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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: 12/10/2010
SPC Glucophage 500 mg and 850 mg film coated 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 12/10/2010 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 12/10/2010
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:

1.                  MARKETING AUTHORISATION HOLDER

 

Merck Serono Limited

Bedfont Cross, Stanwell Road, Feltham, Middlesex, TW14 8NX, UK

 

 

2.                  MARKETING AUTHORISATION NUMBER(S)

 

PL 11648/0085-0086
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 21/04/2010 and displayed until 17/08/2010
Reasons for adding or updating:
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
  • Change to section 7 - Marketing Authorisation Holder
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


Change to section 7: MA Holder

Merck Serono Limited, Bedfont Cross, Stanwell Road, Feltham, Middlesex, TW14 8NX, UK

Change to section 8: MA Number

PL 11648/0085-0086

 
Updated on 27/11/2009 and displayed until 21/04/2010
Reasons for adding or updating:
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   03-Nov-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Incorrect date of revision of text was previously provided.
Updated on 01/05/2009 and displayed until 27/11/2009
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
Date of revision of text on the SPC:   01-Oct-2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.4 - update of surgery warning

Section 5.1 Addition of ATC Code

ATC code: A10BA02



Date of Renewal:

9. DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION

 

01/10/2007
Updated on 21/04/2005 and displayed until 01/05/2009
Reasons for adding or updating:
  • Change to section 4.3 - Contra-indications
  • Change to section 4.8 - Undesirable Effects
Updated on 15/06/2004 and displayed until 21/04/2005
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic Indications
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 6. 5 - Nature and Contents of Container
Updated on 25/06/2003 and displayed until 15/06/2004
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
Updated on 20/09/2002 and displayed until 25/06/2003
Reasons for adding or updating:
  • Change to section 3 - pharmaceutical form
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 9 - Date of Renewal of Authorisation
Updated on 25/06/2001 and displayed until 20/09/2002
Reasons for adding or updating:
  • No reasons supplied
Updated on 15/03/2001 and displayed until 25/06/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 19/04/2000 and displayed until 15/03/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 06/09/1999 and displayed until 19/04/2000
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  metformin hydrochloride