News about supervision and inspection of pharmaceutical companies
Withdrawal of one more batch of counterfeit packs of the schizophrenia medicine Xeplion 150 mg
| 01 August 2017 |
German and Danish parallel importers and the Danish Medicines Agency are now withdrawing the fourth batch of Xeplion 150 mg from wholesale distributors, hospitals and pharmacies, because the batch contains counterfeit packs.
Counterfeit packs of the schizophrenia medicine Xeplion 150 mg
| 27 July 2017 |
One German and several Danish parallel importers and the Danish Medicines Agency have withdrawn several batches of Xeplion 150 mg from wholesale distributors, hospitals and pharmacies, because the batches contained counterfeit packs.
More batches of EpiPen® are withdrawn
| 06 April 2017 |
MEDA has decided to withdraw four more batches of EpiPen®. The withdrawal concerns two batches of EpiPen® 300 micrograms/dose and two batches of EpiPen® Jr 150 micrograms/dose. The latter is used for acute hypersensitivity reactions in children. The reason for the withdrawal is that there is a risk that the auto-injector does not work.
Withdrawal of a batch of EpiPen® 300 micrograms
| 17 March 2017 |
MEDA recalls a batch of the adrenaline product EpiPen® 300 micrograms/dose, which is used for sudden allergic reactions. There is a risk that the auto-injector does not work. The withdrawal concerns product number 578818 with batch number: 5FA665B and expiry date 03/2017.
EuropharmaDK regains its authorisation
| 13 March 2017 |
The Danish Medicines Agency has decided to lift the suspension of EuropharmaDK's manufacturing and importation authorisation, following the outcome of a follow-up inspection of EuropharmaDK ApS on 8 March where the Danish Medicines Agency ascertained that the critical findings had been corrected.
New transatlantic agreement on mutual recognition of inspections
| 03 March 2017 |
The EU and the USA have agreed to recognise inspections of manufacturing sites for human medicines conducted in their respective territories on both sides of the Atlantic.
Update on Europharma DK
| 03 February 2017 |
Europharma DK can now legally sell medicines repacked and released by Abacus Medicine.
Suspension of Europharma DK ApS’ authorisation to manufacture and distribute parallel imported medicinal products
| 03 January 2017 |
Today, 3 January 2017, the Danish Medicines Agency suspended Europharma DK ApS’ authorisation number 30308 issued on 23 March 2015 for the manufacturing and import of medicinal products and intermediate products (GMP authorisation).