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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: 15/09/2009
SPC Refolinon Tablets

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 15/09/2009 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.9 - Overdose
  • Change to section 4.6 - Pregnancy and Lactation
Date of revision of text on the SPC:   01-Aug-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.6:

Clarification to information regarding the studies carried out in pregnant or breast feeding women whilst taking Refolinon.

The information is mainly administrative changes.

Section 4.9:

Administrative changes to provide clarification on the contents of the section.
No new information added.
Updated on 05/02/2008 and displayed until 15/09/2009
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01/2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 7.0 : change of MAH holder address

Section 10: change of revision date
Updated on 19/12/2005 and displayed until 05/02/2008
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 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.8 - Undesirable Effects
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 9 - Date of Renewal of Authorisation
  • Change to section 10 (date of (partial) revision of the text
Updated on 17/06/2005 and displayed until 19/12/2005
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 28/09/2004 and displayed until 17/06/2005
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 8 - MA number
  • Change to section 10 (date of (partial) revision of the text
Updated on 25/07/2001 and displayed until 28/09/2004
Reasons for adding or updating:
  • Change from datasheet to SPC

Active Ingredients/Generics

 
  calcium folinate