Meda Pharmaceuticals

Sky Way House, Parsonage Road, Takeley, Bishop's Stortford, CM22 6PU
Telephone: 0845 460 0000
Fax: 0845 460 0002
Medical Information Direct Line: +44 (0)1748 828 810
Medical Information e-mail: meda@professionalinformation.co.uk
Medical Information Fax: +44 (0)1748 828 801
Out of Hours contact: +44 (0)1748 828 810

Summary of Product Characteristics last updated on the eMC: 30/03/2011
SPC Cyclo-Progynova 2mg

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 30/03/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 6. 5 - Nature and Contents of Container
Date of revision of text on the SPC:   14-Mar-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Change to sections 4.2., 4.4, 4.8., and 6.5. of the SPC.  Addition of hereditary angioedema warning
Updated on 17/06/2010 and displayed until 30/03/2011
Reasons for adding or updating:
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
Date of revision of text on the SPC:   31-Dec-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Change to section 8 following change of ownership approval
Updated on 15/07/2008 and displayed until 17/06/2010
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Date of revision of text on the SPC:   03-Jul-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Change to MAH address
Updated on 02/11/2006 and displayed until 15/07/2008
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Date of revision of text on the SPC:   10/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 7 - change of Marketing Authorisation holder
Updated on 09/06/2005 and displayed until 02/11/2006
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
Updated on 12/12/2003 and displayed until 09/06/2005
Reasons for adding or updating:
  • SPC Retired pending re-submission
  • Change to section 4.1 - Therapeutic Indications
Updated on 24/03/2003 and displayed until 12/12/2003
Reasons for adding or updating:
  • Change to section 2 - qualitative and quantitative composition
Updated on 21/03/2003 and displayed until 24/03/2003
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Updated on 31/05/2002 and displayed until 21/03/2003
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 8 - MA number

Active Ingredients/Generics

 
   norgestrel
   estradiol valerate