✨ 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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✨ LLM interpretation of page content
🏥
Approval of Lemsip Max Cold & Flu + Chesty Cough
(continued from previous page)
🏥 Health & Social Welfare22 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 WelfareMedicine, Provisional Consent, Amirol, Ixempra, AFT Pharmaceuticals, Bristol-Myers Squibb
NZ Gazette 2008, No 133