SOHONOS palovarotene 10 mg capsule blister pack, Ipsen Pty Ltd , CON-1302
Product name
SOHONOS palovarotene 10 mg capsule blister pack
Sponsor name
Ipsen Pty Ltd
Consent start
Consent no.
CON-1302
Duration
The consent is effective from 17 December 2024 until 31 December 2025.
Standard
• Paragraph 8(1)(d) – The name of the dosage form
• Paragraph 8(1)(h) - the storage conditions applicable to the medicine
• Paragraph 8(1)(i) - the name and contact details of the sponsor or distributor of the medicine
• Subsection 8(2) - The label on a container for a medicine must include a minimum space of 70 x 30 millimetres for the dispensing label
• Subsection 9(3) - The name of the medicine and the name(s) of active ingredient(s) on the main label must:
(a) appear as a cohesive unit by the placing of the name and quantity of each active ingredient together on separate lines of text either
(i) immediately below the name of the medicine; or
(ii) where the trademark of the medicine might be disrupted or obscured, adjacent to the name of the medicine; and
(b) not be separated by any text or graphics, except where additional information is:
(i) required or permitted by:
(A) paragraph 11(2)(j); or
(B) subsection 11(6); or
(ii) in relation to identifying the different formulations of the medicines contained in a composite pack.
• Subsection 9(5) - Subject to subsections 9(6), 9(7), 9(8) and 9(9), the name of the active ingredient(s) and the quantity or proportion of active ingredient(s) must be displayed in a text size of not less than 3.0 millimetres.
• Subparagraph 10(14)(a)(ix) – the blister pack must include the name of the sponsor or distributor, or registered trademark if it readily identifies the sponsor or distributor of the medicine.
of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
• Paragraph 8(1)(h) - the storage conditions applicable to the medicine
• Paragraph 8(1)(i) - the name and contact details of the sponsor or distributor of the medicine
• Subsection 8(2) - The label on a container for a medicine must include a minimum space of 70 x 30 millimetres for the dispensing label
• Subsection 9(3) - The name of the medicine and the name(s) of active ingredient(s) on the main label must:
(a) appear as a cohesive unit by the placing of the name and quantity of each active ingredient together on separate lines of text either
(i) immediately below the name of the medicine; or
(ii) where the trademark of the medicine might be disrupted or obscured, adjacent to the name of the medicine; and
(b) not be separated by any text or graphics, except where additional information is:
(i) required or permitted by:
(A) paragraph 11(2)(j); or
(B) subsection 11(6); or
(ii) in relation to identifying the different formulations of the medicines contained in a composite pack.
• Subsection 9(5) - Subject to subsections 9(6), 9(7), 9(8) and 9(9), the name of the active ingredient(s) and the quantity or proportion of active ingredient(s) must be displayed in a text size of not less than 3.0 millimetres.
• Subparagraph 10(14)(a)(ix) – the blister pack must include the name of the sponsor or distributor, or registered trademark if it readily identifies the sponsor or distributor of the medicine.
of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The products do not conform because they: • will be supplied in a Canadian label
which has the following non-compliance: • The carton does not use the correct
dosage form name (capsule in place of hard capsule), • the storage conditions
are not the approved storage conditions (15°C to 30°C in place of 'Store below
25°C.). • The Australian sponsor details are not included on the carton. • The
quantity of the active ingredient is not included as a cohesive unit. • The name
of the active ingredient is in a text size less than 3.0 mm on the main label. •
The blister pack does not include the correct sponsor details.
Conditions imposed
1. Prior to supply, the labels will have the Registration number, and the
Poison Standard Signal Heading applied as described in your correspondence
dated 17 December 2024 (TRIM reference: D24-5321512)
2. The Australian CMI will be included when the medicine is supplied.
3. The medicine will only be supplied to the two patients as described in the
application.
Therapeutic product type
Prescription medicines