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Gazette notice - required advisory statements for medicine labels (RASML)

Published in the Commonwealth of Australia Gazette No. GN 36, 10 September 2008

September 2008

Related information

Therapeutic Goods Regulations 1990

I, PIO CESARIN, Head, Office of Non-Prescription Medicines, Therapeutic Goods Administration, give notice as follows:

The document entitled Required Advisory Statements for Medicine Labels (Edition 1, including update 3.1) dated April 2008 (RASML) has been updated. The changes proposed as follows:

1. Remove the following entries from Section 1 - MEDICINES TO WHICH ADVISORY STATEMENTS APPLY:

Substance Change type
Aspirin (Entry 1 of7) Amendment
Aspirin (Entry 2 of7) Amendment
Aspirin (Entry 5 of7) Amendment
Aspirin (Entry 6 of7) Amendment
Aspirin (Entry 7 of7) Amendment
Diclofenac (Entry 2 of 2) Amendment
Ibuprofen (Entry 2 of 4) Amendment
Ibuprofen (Entry 4 of 4) Amendment
Ketoprofen (Entry 2 of 2) Amendment
Mefenamic acid (Entry 2 of 2) Amendment
Naproxen (Entry 2 of 2) Amendment

and replace them with the following:

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Medicines Containing ... Which Meet The Following Conditions ... Require Statement(s) Gazettal Date
Aspirin
(Entry 1 of 7)

For the purpose of exclusion from the Schedules to the SUSDP, when:

  1. each dosage unit contains more than 100 mg of aspirin; and
  2. the preparation is NOT indicated for the inhibition of platelet aggregation.
 126, 127, 128, 140, 130, 141, 10, 142, 176 10 Sep 2008
Aspirin
(Entry 2 of 7)

For the purpose of exclusion from the Schedules to the SUSDP, when:

  1. each dosage unit contains more than 100 mg of aspirin; and
  2. the preparation is indicated for the inhibition of platelet aggregation.
 126, 127, 128, 140, 130, 141, 10, 176 10 Sep 2008
Aspirin
(Entry 5 of 7)

When included in a Schedule to the SUSDP, and:

  1. the preparation is indicated exclusively for treatment of dysmenorrhoea; and
  2. NOT in sustained release preparations containing 650mg or more of aspirin; and
  3. NOT in combination with other therapeutically active substances (other than an effervescent agents)
 126, 127, 128, 140, 130, 141, 10, 142 10 Sep 2008
Aspirin
(Entry 6 of 7)

When included in a Schedule to the SUSDP, and:

  1. in combination with other therapeutically active substances (other than an effervescent agents); and
  2. NOT in sustained release preparations containing 650mg or more of aspirin; and
  3. the preparation is NOT indicated:
    1. for inhibition of platelet aggregation; or
    2. exclusively for treatment of dysmenorrhoea.
 126, 127, 128, 140, 130, 141, 10, 176 10 Sep 2008
Aspirin
(Entry 7 of 7)

When included in a Schedule to the SUSDP, and:

  1. NOT in combination with other therapeutically active substances (other than an effervescent agents); and
  2. NOT in sustained release preparations containing 650mg or more of aspirin; and
  3. the preparation is NOT indicated:
    1. for inhibition of platelet aggregation; or
    2. exclusively for treatment of dysmenorrhoea.
 126, 127, 128, 140, 130, 141, 10, 142, 176 10 Sep 2008
Diclofenac
(Entry 2 of 2)

When:

  1. included in a Schedule to the SUSDP; and
  2. the preparation is NOT indicated exclusively for the treatment of dysmenorrhoea.
 (126, 127, 149, 130, 159, 160, 176)j 10 Sep 2008
Ibuprofen
(Entry 2 of 4)		 For the purpose of exclusion from the Schedules to the SUSDP, when the preparation is for oral use and is NOT indicated exclusively for the treatment of dysmenorrhoea. 126, 127, 151, 130, 131, 132, 159, 160, 176 10 Sep 2008
Ibuprofen
(Entry 4 of 4)

When:

  1. included in a Schedule to the SUSDP; and
  2. the preparation is NOT indicated exclusively for the treatment of dysmenorrhoea.
 (126, 127, 149, 130, 159, 160, 176)j 10 Sep 2008
Ketoprofen
(Entry 2 of 2)

When:

  1. included in a Schedule to the SUSDP; and
  2. the preparation is NOT indicated exclusively for the treatment of dysmenorrhoea.
 (126, 127, 149, 130, 159, 160, 176)j 10 Sep 2008
Mefenamic acid
(Entry 2 of 2)

When:

  1. included in a Schedule to the SUSDP; and
  2. the preparation is NOT indicated exclusively for the treatment of dysmenorrhoea.
 (126, 127, 149, 130, 159, 160, 176)j 10 Sep 2008
Naproxen
(Entry 2 of 2)

When:

  1. included in a Schedule to the SUSDP; and
  2. the preparation is NOT indicated exclusively for the treatment of dysmenorrhoea.
 (126, 127, 149, 130, 159, 160, 176)j 10 Sep 2008

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2. Add the following entry to Section 2 - ADVISORY STATEMENTS (after entry number 175):

No Statement Text Gazettal Date
176 Do not use [this product/insert the name of the product] during the first 6 months of pregnancy, except on doctor's advice. Do not use at all during the last 3 months of pregnancy. 10 Sep 2008

Other minor consequential and editorial amendments have been made in accordance with the RASML Update 4 Consultation document.

The RASML Update 4 Record of Decisions and Reasons <http://www.tga.gov.au/meds/rasml.htm#updates>, incorporating details of changes made and the reasons for decisions have been published on the TGA's website.

The updated RASML <http://www.tga.gov.au/meds/rasml.htm#rasml> incorporating the changes outlined above will be published on the TGA's website from September 2008.

This Notice comes into effect on the date it is gazetted.

Dated 29 August 2008

Pio Cesarin
Head, Office of Non-Prescription Medicines, Therapeutic Goods Administration

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