Tenecteplase - medicine shortage information

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More information about medicine shortages and how to access alternative medicines is available at the Medicine Shortages hub

Product details Supply Impact Dates Further Details
METALYSE tenecteplase (rch) 50mg powder for injection vial plus prefilled syringe
AUST R: 75013
Active ingredients:
Tenecteplase

Dosage form:
Injection, powder for

Sponsor:
Boehringer Ingelheim Pty Ltd

Phone:
02 8875 8800

From
10 Jul 2022
to
31 Dec 2024

Shortage status:
Current

Availability:
Limited Availability

Reason:
Unexpected increase in consumer demand

Management action:
A TGA web statement is available at https://www.tga.gov.au/alert/shortage-tenecteplase-metalyse. The TGA has approved a shelf-life extension of an additional 12 months from the original expiry date on the packaging for Metalyse batches with an original expiry date from January 2022 up to March 2025.
Unregistered alternative products have been approved for supply under Section 19A. For information on supply, contact the approval holders: Pro Pharmaceuticals Group Pty Ltd (Phone: 1300 077 674) or Medsurge Healthcare Pty Ltd (Phone: 1300 788 261).

METALYSE tenecteplase (rch) 40mg powder for injection vial plus prefilled syringe
AUST R: 75012
Active ingredients:
Tenecteplase

Dosage form:
Injection, powder for

Sponsor:
Boehringer Ingelheim Pty Ltd

Phone:
02 8875 8800

Deletion from market:
02 Sep 2024

Shortage status:
Discontinued

Availability:
Reduction in supply until supply is exhausted

Reason:
Commercial Changes / Commercial viability

Management action:
An alternative strength is in limited availability.
A TGA web statement is available at www.tga.gov.au/safety/shortages/medicine-shortage-alerts/tenecteplase-metalyse-shortage-update