FAMPYRA fampridine 10mg modified release tablets bottle, Link Medical Products Pty Ltd T/A Link Pharmaceuticals, CON-1439
Product name
FAMPYRA fampridine 10mg modified release tablets bottle
Sponsor name
Link Medical Products Pty Ltd T/A Link Pharmaceuticals
ARTG details
AUST R 170002
Consent start
Consent no.
CON-1439
Duration
The consent is effective from 16 December 2025 until 30 September 2026.
Standard
Multiple requirements of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The product does not comply as: • The carton and bottle label include
information in English as well as French [paragraph 7(2)(a)]. • The carton does
not include the name of the medicine on three opposing sides [paragraph
8(1)(o)]. • The carton does not have a dedicated prescribing label space
[subsection(8)(2)]. • The active ingredient name on the bottle label is in text
that is less than 3.0mm high [subsection 9(5)]. • The storage conditions for the
medicine stated on the bottle label and carton 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’ [subsection 11(5)]. • The dosage from on
the bottle label and carton is written as “extended release tablets” in place of
“modified release tablets” [paragraph 9(1)(h)]. • The labels do not include the
product name, active ingredient and quantity of the active as a cohesive unit
[paragraph 9(3)(a)].
Conditions imposed
A ‘Dear Healthcare Provider’ letter will be supplied with each affected batch
describing the differences between the labels.
The labels will be over-stickered to include the Australian registration number
and the Poison Standard signal headings.
Import, Supply, &/or Export
import and supply
Therapeutic product type
Prescription medicines