Revised: 31 May 2019
Medicines
Medsafe Product Detail |   | |
|---|---|---|
| File ref: TT50-7316/3 |
| Trade Name | Dose Form | Strength | Identifier |
| Maxigesic IV | Solution for infusion | 1000mg/300mg | |
| Sponsor | Application date | Registration situation | Classification |
| AFT Pharmaceuticals Ltd P O Box 33203 Takapuna Auckland 0740 | 2/2/2018 | Consent given Approval date: 10/10/2019 | Prescription |
| Reference product: Maxigesic Film coated tablet 500mg/150mg | |||
Composition
| Component | Ingredient | Manufacturer |
| solution for infusion | Active | |
| Ibuprofen sodium dihydrate 3.85 mg/mL equivalent to ibuprofen 3mg/mL | Solara Active Pharma Sciences Limited A1/B Sipcot Industrial Complex Kudikadu Village, Cuddalore Tamil Nadu 607 005 INDIA | |
| Solara Active Pharma Sciences Limited Mathur Road Periyakalapet Puducherry 605014 INDIA | ||
| Paracetamol 10 mg/mL | Atabay Kimya Sanayi Ve Ticaret AS Acibadem Koftuncu Sokak No 1 Kadikoy Istanbul 34718 TURKEY | |
| Atabay Kimya Sanayi Ve Ticaret AS Dilovasi Organize Sanayi Bolgesi 4. Kisim Sakarya Caddesi, No.28 Gebze Kocaeli 41400 TURKEY | ||
| Excipient | ||
| Cysteine hydrochloride monohydrate | ||
| Dibasic sodium phosphate dihydrate | ||
| Hydrochloric acid | ||
| Mannitol | ||
| Sodium hydroxide | ||
| Water for injection |
Production
| Manufacturing step | Manufacturer |
| Finished Product Testing | S.M. Farmaceutici SRL Zona Industriale Tito PZ 85050 ITALY |
| Manufacture of Final Dose Form | S.M. Farmaceutici SRL Zona Industriale Tito PZ 85050 ITALY |
| Packing | S.M. Farmaceutici SRL Zona Industriale Tito PZ 85050 ITALY |
| Secondary Packaging | AFT Pharmaceuticals Ltd Level 1, Nielsen Building 129 Hurstmere Road Takapuna Auckland 0622 |
| NZ Site of Product Release | AFT Pharmaceuticals Ltd Level 1, Nielsen Building 129 Hurstmere Road Takapuna Auckland 0622 |
Packaging
| Package | Contents | Shelf Life |
| Vial, glass, Glass vial closed with bromobutyl stopper, 100ml volume | 10 dose units | 24 months from date of manufacture stored at or below 25°C protect from light. Do not refrigerate or freeze |
Indications
Maxigesic IV is indicated in adults for the relief of mild to moderate pain and the reduction of fever, where an intravenous route of administration is considered clinically necessary.
Latest Regulatory Activity
| Application Date | Application Type | Change(s) | Status | Payment Date | Priority |
| 1/5/2024 | Self-Assessable Change Notification | Data sheet - G1 (Self assessable) | Awaiting payment | ||
| 2/2/2018 | New Higher-risk Medicine Application | New higher-risk medicine that does not contain a new active substance | Granted 10/10/2019 | 23/2/2018 |
