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NATULAN procarbazine 50mg (as hydrochloride) capsule blister pack , Link Medical Products Pty Ltd T/A Link Pharmaceuticals, CON-1357
Product name
NATULAN procarbazine 50mg (as hydrochloride) capsule blister pack
Sponsor name
Link Medical Products Pty Ltd T/A Link Pharmaceuticals
Batches
4G9326A
Consent start
Consent no.
CON-1357
Duration
The consent is effective from 7 May 2025 until 30 April 2026.
Standard
Paragraph 8(1)(g) and subparagraph 10(14)(a)(viii) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The products do not conform because the expiry date included on both the carton
and the blister pack for Batch 4G9326A indicate a shelf life for the product of
4 years, whereas the registered shelf life in Australia in only 3 years.
Conditions imposed
A ‘Dear Healthcare Provider’ letter will be supplied with the affected batch
describing the shelf-life difference.
Import, Supply, &/or Export
import and supply
Therapeutic product type
Prescription medicines