Consent to the Distribution of New Medicines

Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicines set out in the Schedule hereto:

Schedule

*Product:*	Bupivacaine 0.25% with Adrenaline 1:400,000 Phebra
Active Ingredients:	Adrenaline acid tartrate 4.95mcg/mL equivalent to adrenaline 2.5mcg/mL Bupivacaine hydrochloride monohydrate 2.639mg/mL equivalent to bupivacaine hydrochloride 2.5mg/mL
Dosage Form:	Solution for injection
New Zealand Sponsor:	Phebra NZ Limited
Manufacturer:	Phebra Pty Limited, Sydney, Australia

*Product:*	Bupivacaine 0.5% with Adrenaline 1:200,000 Phebra
Active Ingredients:	Adrenaline acid tartrate 10mcg/mL equivalent to adrenaline 5mcg/mL Bupivacaine hydrochloride monohydrate 5.277mg/mL equivalent to bupivacaine hydrochloride 5mg/mL
Dosage Form:	Solution for injection
New Zealand Sponsor:	Phebra NZ Limited
Manufacturer:	Phebra Pty Limited, Sydney, Australia

*Product:*	Keytruda SC (395mg/2.4mL)
Active Ingredient:	Pembrolizumab 165mg/mL
Dosage Form:	Solution for injection
New Zealand Sponsor:	Merck Sharp & Dohme (New Zealand) Limited
Manufacturer:	BSP Pharmaceuticals SpA, Latina Scalo, Italy

*Product:*	Keytruda SC (790mg/4.8mL)
Active Ingredient:	Pembrolizumab 165mg/mL
Dosage Form:	Solution for injection
New Zealand Sponsor:	Merck Sharp & Dohme (New Zealand) Limited
Manufacturer:	BSP Pharmaceuticals SpA, Latina Scalo, Italy

Dated this 5th day of May 2026.

CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).

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