EMA — authorised 20 January 2000
- Marketing authorisation holder: Ferring Pharmaceuticals A/S
- Status: approved
🇪🇺 Antocin Ii in European Union
EMA authorised Antocin Ii on 20 January 2000
Marketing authorisations
EMA — authorised 20 January 2000
- Application: EMEA/H/C/000253
- Marketing authorisation holder: Ferring Pharmaceuticals A/S
- Local brand name: Tractocile
- 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.
- Status: approved
EMA — authorised 31 July 2013
- Application: EMEA/H/C/002329
- Marketing authorisation holder: Sun Pharmaceutical Industries Europe B.V.
- Local brand name: Atosiban SUN
- Indication: Atosiban 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.
- Status: approved
Antocin Ii in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in European Union
Frequently asked questions
Is Antocin Ii approved in European Union?
Yes. EMA authorised it on 20 January 2000; EMA authorised it on 20 January 2000; EMA authorised it on 31 July 2013.
Who is the marketing authorisation holder for Antocin Ii in European Union?
Ferring Pharmaceuticals A/S holds the EU marketing authorisation.