COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
On December 23, 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:
- telmisartan/amlodipine (as besylate)(TWYNSTA) 40/10 mg tablet blister pack
[Aust R 166264]
by Boehringer Ingelheim Pty Ltd North Ryde, NSW (“the Company”);
That do not conform with paragraphs 3(2)(h) & (i) of Therapeutic Goods Order (TGO) 69, in that the batch number and expiry date prefixes printed on the foils do not immediately precede the respective batch number and expiry dates.
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 batch 207592 of the product.
- The foil labels subject to this consent to supply are as provided with the submissions; the batch number and expiry date prefixes printed on the foils do not immediately precede the respective batch number and expiry date, but are nonetheless present.
- No other changes have been made to the products.
- The amended Dear Pharmacist letter provided with the Company letter of November 8, 2013, which sets out the circumstances surrounding this consent to supply and reminds patients to keep the blister strips with the outer carton, will be supplied with affected batches of products.