3 DECEMBER NEW ZEALAND GAZETTE 4647

Name and Strength Form Name and Address of Manufacturer Proprietary Name

                                                                                                      (if any)

Sotalol hydrochloride 80 mg, 160 mg Tablets Hexal-Pharma GmbH., Holzkirchen, Germany Sotahexal

Trovafloxacin mesylate Tablets, film Heinrich Mack Nachf, Illertissen, Bavaria,
123.15 mg, 246.3 mg coated Germany and Pfizer Pty Limited, West Ryde,
equivalent to 100 mg, 200 mg trovafloxacin New South Wales, Australia

Alatrofloxacin mesylate Infusion, Pfizer SA., de Poce-sur-cisse, Amboise Cedex,
7.86 mg/mL equivalent concentrate France Trovan IV
5 mg/mL trovafloxacin

Dated this 23rd day of November 1998.

G. R. BOYD, Chief Advisor, Regulation and Safety, pursuant to delegation given by the Minister of Health on the 20th day of February 1997.

go8522

Consent to the Distribution of a New Medicine

Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicine set out in the Schedule hereto:

Schedule

Name and Strength Form Name and Address of Manufacturer Proprietary Name

                                                                                                      (if any)

Gemcitabine hydrochloride Infusion, Lilly Technology Center, Indianapolis, Indiana,
228 mg, 1140 mg, equivalent to 200 mg, 1 g solution United States of America and Lilly France SA., Gemzar
gemcitabine free base Fegersheim, France

Ipratropium bromide Inhalation, Glaxo Wellcome GmbH & Co., Bad Oldesloe,
(monohydrate) 0.25 mg/mL solution Germany Zipovair Nebules

Dated this 26th day of November 1998.

G. R. BOYD, Chief Advisor, Regulation and Safety, pursuant to delegation given by the Minister of Health on the 20th day of November 1998.

go8647

Renewal of Provisional Consent to the Distribution of New Medicine

Pursuant to section 23 of the Medicines Act 1981, the Minister of Health hereby provisionally consents to the sale, supply or use in New Zealand of the new medicine set out in the Schedule hereto:

Schedule

Name and Strength Form Name and Address of Manufacturer Proprietary Name

                                                                                                      (if any)

Factor VIII (human) 250 IU Injection, CSL Limited, Bioplasma Division, AHF (High Purity)
with water for injection powder with Broadmeadows, Victoria, Australia Dried Factor VIII
100% as diluent diluent

Note: This consent is valid for 2 years from the 25th day of February 1999.

Dated this 26th day of November 1998.

G. R. BOYD, Chief Advisor, Regulation and Safety, pursuant to delegation given by the Minister of Health on the 20th day of February 1997.

go8563

Provisional Consent to the Distribution of a New Medicine

Pursuant to section 23 of the Medicines Act 1981, the Minister of Health hereby provisionally consents to the sale, supply or use in New Zealand of the new medicine set out in the Schedule hereto: