Shortage of Dantrium powder
19 April 2017
Update: Information about Ryanodex (dantrolene sodium), temporary substitute to Dantrium, available here
Shortage of Dantrium powder for injection 20 mg (for intravenous injection) vials and alternative supply arrangement under Section 19A of the Therapeutic Goods Act.
The ASA has received communication from Pfizer regarding the following:
- DANTRIUM® powder for injection 20 mg (for intravenous injection) AUST R 14435 sponsored by Pfizer Australia Pty Ltd is unavailable due to an unexpected third party manufacturing issue.
- It is expected to be back in stock by late December 2017.
- Pfizer has arranged a supply of an alternative product, RYANODEX® (dantrolene sodium) for injectable suspension (250mg) on a temporary basis.
- This product is NOT registered in Australia and supply is authorised under an exemption granted by the Therapeutic Goods Administration (TGA) under section 19A of the Therapeutic Goods Act 1989 until late May 2017.
For more information please see here