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A corrigendum to this notice was published on 3 February 2020, Notice No. 2020-go419.

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: Adapalene Cream BNM
Active Ingredient: Adapalene 1mg/g
Dosage Form: Topical cream
New Zealand Sponsor: Boucher & Muir (New Zealand) Limited t/a BNM Group
Manufacturer: C.P.M. Contract Pharma Gmbh & Co KG, Feldkirchen-Westerham, Germany
   
Product: Adapalene Gel BNM
Active Ingredient: Adapalene 1mg/g
Dosage Form: Topical gel
New Zealand Sponsor: Boucher & Muir (New Zealand) Limited t/a BNM Group
Manufacturer: C.P.M. Contract Pharma Gmbh & Co KG, Feldkirchen-Westerham, Germany
   
Product: Aimovig
Active Ingredient: Erenumab 70mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Amgen Manufacturing Limited, Juncos, Puerto Rico
   
Product: Aimovig (Pre-filled Pen)
Active Ingredient: Erenumab 70mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Amgen Manufacturing Limited, Juncos, Puerto Rico
   
Product: Ambrisentan
Active Ingredient: Ambrisentan 5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Devatis Limited
Manufacturer: Deva Holding AS, Tekirdag, Turkey
   
Product: Ambrisentan
Active Ingredient: Ambrisentan 10mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Devatis Limited
Manufacturer: Deva Holding AS, Tekirdag, Turkey
   
Product: Ambrisentan Mylan
Active Ingredient: Ambrisentan 5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Mylan Laboratories Limited, Sinnar, India
   
Product: Ambrisentan Mylan
Active Ingredient: Ambrisentan 10mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Mylan Laboratories Limited, Sinnar, India
   
Product: Amoxiclav-Duo
Active Ingredients: Amoxicillin trihydrate 91.84mg/mL equivalent to amoxicillin 80mg/mL
Potassium clavulanate 27.154mg/mL equivalent to clavulanic acid 11.40mg/mL
Dosage Form: Powder for oral suspension
New Zealand Sponsor: Devatis Limited
Manufacturer: Deva Holding AS, Tekirdag, Turkey
   
Product: Amoxiclav-Forte
Active Ingredients: Amoxicillin trihydrate 57.4mg/mL equivalent to Amoxicillin 50mg/mL
Potassium clavulanate 29.776mg/mL equivalent to clavulanic acid 12.5mg/mL
Dosage Form: Powder for oral suspension
New Zealand Sponsor: Devatis Limited
Manufacturer: Deva Holding AS, Tekirdag, Turkey
   
Product: Belsomra
Active Ingredient: Suvorexant 15mg
Dosage Form: Tablet
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturer: MSD International GmbH (Puerto Rico Branch) LLC, Las Piedras, Puerto Rico
   
Product: Belsomra
Active Ingredient: Suvorexant 20mg
Dosage Form: Tablet
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturer: MSD International GmbH (Puerto Rico Branch) LLC, Las Piedras, Puerto Rico
   
Product: Bosentan Sandoz
Active Ingredient: Bosentan monohydrate 64.541mg equivalent to bosentan 62.5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Abdi Ibrahim Ilac San. ve Tic. A.S., Istanbul, Turkey
   
Product: Bosentan Sandoz
Active Ingredient: Bosentan monohydrate 129.082mg equivalent to bosentan 125mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Abdi Ibrahim Ilac San. ve Tic. A.S., Istanbul, Turkey
   
Product: Citrol
Active Ingredient: Calcipotriol 0.05mg/mL
Dosage Form: Topical solution
New Zealand Sponsor: REX Medical Limited
Manufacturer: Sofarimex Industria Quimica e Farmaceutica Lda, Agualva, Portugal
   
Product: Darunavir Sandoz
Active Ingredient: Darunavir 600mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Remedica Limited, Limassol, Cyprus
   
Product: Darunavir Sandoz
Active Ingredient: Darunavir 800mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Remedica Limited, Limassol, Cyprus
   
Product: Ephedrine Hydrochloride Aguettant
Active Ingredient: Ephedrine hydrochloride 3mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Juno Pharmaceuticals NZ Limited
Manufacturer: Laboratoire Aguettant, Champagne-Serrières, France
   
Product: Ephedrine Hydrochloride Aguettant (Pre-filled Syringe)
Active Ingredient: Ephedrine hydrochloride 3mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Juno Pharmaceuticals NZ Limited
Manufacturer: Laboratoire Aguettant SA, Lyon, France
   
Product: Fluad
Active Ingredients: Influenza virus A/Michigan/45/2015 (H1N1) pdm09 – like strain 15mcg
Influenza virus A/Switzerland/8060/2017 (H3N2) – like strain 15mcg
Influenza virus B/Phuket/3073/2013 – like strain 15mcg
Dosage Form: Suspension for injection
New Zealand Sponsor: Seqirus (NZ) Limited
Manufacturers: Seqirus Vaccines Limited, Liverpool, United Kingdom
Seqirus Inc., North Carolina, United States of America
   
Product: Mupirocin Nasal Ointment (Medicianz)
Active Ingredient: Mupirocin calcium 21.5mg/g equivalent to mupirocin 20mg/g
Dosage Form: Topical ointment
New Zealand Sponsor: Medicianz Healthcare Limited, distributed by Medsurge Healthcare Limited
Manufacturer: Paul W Beyvers GmbH, Berlin, Germany
   
Product: Mupirocin Nasal Ointment (Medsurge)
Active Ingredient: Mupirocin calcium 21.5mg/g equivalent to mupirocin 20mg/g
Dosage Form: Topical ointment
New Zealand Sponsor: Medicianz Healthcare Limited, distributed by Medsurge Healthcare Limited
Manufacturer: Paul W Beyvers GmbH, Berlin, Germany
   
Product: Shingrix
Active Ingredient: Recombinant varicella zoster virus glycoprotein E 50mcg
Dosage Form: Powder for injection
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturer: GlaxoSmithKline Biologicals SA, Wavre, Belgium  
   
Product: Spazmol
Active Ingredient: Hyoscine butylbromide 20mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Devatis Limited
Manufacturer: Deva Holding AS, Kartepe, Turkey


Dated this 10th day of January 2020.

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