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Recent Approvals of Medicines Containing a New Active Ingredient

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Prescriber Update 39(1): 5
March 2018

For period 16 October 2017 to 15 January 2018.

Trade Name (active ingredient)*	Dose Form and Strength	Therapeutic Area
Aldurazyme (laronidase)^†	Concentrate for infusion 500 U/5 mL	Mucopolysaccharidosis I (MPS I; alpha-L-iduronidase deficiency)
Alecensa (alectinib)	Capsule 150 mg	Anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC)
Belkyra (deoxycholic acid)	Solution for injection 20 mg/2 mL (10 mg/mL)	Improvement in appearance of submental fat in adults
Darzalex (daratumumab)	Concentrate for infusion 100 mg/5mL and 400 mg/20 mL	Multiple myeloma
Esmya (ulipristal)	Tablet 5 mg	Uterine fibroids
Glassia (alpha-1 proteinase inhibitor)	Solution for injection 1000 mg/50 mL (20 mg/mL)	Emphysema due to congenital deficiency of alpha1-proteinase inhibitor (alpha1-antitrypsin deficiency)
Hexvix (hexaminolevulinate)^†	Powder for injection 85 mg with diluent	Diagnostic use only. Used in cystoscopy to detect bladder cancer
Ocrevus (ocrelizumab)	Concentrate for infusion 300 mg/10 mL	Multiple sclerosis (MS)
Venclexta (venetoclax)^†	Film coated tablet 10 mg	Chronic lymphocytic leukaemia (CLL)
Xiaflex (collagenase clostridium histolyticum)	Powder for injection 900 mcg	Dupuytren's contracture and Peyronie's disease

* New active ingredient shown in bold type
^† Not available

The data sheets for currently marketed prescription medicines are published on the Medsafe website (www.medsafe.govt.nz/Medicines/infoSearch.asp).