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Recall of Nobligan® oral drops in Denmark

03 July 2008

In cooperation with the Danish Medicines Agency, Grünenthal Aps has decided to recall all packs of Nobligan® oral drops, 100mg/ml (pack sizes of 10 ml and 96 ml) in Denmark.

The recall only affects the Danish market and is caused by a misprint in the Danish package leaflet, which erroneously reads "Nobligan, 50 mg orale dråber, opløsning", but should have read "Nobligan, 100mg/ml orale dråber, opløsning".

The text on the packaging and bottle is correct.

Nobligan® oral drops contain the active substance tramadol and is used to relieve mild to moderate pain.

Consumers should always follow the dose prescribed by the doctor. If you are unsure about what the correct dose is, we advise you to contact your doctor immediately.

There are alternative tramadol-containing products on the Danish market (tablets, capsules and solutions for injection).

However, Nobligan® is the only tramadol-containing product available as oral drops, and the Danish Medicines Agency is therefore aware that certain patients in Denmark need the product. Patients in need of Nobligan® oral drops are advised to contact their general practitioner, who, on behalf of the patient, can apply for a compassionate use permit, so that the patient may still receive Nobligan® oral drops.

For further information about the recall, please contact Rasmus Borup , tel.+45 4488 9683.

For further information about compassionate use permits for Nobligan®, please contact Jeanne Majland, tel.+45 4488 9649.

Danish Medicines Agency, 3 July 2008