COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Sections 14 and 14A Notice
On 24 September 2015, a delegate of the Secretary of the Department of Health, on the application of Bayer Australia Pty Ltd, consented under sections 14 and 14A of the Therapeutic Goods Act 1989 (the Act) to the importation and supply of:
ARTG Registration Number | ARTG Name |
91116 | AERIUS desloratadine 5mg tablet |
97260 | AERIUS FOR CHILDREN SYRUP desloratadine 2.5mg/5ml oral liquid |
53516 | CLARATYNE-D WITH DECONGESTANT tablet |
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 |
218997 | DEMAZIN 12 HOUR RELIEF NASAL SPRAY oxymetazoline hydrochloride |
161596 | DRIXINE DECONGESTANT NASAL SPRAY oxymetazoline hydrochloride |
181889 | DRIXINE NO DRIP FORMULA MENTHOL AROMA PUMP MIST NASALSPRAY 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 |
that will not conform to the requirements of paragraph 3(2)(g) of the Therapeutic Goods Order No. 69 – General requirements for labels for medicine, in that the medicine labels do not include all of the advisory statements that are required by schedule 2 of the Medicines Advisory Statements Specification 2014 (the Specification), which is due to come into effect on 12 December 2015.
In particular, the labels of the medicines do not include the following advisory statements required by the Specification (or alternative statements that fully convey the same intent), as applicable:
- For the medicines containing pseudoephedrine: ‘This product may cause sleeplessness if it is taken up to several hours before going to bed.’
- For the medicines containing desloratadine: ‘If you are pregnant or breastfeeding, check with your doctor or pharmacist before using this medicine’.
- For the medicines containing oxymetazoline: ‘Do not give to children aged between 6 and 11 years of age, except on the advice of a doctor, pharmacist or nurse practitioner’.
- For the DEMAZIN oral liquid medicines: ‘Do not give to children aged between 6 and 11 years of age, except on the advice of a doctor, pharmacist or nurse practitioner’.
- For the DEMAZIN oral liquid medicines containing phenylephrine: ‘This product may cause sleeplessness’.
The consent is effective from 12 December 2015 until 12 December 2016.
The consent is subject to the following condition:
- The labels to which this consent applies are those previously approved by the TGA for the former sponsor Merck Sharp & Dohme (Australia).