Revised: 31 May 2019

Medicines

 

Medsafe Product Detail

File ref: TT50-8768/1
Trade NameDose FormStrengthIdentifier
Instillagel LidoTopical gel2% w/w
SponsorApplication dateRegistration situationClassification
Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
P O Box 62027
Sylvia Park
AUCKLAND 1644
14/11/2017Consent given
Approval date: 31/10/2019
Labelling exemption expires 31/10/2021
Pharmacy only
 

Composition

ComponentIngredientManufacturer
topical gelActive 
 Lidocaine hydrochloride 20 mg/gMoehs Catalana SL
Poligono Industrial Rubi Sur
Cesar Martinell I Brunet 12A
Rubi
Barcelona 08191
Spain
 Excipient 
 Hypromellose
 Purified water
 Sodium hydroxide

Production

Manufacturing stepManufacturer
Finished Product TestingKlosterfrau Berlin GmbH
Motzener Strasse 41
Berlin 12277
Germany
 Labor LS SE & Co.KG
Mangelsfeld 4
Bad Bocklet
Grossenbrach 97708
Germany
Manufacture of Final Dose FormKlosterfrau Berlin GmbH
Motzener Strasse 41
Berlin 12277
Germany
PackingKlosterfrau Berlin GmbH
Motzener Strasse 41
Berlin 12277
Germany
NZ Site of Product ReleasePharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
58 Richard Pearse Drive
Airport Oaks
Mangere
AUCKLAND 2022

Packaging

PackageContentsShelf Life
Applicator, pre-filled, single dose, 11 mL syringe in blister pack10 dose units36 months from date of manufacture stored at or below 25°C
Applicator, pre-filled, single dose, 6 mL syringe in blister pack10 dose units36 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 DateApplication TypeChange(s)StatusPayment DatePriority
21/7/2020Changed Medicine NotificationLabelling - Grade 2Initial evaluation30/7/2020 
14/11/2017New Lower-risk Medicine ApplicationNew lower-risk medicineGranted 31/10/201912/12/2017 
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