants (SSRIs)
On 1 March 20111, we published information about two cases of neonatal death in infants whose mothers had been treated with fluoxetine during pregnancy. Since then, we have performed an extended search for adverse drug reaction (side effect) data for all antidepressants of the SSRI type and also for all cases of abortions. Data show a further two cases of neonatal death as well as 12 reports of intra-uterine death (foetal death) or abortions. Even though the risk is small, serious adverse reactions may occur in the foetus and the newborn child if pregnant women are treated with an antidepressant of the SSRI type. The risk should, however, be weighed against the beneficial effect of SSRIs for pregnant women who suffer from a serious disorder requiring treatment.
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11 March 2011 /Side effects and trials
Changes in EudraCT version 8
With the update of EudraCT from version 7 to version 8, several changes have been made to the underlying structure.
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10 March 2011 /Authorisation and supervision
Issuance of GMP certificates in relation to GMP inspection
The Danish Medicines Agency issues a GMP certificate or a statement of non-compliance with GMP within 90 days after a GMP inspection (inspection of good manufacturing practice). This is done in accordance with the agreed European procedures for inspectorates.
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08 March 2011 /About us
Reception for Professor Per Helboe
At the end of April, Professor Per Helboe will be retiring from his position as Senior Director of Division at the Danish Medicines Agency. We invite you to a reception in his honour on Friday 8 April 2011 from 14:00 to 16:00 at the Danish Medicines Agency.
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08 March 2011 /Authorisation and supervision
Voluntary inspection of GLP activities of safety studies involving medical devices
Due to changes to the division of work between the Danish Accreditation and Metrology Fund (DANAK) and the Danish Medicines Agency related to inspections of good laboratory practice (GLP), the Danish Medicines Agency will in future be inspecting GLP trials of medical devices.
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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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04 March 2011 /Side effects and trials
EudraCT portal unavailable 3 – 10 March 2011
The EudraCT website will be unavailable from Thursday 3 March 2011 to Thursday 10 March 2011 due to the rollout of EudraCT version 8.
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03 March 2011 /Prices and reimbursement
The Danish Medicines Agency begins ad hoc reassessment of reimbursement status of glucosamine (M01AX05)
Clinical studies have called into question the efficacy of glucosamine for the alleviation of painful osteoarthritis. This has contributed to the Danish Medicines Agency’s decision to initiate ad hoc reassessment of glucosamine-containing medicines, which today have general conditional reimbursement when prescribed for the alleviation of symptoms of mild to moderate osteoarthritis and when prescribed to old-age pensioners.
