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Independent report vindicates Salamol decision

January 2006

Independent report vindicates Salamol decision

A report by Government medicines assessment agency Medsafe has confirmed that the Salamol brand of salbutamol asthma inhalers is safe and effective.

Medsafe commissioned tests after a number of complaints were received about the Salamol inhalers, which were introduced from February 2005.

Testing carried out by ESR in New Zealand and TGAL in Australia found that Salamol inhalers delivered the correct dosage in line with the product specifications, and that regular cleaning, as specified in the instructions for all CFC-free inhalers, could avert clogging.

The report concludes: "Following investigation and testing Medsafe was satisfied that Salamol met the international requirements and guidelines for quality, safety and efficacy required for a medicine registered and distributed in New Zealand."[1]

PHARMAC Medical Director Dr Peter Moodie says the report reinforces the initial view that Salamol inhalers are just as safe and effective for New Zealanders with asthma as Ventolin inhalers.

"The findings of this report are reassuring," Dr Moodie says. "We did have concerns raised with us earlier this year and felt it was wise to work with Medsafe to have those concerns addressed.

"The findings show that both patients and prescribers can have confidence in the effectiveness of Salamol, and that there are no clinical issues for people changing from Ventolin to Salamol."

Pending the outcome of testing, PHARMAC agreed to continue to subsidise Ventolin inhalers at the same level as Salamol. Ventolin inhalers incur a manufacturer's surcharge, and will continue to be funded until at least 2007.

Salamol has steadily gained acceptance in New Zealand and now accounts for up to 30% of all salbutamol inhalers dispensed.

  • Full report is available at www.medsafe.govt.nz

  • ENDS

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