Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Atosiban SUN   

   This product is authorized under a different brandname in the EU in the folowing languages:
   - Atosibano SUN (PT)
Auth. number : EU/1/13/852
INN : atosiban
ATC: Anatomical main group: G - Genito urinary system and sex hormones
Therapeutic subgroup: G02 - Other gynecologicals
Pharmacological subgroup: G02C - Other gynecologicals
Chemical subgroup: G02CX - Other gynecologicals
Chemical substance: G02CX01 - Atosiban
(See WHO ATC Index)
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
Marketing Authorisation Holder: Sun Pharmaceutical Industries Europe BV
Polarisavenue 87, NL-2132 JH Hoofddorp, Nederland

  EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

 

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
02/08/2013 Centralised - Authorisation EMEA/H/C/2329 (2013)5139 of 31/07/2013
24/10/2013 Centralised - Variation EMEA/H/C/2329/IB/1
Updated with Decision(2014)7657 of 15/10/2014
17/10/2014 Centralised - Yearly update (2014)7657 of 15/10/2014