Summary of Product Characteristics
last updated on the eMC:
16/12/2010
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 16/12/2010 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.2 - Posology and method of administration
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 5.2 - Pharmacokinetic Properties
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 13-Dec-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section
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Summary of change
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4.2
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Details on patients over 50 added, word ‘severe’ removed from renal impairment text.
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4.4
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Word ‘severe’ removed from renal impairment text, post marketing data added
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5.2
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Whole section reworded
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10
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Date of approval added
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Updated on 29/11/2010 and displayed until 16/12/2010
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Reasons for adding or updating:
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Change to section 4.3 - Contraindications
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Change to section 4.8 - Undesirable Effects
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 25-Oct-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section
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Summary of change
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4.3
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Renal disease section updated
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4.8
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Adverse event titles updated – whole section updated
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10.
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Date of approval added
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Updated on 14/04/2009 and displayed until 29/11/2010
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 10-Mar-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 4.8 - To include breast disorder type reactions associated with ranitidine
Section 10 - Date change to: 10 March 2009
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Updated on 05/01/2009 and displayed until 14/04/2009
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Reasons for adding or updating:
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Change to section 4.2 - Posology and method of administration
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 18-Dec-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.2 - To include statement on Renal Impairment and creatinine clearance
Section 10 - Date Change to 18 December 2008
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Updated on 19/11/2008 and displayed until 05/01/2009
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Reasons for adding or updating:
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Change to section 3 - Pharmaceutical form
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 17-Nov-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 3 - Injection (Aqueous solution)
A clear colourless to pale yellow liquid, practically free from particles
(Add the bold text above)
Section 10 - 17 November 2008 (delete 7 October 2008)
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Updated on 20/10/2008 and displayed until 19/11/2008
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Reasons for adding or updating:
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Change to section 4.1 - Therapeutic indications
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Change to section 4.2 - Posology and method of administration
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Change to section 5.1 - Pharmacodynamic Properties
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Change to section 5.2 - Pharmacokinetic Properties
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 07-Oct-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.1 - changed headed to Children 6 months to 18 years
Section 4.2 - added paragraph on Prophylaxis of stress ulceration in seriously ill patients
Section 5.1 - added paragraph on use of ranitidine in children to prevent stress ulcers
Section 5.2 - changes to Special Patient Populations
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Updated on 02/05/2007 and displayed until 20/10/2008
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 21/08/2006 and displayed until 02/05/2007
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Reasons for adding or updating:
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Change to section 4.4 - Special Warnings and Precautions for Use
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Change to section 10 (date of (partial) revision of the text
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Change from BAN to rINN
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| Date of revision of text on the SPC: 08/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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For further information, please contact GlaxoSmithKline on +44 (0)800 221 441
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Updated on 24/07/2006 and displayed until 21/08/2006
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Reasons for adding or updating:
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New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
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