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Merck Serono
Bedfont Cross, Stanwell Road, Feltham, Middlesex, TW14 8NX, UK
Telephone: +44 (0)208 818 7200
Fax: +44 (0)208 818 7267
Medical Information Direct Line: +44 (0)208 818 7373
Medical Information e-mail: medinfo.uk@merckserono.net
Medical Information Fax: +44 (0)208 818 7274

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: 11/10/2010
SPC GLUCOPHAGE 500 mg and 1000mg powder for oral solution in sachets

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 11/10/2010 and displayed until Current
Reasons for adding or updating:
  • Change to joint SPC covering all presentations
Date of revision of text on the SPC:   01-Oct-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


To consolidate all SmPC's for the range so that details for tablets and powders are as similar as possible.
Updated on 07/10/2010 and displayed until 11/10/2010
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
Date of revision of text on the SPC:   01-Apr-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
The following information updated:

7.       MARKETING AUTHORISATION HOLDER

 

Merck Serono Limited

Bedfont Cross, Stanwell Road

Feltham, Middlesex

TW14 8NX

United Kingdom

 

 

8.       MARKETING AUTHORISATION NUMBER(S)

 

GLUCOPHAGE 500 mg powder for oral solution in sachets: PL 11648/0088

GLUCOPHAGE 1000 mg powder for oral solution in sachets: PL 11648/0090
Updated on 17/08/2010 and displayed until 07/10/2010
Reasons for adding or updating:
  • Change to section 5.1 - Pharmacodynamic Properties
Date of revision of text on the SPC:   01-Apr-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
The following statement added to section 5.1

'In clinical studies, use of metformin was associated with either a stable body weight or modest weight loss'
Updated on 07/04/2009 and displayed until 17/08/2010
Reasons for adding or updating:
  • New SPC for new product
Date of revision of text on the SPC:  
Legal Category:   POM
Black Triangle (CHM):   NO

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

Active Ingredients/Generics

 
  metformin hydrochloride