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Notice Type
Departmental
Notice Title

Provisional Consent to the Distribution of a New Medicine

Publication Date
31 Aug 2017

Tags

Medicines Act Provisional consent to the distribution of new medicines Health

Notice Number

2017-go4493

Issue Number

88
Title
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File Type and Size
PDF (21 KB)

Pursuant to section 23(1) 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

Product:
Active Ingredient:

Dosage Form:
New Zealand Sponsor:
Manufacturer:

Cathejell Lignocaine 2% gel
Lidocaine hydrochloride monohydrate 2.133%w/w
equivalent to lidocaine hydrochloride anhydrous 2%w/w
Topical gel
InterPharma (NZ) Limited
Pharm. Fabrik Montavit Ges.m.b.H, Absam, Austria

Note: This consent is given subject to the following conditions:

  • Provisional consent is given subject to the following restriction: The medicine may only be marketed or distributed when no other lignocaine hydrochloride 2% gel with consent to distribute for urethral use is available in the New Zealand market.

Also note: This consent is valid for one year from the date of publication of this notice.

Dated this 25th day of August 2017.

CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).