✨ Medicines Consent Notices




NEW ZEALAND GAZETTE, No. 165

29 SEPTEMBER 2005


Product:
m-Fluconazole
Active Ingredient:
Fluconazole 150mg
Dosage Form:
Capsule
New Zealand Sponsor:
Multichem NZ Limited
Manufacturer:
Pharmathen SA, Pallini, Attikis, Greece

Product:
m-Fluconazole
Active Ingredient:
Fluconazole 200mg
Dosage Form:
Capsule
New Zealand Sponsor:
Multichem NZ Limited
Manufacturer:
Pharmathen SA, Pallini, Attikis, Greece

Product:
m-Fluconazole
Active Ingredient:
Fluconazole 50mg
Dosage Form:
Capsule
New Zealand Sponsor:
Multichem NZ Limited
Manufacturer:
Pharmathen SA, Pallini, Attikis, Greece

Product:
Mylanta Double Strength
Active Ingredients:
Aluminium hydroxide 400mg
Magnesium hydroxide 400mg
Simeticone 40mg
Dosage Form:
Tablet
New Zealand Sponsor:
Pfizer Consumer Healthcare Div. of Pfizer New Zealand Limited
Manufacturer:
Pfizer Laboratories (Pty) Limited, Retreat, Cape Town, South Africa

Product:
Mylanta Original
Active Ingredients:
Aluminium hydroxide 200mg
Magnesium hydroxide 200mg
Simeticone 20mg
Dosage Form:
Tablet
New Zealand Sponsor:
Pfizer Consumer Healthcare Div. of Pfizer New Zealand Limited
Manufacturer:
Pfizer Laboratories (Pty) Limited, Retreat, Cape Town, South Africa

Product:
Rubifen SR
Active Ingredient:
Methylphenidate hydrochloride 20mg
Dosage Form:
Modified release tablet
New Zealand Sponsor:
AFT Pharmaceuticals Limited
Manufacturer:
Laboratorios Rubio SA, Castellbisbal, Barcelona, Spain

Product:
Total Care One
Active Ingredients:
Trometamol 12mg/mL
Tyloxapol 0.25mg/mL
Dosage Form:
Contact lens solution
New Zealand Sponsor:
Advanced Medical Optics Australia Pty Limited
Manufacturer:
Advanced Medical Optics (Hangzhou) Co Limited, Hangzhou, Zhejiang, China

Product:
Tramal Oral Drops
Active Ingredien:
Tramadol hydrochloride 100mg/mL
Dosage Form:
Oral solution
New Zealand Sponsor:
CSL New Zealand Limited
Manufacturer:
Grunenthal GmbH, Stolberg, Germany

Dated this 26th day of September 2005.

DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).


Consent to the Distribution of a Changed Medicine

Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the changed medicine which was referred to the Minister of Health under the provisions of section 24 (5) of the Act and is set out in the Schedule hereto:

Schedule

Product:
Arcoxia
Active Ingredient:
Etoricoxib 120mg
Dosage Form:
Film coated tablet
New Zealand Sponsor:
Merck Sharp & Dohme (New Zealand) Limited
Manufacturer:
Merck & Co Inc, Stonewall Plant, Elkton, Virginia, United States of America



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Online Sources for this page:

VUW Te Waharoa PDF NZ Gazette 2005, No 165


Gazette.govt.nz PDF NZ Gazette 2005, No 165





✨ LLM interpretation of page content

πŸ₯ Renewal of Provisional Consent to the Distribution of a New Medicine (continued from previous page)

πŸ₯ Health & Social Welfare
26 September 2005
Medicines, Provisional Consent, Renewal, Fluconazole, Mylanta, Rubifen SR, Total Care One, Tramal
  • DON MATHESON, Deputy Director-General, Public Health

πŸ₯ Consent to the Distribution of a Changed Medicine

πŸ₯ Health & Social Welfare
26 September 2005
Medicines, Consent, Changed Medicine, Arcoxia, Etoricoxib