Tractocile
·
- Prescription status not stated
- Urinary and reproductive system, hormones
- Active substance
- Atosiban
- Made by
- Ferring Pharmaceuticals A/S
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
What it is for
- 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.
EMA’s data export replaced some characters it could not represent (for example “≥”) with “?”. The text is shown exactly as exported; the wording on the EMA page is authoritative.
From the official label · 2026-09-30 · European Medicines Agency
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
SpainNo exact match for this strength and form
NetherlandsNo exact match for this strength and form
SwitzerlandNo exact match for this strength and form
Details
| Made by | Ferring Pharmaceuticals A/S |
|---|---|
| Active substance | Atosiban |
| Used in | Urinary and reproductive system, hormones |
| Classification | G02CX01 · Urinary and reproductive system, hormones |
| Authorised on | 2000-01-20 |
| Last updated by the regulator | 2022-03-30 |
| EMA product number | EMEA/H/C/000253 |
Source: European Medicines Agency — medicine data · 2026-09-30 · not reviewed by a clinician
Source: European Medicines Agency (EMA). Product information as published by EMA. Reuse terms: EMA legal notice (reproduction authorised).
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.