COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Section 14 and 14A Notice
On 11 February 2015, 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”), on the application of BGP Products Pty Ltd, gave consent to the importation and supply of:
- please see complete list of products below, that do not conform with the requirements of paragraph 3(2)(l) of the Therapeutic Goods Order No. 69 – General requirements for labels for medicines, in that the labels bear the previous sponsor details.
The consent is effective from the date of this letter until 11 February 2017.
The delegate of the Secretary, under subsection 15(1) of the Act, made the consent subject to the following conditions:
- The labels to which this consent applies are those currently approved.
- Arrangements are in place that any correspondence concerning the products will be promptly referred from the former sponsor (Abbott Australasia Pty Ltd) to the current sponsor (BGP Products Pty Ltd).
- No other changes have been made to the products.
List of Products
No | AUST R | Product |
1 | 54033 | verapamil hydrochloride (CORDILOX 180 SR) 180 mg tablet blister pack |
2 | 10681 | verapamil hydrochloride (CORDILOX SR) 240 mg tablet blister pack |
3 | 54032 | verapamil hydrochloride (ISOPTIN 180 SR)180 mg tablet blister pack |
4 | 12801 | verapamil hydrochloride (ISOPTIN SR) 240 mg tablet blister pack |
5 | 12796 | verapamil hydrochloride (ISOPTIN) 5 mg/2 mL injection ampoule |
6 | 65502 | verapamil hydrochloride (ISOPTIN) 40 mg tablet blister pack |
7 | 65503 | verapamil hydrochloride (ISOPTIN) 80 mg tablet blister pack |
8 | 65504 | verapamil hydrochloride (ISOPTIN) 160 mg tablet blister pack |
9 | 65505 | verapamil hydrochloride (ISOPTIN) 120 mg tablet blister pack |
10 | 13295 | lactulose (DUPHALAC) 667 mg/mL oral liquid bottle |
11 | 45455 | trandola pril (GOPTEN) l mg capsules blister pack |
12 | 45456 | trandola pril (GOPTEN) 0.5 mg capsule blister pack |
13 | 45457 | trandolapril (GOPTEN) 2 mg capsules blister pack |
14 | 96969 | trandolapril (GOPTEN) 4 mg capsule blister pack |
15 | 50682 | clarithromycin (KLACID) 500 mg tablet bottle |
16 | 52473 | clarithromycin (KLACID) 500 mg tablet blister pack |
17 | 56729 | clarithromycin (KLACID) 250 mg/5 mL powder for oral liquid bottle |
18 | 57632 | fluvoxamine maleate (LUVOX) 50 mg tablet blister pack |
19 | 57633 | fluvoxamine maleate (LUVOX) 100 mg tablet blister pack |
20 | 59522 | dried ferrous sulfate (FERRO-GRADUMET) 325 mg tablet bottle |
21 | 61687 | betahistine dihydrochloride (SERC) 16 mg tablet blister pack |
22 | 64400 | eprosartan (as mesylate) (TEVETEN) 400 mg tablet blister pack |
23 | 73779 | eprosartan (as mesylate) (TEVETEN) 600 mg tablet blister pack |
24 | 66841 | FERROGRAD C tablet bottle |
25 | 75888 | oestradiol (as hemihydrate) ZUMENON 2 mg tablet blister pack |
26 | 77937 | FGF tablet bottle (reformulation 2) |
27 | 219882 | oestradiol (FEMOSTON) 1/10 l mg and oestradiol l mg with dydrogesterone 10 mg tablet blister pack composite pack |
28 | 75889 | oestradiol (FEMOSTON) 2/10 2 mg and oestradiol 2 mg with dydrogesterone 10 mg tablet blister pack composite pack |
29 | 78654 | FEMOSTON-CONTI tablet blister pack |
30 | 79335 | mebeverine hydrochloride (COLOFAC) 135 mg tablet blister pack |
31 | 79564 | clarithromycin (KLACID) 250 mg tablet blister pack |
32 | 79576 | clarithromycin (KLACID) 250 mg tablet bottle |
33 | 80659 | ibuprofen (BRUFEN) 400 mg tablet blister pack |
34 | 104663 | trandolapril (TARKA 2/180) 2 mg & verapamil hydrochloride 180 mg tablet blister pack |
35 | 104664 | trandolapril (TARKA 4/240) 4 mg & verapamil hydrochloride 240 mg tablet blister pack |
36 | 114119 | moxonidine (PHYSIOTENS) 200 microgram tablet blister pack |
37 | 114121 | moxonidine (PHYSIOTENS) 400 microgram tablet blister pack |
38 | 114122 | moxonidine (NORMATENS) 200 microgram tablet blister pack |
39 | 114124 | moxonidine (NORMATENS) 400 microgram tablet blister pack |
40 | 118634 | fenofibrate (LIPIDIL) 145 mg tablet blister |
No | AUST R | Product |
41 | 118642 | fenofibrate (LIPIDIL) 48 mg tablet blister |
42 | 120955 | lercanidipine hydrochloride (ZAN-EXTRA 10/10) 10 mg and enalapril maleate 10 mg film coated tablets blister pack |
43 | 120961 | lercanidipine hydrochloride (ZAN-EXTRA 10/20) 10 mg and enalapril maleate 20 mg film coated tablets blister pack |
44 | 121315 | terazosin 1 mg (as hydrochloride dihydrate) (HYTRIN) and terazosin 2 mg (as hydrochloride dihydrate) (HYTRIN) tablet blister pack composite pack |
45 | 121316 | terazosin (as hydrochloride dehydrate) (HYTRIN) 1 mg tablet blister pack |
46 | 121317 | terazosin (as hydrochloride dehydrate) (HYTRIN) 2 mg tablet blister pack |
47 | 121318 | terazosin (as hydrochloride dehydrate) (HYTRIN) 5 mg tablet blister pack |
48 | 121319 | terazosin (as hydrochloride dehydrate) (HYTRIN) 10 mg tablet blister pack |
49 | 143172 | eprosartan (TEVETEN PLUS 600/12.5) 600 mg hydrochlorothiazide 12.5 mg tablet blister |
50 | 77506 | lercanidipine hydrochloride (ZANIDIP) 10 mg film coated tablet blister pack |
51 | 93733 | lercanidipine hydrochloride (ZANIDIP) 20 mg film coated tablet blister pack |
52 | 152707 | lercanidipine (LERCAN) hydrochloride l0 mg tablet blister pack |
53 | 152708 | lercanidipine (LERCAN) hydrochloride 20 mg tablet blister pack |
54 | 152709 | lercanidipine hydrochloride (LERCADIP) 10 mg tablet blister pack |
55 | 152710 | lercanidipine hydrochloride (LERCADIP) 20 mg tablet blister pack |
56 | 165899 | lercanidipine hydrochloride (ZANICAN) 10 mg film coated tablet blister pack |
57 | 165900 | lercanidipine hydrochloride (ZANICAN) 20 mg film coated tablet blister pack |
58 | 165913 | lercanidipine hydrochloride (LERCANIDIPINE SANDOZ) 10 mg film coated tablet blister pack |
59 | 165914 | lercanidipine hydrochloride (LERCANIDIPINE SANDOZ) 20 mg film coated tablet blister pack |
60 | 155717 | omega-3-acid ethyl esters 90 (OMACOR) 1000 mg soft capsule bottle |
61 | 158451 | pancreatic extract (CREON 40,000) 400 mg capsules of enteric-coated minimicropsheres bottle |
62 | 158452 | pancreatic extract (CREON 25,000) 300mg capsule bottle |
63 | 158453 | CREON 10,000 capsule bottle (reformulation) |
64 | 166118 | pancreatic extract (CREON MICRO) 20 g enteric coated granules bottle |
65 | 215555 | inactivated influenza ( INFLUVAC) 0.5 mL vaccine long syringe with 16 mm needle |
66 | 81465 | inactivated influenza (INFLUVAC) 0.5 mL vaccine syringe |