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GlaxoSmithKline UK
Stockley Park West, Uxbridge, Middlesex, UB11 1BT
Telephone: +44 (0)800 221 441
Fax: +44 (0)208 990 4328
Medical Information e-mail: customercontactuk@gsk.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: 01/02/2012
SPC Flolan Injection 1.5mg

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 01/02/2012 and displayed until Current
Reasons for adding or updating:
  • 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:   24-Jan-2012
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Section 4.8 - Adverse Events - Endocrine Disorders     - added -  Very rare Hyperthyroidism
Section 10 - updated date of revision
Updated on 29/11/2011 and displayed until 01/02/2012
Reasons for adding or updating:
  • Change to section 10 date of revision of the text
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   25-Nov-2011
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Section 4.8 - Addition of “catheter-related infections caused by organisms not always considered pathogenic (including micrococcus)” has been added to Section 4.8 of the SmPC with  frequency “common” in line with GDS 18
Section 10 - Date of revision updated
Updated on 15/07/2011 and displayed until 29/11/2011
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
Date of revision of text on the SPC:   27-Jun-2011
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Section 1 - re-insertion of black triangle
Updated on 05/07/2011 and displayed until 15/07/2011
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
  • 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 4.6 - Pregnancy and Lactation
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 6. 3 - Shelf Life
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • 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:   27-Jun-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 1 - Remove black triangle for Flolan 1.5 mg

Section 4.4 – Updated with information on Special warnings and precautions

Section 4.5 – Updated with information on interactions

Section 4.6 – Updated with information on fertility, pregnancy and lactation

Section 4.8 – Updated with information on adverse reactions

Section 4.9 – Updated with information on overdose

Section 5.1 – Typos corrected

Section 6.3 – Include a hyphen in freeze-dried

Section 6.4 – Updated Special precautions for storage

Section 6.5 – Include a hyphen in freeze-dried

Section 6.6 – Updated Special precautions for disposal and other handling

Section 8 – Updated to included GlaxoSmithKline Glycine Buffer Diluent PL 10949/0311

Section 10 - Updated with new date of revision of text
Updated on 03/10/2006 and displayed until 05/07/2011
Reasons for adding or updating:
  • 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:   09/2006
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company

For further information, please contact GlaxoSmithKline on +44 (0)800 221 441
Updated on 14/01/2005 and displayed until 03/10/2006
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Updated on 28/01/2004 and displayed until 14/01/2005
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 27/01/2004 and displayed until 28/01/2004
Reasons for adding or updating:
  • Change to section 1 - trade name
Updated on 24/09/2002 and displayed until 27/01/2004
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 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 5.3 - Preclinical Safety Data
Updated on 19/09/2002 and displayed until 24/09/2002
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.9 - Overdose
Updated on 10/01/2002 and displayed until 19/09/2002
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 6. 6 - Instruction for Use/Handling
Updated on 30/08/2001 and displayed until 10/01/2002
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 28/08/2001 and displayed until 30/08/2001
Reasons for adding or updating:
  • New SPC for new product

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