Seqirus - Nervoderm Lidocaine

Therapeutic Goods Act 1989

Approval under section 42DF for use of restricted representations by Seqirus Pty Ltd

I, Leanne McCauley, Director, Advertising Compliance Unit, Regulatory Practice, Education and Compliance Branch and Delegate of the Secretary to the Department of Health, on receipt of an application from Seqirus Pty Ltd, have approved under section 42DF of the Therapeutic Goods Act 1989 (the Act) the restricted representations described in paragraph (a) below for use in advertisements directed to consumers, for the product identified in paragraph (b), provided the conditions identified in paragraphs (c) to (h) are met:

1. to the effect that the Medicine is for 'symptomatic relief of nerve pain associated with medically diagnosed post-herpetic neuralgia'
2. NERVODERM lidocaine (lignocaine) 5% w/w dermal patch (AUST R 280081)
   On the main label:
3. the entire representation must appear exactly as it is set out in (a) on the main label¹ (being the consumer-facing side of the packaging) of the Medicine and be presented:
   1. as the dominant message about the therapeutic use of the Medicine;²
   2. in a manner that is not broken up by additional text or images (the representation does not have to be on a single line if the design or pack dimensions prevent this), and
   3. with prominence i.e. standing out so as to be easily read from a normal viewing distance.
      Other panels of the label:
4. the first reference to post-herpetic neuralgia must be 'medically diagnosed post-herpetic neuralgia' written in full (not abbreviated) and presented in a manner that is prominently displayed or communicated, i.e. standing out so as to be easily read from a normal viewing distance, and/or heard and understood.³
5. the representation set out in (a), or words to the effect of that representation, must be the dominant take-out message of the advertisement.⁴
6. the use of the restricted representation for the Medicine must be accompanied by a warning, prominently displayed or communicated, i.e. standing out so as to be easily read from a normal viewing distance, which advises consumers to seek medical advice if symptoms persist.
   In other consumer advertising:
7. the first reference to post-herpetic neuralgia in consumer advertising must be 'medically diagnosed post-herpetic neuralgia' written in full (not abbreviated) and presented in a manner that is prominently displayed or communicated, i.e. standing out so as to be easily read from a normal viewing distance, and/or heard and understood.⁴
8. the representation set out in (a), or words to the effect of that representation, must be the dominant take-out message of the advertisement.⁴

Dated this 28th day of March 2017

Leanne McCauley
Delegate of the Secretary to the Department of Health; and
Director
Advertising Compliance Unit 
Regulatory Practice, Education and Compliance Branch

Footnotes

1. As defined in Therapeutic Goods Order No. 69 (General requirements for labels for medicines) and Therapeutic Goods Order No. 92 (Standard for labels of non-prescription medicines).
2. Imposing this condition ensures that there is no confusion for consumers about the approved indication for the Medicine.
3. Imposing this condition reinforces the message to consumers that the Medicine is for a very specific medical condition and is not for use in other painful conditions which may share similar symptoms. It also ensures that consumers are aware of what the acronym 'PHN' (if referenced elsewhere) means.
4. Imposing these conditions reinforces the message to consumers that the Medicine is for a very specific medical condition and is not for use in other painful conditions which may share similar symptoms, whilst providing the Applicant with some flexibility in the use of the representation in advertising.