Gazette.govt.nzPursuant 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).