COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Section 14 and 14A Notice
On November 12 2014, 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”), by application of Alphapharm Pty Ltd gave consent to the importation and supply of:
All products in Attachment 1 that do not conform with the requirements of clause 3(2)(l) of the Therapeutic Goods Order No. 69- General requirements for labels for medicines, in that the sponsor details on the labels are those of the previous sponsor (Aspen Pharmacare) instead of the current one Alphapharm Pty Ltd.
The consent is effective from November 12 2014 until September 10 2015.
The delegate of the Secretary has, under subsection 15(1) of the Act, made the consent subject to the following conditions:
- The labels to which this consent applies are those previously approved for the former sponsor Aspen Pharmacare, and arrangements are in place for the prompt referral of any queries or complaints concerning the products to the current sponsor, Alphapharm Pty Ltd.
Attachment 1
AUST R No. | Product | Submission Number |
152014 | adenosine (ASPEN ADENOSINE) 6 mg/2 mL solution for injection vial | PM-2014-03395-1-3 |
90881 | ampicillin (as sodium)(AMPICYN) 1 g powder for injection vial | PM-2014-3396-1-2 |
29354 | ampicillin (as sodium)(AUSTRAPEN) 1 g powder for injection vial | PM-2014-3396-1-2 |
29349 | ampicillin (as sodium)(AUSTRAPEN) 500 mg powder for injection vial | PM-2014-3396-1-2 |
146755 | azithromycin (AZITH)500 mg powder for injection vial | PM-2014-3397-1-2 |
148218 | ceftriaxone sodium (ASPEN CEFTRIAXONE)1 g powder for injection vial | PM-2014-3398-1-2 |
163200 | dexamethasone phosphate (DEXMETHSONE) 4 mg/1 mL (as dexamethasone sodium phosphate) solution for injection vial | PM-2014-3399-1-5 |
163199 | dexamethasone phosphate (DEXMETHSONE) 8 mg/2 mL (as dexamethasone sodium phosphate) solution for injection vial | PM-2014-3399-1-5 |
144524 | ketorolac trometamol (KETORAL INJECTION) 30 mg/1 mL injection syringe | PM-2014-3400-1-1 |
161750 | methylprednisolone (as sodium succinate)(METHYLPRED) 1.0 g powder for injection vial | PM-2014-3401-1-5 |
145102 | methylprednisolone (as sodium succinate)(METHYLPRED) 125 mg powder for injection vial | PM-2014-3401-1-5 |
145028 | methylprednisolone (as sodium succinate)(METHYLPRED) 40 mg powder for injection vial | PM-2014-3401-1-5 |
145103 | methylprednisolone (as sodium succinate) (METHYLPRED) 500 mg powder for injection vial | PM-2014-3401-1-5 |
144970 | piperacillin (as sodium) (TAZOPIP) 4 g/0.5 g, 4 g and tazobactam (as sodium) 0.5 g powder for injection vial | PM-2014-3402-1-2 |
165350 | vecuronium bromide (VECURE) 10 mg powder for injection vial | PM-2014-3403-1-1 |