Notice Type
Departmental
Notice Title

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 set out in the Schedule hereto:

Schedule

Product: Olimel N12-640
Component 1:  
Active Ingredients:

Alanine 20.6g/L
Arginine 13.95g/L
Aspartic acid 4.12g/L
Glutamic acid 7.11g/L
Glycine 9.87g/L
Histidine 8.49g/L
Isoleucine 7.11g/L
Leucine 9.87g/L
Lysine acetate 15.8g/L equivalent to lysine 11.20g/L
Methionine 7.11g/L
Phenylalanine 9.87g/L
Proline 8.49g/L
Serine 5.62g/L
Threonine 7.11g/L
Tryptophan 2.37g/L
Tyrosine 0.37g/L
Valine 9.11g/L

Dosage Form: Emulsion for infusion
Component 2:  
Active Ingredient: Glucose monohydrate 302.5g/L equivalent to glucose anhydrous 275g/L
Dosage Form: Emulsion for infusion
Component 3:  
Active Ingredients: Olive oil 140g/L
Soya oil 35g/L
Dosage Form: Emulsion for infusion
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturer: Baxter SA, Lessines, Belgium
Product: Olimel N12-640E
Component 1:  
Active Ingredients:

Alanine 20.6g/L
Arginine 13.95g/L
Aspartic acid 4.12g/L
Glutamic acid 7.11g/L
Glycine 9.87g/L
Histidine 8.49g/L
Isoleucine 7.11g/L
Leucine 9.87g/L
Lysine acetate 15.8g/L equivalent to lysine 11.20g/L
Magnesium chloride hexahydrate 1.52g/L
Methionine 7.11g/L
Phenylalanine 9.87g/L
Potassium chloride 4.19g/L
Proline 8.49g/L
Serine 5.62g/L
Sodium acetate trihydrate 2.81g/L
Sodium glycerophosphate 6.89g/L
Threonine 7.11g/L
Tryptophan 2.37g/L
Tyrosine 0.37g/L
Valine 9.11g/L

Dosage Form: Emulsion for infusion
Component 2:  
Active Ingredients: Calcium chloride dihydrate 1.94g/L
Glucose monohydrate 302.5g/L equivalent to glucose anhydrous 275.0g/L
Dosage Form: Emulsion for infusion
Component 3:  
Active Ingredients: Olive oil 140g/L
Soya oil 35g/L
Dosage Form: Emulsion for infusion
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturer: Baxter SA, Lessines, Belgium


Dated this 15th day of September 2020.

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