Medicines Approval Notices




28 SEPTEMBER 2006

NEW ZEALAND GAZETTE, No. 112

3301

Product:
Arrow – Roxithromycin 150

Active Ingredient:
Roxithromycin 150mg

Dosage Form:
Coated tablet

New Zealand Sponsor:
Arrow Pharmaceuticals (NZ) Limited

Manufacturer:
Rivopharm SA, Manno, Switzerland

Product:
Arrow – Roxithromycin 300

Active Ingredient:
Roxithromycin 300mg

Dosage Form:
Coated tablet

New Zealand Sponsor:
Arrow Pharmaceuticals (NZ) Limited

Manufacturer:
Rivopharm SA, Manno, Switzerland

Product:
Arrow – Sumatriptan

Active Ingredient:
Sumatriptan succinate 100mg

Dosage Form:
Film coated tablet

New Zealand Sponsor:
Arrow Pharmaceuticals (NZ) Limited

Manufacturer:
Cobalt Pharmaceuticals Inc., Mississauga, Ontario, Canada

Product:
Arrow – Sumatriptan

Active Ingredient:
Sumatriptan succinate 50mg

Dosage Form:
Film coated tablet

New Zealand Sponsor:
Arrow Pharmaceuticals (NZ) Limited

Manufacturer:
Cobalt Pharmaceuticals Inc., Mississauga, Ontario, Canada

Product:
DP-Cipro

Active Ingredient:
Ciprofloxacin 200mg

Dosage Form:
Solution for infusion

New Zealand Sponsor:
Douglas Pharmaceuticals Limited

Manufacturer:
Hikma Farmaceutica (Portugal) Lda, Fervenca, Terrugem - Sintra, Portugal

Product:
Estalis Sequi

Active Ingredient:
Oestradiol hemihydrate 0.78mg equivalent to 50µg/24 hours

Dosage Form:
Phase I patch Transdermal patch

Active Ingredients:
Norethisterone acetate 2.7mg equivalent to 140µg/24 hours

Oestradiol hemihydrate 0.62mg equivalent to 50µg/24 hours

Dosage Form:
Phase II patch Transdermal patch

New Zealand Sponsor:
Novartis New Zealand Limited Pharmaceutical Sector

Manufacturer:
Noven Pharmaceuticals Inc, Miami, Florida, United States of America

Product:
Estalis Sequi

Active Ingredient:
Oestradiol hemihydrate 0.78mg equivalent to 50µg/24 hours

Dosage Form:
Phase I Transdermal patch

Active Ingredients:
Norethisterone acetate 4.8mg equivalent to 250µg/24 hours

Oestradiol hemihydrate 0.512mg equivalent to 50µg/24 hours

Dosage Form:
Phase II Transdermal patch

New Zealand Sponsor:
Novartis New Zealand Limited Pharmaceutical Sector

Manufacturer:
Noven Pharmaceuticals Inc, Miami, Florida, United States of America

Product:
Gastro-Soothe

Active Ingredient:
Hyoscine butylbromide 10mg

Dosage Form:
Tablet

New Zealand Sponsor:
AFT Pharmaceuticals Limited

Manufacturer:
Matrix Laboratories Limited, Sinnar, Nashik, Maharashtra, India

Product:
Genteal Gel

Active Ingredients:
Carbomer 980 2mg/g

Hypromellose 3mg/g

Dosage Form:
Ophthalmic gel

New Zealand Sponsor:
Novartis New Zealand Limited Pharmaceutical Sector

Manufacturer:
Excelvision AG, Hettlingen, Switzerland

Product:
Itrazole

Active Ingredient:
Itraconazole 100mg

Dosage Form:
Capsule

New Zealand Sponsor:
Pacific Pharmaceuticals Limited

Manufacturer:
Martec Scientific Inc, Kansas City, Missouri, United States of America



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Online Sources for this page:

VUW Te Waharoa PDF NZ Gazette 2006, No 112


Gazette.govt.nz PDF NZ Gazette 2006, No 112





✨ LLM interpretation of page content

🏥 Consent to the Distribution of New Medicines (continued from previous page)

🏥 Health & Social Welfare
Medicines Act 1981, New Medicines, Aquamid, Polyacrylamide

🏥 Approval of Arrow - Roxithromycin 150

🏥 Health & Social Welfare
Medicine, Roxithromycin, Coated tablet, Arrow Pharmaceuticals

🏥 Approval of Arrow - Roxithromycin 300

🏥 Health & Social Welfare
Medicine, Roxithromycin, Coated tablet, Arrow Pharmaceuticals

🏥 Approval of Arrow - Sumatriptan 100mg

🏥 Health & Social Welfare
Medicine, Sumatriptan, Film coated tablet, Arrow Pharmaceuticals

🏥 Approval of Arrow - Sumatriptan 50mg

🏥 Health & Social Welfare
Medicine, Sumatriptan, Film coated tablet, Arrow Pharmaceuticals

🏥 Approval of DP-Cipro

🏥 Health & Social Welfare
Medicine, Ciprofloxacin, Solution for infusion, Douglas Pharmaceuticals

🏥 Approval of Estalis Sequi Phase I

🏥 Health & Social Welfare
Medicine, Oestradiol, Norethisterone, Transdermal patch, Novartis

🏥 Approval of Estalis Sequi Phase II

🏥 Health & Social Welfare
Medicine, Oestradiol, Norethisterone, Transdermal patch, Novartis

🏥 Approval of Gastro-Soothe

🏥 Health & Social Welfare
Medicine, Hyoscine butylbromide, Tablet, AFT Pharmaceuticals

🏥 Approval of Genteal Gel

🏥 Health & Social Welfare
Medicine, Carbomer, Hypromellose, Ophthalmic gel, Novartis

🏥 Approval of Itrazole

🏥 Health & Social Welfare
Medicine, Itraconazole, Capsule, Pacific Pharmaceuticals