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 which were referred to the Minister of Health under the provisions of section 24(5) of the Act and are set out in the Schedule hereto:

Schedule

Product:
Active Ingredients:
















Dosage Form:

New Zealand Sponsor:
Manufacturer:

Glamin
Alanine 16g/L
Arginine 11.3g/L
Aspartic acid 3.4g/L
Glutamic acid 5.6g/L
Glycyl-L-glutamine 30.27g/L
Glycyl-L-tyrosine 3.45g/L
Histidine 6.8g/L
Isoleucine 5.6g/L
Leucine 7.9g/L
Lysine acetate 12.7g/L
Methionine 5.6g/L
Phenylalanine 5.85g/L
Proline 6.8g/L
Serine 4.5g/L
Threonine 5.6g/L
Tryptophan 1.9g/L
Valine 7.3g/L
Solution for infusion
Fresenius Kabi New Zealand Limited
Fresenius Kabi Austria GmbH, Graz, Austria

Product:
Active Ingredients:

Dosage Form:

New Zealand Sponsor:
Manufacturers:

Sudafed PE Sinus + Anti-inflammatory Pain Relief (General sale)
Ibuprofen 200mg
Phenylephrine hydrochloride 5mg
Tablet
Johnson & Johnson (New Zealand) Limited
Johnson & Johnson Pty Limited, Cape Town, South Africa
Janssen-Cilag, Val de Reuil, France
Probiotec Pharma Pty Limited, Melbourne, Australia

Product:
Active Ingredients:

Dosage Form:

New Zealand Sponsor:
Manufacturers:

Sudafed PE Sinus + Anti-inflammatory Pain Relief (Pharmacy only)
Ibuprofen 200mg
Phenylephrine hydrochloride 5mg
Tablet
Johnson & Johnson (New Zealand) Limited
Johnson & Johnson Pty Limited, Cape Town, South Africa
Janssen-Cilag, Val de Reuil, France
Probiotec Pharma Pty Limited, Melbourne, Australia

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturers:

Symbicort 100/6 Turbuhaler
Budesonide 80mcg equivalent to 100mcg metered dose
Formoterol fumarate 4.5mcg equivalent to 6mcg metered dose
Powder for inhalation
AstraZeneca Limited
AstraZeneca AB, Sodertalje, Sweden

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturers:

Symbicort 200/6 Turbuhaler
Budesonide 160mcg equivalent to 200mcg metered dose
Formoterol fumarate 4.5mcg equivalent to 6mcg metered dose
Powder for inhalation
AstraZeneca Limited
AstraZeneca AB, Sodertalje, Sweden

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturers:

Symbicort 400/12 Turbuhaler
Budesonide 320mcg equivalent to 400mcg metered dose
Formoterol fumarate 9mcg equivalent to 12mcg metered dose
Powder for inhalation
AstraZeneca Limited
AstraZeneca AB, Sodertalje, Sweden

Product:
Active Ingredients:









Dosage Form:

New Zealand Sponsor:
Manufacturers:

Synflorix
Pneumococcal polysaccharide type 1 1mcg
Pneumococcal polysaccharide type 14 1mcg
Pneumococcal polysaccharide type 18C 3mcg
Pneumococcal polysaccharide type 19F 3mcg
Pneumococcal polysaccharide type 23F 1mcg
Pneumococcal polysaccharide type 4 3mcg
Pneumococcal polysaccharide type 5 1mcg
Pneumococcal polysaccharide type 6B 1mcg
Pneumococcal polysaccharide type 7F 1mcg
Pneumococcal polysaccharide type 9V 1mcg
Suspension for injection
GlaxoSmithKline (NZ) Limited
GlaxoSmithKline Biologicals SA, Rixensart, Belgium
GlaxoSmithKline Biologicals (France), Saint-Amand-Les-Eaux, France

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturers:

Utrogestan
Progesterone 100mg
Capsule
Pharmaco (NZ) Limited
Capsugel, Ploermel, France
Cyndea Pharma S.L., Soria, Spain
Olic (Thailand) Limited, Ayutthaya, Thailand

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturers:

Utrogestan
Progesterone 200mg
Capsule
Pharmaco (NZ) Limited
Capsugel, Ploermel, France
Cyndea Pharma S.L., Soria, Spain
Olic (Thailand) Limited, Ayutthaya, Thailand

Dated this 21st day of June 2019.

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