Revised: 31 May 2019
Medicines
Medsafe Product Detail | ||
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File ref: TT50-8768/1 |
Trade Name | Dose Form | Strength | Identifier |
Instillagel Lido | Topical gel | 2% w/w | |
Sponsor | Application date | Registration situation | Classification |
Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics P O Box 62027 Sylvia Park AUCKLAND 1644 | 14/11/2017 | Consent given Approval date: 31/10/2019 | Pharmacy only |
Composition
Component | Ingredient | Manufacturer |
topical gel | Active | |
Lidocaine hydrochloride 20 mg/g | Moehs Catalana SL Poligono Industrial Rubi Sur Cesar Martinell I Brunet 12A Rubi Barcelona 08191 SPAIN | |
Excipient | ||
Hypromellose | ||
Purified water | ||
Sodium hydroxide |
Production
Manufacturing step | Manufacturer |
Finished Product Testing | Klosterfrau Berlin GmbH Motzener Strasse 41 Berlin 12277 GERMANY |
Labor LS SE & Co.KG Mangelsfeld 4 Bad Bocklet Grossenbrach 97708 GERMANY | |
Manufacture of Final Dose Form | Klosterfrau Berlin GmbH Motzener Strasse 41 Berlin 12277 GERMANY |
Overlabelling | Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics 58 Richard Pearse Drive Airport Oaks Mangere AUCKLAND 2022 |
Packing | Klosterfrau Berlin GmbH Motzener Strasse 41 Berlin 12277 GERMANY |
NZ Site of Product Release | Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics 58 Richard Pearse Drive Airport Oaks Mangere AUCKLAND 2022 |
Packaging
Package | Contents | Shelf Life |
Applicator, pre-filled, single dose, 11 mL syringe in blister pack | 10 dose units | 36 months from date of manufacture stored at or below 25°C |
Applicator, pre-filled, single dose, 6 mL syringe in blister pack | 10 dose units | 36 months from date of manufacture stored at or below 25°C |
Indications
Local anaesthetic and lubrication for insertion of catheters and instruments during cystoscopy, catheterisation, exploration by sound and other endourethral operations; proctoscopy and rectoscopy.
Latest Regulatory Activity
Application Date | Application Type | Change(s) | Status | Payment Date | Priority |
12/8/2022 | Self-Assessable Change Notification | Labelling - Grade 1 (Self assessable) | Notified | 15/8/2022 | |
14/11/2017 | New Lower-risk Medicine Application | New lower-risk medicine | Granted 31/10/2019 | 12/12/2017 |