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FAMPYRA fampridine 10mg modified release tablets bottle, Link Medical Products Pty Ltd T/A Link Pharmaceuticals, CON-1361
Product name
FAMPYRA fampridine 10mg modified release tablets bottle
Sponsor name
Link Medical Products Pty Ltd T/A Link Pharmaceuticals
Batches
150428
Consent start
Consent no.
CON-1361
Duration
The consent is effective from 3 June 2025 until 31 January 2026.
Standard
Subsection 8(2); subsection 9(3); subsection 9(5); paragraph 8(1)(h); paragraph 8(1)(d); paragraph 8(1)(i); and, paragraph 9(1)(h) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The products do not comply because: • The carton does not have a dedicated
prescribing label space. • The active ingredient name is in text that is less
than 3.0mm high. • The storage conditions on the medicine say 'Store 15° - 30°C.
Protect from light and moisture’ compared to the Australian conditions which are
‘Store below 25°C. Store in original bottle’. • The dosage from is written as
“extended-release tablets” in place of “modified release tablets”. • The labels
do not include the product name, active ingredient and quantity of the active as
a cohesive unit.
Conditions imposed
1. A ‘Dear Healthcare Provider’ letter will be supplied with each affected batch
describing the differences between the labels.
2. The labels will be over-stickered to include the registration number and the
Poison Standard signal headings.
Import, Supply, &/or Export
import and supply
Therapeutic product type
Prescription medicines