Revised: 31 May 2019
Medicines
Medsafe Product Detail | ||
|---|---|---|
| File ref: TT50-0538 |
| Trade Name | Dose Form | Strength | Identifier |
| Hirudoid | Topical cream | 0.3 % | |
| Sponsor | Application date | Registration situation | Classification |
| Pharmabroker Sales Ltd P O Box 302-234 North Harbour Postal Centre AUCKLAND | 31/12/1969 | Consent given Approval date: 31/12/1969 | General sale |
Composition
| Component | Ingredient | Manufacturer |
| topical cream | Active | |
| Heparinoids 0.3% equivalent to to mucopolysacch.polysulph. acid ester 25000 U (bovine) | Daiichi Sankyo Altkirch S.a.r.l. 39 Rue du 3eme Zouaves F-68130 Altkirch/Haut Rhin FRANCE | |
| Excipient | ||
| Cetostearyl alcohol | ||
| Isopropyl alcohol | ||
| Lanolin | ||
| Methyl hydroxybenzoate | ||
| Myristyl alcohol | ||
| Potassium hydroxide | ||
| Propyl hydroxybenzoate | ||
| Purified water | ||
| Stearic acid | ||
| Thymol |
Production
| Manufacturing step | Manufacturer |
| Finished Product Testing | Olic (Thailand) Limited Bangpa-In Industrial Estate 166 Moo 16, Udomsorayuth Road, Bankrasan Sub-District, Ayutthaya Prov. 13160 THAILAND |
| Manufacture of Final Dose Form | Mobilat Produktions GmbH Luitpoldstrasse 1 Pfaffenhofen 85276 GERMANY |
| Olic (Thailand) Limited Bangpa-In Industrial Estate 166 Moo 16, Udomsorayuth Road, Bankrasan Sub-District, Ayutthaya Prov. 13160 THAILAND | |
| Packing | Mobilat Produktions GmbH Luitpoldstrasse 1 Pfaffenhofen 85276 GERMANY |
| Olic (Thailand) Limited Bangpa-In Industrial Estate 166 Moo 16, Udomsorayuth Road, Bankrasan Sub-District, Ayutthaya Prov. 13160 THAILAND | |
| NZ Site of Product Release | No site specified |
Packaging
| Package | Contents | Shelf Life |
| Tube, 1x14g | 14 g | 60 months from date of manufacture stored at or below 25°C |
| Tube, 1x20g | 20 g | 60 months from date of manufacture stored at or below 25°C |
| Tube, 1x40g | 40 g | 60 months from date of manufacture stored at or below 25°C |
Latest Regulatory Activity
| Application Date | Application Type | Change(s) | Status | Payment Date | Priority |
| 13/1/2020 | Changed Medicine Notification | Labelling - Grade 2 | Granted 1/4/2020 | 22/1/2020 |
