✨ Medicinal Product Notices




NEW ZEALAND GAZETTE, No. 124
23 SEPTEMBER 2010

Product:
Compound Sodium Lactate
Active Ingredients:
Calcium chloride dihydrate 0.27g
Potassium chloride 0.4g
Sodium chloride 6g
Sodium lactate 3.17g

Dosage Form:
Solution for infusion

New Zealand Sponsor:
Fresenius Kabi New Zealand Limited

Manufacturers:
FEDERA Limoges SAS, Louviers Cedex, France
Fresenius Kabi Norge AS, Halden, Norway

Product:
Dobuject
Active Ingredient:
Dobutamine hydrochloride 56.05mg equivalent to dobutamine 50mg

Dosage Form:
Concentrate for infusion

New Zealand Sponsor:
Mylan New Zealand Limited

Manufacturer:
BerliMed SA, Madrid, Spain

Product:
I-Amlodipine
Active Ingredient:
Amlodipine besilate 13.88mg equivalent to 10mg amlodipine

Dosage Form:
Tablet

New Zealand Sponsor:
Ipca Pharma (NZ) Pty Limited

Manufacturer:
Ipca Laboratories Limited, Silvassa, India

Product:
I-Amlodipine
Active Ingredient:
Amlodipine besilate 6.935mg equivalent to 5mg amlodipine

Dosage Form:
Tablet

New Zealand Sponsor:
Ipca Pharma (NZ) Pty Limited

Manufacturer:
Ipca Laboratories Limited, Silvassa, India

Product:
Omezol Relief modified release (prescription)
Active Ingredient:
Omeprazole 10mg

Dosage Form:
Modified release capsule

New Zealand Sponsor:
Mylan New Zealand Limited

Manufacturer:
Matrix Laboratories Limited, Nashik, India

Product:
Omezol Relief modified release (restricted)
Active Ingredient:
Omeprazole 10mg

Dosage Form:
Modified release capsule

New Zealand Sponsor:
Mylan New Zealand Limited

Manufacturer:
Matrix Laboratories Limited, Nashik, India

Product:
Omezol Relief modified release
Active Ingredient:
Omeprazole 20mg

Dosage Form:
Modified release capsule

New Zealand Sponsor:
Mylan New Zealand Limited

Manufacturer:
Matrix Laboratories Limited, Nashik, India

Product:
Omezol Relief modified release
Active Ingredient:
Omeprazole 40mg

Dosage Form:
Modified release capsule

New Zealand Sponsor:
Mylan New Zealand Limited

Manufacturer:
Matrix Laboratories Limited, Nashik, India

Product:
Stavudine
Active Ingredient:
Stavudine 1.05mg/mL

Dosage Form:
Powder for oral solution

New Zealand Sponsor:
REX Medical Limited

Manufacturer:
Cipla Limited, Salcette, India

Product:
Vedafil
Active Ingredient:
Sildenafil citrate 140.483mg equivalent to sildenafil 100mg

Dosage Form:
Film coated tablet

New Zealand Sponsor:
Mylan New Zealand Limited

Manufacturer:
Matrix Laboratories Limited, Nashik, India

Product:
Vedafil
Active Ingredient:
Sildenafil citrate 35.121mg equivalent to sildenafil 25mg

Dosage Form:
Film coated tablet

New Zealand Sponsor:
Mylan New Zealand Limited

Manufacturer:
Matrix Laboratories Limited, Nashik, India



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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2010, No 124





✨ LLM interpretation of page content

πŸ₯ Consent to the Distribution of New Medicines

πŸ₯ Health & Social Welfare
Medicines, Distribution, Compound Sodium Lactate, Dobuject, I-Amlodipine, Omezol Relief, Stavudine, Vedafil, Health Regulations