Planned maintenance may cause outages to the Department of Health and Aged Care’s network from 5:15 pm AEDT on 30 November to 10:00 pm AEDT on 1 December 2024. Access to TGA databases such as TBS Portal, ARTG and DAEN may be affected. We apologise for any inconvenience.
BOSENTAN SANDOZ bosentan (as monohydrate) 125 mg film coated tablet blister pack, Sandoz Pty Ltd, CON-203
Product name
BOSENTAN SANDOZ bosentan (as monohydrate) 125 mg film coated tablet blister pack
Sponsor name
Sandoz Pty Ltd
ARTG
242053
Batches
17B231, with expiry date 02/2020, 362 units 17B232, with expiry date 02/2020, 390 units.
Consent start
Consent no.
CON-203
Standard
Subclauses 3(2)(h) and (i) of Therapeutic Goods Order No. 69.
Non-compliance with standard
The foil labels lack the appropriate prefix for batch number and expiry date.
Conditions imposed
1.A Dear Healthcare provider letter identical to that provided to the
TherapeuticGoodsAdministrationon 15 August 2017, advising them to remind
patients to keep the blister packs with the correctly labelled carton, must be
provided with each of the affected batches;
2.The carton and foil labels to which this consent applies are those
provided with the application.
Therapeutic product type
Prescription medicines