This brand name is authorized in Austria, Brazil, Croatia, Cyprus, Estonia, Finland, France, Hong Kong SAR China, Ireland, Italy, Lithuania, Mexico, Netherlands, Nigeria, Poland, Romania, South Africa, Spain, Turkey, UK.
The drug TRACTOCILE contains one active pharmaceutical ingredient (API):
1
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UNII
0P5DNO7CEF - ATOSIBAN ACETATE
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Atosiban is a synthetic peptide which is a competitive antagonist of human oxytocin at receptor level. In human pre-term labour, atosiban at the recommended dosage antagonises uterine contractions and induces uterine quiescence. |
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Below package inserts are available for further reading:
| Document | Type | Information Source | |
|---|---|---|---|
| TRACTOCILE Solution for injection | MPI, EU: SmPC | European Medicines Agency (EU) | |
| Tractocile 7.5 mg/ml Solution for injection | 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 | |
|---|---|---|
| G02CX01 | Atosiban | G Genito urinary system and sex hormones → G02 Other gynecologicals → G02C Other gynecologicals → G02CX Other gynecologicals |
This drug has been assigned below unique identifiers within the countries it is being marketed:
| Country | Identification scheme | Identifier(s) |
|---|---|---|
| BR | Câmara de Regulação do Mercado de Medicamentos | 521401101155316, 521401102151314 |
| EE | Ravimiamet | 1196782, 1196793 |
| ES | Centro de información online de medicamentos de la AEMPS | 99124001, 99124002 |
| FI | Lääkealan turvallisuus- ja kehittämiskeskus | 561555, 561563 |
| FR | Base de données publique des médicaments | 61710552, 62476853 |
| GB | Medicines & Healthcare Products Regulatory Agency | 47900, 47908 |
| HK | Department of Health Drug Office | 48228, 48229 |
| IT | Agenzia del Farmaco | 035026018, 035026020 |
| LT | Valstybinė vaistų kontrolės tarnyba | 1031314, 1031315 |
| MX | Comisión Federal para la Protección contra Riesgos Sanitarios | 549M2001 |
| NG | Registered Drug Product Database | B4-6502, B4-6503 |
| NL | Z-Index G-Standaard | 14568101, 14568128 |
| NL | Z-Index G-Standaard, PRK | 52582, 52590 |
| PL | Rejestru Produktów Leczniczych | 100099395, 100099403 |
| RO | Agenția Națională a Medicamentului și a Dispozitivelor Medicale | W53605001, W53606001 |
| TR | İlaç ve Tıbbi Cihaz Kurumu | 8697621760103, 8697621770096 |
| ZA | Health Products Regulatory Authority | 36/18.9/0335, 36/18.9/0336 |
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