β¨ Biosecurity and Medicines Notices
NEW ZEALAND GAZETTE, No. 136 β 6 NOVEMBER 2014
for the purposes of Part 5A of the Biosecurity Act 1993, Pipfruit NZ Incorporated represents the pipfruit sector that grows fresh pipfruit for consumption.
Dated at Wellington this 24th day of October 2014.
Hon NATHAN GUY, Minister for Primary Industries.
2014-go6774
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:
Arrow - Tranexamic Acid
Active Ingredient:
Tranexamic acid 100mg/mL
Dosage Form:
Solution for injection
New Zealand Sponsor:
Actavis New Zealand Limited
Manufacturer:
Gland Pharma Limited, Andhara Pradesh, India
Product:
Giotrif
Active Ingredient:
Afatinib dimaleate 29.56mg equivalent to Afatinib 20mg
Dosage Form:
Film coated tablet
New Zealand Sponsor:
Boehringer Ingelheim (NZ) Limited
Manufacturer:
Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim am Rhein, Germany
Product:
Giotrif
Active Ingredient:
Afatinib dimaleate 44.34mg equivalent to Afatinib 30mg
Dosage Form:
Film coated tablet
New Zealand Sponsor:
Boehringer Ingelheim (NZ) Limited
Manufacturer:
Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim am Rhein, Germany
Product:
Giotrif
Active Ingredient:
Afatinib dimaleate 59.12mg equivalent to Afatinib 40mg
Dosage Form:
Film coated tablet
New Zealand Sponsor:
Boehringer Ingelheim (NZ) Limited
Manufacturer:
Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim am Rhein, Germany
Product:
Giotrif
Active Ingredient:
Afatinib dimaleate 73.9mg equivalent to Afatinib 50mg
Dosage Form:
Film coated tablet
New Zealand Sponsor:
Boehringer Ingelheim (NZ) Limited
Manufacturer:
Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim am Rhein, Germany
Product:
Harvoni
Active Ingredients:
Ledipasvir 90mg
Sofosbuvir 400mg
Dosage Form:
Film coated tablet
New Zealand Sponsor:
Gilead Sciences (NZ)
Manufacturers:
Gilead Sciences Limited, County Cork, Ireland
Patheon Inc, Ontario, Canada
Product:
Montelukast Mylan
Active Ingredient:
Montelukast sodium 4.15mg equivalent to Montelukast 4mg
Dosage Form:
Chewable tablet
New Zealand Sponsor:
Mylan New Zealand Limited
Manufacturer:
Mylan Laboratories Limited, Maharashtra State, India
Product:
Montelukast Mylan
Active Ingredient:
Montelukast sodium 5.19mg equivalent to Montelukast 5mg
Dosage Form:
Chewable tablet
New Zealand Sponsor:
Mylan New Zealand Limited
Manufacturer:
Mylan Laboratories Limited, Maharashtra State, India
Dated this 31st day of October 2014.
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β¨ LLM interpretation of page content
πΎ
Approval of Pipfruit NZ Incorporated
(continued from previous page)
πΎ Primary Industries & Resources24 October 2014
Biosecurity Act 1993, Pipfruit Sector, Organisation Representation
- Hon Nathan Guy, Minister for Primary Industries
π₯ Consent to Distribution of New Medicines
π₯ Health & Social Welfare31 October 2014
Medicines Act 1981, New Medicines, Distribution Consent, Pharmaceutical Products
- Minister of Health
NZ Gazette 2014, No 136