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 10/11/2022
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
OverlabellingPharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
58 Richard Pearse Drive
Airport Oaks
Mangere
AUCKLAND 2022
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
10/9/2020Changed Medicine NotificationFinished product packing site - Grade 1; Labelling - Grade 3Granted 13/11/202022/10/2020 
21/7/2020CMN 24(5)Labelling - Grade 3QA Review30/7/2020 
14/11/2017New Lower-risk Medicine ApplicationNew lower-risk medicineGranted 31/10/201912/12/2017 
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