Revised: 31 May 2019
Medicines
Medsafe Product Detail |  | |
|---|---|---|
| File ref: TT50-9773 |
| Trade Name | Dose Form | Strength | Identifier |
| Pheburane | Oral granules | 483 mg | |
| Sponsor | Application date | Registration situation | Classification |
| Orpharma NZ Limited c/o Staples Rodway Limited Level 9, 45 Queen Street P O Box 3899 Auckland 1140 | 3/6/2015 | Consent given Approval date: 29/10/2015 | Prescription |
Composition
| Component | Ingredient | Manufacturer |
| oral granules | Active | |
| Sodium phenylbutyrate 84 g Equivalent to 483 mg of sodium phenylbutyrate per gram of granules | CU Chemie Uetikon GmbH Raiffeisenstrasse 4 Lahr 77933 GERMANY | |
| Central Glass Germany GmbH Kantstrasse 2 Halle-Kuensebeck GERMANY | ||
| Laboratoires Synth-Innove 2, bis rue Dupontde l'Eure Paris 75020 FRANCE | ||
| Excipient | ||
| Ethylcellulose | ||
| Hypromellose | ||
| Macrogol 1500 | ||
| Povidone | ||
| Sugar spheres |
Production
| Manufacturing step | Manufacturer |
| Finished Product Testing | Rottendorf Pharma GmbH Ostenfelder Strasse 51 - 61 Ennigerloh 59320 GERMANY |
| Manufacture of Final Dose Form | Rottendorf Pharma GmbH Ostenfelder Strasse 51 - 61 Ennigerloh 59320 GERMANY |
| Packing | Rottendorf Pharma GmbH Am Fleigendahl 3 Ennigerloh 59320 GERMANY |
| Secondary Packaging | Eurocept International Trapgans 5 Ankveen 1244RL NETHERLANDS |
| Lucane Pharma 172 rue de Charonne Paris 75011 FRANCE | |
| Tjoapack Netherlands B.V. Nieuwe Donk 9 Etten-Leur 4879AC NETHERLANDS | |
| NZ Site of Product Release | Max Health Limited Office 6 One Link Building 2 Segar Ave, Pt Chevalier Auckland |
Packaging
| Package | Contents | Shelf Life |
| Bottle, 250 cc HDPE Duma Twist-off bottle with desiccant, child-resistant cap, and measuring spoon | 174 g | 36 months from date of manufacture stored at or below 30°C 45 days opened stored at or below 30°C 7 days reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light |
Indications
Pheburane is indicated as adjunctive therapy in the chronic management of urea cycle disorders, involving deficiencies of carbamylphosphate synthetase, ornithine transcarbamylase or argininosuccinate synthetase. Pheburane should be used with dietary protein restriction and, in some cases, dietary supplements (e.g., essential amino acids, arginine, citrulline, and protein-free calorie supplements).
Pheburane is indicated in all patients with neonatal-onset presentation (complete enzyme deficiencies, presenting within the first 28 days of life). It is also indicated in patients with late-onset disease (partial enzyme deficiencies, presenting after the first month of life) who have a history of hyperammonaemic encephalopathy.
Geriatrics (> 65 years of age):
Pheburane has not been studied in the geriatric population.
Latest Regulatory Activity
| Application Date | Application Type | Change(s) | Status | Payment Date | Priority |
| 19/2/2024 | Changed Medicine Notification | Active ingredient manufacture - G5; Active ingredient specifications/test methods - G1; Active ingredient specifications/test methods - G2; Editorial updates to Module 3 documents | Granted 25/3/2024 | 1/3/2024 | |
| 3/6/2015 | New Higher-risk Medicine Application | Abridged new higher-risk medicine containing one or more new active substance | Granted 29/10/2015 | 17/6/2015 | Y |
