COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Sections 14 and 14A Notice
On 27 October 2015, a delegate of the Secretary of the Department of Health, on the application of Merck Sharp & Dohme (Australia) Pty Ltd, consented under sections 14 and 14A of the Therapeutic Goods Act 1989 (the Act) to the importation and supply of
- Temozolomide (ASTROMIDE) capsule 5 mg sachet [AUST R 197463]
- Temozolomide (ASTROMIDE) capsule 20 mg sachet [AUST R 197464]
- Temozolomide (ASTROMIDE) capsule 100 mg sachet [AUST R 197465]
- Temozolomide (ASTROMIDE) capsule 140 mg sachet [AUST R 197466]
- Temozolomide (ASTROMIDE) capsule 180 mg sachet [AUST R 197467]
- Temozolomide (ASTROMIDE) capsule 250 mg sachet [AUST R 197468]
that do not conform with the requirements of the of paragraphs 3(2)(l) and 3(12)(b) of Therapeutic Goods Order No. 69, General requirements for labels for medicines, in that the labels do not include the current sponsor/distributor name and address.
The consent is effective from 27 October 2015 and is restricted to the batches of products listed below.
3BOTB02002 & 3BOTB03002 (5 mg)
3CAPB01001 & 4CAPB01001 (20 mg)
4DZAB01001 (100 mg)
4PUAB01001 & 4PUAB02001 (140 mg)
4MADB01001 (180 mg)
4LTAB01001 (250 mg)
The consent is subject to the following conditions:
- The labels to which this consent applies are those previously approved for the former distributor of the products, Willow Pharmaceuticals Pty Ltd and arrangements are in place with the former distributor for the prompt referral of any queries or complaints concerning the products to the current sponsor of the products, Merck Sharp & Dohme (Australia) Pty Ltd or to Amneal Pharmaceuticals Pty Ltd, the intended distributor of the products.