News about Special product areas
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Assessment of new names of authorised veterinary medicines under the new veterinary regulation
| 22 February 2022 |
The assessment of names for already authorised veterinary medicines must be approved by the Danish Medicines Agency before the submission of a variation application.
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Reimbursement of medicinal cannabis of the pilot programme effective as of 1 January 2019
| 16 January 2019 |
On 1 January 2019, a special reimbursement scheme for medicinal cannabis in the four-year pilot programme entered into force. Reimbursement is retroactive for purchases made in 2018.
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Three research projects to increase our knowledge of medicinal cannabis
| 01 November 2018 |
Three projects have just been granted funds to give us more knowledge about the efficacy of medicinal cannabis. A total of DKK 5 million have been distributed of the funds that were appropriated by the negotiating parliamentary parties under the special funds agreement 2018-2021 to accumulate scientific knowledge of medicinal cannabis.
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12 applications for allocation of special funds related to medicinal cannabis
| 30 May 2018 |
The application deadline for the second allocation of special funds for accumulation of scientific knowledge in regard to the medicinal cannabis pilot programme has now expired. The Danish Medicines Agency received 12 applications.
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What is medicinal cannabis?
| 12 April 2018 |
The Danish Medicines Agency has produced a short infographic film illustrating the different types of medicinal cannabis.
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Infographic on the medicinal cannabis pilot programme
| 21 March 2018 |
The Danish Medicines Agency has produced a short infographic film about the medicinal cannabis pilot programme. The film gives a brief introduction to the programme and is intended for sharing on social media.
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New funds for accumulation of knowledge about medicinal cannabis
| 20 March 2018 |
The parties negotiating the special funds have earmarked a further DKK 5 million to increase knowledge about the use and effect of medicinal cannabis. You can apply for the funds now.
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Collection of scientific experience for medicinal cannabis pilot programme
| 05 October 2017 |
One or more research projects should be carried out for the purpose of gathering scientific experience on medicinal cannabis. The projects will form part of the medicinal cannabis pilot programme.
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Bravecto® may cause convulsions in dogs on rare occasions
| 10 August 2017 |
The European Medicines Agency has reviewed the adverse events of Bravecto®, a veterinary medicine used to treat flea and tick infestations in dogs. The conclusion is that the medicine may on very rare occasions cause convulsions in dogs – primarily in dogs with pre-existing epilepsy.
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The European Commission's decision concerning veterinary medicinal products containing zinc oxide
| 06 July 2017 |
On 26 June 2017, the European Commission adopted a decision to withdraw all marketing authorisations for veterinary medicinal products containing zinc oxide administered orally to food producing species. The medicinal products affected by the decision appear from Annex I to the decision.
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Adverse event reports for centrally authorised veterinary medicinal products should not be sent to the DKMA
| 03 July 2017 |
The Danish Medicines Agency no longer requests the direct transfer of serious and unexpected third-country adverse event reports for centrally authorised veterinary medicinal products.
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New recommendation for phasing out zinc oxide for young pigs
| 21 March 2017 |
The European Medicines Agency's Committee for Medicinal Products for Veterinary Use (CVMP) has confirmed a previous decision to phase out zinc oxide. Consequently, the CVMP has once more recommended to the European Commission that medicinal products containing zinc oxide for the prevention of diarrhoea in young pigs should be withdrawn from the market.
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Re-examination of the CVMP's decision to phase out zinc oxide for young pigs
| 05 January 2017 |
The European Medicines Agency's Committee for Medicinal Products for Veterinary Use (CVMP) will re-examine the decision to phase out medicinal products containing zinc oxide for the prevention of diarrhoea in young pigs.
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New chair of PhVWP-V
| 20 December 2016 |
Lisbet Vesterager Borge, veterinarian, has been elected chair of the European Pharmacovigilance Working Party Veterinary (PhVWP-V).
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Zinc oxide for young pigs to be phased out
| 19 December 2016 |
The European Medicines Agency's Committee for Medicinal Products for Veterinary Use (CVMP) has recommended to the European Commission that medicinal products containing zinc oxide for the prevention of diarrhoea in young pigs should be withdrawn from the market.
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Marketing authorisation for medicine for cows suspended in the EU/EEA
| 20 July 2016 |
On 14 July 2016, the Committee for Medicinal Products for Veterinary Use (CVMP) recommended that the marketing authorisation for the centrally authorised medicinal product Velactis (cabergoline) be suspended temporarily. Velactis is used to reduce milk production in dairy cows at the time of drying off. The recommendation follows reports of serious adverse events after treatment with Velactis.
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Use of medicine for cows suspended
| 21 June 2016 |
Today, the Danish Medicines Agency has decided to suspend the use of the veterinary medicine Velactis, which is used to reduce milk production (drying-off) in dairy cows.
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Updated list of biological medicinal products
| 04 February 2016 |
The Danish Medicines Agency has added five new medicinal products to the list of biological and biosimilar medicinal products.
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The Danish Medicines Agency has a new website
| 04 January 2016 |
Today, the Danish Medicines Agency launched its new website – laegemiddelstyrelsen.dk/en – where you can read about and subscribe to news about licensing and supervision of medicines, side effects, reimbursement, pharmacies and medical devices.
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Proposal for SPC harmonisation of a veterinary medicinal product
According to Article 69-72 of Regulation (EU) 2019/6, National Competent Authorities (NCAs) as well as Marketing Authorisation Holders (MAHs) may propose harmonisation of the SPCs of Reference Veterin