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Orion Pharma (UK) Limited
Oaklea Court, 22 Park Street, Newbury, Berkshire, RG14 1EA
Telephone: +44 (0)1635 520 300
Fax: +44 (0)1635 580 180
Medical Information e-mail: medicalinformation@orionpharma.com
Out of Hours Telephone: +44 (0)1635 520 300

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: 14/07/2010
SPC Indivina

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 14/07/2010 and displayed until Current
Reasons for adding or updating:
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Jun-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
In section 10 (revision of text) changed to June 2010
Updated on 27/09/2006 and displayed until 14/07/2010
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 22/09/2006 and displayed until 27/09/2006
Reasons for adding or updating:
  • Change to section 8 - MA number
  • Change to section 10 (date of (partial) revision of the text
Date of revision of text on the SPC:   07/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
The MA number for the product has been amended
Updated on 24/03/2005 and displayed until 22/09/2006
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 10 (date of (partial) revision of the text
Updated on 16/07/2004 and displayed until 24/03/2005
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic Indications
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.8 - Undesirable Effects
Updated on 02/06/2004 and displayed until 16/07/2004
Reasons for adding or updating:
  • SPC Retired pending re-submission
  • Removal of Black Triangle
Updated on 11/06/2003 and displayed until 02/06/2004
Reasons for adding or updating:
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.3 - Contra-indications
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
Updated on 28/06/2002 and displayed until 11/06/2003
Reasons for adding or updating:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC

Active Ingredients/Generics

 
  medroxyprogesterone acetate
  estradiol valerate