✨ Medicines Notices




16 JANUARY 2014 NEW ZEALAND GAZETTE, No. 4 127

Product: Ropaccord
Active Ingredient: Ropinirole hydrochloride 5.7mg equivalent to Ropinirole 5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Accord Healthcare NZ Limited
Manufacturer: Intas Pharmaceuticals Limited, Gujarat, India

Dated this 10th day of January 2014.

STEWART JESSAMINE, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).

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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 which were referred to the Minister of Health under the provisions of section 24(5) of the Act and are set out in the Schedule hereto:

Schedule

Product: Floair HFA Inhaler
Active Ingredient: Fluticasone propionate 0.05mg
Dosage Form: Aerosol inhaler, metered dose
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Goa, India

Product: Floair HFA Inhaler
Active Ingredient: Fluticasone propionate 0.125mg
Dosage Form: Aerosol inhaler, metered dose
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Goa, India

Product: Floair HFA Inhaler
Active Ingredient: Fluticasone propionate 0.25mg
Dosage Form: Aerosol inhaler, metered dose
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Goa, India

Product: Meterol HFA Inhaler
Active Ingredient: Salmeterol xinafoate 0.0363mg equivalent to Salmeterol 0.025mg
Dosage Form: Aerosol inhaler, metered dose
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Goa, India

Dated this 10th day of January 2014.

STEWART JESSAMINE, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).

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Renewal of Provisional Consent to the Distribution of a Medicine

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 medicine set out in the Schedule hereto:

Schedule

Product: Cal.D.Forte
Active Ingredient: Colecalciferol 1.25mg equivalent to 50,000IU
Dosage Form: Coated tablet
New Zealand Sponsor: PSM Healthcare Limited trading as API Consumer Brands
Manufacturer: PSM Healthcare Limited trading as API Consumer Brands, Auckland, New Zealand

Note: This renewed consent is valid for six months from 12 February 2014.

Dated this 10th day of January 2014.

STEWART JESSAMINE, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).

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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2014, No 4





✨ LLM interpretation of page content

πŸ₯ Consent to the Distribution of Ropaccord

πŸ₯ Health & Social Welfare
10 January 2014
Medicines Act, New Medicines, Distribution, Consent, Ropaccord
  • Stewart Jessamine, Group Manager, Medsafe, Ministry of Health

πŸ₯ Consent to the Distribution of New Medicines

πŸ₯ Health & Social Welfare
10 January 2014
Medicines Act, New Medicines, Distribution, Consent, Floair HFA Inhaler, Meterol HFA Inhaler
  • Stewart Jessamine, Group Manager, Medsafe, Ministry of Health

πŸ₯ Renewal of Provisional Consent to the Distribution of Cal.D.Forte

πŸ₯ Health & Social Welfare
10 January 2014
Medicines Act, Provisional Consent, Renewal, Cal.D.Forte
  • Stewart Jessamine, Group Manager, Medsafe, Ministry of Health