Pfizer Limited

Ramsgate Road, Sandwich, Kent, CT13 9NJ
Telephone: +44 (0)1304 616 161
Fax: +44 (0)1304 656 221

Summary of Product Characteristics last updated on the eMC: 02/12/2011
SPC Provera Tablets 2.5 mg, Provera Tablets 5 mg & Provera Tablets 10 mg

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 02/12/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   01-Nov-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Sections 4.3, 4.5, 4.6 and 4.8 updated
Updated on 29/09/2010 and displayed until 02/12/2011
Reasons for adding or updating:
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
  • Change to section 10 date of revision of the text
  • Change of Marketing Authorisation Holder
Date of revision of text on the SPC:   01-Sep-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

The MAH details are changed to Pfizer and the marketing authorisation number and date are updated accordingly
Updated on 17/09/2009 and displayed until 29/09/2010
Reasons for adding or updating:
  • Improved Electronic Presentation
Date of revision of text on the SPC:   01-Mar-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

None provided
Updated on 05/06/2008 and displayed until 17/09/2009
Reasons for adding or updating:
  • New individual SPC (was previously included in combined SPC)
Date of revision of text on the SPC:  
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

None provided

Active Ingredients/Generics

 
   medroxyprogesterone acetate