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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: 08/09/2011
SPC Medrone Tablets 16mg

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 08/09/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 6. 3 - Shelf Life
Date of revision of text on the SPC:   01-Sep-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 6.3 updated to reflect the 5 year shelf life.
Updated on 06/09/2011 and displayed until 08/09/2011
Reasons for adding or updating:
  • Change to section 5.1 - Pharmacodynamic Properties
Date of revision of text on the SPC:   15-Aug-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
SmPC  - update to section 5.1
Updated on 16/08/2011 and displayed until 06/09/2011
Reasons for adding or updating:
  • Change to section 5.2 - Pharmacokinetic Properties
Date of revision of text on the SPC:   11-Aug-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Update to section 5.2
Updated on 30/06/2011 and displayed until 16/08/2011
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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
Date of revision of text on the SPC:   21-Jun-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Updated sections 4.3, 4.4, 4.5, 4.6, 4.7, 4.8 & 4.9
Updated on 19/11/2009 and displayed until 30/06/2011
Reasons for adding or updating:
  • Change to section 3 - Pharmaceutical form
Date of revision of text on the SPC:   06-Nov-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 3
The new product description has been added to the SmPC along with information that the scoreline is not functional
Updated on 03/09/2008 and displayed until 19/11/2009
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.4 - Special warnings and precautions for Use
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


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 09/04/2008 and displayed until 03/09/2008
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 09/04/2008
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 25/10/2006 and displayed until 10/03/2008
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
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
Section 7 - Change to MAH address
Updated on 16/08/2005 and displayed until 25/10/2006
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 06/09/1999 and displayed until 16/08/2005
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  methylprednisolone