COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Sections 14 and 14A Notice
On 22 October 2015, a delegate of the Secretary of the Department of Health, on the application of Novartis Pharmaceuticals Australia Pty Ltd, consented under sections 14 and 14A of the Therapeutic Goods Act 1989 (the Act) to the importation and supply of
Product | AUST R |
ofatumumab (rmc) (ARZERRA) 100 mg/5 mL injection concentrate vial | 196945 |
ofatumumab (rmc) (ARZERRA) 1000 mg/50 mL injection concentrate vial | 218896 |
topotecan (as hydrochloride) (HYCAMTIN) 0.25 mg hard capsules | 152704 |
topotecan (as hydrochloride) (HYCAMTIN) 1 mg hard capsules | 152706 |
topotecan (as hydrochloride) (HYCAMTIN) 4 mg powder for injection vial | 58598 |
topotecan (as hydrochloride) (HYCAMTIN) 1 mg powder for injection vial | 73355 |
trametinib (MEKINIST) 0.5 mg (as dimethyl sulfoxide) tablet HDPE bottle and CRC | 205917 |
trametinib (MEKINIST) 1 mg (as dimethyl sulfoxide) tablet HDPE bottle and CRC | 205918 |
trametinib (MEKINIST) 2 mg (as dimethyl sulfoxide) tablet HDPE bottle and CRC | 205919 |
eltrombopag (REVOLADE) 25 mg film-coated tablet blister pack | 158419 |
eltrombopag (REVOLADE) 50 mg film-coated tablet blister pack | 158356 |
eltrombopag (REVOLADE) 75 mg film-coated tablet blister pack | 200121 |
dabrafenib (as mesilate) (TAFINLAR) 50 mg capsule bottle | 200922 |
dabrafenib (as mesilate) (TAFINLAR) 75 mg capsule bottle | 200936 |
lapatinib (TYKERB) 250 mg (as ditosylate monohydrate) tablet bottle | 185997 |
lapatinib (TYKERB) 250 mg (as ditosylate monohydrate) tablet blister pack | 132305 |
pazopanib (VOTRIENT) 400 mg tablet bottle | 161281 |
pazopanib (VOTRIENT) 200 mg tablet bottle | 161282 |
that do not conform with the requirements of paragraph 3(2)(l) of Therapeutic Goods Order No. 69- General requirements for labels for medicines, in that the product labels do not include the contact and other details of the current sponsor.
The consent is effective from the 22 October 2015 until the 31 December 2016.
The consent is subject to the following conditions:
- The labels to which this consent applies are those previously approved for the former sponsor, GlaxoSmithKline Australia Pty Ltd and arrangements are in place with the former sponsor for the prompt referral of any queries or complaints concerning the products to Novartis Pharmaceuticals Australia Pty Ltd.