Tractocile (atosiban)
- Region
- 🇪🇺 EU
- Active substance
- atosiban
- Company
- Ferring Pharmaceuticals A/S
- Status
- Authorised
- Therapeutic area
- Obstetric Labor, Premature
- EU approval
- Thu 20 Jan 2000
- Application
- EMEA/H/C/000253
- ATC
- G02CX01
- Official record
- www.ema.europa.eu
Indication
Tractotile is indicated to delay imminent pre-term birth in pregnant adult women with: regular uterine contractions of at least 30 seconds duration at a rate of ? 4 per 30 minutes; a cervical dilation of 1 to 3 cm (0-3 for nulliparas) and effacement of ? 50%; a gestational age from 24 until 33 completed weeks; a normal foetal heart rate.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Atosiban SUN Authorised · Sun Pharmaceutical Industries Europe B.V.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.