bosentan monohydrate - medicine shortage information

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Product details Supply Impact Dates Further Details
BOSENTAN VIATRIS bosentan (as monohydrate) 125 mg film-coated tablet bottle
AUST R: 206776
Active ingredients:
bosentan monohydrate

Dosage form:
Tablet, film coated

Sponsor:
Alphapharm Pty Ltd

Phone:
1800 274 276

From
07 Jul 2025
to
12 Aug 2025

Shortage status:
Resolved

Availability:
Available

Reason:
Manufacturing

TRACLEER bosentan 125mg (as monohydrate) tablet bottle
AUST R: 91920
Active ingredients:
bosentan monohydrate

Dosage form:
Tablet, film coated

Sponsor:
Janssen-Cilag Pty Ltd

Phone:
1800 226 334

Deletion from market:
31 Dec 2024

Shortage status:
Discontinued

Availability:
Reduction in supply until supply is exhausted

Reason:
Commercial Changes / Commercial viability

Management action:
Alternative generic products are available. The sponsor will continue to supply to existing eligible patients enrolled in the compassionate supply program until the end of December 2024.

TRACLEER bosentan 62.5mg (as monohydrate) tablet bottle
AUST R: 91919
Active ingredients:
bosentan monohydrate

Dosage form:
Tablet, film coated

Sponsor:
Janssen-Cilag Pty Ltd

Phone:
1800 226 334

Deletion from market:
31 Dec 2024

Shortage status:
Discontinued

Availability:
Reduction in supply until supply is exhausted

Reason:
Commercial Changes / Commercial viability

Management action:
Alternative generic products are available. The sponsor will continue to supply to existing eligible patients enrolled in the compassionate supply program until the end of December 2024.