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ProStrakan

Galabank Business Park, Galashiels, TD1 1QH
Telephone: +44 (0)1896 664 000
Fax: +44 (0)1896 664 001
WWW: http://www.ProStrakan.com
Medical Information e-mail: medinfo@prostrakan.com

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 07/03/2012
SPC Abstral Sublingual Tablets

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.

Updated on 07/03/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 6. 3 - Shelf Life
Date of revision of text on the SPC:   02-Nov-2011
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
In section 6.3, the shelf-life has been changed from 2 to 3 years.
Updated on 03/06/2010 and displayed until 07/03/2012
Reasons for adding or updating:
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   17-Feb-2010
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company


In section 5.1, the text has been updated to reflect new data showing that the onset of action is 10 minutes following administration. A graphic illustration of this data has been added.

In section 6.5, the description of the container has been expanded to include full details of packaging components. The container itself is unchanged.

Updated on 23/03/2010 and displayed until 03/06/2010
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
Date of revision of text on the SPC:   14-Oct-2009
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Clarification of dosage schedule.
Updated on 08/01/2009 and displayed until 23/03/2010
Reasons for adding or updating:
  • New SPC for new product
Date of revision of text on the SPC:  
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
None provided

Active Ingredients/Generics

 
  fentanyl citrate