Decision

20 November 2015: promotion of Sirdupla

Published 30 December 2015

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This publication is available at https://www.gov.uk/government/publications/advertising-investigations-november-2015/20-november-2015-promotion-of-sirdupla

GSK complained about advertising of Sirdupla (salmeterol/fluticasone) on Mylan’s website, in a leave piece and in a healthcare professional journal.

The complainant alleged that claims for therapeutic equivalence to Seretide were misleading because there is no Sirdupla product available as an equivalent to the lowest dosage strength of Seretide. Because of this, the summary of product characteristics (SPC) indications and use of Sirdupla were more limited than those of Seretide but this, and the more restricted spacer choice were not apparent in the advertisements.

MHRA upheld the complaint. Mylan agreed to amend their advertising including their website, to withdraw the leave piece and to publish a corrective statement.

0.1 Corrective statement

Important information when prescribing Sirdupla (salmeterol xinafoate/fluticatose proprionate)

Dear prescriber

Mylan Sirdupla

The MHRA have asked Mylan to provide a corrective statement to emphasise certain product messages relating to Sirdupla. This follows action on a complaint about advertising on the Mylan website, an advertisement in Nursing Times and a leave piece.

It is the view of the MHRA that prescribers should be given prominent notice of the following product messages:

  • Sirdupla is available as a metered dose inhaler. Each metered dose contains 25 micrograms of salmeterol (as salmeterol xinafoate) and either 125 or 250 micrograms of fluticasone propionate

  • Sirdupla is therapeutically equivalent to its comparator product Seretide at equivalent doses but is not available in all the same strengths as Seretide

  • It is only indicated in adults 18 years of age and older for the regular treatment of asthma where use of a combination product (long-acting b2 agonist and inhaled corticosteroid) is appropriate

  • Sirdupla should not be used for patients with mild asthma

  • Only the Aerochamber Plus® spacer device should be used with Sirdupla.

Mylan has since updated its promotional materials to reflect these core messages.

Mylan are committed to ensuring the safe and appropriate use of our products.

If you have any questions in relation to Sirdupla or these materials, please contact Mylan’s Medical information team on 01707 853000 or email info@Mylan.co.uk.

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