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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: 21/01/2010
SPC Emcor, Emcor LS

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 21/01/2010 and displayed until Current
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   13-Jul-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Change to section 7: MA Holder

From

E Merck Ltd

To

Merck Serono Ltd

Change to Section 8: MA Number

From

PL 0493/0126

PL 0493/0127


To

PL 11648/0069

PL 11648/0070

Change to sectiopn 10: Revision of date of text to reflect the date the change of ownership application was approved:

From

24 April 2009

To

13 July 2009
Updated on 15/10/2009 and displayed until 21/01/2010
Reasons for adding or updating:
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   24-Apr-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
3 April 2009 was added as date of revision of text in error as this was the date that was on the SPC fragments submitted to the MHRA in response to an RFI on 08 April 2009. The date should have been 24th April 2009, which is the date of the approval of the variation (PL00493/0127-0027) which impacts the SPC.
Updated on 15/05/2009 and displayed until 15/10/2009
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   03-Apr-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


The changes tom SPC were to include include core safety data.

 

The changes were widespread through-out document.

Updated on 04/02/2009 and displayed until 15/05/2009
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
Date of revision of text on the SPC:   03-Feb-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


The following added:

2. Qualitative and Quantitative Composition

Each tablet contains 5 mg bisoprolol hemifumarate

 

Each tablet contains 10 mg bisoprolol hemifumarate

 

For excipients, see section 6.1.

 

3. Pharmaceutical Form

Emcor LS 5 mg Tablets: Film-coated tablet. Yellowish white, heart-shaped, scored and film-coated tablets

Emcor 10 mg Tablets: Film-coated tablet. Pale orange - light orange, heart-shaped, scored and film-coated tablets
Updated on 23/10/2008 and displayed until 04/02/2009
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Date of revision of text on the SPC:   22-Oct-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
change to section 7 MA Holder Address to:

7 Marketing Authorisation Holder

 

E. Merck Ltd.  

Bedfont Cross, Stanwell Road

Feltham, Middlesex

TW14 8NX, UK
Updated on 20/11/2007 and displayed until 23/10/2008
Reasons for adding or updating:
  • Change to section 6.1 - List of Excipients
Date of revision of text on the SPC:   11/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Changed
 
6         Pharmaceutical Particulars
6.1      List of excipients
 
Tablet core: silicon dioxide, magnesium stearate, insoluble poly (1- vinyl - 2 - pyrrolidone) microcrystalline cellulose, corn starch, calcium hydrogen phosphate.
 
Film coating: Iron oxide yellow (E172), Iron oxide red (E172) (10mg only), dimethicone, macrogol 400, titanium dioxide (E171), hypromellose.
 
To
 
6         Pharmaceutical Particulars
6.1      List of excipients
 

Tablet core: silica, colloidal anhydrous; magnesium stearate;  crospovidone; cellulose, microcrystalline; maize starch; calcium hydrogen phosphate, anhydrous.

Film coating: iron oxide red (E172); iron oxide yellow (E172); dimethicone; macrogol 400; titanium dioxide (E171); hypromellose.
Updated on 20/04/2006 and displayed until 20/11/2007
Reasons for adding or updating:
  • Change to section 9 - Date of Renewal of Authorisation
Updated on 08/01/2003 and displayed until 20/04/2006
Reasons for adding or updating:
  • 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 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
Updated on 02/08/2001 and displayed until 08/01/2003
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 06/09/1999 and displayed until 02/08/2001
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  bisoprolol hemifumarate