Compliance check of package leaflets and product labelling (winter 2009/2010)

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 executive order on labelling (see the factbox to the right).

Based on this check, marketing authorisation holders have changed or will change the design of the outer and/or inner packaging of the following medicinal products:

• Symbicort Mite Turbuhaler, inhalation powder 4.5/80 microgram/dose, Paranova Danmark A/S
• Pulmicort Turbohaler, inhalation powder, 200 microgram/dose, Paranova Danmark A/S
• Pulmicort Turbuhaler, inhalation powder, 100 microgram/dose, Paranova Danmark A/S 

• Symbicort Forte Turbohaler, inhalation powder 9/320 microgram/dose, Paranova Danmark A/S

• Pulmicort Turbohaler, inhalation powder, 400 microgram/dose, Orifarm A/S
• Pulmicort Turbuhaler, inhalation powder, 400 microgram/dose, Orifarm A/S
• Rilast forte Turbuhaler, inhalation powder, 9/320 microgram/dose, Orifarm A/S
• Serevent, inhalation powder, 50 microgram disks, Orifarm A/S
• Symbicort Forte Turbohaler, inhalation powder , 9+320 microgram/dose, Orifarm A/S
• Symbicort Forte Turbuhaler, inhalation powder , 9+320 microgram/dose, Orifarm A/S

• Symbicort Mite Turbohaler, inhalation powder, 4.5+ 80 microgram/dose, Orifarm A/S
• Oxis Turbuhaler, inhalation powder, 4.5 microgram/dose, Abacus Medicines A/S

• Pulmicort Turbuhaler, inhalation powder, 200 microgram/dose, PharmaCoDane ApS 
• Symbicort Forte Turbuhaler, inhalation powder, 9+320 microgram/dose, PharmaCoDane ApS
• Symbicort Turbuhaler, inhalation powder, 4.5+160 microgram/dose, PharmaCoDane ApS

• Oxis Turbuhaler, inhalation powder, 9 microgram/dose, EuroPharmaDK ApS
• Oxis Turbuhaler, inhalation powder, 4.5 microgram/dose, EuroPharmaDK ApS
• Pulmicort turbohaler, inhalation powder, 400 microgram/dose, EuroPharmaDK ApS

• Pulmicort Turbuhaler, inhalation powder, 200 microgram/dose, SinGad Pharma ApS
• Symbicort Turbuhaler, inhalation powder, 4.5+160 microg/dose, SinGad Pharma ApS

• Flixotide, inhalation powder, 250 microgram disks, 2care4 ApS
• Oxis Turbuhaler, inhalation powder, 4.5 microgram/dose, 2care4 ApS
• Pulmicort Turbuhaler, inhalation powder, 100 mickrogram/dose, 2care4 ApS
• Pulmicort Turbuhaler, inhalation powder, 200 microgram/dose, 2care4 ApS
• Serevent, inhalation powder, 50 microgram disks, 2care4 ApS
• Oxis Turbuhaler, inhalation powder, 9 microgram/dose, 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:

• Assieme Mite Turbohaler, inhalation powder 4.5/80 microgram/dose, Paranova Danmark A/S
• Pulmicort Turbuhaler, inhalation powder, 400 microgram/dose, Paranova Danmark A/S
• Flixotide, pressurised inhalation, suspension, 125 microgram/dose, Paranova Danmark A/S
• Sinestic, inhalation powder 4.5/160 microgram/dose, Paranova Danmark A/S
• Pulmicort Turbohaler, inhalation powder, 400 microgram/dose, Paranova Danmark A/S
• Symbicort Forte Turbuhaler, inhalation powder , 9+320 microgram/dose, Paranova Danmark A/S
• Symbicort Turbohaler, inhalation powder 4.5/160 microgram/dose, Paranova Danmark A/S

• Flixotide Diskus, inhalation powder, predispensed, 500 microgram disks, Orifarm A/S
• Symbicort Mite Turbuhaler, inhalation powder, 4.5+80 microgram/dose, Orifarm A/S
• Symbicort Turbohaler, inhalation powder 4.5/160 microgram/dose, Orifarm A/S
• Symbicort Turbuhaler, inhalation powder 4.5/160 microgram/dose, Orifarm A/S
• Pulmicort Turbohaler, inhalation powder, 100 microgram/dose, Orifarm A/S

• Oxis Turbuhaler, inhalation powder, 4.5 microgram/dose, PharmaCoDane ApS
• Pulmicort Turbuhaler, inhalation powder, 400 microgram/dose, PharmaCoDane ApS 
• Seretide, inhalation powder, predispensed, 50 + 500 microgram disks, PharmaCoDane ApS
• Seretide, inhalation powder, predispensed, 50 + 100 microgram disks, PharmaCoDane ApS

• Pulmicort Turbuhaler, inhalation powder, 200 microgram/dose, EuroPharmaDK ApS

• Pulmicort Turbuhaler, inhalation powder, 400 microgram/dose, Abacus Medicines A/S

• StructoKabiven, emulsion for infusion, Fresenius Kabi AB
• StructoKabiven, Electrolyte-free, emulsion for infusion, Fresenius Kabi AB
• StructoKabiven Perifer, emulsion for infusion, Fresenius Kabi AB

• Cozaar Comp, film-coated tablets, 100 microgram/12.5 mg, Orifarm A/S

• Tranexamsyre ”Pfizer”, solution for injection, 100 mg/ml, Pfizer ApS
• S-ketamin ”Pfizer”, solution for injection, 5 mg/ml, Pfizer ApS

• Pro-Epanutin, solution for injection/concentrate for infusion, 75 mg/ml, Pfizer ApS

• Menopur, powder and solvent for injection fluid, solution, 75 IE, Orifarm A/S

• Imolope, tablets, 2 mg, Orifarm Generics A/S

• Alfuzosin Winthrop, prolonged-release tablets, 10 mg, Sanofi-Aventis Denmark A/S

• Natriumklorid ”B. Braun” 9 mg/ml, infusion fluid100 ml bottle, B. Braun Melsungen
• Metronidazol ”B. Braun” 5 mg/ml, infusion fluid 100 ml bottle, B. Braun Melsungen
• Glucos ”B. Braun” 50 mg/ml, infusion fluid100 ml bottle, B. Braun Melsungen

For further information, please contact Charlotte Emilie Renner Mortensen, tel. +45 44 88 or email cem@dkma.dk.

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 executive order on labelling (see the factbox to the right).

Based on this check, the marketing authorisation holders have updated the package leaflets (in the package/or at indlaegsseddel.dk) of the following medicinal product:

• Ciloxan, eye drops, solution, 3 mg/ml, S.A. Alcon-Couvreur N. V.

• Exocin, eye drops, solution, 3 mg/ml, Allergan Pharmaceuticals Ireland

• Fotil Forte, eye drops, solution, 40 + 5 mg/ml, Santen Oy
• Lecrolyn, eye drops, solution, 20 mg/ml, Santen Oy

• Klomipramin ”Mylan”, film-coated tablets, 10 mg, Mylan AB

• Laktulose Medic, oral solution, 667 mg/ml, Medic team A/S
• Medilax, oral solution, 667 mg/ml, Medic team A/S
• Medilax Chokomint, oral solution, 667 mg/ml, Medic team A/S
• Medilax Frugt, oral solution, 667 mg/ml, Medic team A/S
• Probenecid ”Medic”, tablets, 250 mg, Medic team A/S

• Minero, coated tablets, 75 microgram/20 microgram, Orifarm Generics A/S

• Skopolamin “Ophta”, eye drops, 0.2 %, Ophta A/S

• Tobrex Depot, eye drops, 3 mg/ml, Alcon Cusi S. A.

• Vexol, eye drops, suspension, 10 mg/ml, Alcon Laboratories UK Ltd

The compliance check also implied that the Danish Medicines Agency accepted the package leaflets of the following medicinal products:

• Desorelle, tablets, 150 microgram/30 microgram, Sandoz A/S

• Gestoden/Ethinylestradiol ”Schering”, coated tablets, 75/20 microgram, Bayer Schering Pharma AG

• Gestoden/Ethinylestradiol ”Berlipharm”, coated tablets, 75/30 microgram, Bayer A/S

• Nix, shampoo, 1%, ACO Hud Nordic AB

• Vanquin, tablets, 50 mg, Recip A/S

For further information, please contact Erik Wolthers, tel.+45 44 88 97 41 or email ew@dkma.dk.

Danish Medicines Agency, 2 February 2010