News about Side effects and product information
DKMA Update October 2017
| 10 October 2017 |
In this issue of DKMA Update, you can read about the decision to change the dispensing status of a number of opioids, about the new guidelines on medicinal cannabis for doctors, and about the executive order on the import of cannabis products.
New practice for follow-up information on adverse reaction reports
| 29 September 2017 |
The Danish Medicines Agency has introduced a new practice for the processing of pharmaceutical companies' requests for follow-up information on reports of suspected adverse reactions.
E2B acknowledgment format change
| 12 September 2017 |
Companies that use the Danish Medicines Agency's Pharmacovigilance System should be aware that we have changed the MessageFormatRelease value from 2.0 to 1.0.
| 11 September 2017 |
Our newsletter Danish Pharmacovigilance Update changes name to DKMA Update and will from now on contain information about medicinal products in general, patient safety and life science.
Testing the exchange of E2B files
| 16 August 2017 |
Testing the exchange of E2B ICSRs/SUSARs between the Danish Medicines Agency and companies/sponsors must be completed by Friday 29 September 2017.
Adverse reaction reports received from the Danish Patient Compensation Association
| 14 July 2017 |
The marketing authorisation holder of a medicinal product shall not submit reports to the Danish Medicines Agency about any adverse reactions appearing from decisions about compensation for medicinal injuries, which the company has received from the Danish Patient Compensation Association.
Evaluation of a Danish meta-analysis of antidepressants
| 21 June 2017 |
The Danish Medicines Agency has evaluated a Danish meta-analysis made by the Copenhagen Trial Unit on the effects of antidepressants (SSRIs). The analysis attracted extensive media coverage.
Tramadol: It is important that we are informed of side effects
| 13 June 2017 |
Doctors should contact the Danish Medicines Agency if clinical experience shows that the side-effect profile of a medicinal product is not consistent with the summary of product characteristics.
Danish Pharmacovigilance Update, May 2017
| 08 June 2017 |
The May issue of Danish Pharmacovigilance Update.
Danish Pharmacovigilance Update, April 2017
| 22 May 2017 |
The April issue of Danish Pharmacovigilance Update.
Danish Pharmacovigilance Update, March 2017
| 18 April 2017 |
The March issue of Danish Pharmacovigilance Update.
Danish Pharmacovigilance Update, February 2017
| 06 March 2017 |
The February issue of Danish Pharmacovigilance Update.
Takeda Pharma A/S recalls batch of Pamol® in packs of 300 film-coated tablets
| 21 February 2017 |
Takeda Pharma A/S recalls a batch of Pamol® in packs of 300 film-coated tablets after the discovery of Ibumetin 600 mg containing ibuprofen in some packs. Both types of medicine are used for the treatment of mild pain, but they work in different ways and may cause different adverse reactions.
Danish Pharmacovigilance Update, January 2017
| 03 February 2017 |
The January issue of Danish Pharmacovigilance Update.
Danish Pharmacovigilance Update, December 2016
| 06 January 2017 |
The December issue of Danish Pharmacovigilance Update.