Notice Type
Departmental
Notice Title

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: Ambrisentan BNM
Active Ingredient: Ambrisentan 5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Boucher & Muir (New Zealand) Limited t/a BNM Group
Manufacturer: AET Laboratories Private Limited, Sangareddy, India
   
Product: Ambrisentan BNM
Active Ingredient: Ambrisentan 10mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Boucher & Muir (New Zealand) Limited t/a BNM Group
Manufacturer: AET Laboratories Private Limited, Sangareddy, India
   
Product: Octenisept
Active Ingredients: Octenidine hydrochloride 1mg/mL
Phenoxyethanol 20.09mg/mL
Dosage Form: Antiseptic solution
New Zealand Sponsor: Schulke New Zealand Limited
Manufacturer: Schulke & Mayr GmbH, Norderstedt, Germany
   
Product: Soothing Medicated Throat Lozenges
Active Ingredients: Amylmetacresol 0.6mg
Dichlorobenzyl alcohol 1.2mg
Dosage Form: Lozenge
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Makson Health Care (Private) Limited, Mandideep, India
   
Product: Trumenba
Active Ingredients: Neisseria meningitidis group B factor H binding protein subfamily A 0.12mg/mL
Neisseria meningitidis group B factor H binding protein subfamily B 0.12mg/mL
Dosage Form: Suspension for injection
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Pfizer Ireland Pharmaceuticals, Clondalkin, Ireland


Dated this 6th day of September 2021.

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