β¨ 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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β¨ LLM interpretation of page content
π₯ Consent to the Distribution of New Medicines
π₯ Health & Social WelfareMedicines, Distribution, Compound Sodium Lactate, Dobuject, I-Amlodipine, Omezol Relief, Stavudine, Vedafil, Health Regulations
NZ Gazette 2010, No 124