The companies are responsible for ensuring that the package leaflets and labelling of medicines 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 during 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 medicinal products to find out whether they comply with the provisions of the Danish executive order on labelling (see the factbox to the right).
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 medicinal products:
- Delepsine Retard, prolonged-release tablets, 300 mg, Orion Pharma A/S
- Delepsine Retard, prolonged-release tablets, 500 mg, Orion Pharma A/S
- Delepsine, tablets, 300 mg, Orion Pharma A/S
- Delepsine, gastro-resistant tablets, 300 mg, Orion Pharma A/S
- Delepsine, gastro-resistant tablets, 500 mg, Orion Pharma A/S
- Sumatriptan "Actavis", tablets, 50 mg, Actavis A/S
- Sumatriptan "Actavis", tablets, 100 mg, Actavis A/S
- Gabapentin "PCD", capsules, hard, 300 mg, PharmaCoDane ApS
- Detrusitol Retard, prolonged-release capsules, hard, 2.8 mg, EuroPharmaDK ApS
- Xamiol, gel, 50 microgram/0.5 mg /g, Orifarm A/S
- Xamiol, gel, 50 microgram/0.5 mg /g, PharmaCoDane ApS
- Tadol, capsules, hard, 50 mg, PharmaCoDane ApS
- Clozapin "2care4", tablets, 100 mg, 2care4 ApS
The compliance check also implied that the Danish Medicines Agency accepted the design of the outer and/or inner packaging of the following medicinal products:
- Malfin, prolonged-release tablets, 10 mg, Teva
- Malfin, prolonged-release tablets, 100 mg, Teva
- Tafil, tablets, 0.25 mg, Pfizer A/S
- Halcion, tablets, 0.25 mg, Pfizer A/S
- Combar, film-coated tablets, 15 mg, PharmaCoDane ApS
- Combar, film-coated tablets, 30 mg, PharmaCoDane ApS
- Combar, film-coated tablets, 45 mg, PharmaCoDane ApS
- Foradil, pressurised inhalation, solution, 12 microgram/dose, EuroPharmaDK
- Propofol "B. Braun", emulsion for injection/infusion, 5 mg/ml, B. Braun Medical A/S
- Propofol "B. Braun", emulsion for injection/infusion, 10 mg/ml, B. Braun Medical A/S
- Propofol "B. Braun", emulsion for injection/infusion, 20 mg/ml, B. Braun Medical A/S
Compliance check of package leaflets
As part of the package leaflets harmonisation project, the Danish Medicines Agency has checked the package leaflets of selected medicinal products for compliance with the Danish executive order on labelling (see the factbox to the right).
Based on the Danish Medicines Agency's compliance check, the marketing authorisation holders have updated the package leaflets (in the package and/or on www.indlaegsseddel.dk) of the following medicinal product:
- Fenyl butazon OBA, tablets 200 mg, OBA Pharma A/S
- Glucosamin "Ferrosan", 400 mg tablets, Ferrosan A/S
- Dysport, powder for solution for injection, IPSEN AB
- Ibutop, cream, 5%, Actavis Nordic A/S
- Klexane, solution for injection, vial 100 mg/ml, sanofi-aventis Denmark A/S
- Malarone, film-coated tablets, 250+100, GlaxoSmithKline Pharma A/S
- BCG kultur "SSI", powder for bladder irrigation, Danish State Serum Institute
- Pharmalgen Bi, powder and solvent for solution for injection, 120 microg/vial, ALK-Abello A/S
The compliance check also implied that the Danish Medicines Agency accepted the package leaflets of the following medicinal products:
- Glucosamin "Ledflex", film-coated tablets, 400 mg, Ferrosan A/S
- Glucosamin "Jemo", film-coated tablets 400 mg, Jemo Pharma A/S
- Diclon, gastro-resistant tablets, 50 mg, Sandoz A/S
- Brufen, tablets, 600 mg, Abbott Scandinavia
- Todolac, tablets, 200 mg, Norpharma A/S
- Relifex, tablets, 500 mg, Meda A/S
- Piroxicam "Mylan" tablets 20 mg, Mylan ApS
- Navelbine, capsules, soft 20 mg, Pierre Fabre Norden AB
- Bonyl, tablets, 250 mg, Orion Pharma A/S
- Vermox, tablets, 100 mg, Janssen-Cilag A/S
- Ferroplex-Fragula "ERA", tablets, ERA Medical ApS
- Uromixtan, film-coated tablets, 400 mg, Baxter A/S
- Folimet, tablets, 5 mg, DOC Medical A/S
- Folimet, tablets, 1 mg, DOC Medical A/S
- Iomeron, solution for injection 400 mg iodine/ml, Initios Medical AB
- Prohance, solution for injection 279.3 mg/ml, Initios Medical AB
- Vispaque, solution for injection 270 mg iodine/ml, GE Healthcare A/S
- Omnipaque, solution for injection 240 mg I/ml, GE Healthcare
- Zodalex, implant, 3.6 mg, Astra Zeneca A/S
- Persantin, coated tablets, 100 mg, Abacus Medicine Aps
- Lariam, tablets, 250 mg, Roche A/S
- Naproxen "Mylan", tablets 250 mg, Mylan ApS
