This brand name is authorized in Australia, Austria, Brazil, Croatia, Cyprus, Ecuador, Estonia, Finland, France, Hong Kong SAR China, Ireland, Israel, Lithuania, Malta, Netherlands, New Zealand, Poland, Romania, Singapore, South Africa, Spain, Tunisia, Turkey, UK.
The drug ZAVEDOS contains one active pharmaceutical ingredient (API):
1
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UNII
5VV3MDU5IE - IDARUBICIN HYDROCHLORIDE
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Idarubicin is a DNA intercalating anthracycline which interacts with the enzyme topoisomerase II and has an inhibitory effect on nucleic acid synthesis. Idarubicin has been shown to have a higher potency with respect to daunorubicin and to be an effective agent against murine leukaemia and lymphomas both by i.v. and oral routes. |
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Below package inserts are available for further reading:
| Document | Type | Information Source | |
|---|---|---|---|
| ZAVEDOS Powder for solution for injection | MPI, EU: SmPC | Medicines & Healthcare Products Regulatory Agency (GB) | |
| ZAVEDOS Capsules | MPI, EU: SmPC | Medicines & Healthcare Products Regulatory Agency (GB) |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
| ATC Group | Classification | |
|---|---|---|
| L01DB06 | Idarubicin | L Antineoplastic and immunomodulating agents → L01 Antineoplastic agents → L01D Cytotoxic antibiotics and related substances → L01DB Anthracyclines and related substances |
This drug has been assigned below unique identifiers within the countries it is being marketed:
| Country | Identification scheme | Identifier(s) |
|---|---|---|
| AU | Pharmaceutical Benefits Scheme | 4440Q, 7247K |
| BR | Câmara de Regulação do Mercado de Medicamentos | 522717090058317, 522717090058417 |
| EC | Agencia Nacional de Regulación, Control y Vigilancia Sanitaria | 23.789-1-06-11 |
| EE | Ravimiamet | 1041208, 1041219, 1041220, 1041231, 1656064, 1706701, 1706712, 1706723, 1888128 |
| ES | Centro de información online de medicamentos de la AEMPS | 60071, 60072 |
| FI | Lääkealan turvallisuus- ja kehittämiskeskus | 001322, 001372, 169185 |
| FR | Base de données publique des médicaments | 60692261, 65133315, 65964950, 67551530, 67651178, 67815446, 69164614 |
| GB | Medicines & Healthcare Products Regulatory Agency | 44547, 44552, 44560, 44563 |
| HK | Department of Health Drug Office | 34636 |
| HR | Agencija za lijekove i medicinske proizvode | HR-H-362248325 |
| IE | Health Products Regulatory Authority | 88223 |
| IL | מִשְׂרַד הַבְּרִיאוּת | 8197 |
| LT | Valstybinė vaistų kontrolės tarnyba | 1010616, 1010617 |
| MT | Medicines Authority | AA565/58701 |
| NL | Z-Index G-Standaard | 13881736 |
| NL | Z-Index G-Standaard, PRK | 52507, 52515, 52523 |
| NZ | Medicines and Medical Devices Safety Authority | 6062, 6066 |
| PL | Rejestru Produktów Leczniczych | 100072440, 100072456, 100369564 |
| RO | Agenția Națională a Medicamentului și a Dispozitivelor Medicale | W65096001, W65097001 |
| SG | Health Sciences Authority | 06712P, 06713P, 09971P, 09972P, 09973P, 12455P, 12456P |
| TN | Direction de la Pharmacie et du Médicament | 10803211H |
| TR | İlaç ve Tıbbi Cihaz Kurumu | 8699524790225, 8699524790232 |
| ZA | Health Products Regulatory Authority | 33/26/0211, 33/26/0212, 33/26/0213, Y/26/16, Y/26/17 |
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