Last Updated on eMC 21-06-2013 View medicine  | Ferring Pharmaceuticals Ltd Contact details

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC.  For each version, we show the dates it was published on the eMC and the reasons for change.

Reasons for adding or updating:

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Date of revision of text on the SPC:13-02-2013

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 4.4 - additional information -

Multiple pregnancy and tocolytics like calcium channel blockers and betamimetics are known to be associated with increased risk of pulmonary oedema. Therefore, atosiban should be used with caution in case of multiple gestations and/or concomitant administration of other tocolytics.


Section 4.8 - additional information -

Respiratory events like dyspnoea and pulmonary oedema, particularly in association with concomitant administration of other tocolytics like calcium antagonists and beta-mimetics and/or multiple pregnancy, have been reported post-marketing

Reasons for adding or updating:

  • Change to section 3 - pharmaceutical form
  • Change to section 4.1 - Therapeutic Indications
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.3 - Contra-indications
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
  • Change to section 5 - Pharmacological Properties
  • Change to section 6.1 - List of Excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 6. 6 - Instruction for Use/Handling
  • Change to section 9 - Date of Renewal of Authorisation
  • Change to section 10 (date of (partial) revision of the text

Reasons for adding or updating:

  • Addition of Legal Category

Reasons for adding or updating:

  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 5.3 - Preclinical Safety Data

Reasons for adding or updating:

  • Removal of Black Triangle

Reasons for adding or updating:

  • Change to section 5.1 - Pharmacodynamic Properties

Reasons for adding or updating:

  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction

Reasons for adding or updating:

  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction

Reasons for adding or updating:

  • Transferred from eMC version 1

Reasons for adding or updating:

  • No reasons supplied

Reasons for adding or updating:

  • No reasons supplied