Companies marketing medicines in Denmark are responsible for ensuring that their package leaflets and labelling comply with the Danish executive order on labelling. The Danish Medicines Agency regularly carries out random compliance checks of package leaflets and product labelling.
Below, you can see which medicines we have checked since winter 2011.
Our compliance check has meant that the labelling or package leaflets of a number of the medicines have been or will be changed.
Compliance check of labelling
In response to complaints and reports, etc. submitted to the Danish Patient Safety Database, the Danish Medicines Agency has examined different elements of the labelling of the below listed medicines.
We have checked the medicines' compliance with the provisions of the Danish executive order no. 869 of 21 July 2011 on the labelling etc. of medicinal products.
Changes to the outer and/or inner packaging
Based on the compliance check carried out by the Danish Medicines Agency, marketing authorisation holders have changed or will change the design of the outer and/or inner packaging of the following medicines:
Amgros I/S
- Noradrenalin SAD, solution for injection 1 mg/ml, Amgros I/S
Janssen-Cilag A/S (TIBOTEC)
- Sufenta, solution for injection 5 microgram/ml, Janssen-Cilag A/S (TIBOTEC)
- Sufenta, solution for injection 50 microgram/ml, Janssen-Cilag A/S (TIBOTEC)
Alcon Danmark A/S
- Mydriacyl, eye drops, solution, 1 %, Alcon Danmark A/S
Actavis A/S
- Felodipin "Actavis", prolonged-release tablets, 5 mg, Actavis A/S
- Amlodipin "Actavis", prolonged-release tablets, 5 mg, Actavis A/S
LEO Pharma A/S
- Innohep, solution for injection, 10,000 anti-Xa IE/ml, LEO Pharma A/S
- Innohep, solution for injection, 20,000 anti-Xa IE/ml, LEO Pharma A/S
EuroPharmaDK
- Asacol, gastro-resistant tablets, 400 mg, EuroPharmaDK
- Pulmicort Turbuhaler, inhalation powder, 400 microgram/dose, EuroPharmaDK
- Lomir Retard, prolonged-release tablets, hard, 5 mg, EuroPharmaDK
Norgine Danmark A/S
- Movicol, powder for oral solution, single-dose sachet, Norgine Danmark A/S
Accepted outer and/or inner packaging
The compliance check also implied that the Danish Medicines Agency accepted the design of the outer and/or inner packaging of the following medicines:
Alcon Danmark A/S
- Cyclogyl, eye drops, solution, 1 %, Alcon Danmark A/S
Amgros I/S
- Morfin SAD, solution for injection , 0.4 mg/ml, vial Amgros I/S
- Morfin SAD, solution for injection , 5 mg/ml, vial Amgros I/S
- Morfin SAD, solution for injection , 10 mg/ml, vial Amgros I/S
- Morfin SAD, solution for injection, 20 mg/ml, vial Amgros I/S
- Glycerylnitrat SAD, solution for injection, 5 mg/ml, vial, Amgros I/S
- Suxameton SAD, solution for injection, 20 mg/ml, vial, Amgros I/S
- Suxameton SAD, solution for injection, 50 mg/ml, vial, Amgros I/S
- Adrenalin SAD, solution for injection 1 mg/ml, vial, Amgros I/S
Nycomed Danmark ApS
- Morfin DAK, solution for injection, 20 mg/ml, vial, Nycomed Danmark ApS
- Metadon DAK, solution for injection, 10 mg/ml, vial, Nycomed Danmark ApS
OctaPharma AB
- Rhesonativ, solution for injection, 625 IE/ml, 1 ml, OctaPharma AB
- Rhesonativ, solution for injection, 625 IE/ml, 2 ml, OctaPharma AB
HEXAL A/S
- Sertralin HEXAL, film-coated tablets, 50 mg, HEXAL A/S
- Zolpidem HEXAL, film-coated tablets, 10 mg, HEXAL A/S
Orifarm A/S
- Zarator, film-coated tablets, 40 mg, Orifarm A/S
EuroPharmaDK
- Tilcitin, film-coated tablets, 20 mg, EuroPharmaDK
Compliance check of package leaflets
In addition, the Danish Medicines Agency has received complaints about package leaflets and has checked the package leaflets of selected medicines in the Danish package leaflet database www.indlaegsseddel.dk.
We have checked the package leaflets' compliance with the provisions of the Danish executive on the labelling etc. of medicinal products.
Based on the compliance check carried out by the Danish Medicines Agency, marketing authorisation holders have changed or will change the content of the package leaflet or have changed or will change the quality of the uploaded format of the package leaflet in www.indlaegsseddel.dk for the following medicines:
PharmaCoDane ApS
- Alendronat "Stada", tablets, 70 mg, PharmaCoDane ApS
MSD Danmark ApS
- Singulair, chewable tablets, 4 mg, MSD Danmark ApS
GlaxoSmithKline
- Ferro Duretter, prolonged-release tablets, 100 mg, GlaxoSmithKline
Mylan ApS
- Metomylan, prolonged-release tablets, 25 mg, Mylan ApS
- Metomylan, prolonged-release tablets, 50 mg, Mylan ApS
- Metomylan, prolonged-release tablets, 100 mg, Mylan ApS
2care4
- Durogesic, transdermal patches, 100 micrograms/hour, 2care4
Orifarm A/S
- AmBisome, powder for solution for infusion, 50 mg, Orifarm A/S
Pfizer ApS
- Tenormin, film-coated tablets, 25 mg, Pfizer ApS
Ratiopharm A/S
- Moxonidin "ratiopharm", film-coated tablets, 0.2 mg, Ratiopharm A/S
- Moxonidin "ratiopharm", film-coated tablets, 0.3 mg, Ratiopharm A/S
- Moxonidin "ratiopharm", film-coated tablets, 0.4 mg, Ratiopharm A/S
PharmaCoDane ApS
- Moxonat, film-coated tablets, 0.2 mg, PharmaCoDane ApS
- Moxonat, film-coated tablets, 0.4 mg, PharmaCoDane ApS
FarmaPlus AS
- Benzylpenicillin "Panpharma", powder for solution for injection or infusion, 1.2 g, FarmaPlus AS
- Benzylpenicillin "Panpharma", powder for solution for injection or infusion, 3 g, FarmaPlus AS
