β¨ Medicine Approvals
NEW ZEALAND GAZETTE, No. 176
17 NOVEMBER 2011
Product:
Gemcitabine-PF
Active Ingredient:
Gemcitabine hydrochloride 227.705mg equivalent to gemcitabine 200mg
Dosage Form:
Powder for infusion
New Zealand Sponsor:
Saltarelo Holdings Limited
Manufacturer:
Onco Therapies Limited, Bangalore Karnataka, India
Product:
Gemcitabine-PF
Active Ingredient:
Gemcitabine hydrochloride 1138.53mg equivalent to gemcitabine 1000mg
Dosage Form:
Powder for infusion
New Zealand Sponsor:
Saltarelo Holdings Limited
Manufacturer:
Onco Therapies Limited, Bangalore Karnataka, India
Product:
Gemcitabine-PF
Active Ingredient:
Gemcitabine hydrochloride 2227.05mg equivalent to gemcitabine 2000mg
Dosage Form:
Powder for injection
New Zealand Sponsor:
Saltarelo Holdings Limited
Manufacturer:
Onco Therapies Limited, Bangalore Karnataka, India
Product:
GN-Gemcitabine
Active Ingredient:
Gemcitabine hydrochloride 227.705mg equivalent to gemcitabine 200mg
Dosage Form:
Powder for infusion
New Zealand Sponsor:
Saltarelo Holdings Limited
Manufacturer:
Onco Therapies Limited, Bangalore Karnataka, India
Product:
GN-Gemcitabine
Active Ingredient:
Gemcitabine hydrochloride 1138.53mg equivalent to gemcitabine 1000mg
Dosage Form:
Powder for injection
New Zealand Sponsor:
Saltarelo Holdings Limited
Manufacturer:
Onco Therapies Limited, Bangalore Karnataka, India
Product:
GN-Gemcitabine
Active Ingredient:
Gemcitabine hydrochloride 2227.05mg equivalent to gemcitabine 2000mg
Dosage Form:
Powder for injection
New Zealand Sponsor:
Saltarelo Holdings Limited
Manufacturer:
Onco Therapies Limited, Bangalore Karnataka, India
Product:
Ibuprofen
Active Ingredient:
Ibuprofen 200mg
Dosage Form:
Coated tablet
New Zealand Sponsor:
Arrow Pharmaceuticals (NZ) Limited
Manufacturer:
Marksans Pharma Limited, Goa, India
Product:
Octreotide MaxRx Injection
Active Ingredient:
Octreotide acetate 0.056mg/mL equivalent to octreotide 50mcg/mL
Dosage Form:
Solution for injection
New Zealand Sponsor:
Max Health Limited
Manufacturer:
GP-Pharm SA, Barcelona, Spain
Product:
Octreotide MaxRx Injection
Active Ingredient:
Octreotide acetate 0.112mg/mL equivalent to octreotide 100mcg/mL
Dosage Form:
Solution for injection
New Zealand Sponsor:
Max Health Limited
Manufacturer:
GP-Pharm SA, Barcelona, Spain
Product:
Octreotide MaxRx Injection
Active Ingredient:
Octreotide acetate 0.56mg/mL equivalent to octreotide 500mcg/mL
Dosage Form:
Solution for injection
New Zealand Sponsor:
Max Health Limited
Manufacturer:
GP-Pharm SA, Barcelona, Spain
Product:
Omnaris
Active Ingredient:
Ciclesonide 50ΞΌg
Dosage Form:
Nasal spray solution
New Zealand Sponsor:
Research Associates Limited
Manufacturer:
Nycomed GmbH, Singen, Germany
Dated this 10th day of November 2011.
DR DON MACKIE, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health
(pursuant to delegation given by the Minister of Health on 6 July 2001).
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β¨ LLM interpretation of page content
π₯
Consent to the Distribution of New Medicines
(continued from previous page)
π₯ Health & Social Welfare10 November 2011
Medicines Act, New Medicine, Gemcitabine-PF, GN-Gemcitabine, Ibuprofen, Octreotide MaxRx Injection, Omnaris
- DR DON MACKIE, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health
NZ Gazette 2011, No 176