Sunday, February 22, 2009

Nycomed - pantoprazole: OTC in EU?

Nycomed’s proton-pump inhibitor pantoprazole is set to become the second non-prescription medicine authorised through Europe’s centralised procedure, following orlistat.

The European Medicines Agency (EMEA) said on 19 February that it had adopted positive opinions for five non-prescription medicines from Nycomed containing 20mg pantoprazole. The OTC medicines are indicated for short-term treatment in adults of reflux symptoms, such as heartburn and regurgitation.

Once the European Commission has adopted the opinions, the five products will be authorised as non-prescription medicines in all 27 member states of the European Union.

At present, pantoprazole is only available without a prescription in Australia, Mexico and Sweden. It is still protected by patents in major European markets.

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