✨ Medicines Approval Notices




28 FEBRUARY 2013 NEW ZEALAND GAZETTE, No. 24 639

Product: Adenuric
Active Ingredient: Febuxostat 120mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Te Arai Biofarma Limited
Manufacturer: Patheon France SA, Bourgoin-Jallieu, France

Product: Apo-Valgan
Active Ingredient: Valganciclovir hydrochloride 496.3mg equivalent to valganciclovir 450mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Pharmachem India Pvt. Limited, Bangalore, India

Product: Docetaxel Sandoz (20mg/2mL)
Active Ingredient: Docetaxel 10mg/mL
Dosage Form: Concentrate for infusion
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Haupt Pharma Wolfratshausen GmbH, Wolfratshausen, Germany

Product: Docetaxel Sandoz (80mg/8mL)
Active Ingredient: Docetaxel 10mg/mL
Dosage Form: Concentrate for infusion
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Haupt Pharma Wolfratshausen GmbH, Wolfratshausen, Germany

Product: Olimel N5-860E
Amino Acid solution compartment:
Active Ingredients:
Alanine 11.9g/L
Arginine 8.06g/L
Aspartic acid 2.38g/L
Glutamic acid 4.11g/L
Glycine 5.7g/L
Histidine 4.91g/L
Isoleucine 4.11g/L
Leucine 5.7g/L
Lysine acetate 9.13g/L equivalent to lysine 6.47g/L
Magnesium chloride hexahydrate 2.03g/L
Methionine 4.11g/L
Phenylalanine 5.7g/L
Potassium chloride 5.59g/L
Proline 4.91g/L
Serine 3.25g/L
Sodium acetate trihydrate 3.74g/L
Sodium glycerophosphate 9.18g/L
Threonine 4.11g/L
Tryptophan 1.37g/L
Tyrosine 0.21g/L
Valine 5.26g/L
Dosage Form: Solution for infusion

Glucose solution compartment:
Active Ingredients:
Calcium chloride dihydrate 1.29g/L
Glucose monohydrate 316.25g/L equivalent to glucose 287.5g/L
Dosage Form: Solution for infusion

Lipid emulsion compartment:
Active Ingredients:
Olive oil 160g/L
Soya oil 40g/L
Dosage Form: Emulsion for infusion
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturer: Baxter SA, Lessines, Belgium

Product: Olimel N7-960
Amino Acid solution compartment:
Active Ingredients:
Alanine 16.02g/L
Arginine 10.85g/L



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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2013, No 24





✨ LLM interpretation of page content

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

πŸ₯ Health & Social Welfare
Medicines, Approval, Distribution, Adenuric, Apo-Valgan, Docetaxel Sandoz, Olimel N5-860E, Olimel N7-960