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Forest Laboratories UK Limited
Riverbridge House, Anchor Boulevard, Crossways Business Park, Dartford, Kent, DA2 6SL
Telephone: +44 (0)1322 421 800
Fax: +44 (0)1322 291 306
WWW: http://www.forestlabs.com
Medical Information e-mail: medinfo@forest-labs.co.uk

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: 08/01/2010
SPC Colomycin Injection

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 08/01/2010 and displayed until Current
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-Dec-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 7 - Marketing Authorisation Holder needs to be amended to the new address, so that it shoudl read as follows;

Forest Laboratories UK Limited
Riverbridge House
Anchor Boulevard
Crossways Business Park
Dartford
Kent DA2 6SL
UK

section 10 Date of revision of the text shoudl be updated to read as follows;

December 2009
Updated on 03/08/2009 and displayed until 08/01/2010
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   24-Jul-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Colomycin Injection 500,000 IU/vial has been discontinued and therefore information regarding this strength has been removed from sections 2, 3, 6.5, 8 and 9.  Section 10 has been updated to show 'July 2009'.

The Colomycin Injection 1 million and 2 million IU/vial strengths remain.
Updated on 27/10/2008 and displayed until 03/08/2009
Reasons for adding or updating:
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   07-Nov-2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 6.4

The sentence 'For storage of solutions following reconstitution refer to 6.3' has been added.

Section 6.5

From:    Type 1 glass vials in outer cartons of 10.

To:        500,000 IU/vial:    Type 1 glass vial with a blue 'flip-off' cap supplied in cartons of ten vials.
            1 million IU/vial:    Type 1 glass vial with a red 'flip-off' cap supplied in cartons of ten vials.
            2 million IU/vial:    Type 1 glass vial with a lilac 'flip-off' cap supplied in cartons of ten vials.

Section 9

The date of renewal of the authorisation has been updated to November 2006.

Section 10

The date of revision of the text has been updated to November 2006.
Updated on 03/05/2006 and displayed until 27/10/2008
Reasons for adding or updating:
  • Change to section 1 - trade name
  • Change to section 3 - pharmaceutical form
  • Change to section 10 (date of (partial) revision of the text
Date of revision of text on the SPC:   17/04/06
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
'For infusion' has been added in the pharmaceutical form in sections 1 and 3.
Updated on 24/12/2004 and displayed until 03/05/2006
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 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 6. 6 - Instruction for Use/Handling
Updated on 11/06/2003 and displayed until 24/12/2004
Reasons for adding or updating:
  • Addition of new strength
Updated on 20/01/2003 and displayed until 11/06/2003
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Updated on 13/11/2002 and displayed until 20/01/2003
Reasons for adding or updating:
  • Change to section 6. 3 - Shelf Life
  • Change to section 6. 4 - Special Precautions for Storage
Updated on 08/10/2002 and displayed until 13/11/2002
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 03/12/2001 and displayed until 08/10/2002
Reasons for adding or updating:
  • Change to section 4.2 - Posology and Method of Administration
Updated on 18/09/2001 and displayed until 03/12/2001
Reasons for adding or updating:
  • Addition of Legal Category
Updated on 14/08/2001 and displayed until 18/09/2001
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 06/09/1999 and displayed until 14/08/2001
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  colistimethate sodium