Medicine Approvals




28 AUGUST 2008

NEW ZEALAND GAZETTE, No. 133

3491

Product:
Lemsip Max Cold & Flu + Chesty Cough (Wild Berry and Hot Orange flavour)

Active Ingredients:

  • Guaifenesin 200mg
  • Paracetamol 1,000mg
  • Phenylephrine hydrochloride 12.2mg equivalent to 10mg phenylephrine

Dosage Form:
Powder for oral solution

New Zealand Sponsor:
Reckitt Benckiser (New Zealand) Limited

Manufacturer:
Reckitt Benckiser Healthcare (UK) Limited, Hull, North Humberside, United Kingdom

Product:
Micolette

Active Ingredients:

  • Sodium citrate, anhydrous 90mg/mL
  • Sodium lauryl sulfoacetate 9mg/mL
  • Sorbitol 624mg/mL

Dosage Form:
Enema

New Zealand Sponsor:
AFT Pharmaceuticals Limited

Manufacturer:
Pinewood Laboratories Limited, Ballymacarbry, Clonmel, Co. Tipperary, Ireland

Product:
Omeprazole Infusion 40 mg

Active Ingredient:

  • Omeprazole 40mg

Dosage Form:
Powder for infusion

New Zealand Sponsor:
Affordable Healthcare Limited

Manufacturer:
Sofarimex Industria Química e Farmacêutica Lda, Agualva, Cacém, Portugal

Product:
Tredaptive

Active Ingredients:

  • Laropiprant 20mg
  • Nicotinic acid 1,000mg

Dosage Form:
Tablet

New Zealand Sponsor:
Merck Sharp & Dohme (New Zealand) Limited

Manufacturer:
MSD Technology Singapore PTE Limited, Singapore

Product:
Yaz

Active Ingredients:

  • Drospirenone 3mg
  • Ethinylestradiol betadex clathrate equivalent to ethinylestradiol 0.02mg

Dosage Form:
Tablet

New Zealand Sponsor:
Bayer New Zealand Limited

Manufacturer:
Schering GmbH und Co Produktions KG, Weimar, Germany

Dated this 22nd day of August 2008.

JOHN HAZELDINE, Acting Deputy Director-General, Sector Accountability and Funding Directorate (pursuant to delegation given by the Minister of Health on 6 July 2001).

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Provisional Consent to the Distribution of New Medicines

Pursuant to section 23 of the Medicines Act 1981, the Minister of Health hereby provisionally consents to the sale, supply or use in New Zealand of the new medicines set out in the Schedule hereto:

Schedule

Product:
Amirol

Active Ingredient:
Amitriptyline hydrochloride 10mg

Dosage Form:
Film coated tablet

New Zealand Sponsor:
AFT Pharmaceuticals Limited

Manufacturer:
Remedica Limited, Limassol, Cyprus

Note: This consent is valid for two years from the date of publication of this notice.

Product:
Amirol

Active Ingredient:
Amitriptyline hydrochloride 25mg

Dosage Form:
Film coated tablet

New Zealand Sponsor:
AFT Pharmaceuticals Limited

Manufacturer:
Remedica Limited, Limassol, Cyprus

Note: This consent is valid for two years from the date of publication of this notice.

Product:
Ixempra

Active Ingredient:
Ixabepilone 15mg

Dosage Forms:

  • Powder for injection
  • Diluent

New Zealand Sponsor:
Bristol-Myers Squibb (NZ) Limited

Manufacturer:
Baxter Oncology GmbH, Halle-Kunsebeck, Germany

Note: This consent is valid for two years from the date of publication of this notice.



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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2008, No 133





✨ LLM interpretation of page content

🏥 Approval of Lemsip Max Cold & Flu + Chesty Cough (continued from previous page)

🏥 Health & Social Welfare
22 August 2008
Medicine, Approval, Cold & Flu, Guaifenesin, Paracetamol, Reckitt Benckiser
  • John Hazeldine, Acting Deputy Director-General, Sector Accountability and Funding Directorate

🏥 Provisional Consent to Distribution of New Medicines

🏥 Health & Social Welfare
Medicine, Provisional Consent, Amirol, Ixempra, AFT Pharmaceuticals, Bristol-Myers Squibb