bosentan monohydrate - medicine shortage information

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Product details Supply Impact Dates Further Details
BOSENTAN GH bosentan (as monohydrate) 125 mg film-coated tablets bottle
AUST R: 235883
Active ingredients:
bosentan monohydrate

Dosage form:
Tablet, film coated

Sponsor:
Generic Health Pty Ltd

Phone:
03 9809 7900

From
01 Dec 2023
to
19 Jul 2024

Shortage status:
Current

Availability:
Limited Availability

Reason:
Transport / Logistic issues / Storage capacity issues

Management action:
Alternative generic products are available.

BOSENTAN APO bosentan (as monohydrate) 62.5 mg film-coated tablet bottle
AUST R: 257754
Active ingredients:
bosentan monohydrate

Dosage form:
Tablet, film coated

Sponsor:
Arrotex Pharmaceuticals Pty Ltd

Phone:
1800195055

Deletion from market:
13 Oct 2023

Shortage status:
Discontinued

Availability:
Reduction in supply until supply is exhausted

Reason:
Commercial Changes / Commercial viability

Management action:
Other brands available.

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:
To be 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:
To be 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.