THERAPEUTIC GOODS ACT 1989
SECTION 14 AND 14A NOTICE
On April 15 2013, the delegate of the Secretary of the Department of Health and Ageing 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 products:
by Boehringer Ingelheim Pty Ltd, (“the Company”);
That does not conform with paragraphs 3(2)(h) & (i) of Therapeutic Goods Order (TGO) 69, in that the batch numbers and expiry date prefixes printed on the foils 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:
- This consent to supply applies to the batches listed in the tables below:
AUST R | Description | Pack size | Batch | Quantity |
68052 | Micardis Tablet 40 mg | 28 | 207509 | 52,817 |
|
|
| 207515 | 5,168 |
|
|
| 208047 | 21,788 |
|
|
| 301589 | 25,844 |
|
|
| 206945 | 98,304 |
|
|
| 206946 | 61,825 |
|
|
| 206947 | 9,216 |
AUST R | Description | Pack size | Batch | Quantity |
82416 | Micardis Plus Tablets 40/12.5 mg | 28 | 207869 | 37,818 |
|
|
| 301663 | 39,933 |
|
|
| 207166A | 2,046 |
82418 | Micardis Plus Tablets 80/12.5 mg | 28 | 207889 | 9,079 |
|
|
| 208026 | 43,460 |
|
|
| 301234 | 37,172 |
|
|
| 301716 | 33,119 |
|
|
| 301715 | 56,336 |
|
|
| 206769 | 7,902 |
|
|
| 207594 | 72,303 |
|
| 7 | 301686 | 15,184 |
143761 | Micardis Plus tablets 80/25 mg | 28 | 207076 | 34,311 |
|
|
| 207043 | 34,277 |
AUST R | Description | Pack size | Batch | Quantity |
166265 | Twynsta Tablets 40 mg + 5 mg | 28 | 205967 | 15,019 |
|
|
| 205541-R | 10,880 |
|
|
| 205538-R | 4,092 |
|
| 7 | 207673 | 24,197 |
|
|
| 205967 | 11,648 |
166264 | Twynsta Tablets 40 mg + 10 mg | 28 | 207592 | 7,417 |
|
|
| 205969 | 1,900 |
|
|
| 206098-R | 3,807 |
166263 | Twynsta Tablets 80 mg + 10 mg | 28 | 206299 | 28,146 |
|
|
| 206301 | 2,108 |
|
|
| 206646 | 24,688 |
|
| 7 | 206397 | 18,252 |
16266 | Twynsta Tablets 80 mg + 10 mg | 28 | 206031 | 6,351 |
|
|
| 206033 | 13,380 |
|
|
| 206650 | 13,310 |
|
| 7 | 206032 | 4,004 |
|
|
| 206033 | 5,413 |
|
|
| 206650 | 9,568 |
AUST R | Description | Pack size | Batch | Quantity |
81525 | Spiriva Capsules 18 mcg | 30 | 262368B | 148,680 |
2. The foil labels subject to this consent to supply are identical to those provided with the submission from the Company dated March 27 2013; 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 products listed in the tables above.
4. The Dear Pharmacist letter provided with your email from the Company of February 6 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.