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:
| Product: | APO-CANDESARTAN HCTZ |
| Active Ingredients: | Candesartan cilexetil 16mg Hydrochlorothiazide 12.5mg |
| Dosage Form: | Tablet |
| New Zealand Sponsor: | Arrotex Pharmaceuticals (NZ) Limited |
| Manufacturer: | Alembic Pharmaceuticals Limited, Tajpura, India |
| Product: | APO-CANDESARTAN HCTZ |
| Active Ingredients: | Candesartan cilexetil 32mg Hydrochlorothiazide 12.5mg |
| Dosage Form: | Tablet |
| New Zealand Sponsor: | Arrotex Pharmaceuticals (NZ) Limited |
| Manufacturer: | Alembic Pharmaceuticals Limited, Tajpura, India |
| Product: | APO-CANDESARTAN HCTZ |
| Active Ingredients: | Candesartan cilexetil 32mg Hydrochlorothiazide 25mg |
| Dosage Form: | Tablet |
| New Zealand Sponsor: | Arrotex Pharmaceuticals (NZ) Limited |
| Manufacturer: | Alembic Pharmaceuticals Limited, Tajpura, India |
| Product: | Pazopanib ADVZ |
| Active Ingredient: | Pazopanib hydrochloride 216.5mg equivalent to pazopanib 200mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Boucher & Muir (New Zealand) Limited t/a BNM Group |
| Manufacturer: | Pharmacare Premium Limited, Birzebbugia, Malta |
| Product: | Pazopanib ADVZ |
| Active Ingredient: | Pazopanib hydrochloride 433mg equivalent to pazopanib 400mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Boucher & Muir (New Zealand) Limited t/a BNM Group |
| Manufacturer: | Pharmacare Premium Limited, Birzebbugia, Malta |
| Product: | Pharmacor Dimethyl Fumarate |
| Active Ingredient: | Dimethyl fumarate 120mg |
| Dosage Form: | Enteric coated capsule |
| New Zealand Sponsor: | Pharmacor Limited |
| Manufacturer: | Alkem Laboratories Limited, Baddi, India |
| Product: | Pharmacor Dimethyl Fumarate |
| Active Ingredient: | Dimethyl fumarate 240mg |
| Dosage Form: | Enteric coated capsule |
| New Zealand Sponsor: | Pharmacor Limited |
| Manufacturer: | Alkem Laboratories Limited, Baddi, India |
| Product: | Skinman Foam |
| Active Ingredient: | Ethanol 77.5%w/w |
| Dosage Form: | Topical solution |
| New Zealand Sponsor: | Ecolab New Zealand |
| Manufacturer: | Starward Pty Limited t/a Inline Cosmetic Laboratories, Brisbane, Australia |
| Product: | Skinman Soft Protect |
| Active Ingredient: | Ethanol 90%w/w |
| Dosage Form: | Topical solution |
| New Zealand Sponsor: | Ecolab New Zealand |
| Manufacturer: | Starward Pty Limited t/a Inline Cosmetic Laboratories, Brisbane, Australia |
| Product: | Vyvanse |
| Active Ingredient: | Lisdexamfetamine dimesilate 20mg |
| Dosage Form: | Capsule |
| New Zealand Sponsor: | Takeda New Zealand Limited |
| Manufacturers: | Patheon Manufacturing Services LLC, North Carolina, United States of America Patheon Pharmaceuticals Inc, Ohio, United States of America Takeda GmbH, Oranienburg, Germany |
| Product: | Vyvanse |
| Active Ingredient: | Lisdexamfetamine dimesilate 40mg |
| Dosage Form: | Capsule |
| New Zealand Sponsor: | Takeda New Zealand Limited |
| Manufacturers: | Patheon Manufacturing Services LLC, North Carolina, United States of America Patheon Pharmaceuticals Inc, Ohio, United States of America Takeda GmbH, Oranienburg, Germany |
| Product: | Vyvanse |
| Active Ingredient: | Lisdexamfetamine dimesilate 60mg |
| Dosage Form: | Capsule |
| New Zealand Sponsor: | Takeda New Zealand Limited |
| Manufacturers: | Patheon Manufacturing Services LLC, North Carolina, United States of America Patheon Pharmaceuticals Inc, Ohio, United States of America Takeda GmbH, Oranienburg, Germany |
Dated this 21st day of August 2024.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).