✨ 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).

go7966



Next Page →



Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2011, No 176





✨ LLM interpretation of page content

πŸ₯ Consent to the Distribution of New Medicines (continued from previous page)

πŸ₯ Health & Social Welfare
10 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