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: 75013Active ingredients:
Tenecteplase
Dosage form:
Injection, powder for
Sponsor:
Boehringer Ingelheim Pty Ltd
Phone:
02 8875 8800
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From
10 Jul 2022
to
31 Dec 2024
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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).
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METALYSE tenecteplase (rch) 40mg powder for injection vial plus prefilled syringe AUST R: 75012Active ingredients:
Tenecteplase
Dosage form:
Injection, powder for
Sponsor:
Boehringer Ingelheim Pty Ltd
Phone:
02 8875 8800
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Deletion from market:
02 Sep 2024
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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
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