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Ostelin Specialist Range Vitamin D 7000IU, Sanofi Consumer Healthcare, CON-1359

Product name
Ostelin Specialist Range Vitamin D 7000IU
Sponsor name
Sanofi Consumer Healthcare
Batches
Bulk batch 1658241
Consent start
Consent no.
CON-1359
Duration
The consent is effective from 27 May 2025 until 14 June 2026.
Standard
Section 14(1), Schedule 1, Item 1(a) of Therapeutic Goods (Standard for Tablets, Capsules and Pills) (TGO 101) Order 2019
Non-compliance with standard
The product does not comply with the standard as the release test assay result for the active ingredient is less than the approved release limits.
Conditions imposed
The bulk batch will be released in the market with a short shelf-life of 16 months reflected on the product label; and the product packed in 24 pack size to provide 6 months usage per pack.
Import, Supply, &/or Export
supply
Therapeutic product type
Registered complementary medicines