✨ 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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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2013, No 131





✨ LLM interpretation of page content

πŸ₯ Consent to Distribution of New Medicines (continued from previous page)

πŸ₯ Health & Social Welfare
19 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

πŸ₯ Renewal of Provisional Consent to the Distribution of Medicines

πŸ₯ Health & Social Welfare
19 September 2013
Medicines Act, Renewal, Priligy, Dapoxetine
  • DR DON MACKIE, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health