This brand name is authorized in United States. It is also authorized in Australia, Austria, Canada, Ecuador, Estonia, Finland, France, Hong Kong SAR China, Ireland, Israel, Japan, Lithuania, Malta, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, South Africa, Spain, Tunisia, Turkey, UK.
The drug RETROVIR contains one active pharmaceutical ingredient (API):
1
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UNII
4B9XT59T7S - ZIDOVUDINE
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Zidovudine is an antiviral agent which is highly active in vitro against retroviruses including the Human Immunodeficiency Virus (HIV). |
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Below package inserts are available for further reading:
| Document | Type | Information Source | |
|---|---|---|---|
| RETROVIR Concentrate for solution for infusion | MPI, EU: SmPC | Medicines & Healthcare Products Regulatory Agency (GB) | |
| RETROVIR Capsules, hard | MPI, EU: SmPC | Medicines & Healthcare Products Regulatory Agency (GB) | |
| RETROVIR Oral solution/syrup | 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 | |
|---|---|---|
| J05AF01 | Zidovudine | J Antiinfectives for systemic use → J05 Antivirals for systemic use → J05A Direct acting antivirals → J05AF Nucleoside and nucleotide reverse transcriptase inhibitors |
This drug has been assigned below unique identifiers within the countries it is being marketed:
| Country | Identification scheme | Identifier(s) |
|---|---|---|
| AU | Pharmaceutical Benefits Scheme | 10266H, 10360G, 10361H |
| CA | Health Products and Food Branch | 01902644, 01902652, 01902660 |
| EC | Agencia Nacional de Regulación, Control y Vigilancia Sanitaria | 26.014-10-04 |
| EE | Ravimiamet | 1113422, 1664670 |
| ES | Centro de información online de medicamentos de la AEMPS | 57486 |
| FI | Lääkealan turvallisuus- ja kehittämiskeskus | 115591 |
| FR | Base de données publique des médicaments | 60132743, 60524598, 63894243, 69290545 |
| GB | Medicines & Healthcare Products Regulatory Agency | 379090, 43938, 43941, 43944, 46203 |
| HK | Department of Health Drug Office | 42757, 59602 |
| IL | מִשְׂרַד הַבְּרִיאוּת | 3108, 3543, 4298, 8648 |
| JP | 医薬品医療機器総合機構 | 6250001M1038 |
| LT | Valstybinė vaistų kontrolės tarnyba | 1090662, 1090663 |
| MT | Medicines Authority | MA1297/00101, PI565/07804A |
| MX | Comisión Federal para la Protección contra Riesgos Sanitarios | 142M91, 248M91 |
| NL | Z-Index G-Standaard | 13619519, 14009919 |
| NL | Z-Index G-Standaard, PRK | 24724, 33499, 36943 |
| NZ | Medicines and Medical Devices Safety Authority | 5021, 5022, 5023 |
| PL | Rejestru Produktów Leczniczych | 100081337, 100081343, 100198097, 100198499 |
| RO | Agenția Națională a Medicamentului și a Dispozitivelor Medicale | W65176002, W65176003, W65176004, W65177001, W65177002 |
| SG | Health Sciences Authority | 07527P |
| TN | Direction de la Pharmacie et du Médicament | 23013011H |
| TR | İlaç ve Tıbbi Cihaz Kurumu | 8699522152285, 8699522572687, 8699522772605 |
| US | FDA, National Drug Code | 49702-211, 49702-212, 49702-213 |
| ZA | Health Products Regulatory Authority | 29/20.2.8/0483 |
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