COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Section 14 and 14A Notice
On 15 December 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”), on the application of Bayer Australia Ltd, gave consent to the importation and supply of:
- the products shown in the attachment that do not conform with the requirements of the paragraph 3(2)(l) of the Therapeutic Goods Order No. 69 – General requirements for labels for medicines (TGO 69), in that their labels display the name and address of the previous sponsor (Merck Sharp & Dohme (Australia) Pty Ltd) instead of displaying the name and address of the current sponsor or supplier.
The consent is effective from 15 December 2014 until 16 December 2017.
The delegate of the Secretary, under subsection 15(1) of the Act, made the consent subject to the following condition:
- The labels to which this consent applies are those previously approved for the former sponsor Merck Sharp & Dohme (Australia) Pty Ltd and arrangements are in place to redirect any queries or complaints concerning the products to Bayer Australia Ltd.
Attachment
List of products to which the consent applies
AUST R | ARTG Label Name | |
91116 | AERIUS desloratadine 5mg tablet | |
97260 | AERIUS FOR CHILDREN SYRUP desloratadine 2.5mg/5mL oral liquid | |
169329 | CHILDREN'S CLARATYNE loratadine 5mg chewable tablet | |
208800 | CHILDREN'S CLARATYNE loratadine 1mg/mL grape flavour oral liquid | |
44453 | CHILDREN'S CLARATYNE loratadine 1mg/mL peach flavour oral liquid | |
34698 | CLARATYNE loratadine 1Omg tablet | |
200430 | CLARATYNE loratadine 10mg tablet (general sale) | |
175273 | CLARATYNE LIQUID-CAPSULES loratadine 10mg capsule | |
207173 | CLARATYNE LIQUID-CAPSULES loratadine 10mg capsule (general sale) | |
217147 | CLARATYNE REDITABS loratadine 10mg orally disintegrating tablet | |
53516 | CLARATYNE-D WITH DECONGESTANT tablet | |
18815 | DEMAZIN 6 HOUR RELIEF tablet | |
218997 | DEMAZIN 12 HOUR RELIEF NASAL SPRAY oxymetazoline hydrochloride | |
136194 | DEMAZIN CHESTY COUGH RELIEF SYRUP oral liquid | |
97036 | DEMAZIN COLD & FLU tablet |
|
97031 | DEMAZIN COUGH, COLD & FLU tablet | |
18813 | DEMAZIN COLD RELIEF BLUE SYRUP bottle | |
57378 | DEMAZIN COLD RELIEF COLOUR FREE SYRUP bottle | |
151700 | DEMAZIN COUGH & COLD RELIEF SYRUP bottle | |
133205 | DEMAZIN DAY & NIGHT COLD & FLU tablet | |
152024 | DEMAZIN PE COLD & FLU RELIEF tablet | |
152023 | DEMAZIN PE COLD & FLU DAY & NIGHT tablet | |
161596 | DRIXINE DECONGESTANT NASAL SPRAY oxymetazoline hydrochloride | |
181889 | DRIXINE NO DRIP FORMULA MENTHOL AROMA PUMP MIST NASAL SPRAY oxymetazoline hydrochloride 500mcg/mL | |
179875 | DRIXINE NO DRIP FORMULA MOISTURISING PUMP MIST NASAL SPRAY oxymetazoline hydrochloride 500mcg/mL | |
166852 | DRIXINE NO DRIP FORMULA ORIGINAL PUMP MIST NASAL SPRAY oxymetazoline hydrochloride 500mcg/mL | |
215798 | NASONEX ALLERGY mometasone furoate 50 mcg/actuation nasal spray |
|
18197 | POLARAMINE SYRUP dexchlorphenirami ne maleate 0.4mg/mL | |
154653 | POLARAMINE COLOUR-FREE dexchlorpheni ramine maleate 2mg tablet | |
18204 | SOLARCAINE SPRAY benzocaine 10mg/g pressurised spray | |
18212 | TINADERM tolnaftate 0.7mg/g pressurisq spray | |
18221 | TINADERM POWDER tolnaftate 0.9mg/g pressurised spray | |
214265 | VIVALAX bottle pack | |
214264 | VIVALAX sachet pack | |