THERAPEUTIC GOODS ACT 1989
SECTION 14 AND 14A NOTICE
On April 19 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 listed in the following table by Aspen Pharmacare Australia Pty Ltd ST LEONARDS, NSW (“the Company”);
That does not conform with paragraphs 3(2)(l) of Therapeutic Goods Order (TGO) 69, in that the sponsor’s name and address details are those of the previous sponsor and not the name and address details of the current sponsor.
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 products until December 2013.
2. The labels for use are those submitted with the application, viz labels bearing the name and address of the previous sponsor, GlaxoSmithKline Australia Pty Ltd.
3. No other changes have been made to the products listed in the following table.
4. Details of the process in place to ensure continuous customer contact with the Company are as described in the e-mail dated April 18 2013.
AUST R | Product details |
11133 | amoxycillin (as trihydrate) (AMOXIL SUGAR FREE SYRUP) 125 mg/ 5 mL powder for oral liquid bottle |
11134 | amoxycillin (as trihydrate) (AMOXIL SUGAR FREE SYRUP) 250 mg/ 5 mL powder for oral liquid bottle |
11137 | amoxycillin (as sodium) (AMOXIL) 1 g powder for injection vial |
11138 | amoxycillin (as trihydrate) (AMOXIL) 250 mg capsule blister pack |
57574 | amoxycillin (as trihydrate) (AMOXIL) 500 mg capsule blister pack |
107408 | amoxycillin (as trihydrate) (AMOXIL PAEDIATRIC DROPS) 100 mg/mL powder for oral liquid bottle |
57927 | paroxetine (as hydrochloride) (AROPAX) 20 mg tablet blister pack |
54900 | amoxycillin and clavulanic acid (AUGMENTIN DUO FORTE) 875 mg and 125 mg tablet blister pack |
67352 | amoxycillin and clavulanic acid (AUGMENTIN DUO 400) 80 mg/mL and 11.4mg/mL powder for oral liquid bottle |
142692 | amoxycillin (as trihydrate) and clavulanic acid (as potassium clavulanate) (AUGMENTIN DUO) 500 mg and 125 mg tablet blister pack |
144172 | amoxycillin (as trihydrate) and clavulanic acid (as potassium clavulanate) (AUGMENTIN) 28.7 mg/mL and 7.4 mg/mL powder for oral liquid bottle |
97456 | pyrimethamine (DARAPRIM) 25 mg tablet blister pack |
97505 | albendazole (ESKAZOLE) 400 mg chewable tablet bottle |
12508 | ceftazidime (as pentahydrate) (FORTUM) 1g powder for injection vial |
12509 | ceftazidime (as pentahydrate) (FORTUM) 2g powder for injection vial |
38346 | sumatriptan (as succinate) (IMIGRAN) 100 mg tablet blister pack |
44465 | sumatriptan (as succinate) (IMIGRAN Mk II) 6 mg/0.5 mL mg injection syringe (N) |
44466 | sumatriptan (as succinate) (IMIGRAN Mk II) 6 mg/0.5 mL mg injection syringe with autoinjector (N) |
52261 | sumatriptan (as succinate) (IMIGRAN) 50 mg tablet blister pack |
61565 | sumatriptan (IMIGRAN S) 10 mg/0.1 mL nasal spray vial |
61566 | sumatriptan (IMIGRAN ) 20 mg/0.1 mL nasal spray vial |
106714 | sumatriptan (as succinate) (IMIGRAN FDT) 50 mg tablet blister pack |
106715 | sumatriptan (as succinate) (IMIGRAN FDT) 100 mg tablet blister pack |
51548 | lamotrigine (LAMICTAL) 25 mg dispersible/ chewable tablet blister pack |
51549 | lamotrigine (LAMICTAL) 100 mg dispersible/ chewable tablet blister pack |
51718 | lamotrigine (LAMICTAL) 5 mg dispersible/ chewable tablet bottle |
57190 | lamotrigine (LAMICTAL) 50 mg dispersible/ chewable tablet blister pack |
57262 | lamotrigine (LAMICTAL) 200 mg dispersible/ chewable tablet blister pack |
77098 | lamotrigine (LAMICTAL) 2 mg dispersible/ chewable tablet bottle |
48176 | mesalazine (MESASAL) 250 mg tablet blister pack |
42947 | mivacurium (as chloride) (MIVACRON) 20 mg/ 10 mL injection ampoule |
62900 | naratriptan (as hydrochloride) (NARAMIG) 2.5 mg tablet blister pack |
55913 | cisatracurium (as besylate) (NIMBEX) 5 mg/ 2.5 mL injection ampoule |
55931 | cisatracurium (as besylate) (NIMBEX) 10 mg/ 5 mL injection ampoule |
55934 | cisatracurium (as besylate) (NIMBEX) 150 mg/ 30 mL injection vial |
53377 | lithium carbonate (QUILONUM SR) 450 mg tablet blister pack |
96866 | ropinirole (as hydrochloride) (REPREVE) 0.25 mg tablet blister pack |
96868 | ropinirole (as hydrochloride) (REPREVE) 0.5 mg tablet blister pack |
96870 | ropinirole (as hydrochloride) (REPREVE) 2 mg tablet blister pack |
11165 | ticarcillin sodium and potassium clavulanate (TIMENTIN) 3.3 g and 119.2 g powder for injection single dose vial |
11008 | atracurium besylate (TRACRIUM) 25 mg/ 2.5 mL injection ampoule |
39289 | atracurium besylate (TRACRIUM) 50 mg/ 5 mL injection ampoule |
73917 | valaciclovir (as hydrochloride) (VALTREX) 500 mg tablet blister pack |
73920 | valaciclovir (as hydrochloride) (VALTREX) 1000 mg tablet blister pack |
66688 | atovaquone (WELLVONE) 750 mg/ 5 mL oral liquid suspension bottle |
12536 | ranitidine (as hydrochloride) (ZANTAC) 50 mg/ 2 mL injection ampoule |
35188 | ranitidine (as hydrochloride) (ZANTAC) 150 mg/ 10 mL oral liquid bottle |
45993 | ranitidine (as hydrochloride) (ZANTAC) 150 mg effervescent tablet tube |
53323 | ranitidine (as hydrochloride) (ZANTAC) 300 mg tablet blister pack |
53324 | ranitidine (as hydrochloride) (ZANTAC) 150 mg tablet blister pack |
66828 | lamivudine (ZEFFIX) 100 mg tablet blister pack |
66829 | lamivudine (ZEFFIX) 5 mg/mL oral solution bottle |
50815 | albendazole (ZENTEL) 200 mg chewable tablet bottle |
47621 | cefuroxime (as axetil) (ZINNAT) 250 mg tablet blister pack |
178687 | cefuroxime (as axetil) (ZINNAT) 125 mg/5 mL granules for oral suspension bottle |
9978 | ondansetron (as hydrocjloride dihydrate) (ZOFRAN) 4 mg/2 mL injection ampoule |
9979 | ondansetron (as hydrocjloride dihydrate) (ZOFRAN) 4 mg tablet blister pack |
9981 | ondansetron (as hydrocjloride dihydrate) (ZOFRAN) 8 mg tablet blister pack |
47264 | ondansetron (as hydrocjloride dihydrate)(ZOFRAN) 8 mg/4 mL injection ampoule |
58872 | ondansetron (as hydrocjloride) (ZOFRAN ORAL LIQUID) 4 mg/5 mL oral liquid bottle |
60801 | ondansetron (ZOFRAN) 16mg suppository blister pack |
63054 | ondansetron (ZOFRAN ZYDIS ONDANSETRON) 4 mg wafer blister pack |
63055 | ondansetron (ZOFRAN ZYDIS ONDANSETRON) 8 mg wafer blister pack |
75233 | bupropion hydrochloride (ZYBAN SR) 150 mg tablet blister pack |