THERAPEUTIC GOODS ACT 1989
SECTION 14 AND 14A NOTICE
On February 7 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 following products by Boehringer Ingelheim Pty Ltd, North Ryde NSW (“the Company”):
- telmisartan (MICARDIS) 40 mg tablet blister pack [Aust R 68052]
- telmisartan (MICARDIS) 80 mg tablet blister pack [Aust R 68053]
- telmisartan/hydrochlorothiazide (MICARDIS PLUS) 80 mg/25 mg tablet blister pack [Aust R 143761]
- telmisartan/hydrochlorothiazide (MICARDIS PLUS) 40 mg/12.5 mg tablet blister pack [Aust R 82416]
- telmisartan/hydrochlorothiazide (MICARDIS PLUS) 80 mg/12.5 mg tablet blister pack [Aust R 82418]
- telmisartan/amlopidine (as besylate) (TWYNSTA) 80 mg/5 mg tablet blister pack [Aust R 166263]
- telmisartan/amlopidine (as besylate) (TWYNSTA) 40 mg/10 mg tablet blister pack [Aust R 166264]
- telmisartan/amlopidine (as besylate) (TWYNSTA) 40 mg/5 mg tablet blister pack [Aust R 166265]
- telmisartan/amlopidine (as besylate) (TWYNSTA) 80 mg/10 mg tablet blister pack [Aust R 166266]
That do not conform with the requirements of paragraph 3(2)(h) and 3(2)(i) of Therapeutic Goods Order 69, in that the batch number and expiry date prefixes printed on the foil labels 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 applies to the following batches:
Stock currently in Australia
Aust R Number | Pack Size | Quantity | Batch Numbers |
68052 | 7 | 9,210 | 204646 |
28 | 147,400 | 203904, 204646, 205771 | |
68053 | 7 | 34,459 | 205529 |
28 | 101,203 | 204445A, 204450, 204617, 204618A, 205529, 205530 | |
82416 | 28 | 37,364 | 205335 |
143761 | 7 | 26,940 | 103820, 205908 |
28 | 175,591 | 204856, 205083, 205084, 205184, 205185 | |
82418 | 7 | 37,845 | 006213, 007103 |
28 | 28,422 | 204894 | |
166265 | 7 | 4,809 | 201284 |
28 | 6,431 | 202282, 202283 | |
166264 | 28 | 2,166 | 202059, 204314 |
166263 | 7 | 4,807 | 202416 |
28 | 10,182 | 200307, 200307A, 200726, 203409 | |
166266 | 28 | 9,546 | 200833, 204523 |
Stock currently in transit to Australia
Aust R Number | Pack Size | Quantity | Batch Numbers |
68052 | 7 | 30,627 | 206547, 206547A |
28 | 107,758 | 205772, 205773, 206547 | |
68053 | 28 | 405,438 | 206697, 206698, 206771, 206950, 206772, 206952, 206951, 206949 |
82416 | 28 | 80,350 | 205922, 206474, 207166 |
82418 | 28 | 178,748 | 206369, 206371, 206370, 207081, 207215 |
143761 | 7 | 9,216 | 207076 |
28 | 69,074 | 205998, 205998A, 207075 | |
166265 | 7 | 19,435 | 202282, 204649, 203777 |
28 | 32,503 | 202282A, 202285, 203777 | |
166264 | 28 | 7,595 | 201451A, 202288, 204314A |
166263 | 7 | 24,208 | 202643, 205534, 203270, 204154 |
28 | 76,160 | 202645, 204154, 204155, 203999, 204156, 205523 | |
166266 | 7 | 9,619 | 204643 |
28 | 42,125 | 204318, 204802, 204757, 204802A |
2. The foil labels subject to this consent are identical to those provided by the Company in correspondence dated December 21 2012; the batch number and expiry date prefixes printed on the foil labels 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 on the previous page.
4. The Dear Pharmacist letter provided in correspondence from the Company dated 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 the affected batches of the products.