β¨ Consent to Distribution of New Medicines
2452 NEW ZEALAND GAZETTE, No. 93 23 AUGUST 2007
Schedule
Product:
Tykerb
Active Ingredient:
Lapatinib ditosilate 405mg equivalent to 250mg Lapatinib free base
Dosage Form:
Tablet
New Zealand Sponsor:
GlaxoSmithKline (NZ) Limited
Manufacturer:
Glaxo Operations UK Limited (t/a Glaxo Wellcome Operations), Priory Street, Ware, Hertfordshire, United Kingdom
Note: This consent is valid for two years from the date of publication of this notice.
Dated this 17th day of August 2007.
ANTHONY HILL, Deputy Director-General, Sector Accountability and Funding Directorate (pursuant to delegation given by the Minister of Health on 6 July 2001).
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Consent to the Distribution of New Medicines
Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicines set out in the Schedule hereto:
Schedule
Product:
DP Finasteride
Active Ingredient:
Finasteride 5mg
Dosage Form:
Tablet
New Zealand Sponsor:
Douglas Pharmaceuticals Limited
Manufacturers:
Kern Pharma SL, Terrassa, Barcelona, Spain
Orion Pharma, Espoo, Finland
Product:
m-Captopril
Active Ingredient:
Captopril 100mg
Dosage Form:
Tablet
New Zealand Sponsor:
Multichem NZ Limited
Manufacturer:
Wockhardt Limited, Chikalthana, Aurangabad, Maharashatra State, India
Product:
m-Captopril
Active Ingredient:
Captopril 12.5mg
Dosage Form:
Tablet
New Zealand Sponsor:
Multichem NZ Limited
Manufacturer:
Wockhardt Limited, Chikalthana, Aurangabad, Maharashatra State, India
Product:
m-Captopril
Active Ingredient:
Captopril 25mg
Dosage Form:
Tablet
New Zealand Sponsor:
Multichem NZ Limited
Manufacturer:
Wockhardt Limited, Chikalthana, Aurangabad, Maharashatra State, India
Product:
m-Captopril
Active Ingredient:
Captopril 50mg
Dosage Form:
Tablet
New Zealand Sponsor:
Multichem NZ Limited
Manufacturer:
Wockhardt Limited, Chikalthana, Aurangabad, Maharashatra State, India
Product:
m-Timolol 0.25% w/v
Active Ingredient:
Timolol maleate 3.4mg/mL equivalent to timolol 2.5mg/mL
Dosage Form:
Eye drops, solution
New Zealand Sponsor:
Multichem NZ Limited
Manufacturer:
FDC Limited, Waluj, District Aurangabad, India
Product:
m-Timolol 0.5% w/v
Active Ingredient:
Timolol maleate 6.8mg/mL equivalent to timolol 5mg/mL
Dosage Form:
Eye drops, solution
New Zealand Sponsor:
Multichem NZ Limited
Manufacturer:
FDC Limited, Waluj, District Aurangabad, India
Product:
Prezista
Active Ingredient:
Darunavir 300mg
Dosage Form:
Tablet
New Zealand Sponsor:
Johnson & Johnson (New Zealand) Limited
Manufacturer:
Janssen Ortho LLC, Mamey Ward, Gurabo, Puerto Rico
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Online Sources for this page:
VUW Te Waharoa —
NZ Gazette 2007, No 93
Gazette.govt.nz —
NZ Gazette 2007, No 93
β¨ LLM interpretation of page content
π₯
Provisional Consent to the Distribution of a New Medicine
(continued from previous page)
π₯ Health & Social Welfare17 August 2007
Medicines Act, Provisional Consent, New Medicine, Distribution, Tykerb, Lapatinib ditosilate
- ANTHONY HILL, Deputy Director-General, Sector Accountability and Funding Directorate
π₯ Consent to the Distribution of New Medicines
π₯ Health & Social WelfareMedicines Act, Consent, Distribution, DP Finasteride, m-Captopril, m-Timolol, Prezista