COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
On December 18, 2013 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 ipratropium bromide (ATROVENT) 250 micrograms /mL inhalation bottle [Aust R 39953].
by Boehringer Ingelheim NORTH RYDE, NSW (“the Company”);
That do not conform with paragraphs 3(9) of Therapeutic Goods Order (TGO) 69, in that the antimicrobial preservative is not stated on the product labels.
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 applies to batch numbers 132431D and 231704E.
- The relevant information is stated in the Consumer Medicine Information (CMI) and Product Information (PI) documents.
- No other changes have been made to the product: ipratropium bromide (ATROVENT) 250 micrograms /mL inhalation bottle [Aust R 39953].