This brand name is authorized in United States. It is also authorized in Australia, Austria, Brazil, Canada, Croatia, Cyprus, Ecuador, Estonia, Finland, France, Hong Kong SAR China, Ireland, Israel, Italy, Japan, Lithuania, Poland, Romania, Singapore, South Africa, Spain, Turkey, UK.
The drug THYROGEN contains one active pharmaceutical ingredient (API):
1
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UNII
AVX3D5A4LM - THYROTROPIN ALFA
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Thyrotropin alfa (recombinant human thyroid stimulating hormone) is a heterodimeric glycoprotein produced by recombinant DNA technology. Binding of thyrotropin alfa to TSH receptors on thyroid epithelial cells stimulates iodine uptake and organification, and synthesis and release of thyroglobulin, triiodothyronine (T3) and thyroxine (T4). |
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Below package inserts are available for further reading:
| Document | Type | Information Source | |
|---|---|---|---|
| THYROGEN Powder for solution for injection | MPI, EU: SmPC | European Medicines Agency (EU) |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
| ATC Group | Classification | |
|---|---|---|
| H01AB01 | Thyrotropin | H Systemic hormonal preparations, excl. Sex hormones and insulins → H01 Pituitary and hypothalamic hormones and analogues → H01A Anterior pituitary lobe hormones and analogues → H01AB Thyrotropin |
This drug has been assigned below unique identifiers within the countries it is being marketed:
| Country | Identification scheme | Identifier(s) |
|---|---|---|
| AU | Pharmaceutical Benefits Scheme | 2700D |
| BR | Câmara de Regulação do Mercado de Medicamentos | 502818100078117, 576720020055217 |
| CA | Health Products and Food Branch | 02246016 |
| EC | Agencia Nacional de Regulación, Control y Vigilancia Sanitaria | 134-MBE-0419 |
| EE | Ravimiamet | 1196805, 1196816 |
| ES | Centro de información online de medicamentos de la AEMPS | 99122002 |
| FI | Lääkealan turvallisuus- ja kehittämiskeskus | 467696 |
| FR | Base de données publique des médicaments | 68937442 |
| GB | Medicines & Healthcare Products Regulatory Agency | 95276 |
| HK | Department of Health Drug Office | 54932 |
| IL | מִשְׂרַד הַבְּרִיאוּת | 4197 |
| IT | Agenzia del Farmaco | 034716011, 034716023 |
| JP | 医薬品医療機器総合機構 | 7990403E1025 |
| LT | Valstybinė vaistų kontrolės tarnyba | 1031290, 1031291 |
| PL | Rejestru Produktów Leczniczych | 100126525 |
| RO | Agenția Națională a Medicamentului și a Dispozitivelor Medicale | W42160001, W42160002 |
| SG | Health Sciences Authority | 13164P |
| TR | İlaç ve Tıbbi Cihaz Kurumu | 8699809799196 |
| US | FDA, National Drug Code | 58468-0030 |
| ZA | Health Products Regulatory Authority | 43/21.3/0869 |
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