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Galen Limited
Seagoe Industrial Estate, Craigavon, Co Armagh, Northern Ireland, BT63 5UA, Ireland
Telephone: +44 (0)28 3833 4974
Fax: +44 (0)28 3835 0206
WWW: http://www.galen.co.uk
Medical Information e-mail: customer.services@galen.co.uk

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: 28/03/2012
SPC Loestrin 20

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 28/03/2012 and displayed until Current
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 6.1 - List of Excipients
  • Change to section 10 date of revision of the text
  • Change to section 2 - Qualitative and quantitative composition
Date of revision of text on the SPC:   15-Mar-2012
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
SPC Sections 2, 4.3, 4.4 and 6.1 updated to include additional information relating to excipients.
Section 4.3 also updated to clarify the description of one of the conditions listed.
Updated on 01/09/2010 and displayed until 28/03/2012
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • SPC Retired pending re-submission
Date of revision of text on the SPC:   27-Aug-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.4 'Special Warnings and Precautions for Use' has been updated regarding the risk factors associated with cervical cancer.
Updated on 09/03/2010 and displayed until 01/09/2010
Reasons for adding or updating:
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
Date of revision of text on the SPC:   26-Feb-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Changes are to Section 8 - New PL number.
Updated on 19/02/2009 and displayed until 09/03/2010
Reasons for adding or updating:
  • Change to section 10 date of revision of the text
  • SPC Retired pending re-submission
Date of revision of text on the SPC:   10-Feb-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Changes are to Section 10: Updated date of revision due to the renewal of the licence.
Updated on 02/06/2008 and displayed until 19/02/2009
Reasons for adding or updating:
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
Date of revision of text on the SPC:   18-Jul-2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 9 - Date of First Authorisation changed to 03 April 1974
Updated on 31/07/2007 and displayed until 02/06/2008
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Date of revision of text on the SPC:   01/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
 Change to Section 7: Marketing Authorisation Holder
Updated on 24/07/2003 and displayed until 31/07/2007
Reasons for adding or updating:
  • Change to section 6.1 - List of Excipients
  • Change to section 10 (date of (partial) revision of the text
Updated on 27/06/2002 and displayed until 24/07/2003
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 27/05/2002 and displayed until 27/06/2002
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 10 (date of (partial) revision of the text
Updated on 02/10/2001 and displayed until 27/05/2002
Reasons for adding or updating:
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 10 (date of (partial) revision of the text
Updated on 28/08/2001 and displayed until 02/10/2001
Reasons for adding or updating:
  • Change to section 4.3 - Contra-indications
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 10 (date of (partial) revision of the text
Updated on 18/07/2001 and displayed until 28/08/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 26/10/2000 and displayed until 18/07/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 13/07/2000 and displayed until 26/10/2000
Reasons for adding or updating:
  • No reasons supplied
Updated on 06/09/1999 and displayed until 13/07/2000
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  ethinylestradiol
  norethisterone acetate