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Astellas Pharma Ltd
3rd Floor, Future House, The Glanty, Egham, Surrey, TW20 9AH
Telephone: +44 (0)1784 419615
Fax: +44 (0)1784 419583
Medical Information Direct Line: 0800 783 5018
Medical Information e-mail: medinfo@gb.astellas.com

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: 04/05/2012
SPC Modigraf 0.2mg & 1mg granules for oral suspension

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 04/05/2012 and displayed until Current
Reasons for adding or updating:
  • Removal of Black Triangle
Date of revision of text on the SPC:   05-Sep-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
The Black Triangle has been removed from Section 1.
Updated on 29/09/2011 and displayed until 04/05/2012
Reasons for adding or updating:
  • 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 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   05-Sep-2011
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company


Section  4.4 Special warnings and precautions for use

Addition of text:

Pure Red Cell Aplasia

Cases of pure red cell aplasia (PRCA) have been reported in patients treated with tacrolimus. All patients reported risk factors for PRCA such as parvovirus B19 infection, underlying disease or concomitant medications associated with PRCA.

 

Section 4.5 Interaction with other medicinal products and other forms of interaction

Lansoprazole has had the ‘e’ added to correct the spelling.

 

 

Section 4.8 Undesirable effects

Blood and lymphatic system disorders : pure red cell aplasia has been added to the Undesirable effects, with the frequency as not known.

 

 

Section 10 Date of Revision of Text
Date of revision updated
Updated on 25/01/2010 and displayed until 29/09/2011
Reasons for adding or updating:
  • New SPC for new product
Date of revision of text on the SPC:  
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
None provided

Active Ingredients/Generics

 
  tacrolimus monohydrate