COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Section 14 and 14A Notice
On February 5, 2014 the delegate of the Secretary of the Department of Health for the purposes of subsection 14 and 14A of the Therapeutic Goods Act 1989 (“the Act”) gave his consent to:
(a) the supply of the product :
- budesonide/eformoterol fumarate dihydrate (SYMBICORT RAPIHALER) 50/3 pressurised metered dose inhaler [AUST R 158898]
by AstraZeneca Pty Ltd, NORTH RYDE, NSW;
That does not conform with the Therapeutic Goods Order (TGO) 69, ‘General requirements for labels for medicines’ in that the canister label states the metered dose of budesonide (50 µg per inhalation) instead of the delivered dose (40 µg/inhalation).
Pursuant to subsection 15(1) of the Act, the consent given by the delegate of the Secretary as described above is subject to the following conditions:
- This consent to supply applies to stock of batch number 400003C00 which has not yet been released for supply (8,488 units).
- The labels to which this consent applies comply in all other respects with TGO 69.
- The Dear Pharmacist letter supplied with AstraZeneca’s electronic mail of February 4, 2014, which sets out the circumstances surrounding this s14 consent, will be distributed with affected product.