COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
On October 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:
The supply of the product:
- meloxicam (MOBIC) 7.5 mg tablet blister pack [Aust R 77694]
- meloxicam (MOBIC) 15 mg tablet blister pack [Aust R 77695]
by Boehringer Ingelheim Pty Ltd, North Ryde, NSW (“the Company”);
That does not conform with paragraphs 3(2)(h) and 3(2)(i) of Therapeutic Goods Order (TGO) 69, in that the prefixes for batch number and expiry date do not immediately precede the respective batch number and expiry date.
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:
- The consent applies to the batches as tabulated below
Description | Strength | Pack size | Quantity | Batch Number(s) |
Mobic Tablets | 7.5 mg | 30 | 11,321 | 344179, 344495 |
Mobic Tablets | 15 mg | 30 | 33,898 | 344182, 344345, 344497 |
2. The foil labels subject to this consent to supply are as provided with the previous submission PM-2013-00510-1-3 dated February 8, 2013 in which 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.
3. No other changes have been made to the product.
4. The Dear Pharmacist letter provided in the electronic mail from the Company dated October 22, 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 product.