Last Updated on eMC 25-04-2014 View medicine  | Concordia International - formerly AMCo 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 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:27-02-2014

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section:-4.1 Therapeutic indications
Section:-4.2 Posology and method of administration
Section:-4.3 Contraindications
Section:-4.4 Special warnings and precautions for use
Section:-4.8 Undesirable effects
Section:-10. Date of revision of the text

Reasons for adding or updating:

  • Change to section 7 - Marketing Authorisation Holder

Date of revision of text on the SPC:30-08-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 7 of the SPC on MArketing Authorisation Holder has been changed from Antigen International Ltd. to Mercury Pharma International Ltd.

Reasons for adding or updating:

  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose

Date of revision of text on the SPC:04-07-2011

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

The mentioned below sections of SPC was amended:

4.8: Undesirable Effects

4.9: Overdose

Reasons for adding or updating:

  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.6 - Pregnancy and Lactation

Date of revision of text on the SPC:14-03-2011

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Following sections of SPC's have been updated:

4.3: Contra-indications

4.4: Special warnings and precautions for use

4.6: Pregnancy and Lactation

 

Reasons for adding or updating:

  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC

Date of revision of text on the SPC:01-01-0001

Legal Category:POM

Black Triangle (CHM): NO