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

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: 27/08/2008
SPC Solu-Medrone 2 Gram

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 27/08/2008 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   03-Apr-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.4 - 'warning - addition of early psychiatric side-effects' added

Section 4.8 - 'warning - addition of early psychiatric side-effects' added
Updated on 14/04/2008 and displayed until 27/08/2008
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   04/2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
 

4.4 – Addition of warning of potential psychiatric side-effects occurring with systemic steroids.

4.8 – Addition of psychiatric side-effects that have been reported with corticosteroids.
Updated on 10/03/2008 and displayed until 14/04/2008
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
Date of revision of text on the SPC:   05/2005
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
 

7.         MARKETING AUTHORISATION HOLDER

 

            Pharmacia Limited

            Ramsgate Road

            Sandwich

            Kent

            CT13 9NJ

            United Kingdom

 
9.         DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION

                       

            6th January 2005

 

 
Updated on 27/09/2005 and displayed until 10/03/2008
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
Updated on 13/09/2005 and displayed until 27/09/2005
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 16/08/2005 and displayed until 13/09/2005
Reasons for adding or updating:
  • Improved Electronic Presentation
  • Pending awaiting re-submission
Updated on 28/08/2001 and displayed until 16/08/2005
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 03/08/2001 and displayed until 28/08/2001
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 06/09/1999 and displayed until 03/08/2001
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  methylprednisolone
  sodium succinate