β¨ Medicines Consent Notices
26 SEPTEMBER 2013 NEW ZEALAND GAZETTE, No. 131 3669
Product: Influvac Junior
Active Ingredients:
- Influenza virus A/California/7/2009 (H1N1) - like strain 7.5mcg
- Influenza virus A/Perth/16/2009 (H3N2) - like strain 7.5mcg
- Influenza virus B/Brisbane/60/2008 - like strain 7.5mcg
Dosage Form: Suspension for injection
New Zealand Sponsor: Abbott Laboratories (NZ) Limited
Manufacturer: Abbott Biologicals BV, Olst, Netherlands
Product: IPCA-Enalapril
Active Ingredient: Enalapril maleate 5mg
Dosage Form: Tablet
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Ipca Laboratories Limited, Dadra and Nagar Haveli, India
Product: IPCA-Enalapril
Active Ingredient: Enalapril maleate 10mg
Dosage Form: Tablet
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Ipca Laboratories Limited, Dadra and Nagar Haveli, India
Product: IPCA-Enalapril
Active Ingredient: Enalapril maleate 20mg
Dosage Form: Tablet
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Ipca Laboratories Limited, Dadra and Nagar Haveli, India
Product: Kadcyla
Active Ingredient: Trastuzumab emtansine 100mg
Dosage Form: Powder for infusion
New Zealand Sponsor: Roche Products (NZ) Limited
Manufacturer: DSM Pharmaceuticals Inc, North Carolina, United States of America
Product: Kadcyla
Active Ingredient: Trastuzumab emtansine 160mg
Dosage Form: Powder for infusion
New Zealand Sponsor: Roche Products (NZ) Limited
Manufacturer: DSM Pharmaceuticals Inc, North Carolina, United States of America
Dated this 19th day of September 2013.
DR DON MACKIE, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).
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Renewal of Provisional Consent to the Distribution of Medicines
Pursuant to section 23(4A) of the Medicines Act 1981, the Minister of Health hereby renews the provisional consent to the sale, supply or use in New Zealand of the medicines set out in the Schedule hereto:
Schedule
Product: Priligy
Active Ingredient: Dapoxetine hydrochloride 33.6mg equivalent to Dapoxetine base 30mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Te Arai Biofarma Limited
Manufacturer: Janssen Ortho LLC, Gurabo, Puerto Rico
Note: This renewed consent is valid for two years from 12 November 2013.
Product: Priligy
Active Ingredient: Dapoxetine hydrochloride 67.2mg equivalent to Dapoxetine base 60mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Te Arai Biofarma Limited
Manufacturer: Janssen Ortho LLC, Gurabo, Puerto Rico
Note: This renewed consent is valid for two years from 12 November 2013.
Dated this 19th day of September 2013.
DR DON MACKIE, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).
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β¨ LLM interpretation of page content
π₯
Consent to Distribution of New Medicines
(continued from previous page)
π₯ Health & Social Welfare19 September 2013
Medicines Act, New Medicines, Influvac Junior, IPCA-Enalapril, Kadcyla
- DR DON MACKIE, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health
π₯ Renewal of Provisional Consent to the Distribution of Medicines
π₯ Health & Social Welfare19 September 2013
Medicines Act, Renewal, Priligy, Dapoxetine
- DR DON MACKIE, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health
NZ Gazette 2013, No 131