Product:

PiperTaz Sandoz

Active Ingredients:

Piperacillin monohydrate 4.198g equivalent to piperacillin sodium 4.2531g equivalent to piperacillin 4.0g

Tazobactam 0.5g equivalent to tazobactam sodium 0.54733g

Dosage Form:

Powder for injection

New Zealand Sponsor:

Novartis New Zealand Limited

Manufacturer:

Sandoz GmbH, Kundl, Austria

Note: This consent is given subject to the following conditions:

– Provisional consent is to be granted for 1 year to address an urgent shortage in the market.

– The medicine may only be marketed or distributed when no other comparable pipercillin/tazobactam medicine with consent under section 20 of the Medicines Act 1981 is available in the New Zealand market, or to meet sole tender obligations.

Also note: This consent is valid for one year from the date of publication of this notice.