Summary of Product Characteristics
last updated on the eMC:
24/04/2012
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 24/04/2012 and displayed until Current
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Reasons for adding or updating:
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Change of Marketing Authorisation Holder
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| Date of revision of text on the SPC: 06-Apr-2012 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Please note changes highlighted in red below:
7. MARKETING AUTHORISATION HOLDER
Alliance Pharmaceuticals Ltd
Avonbridge House
Bath Road
Chippenham
Wiltshire
SN15 2BB
8. MARKETING AUTHORISATION NUMBER(S)
PL 16853/0130
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Updated on 01/11/2010 and displayed until 24/04/2012
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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 4.5 - Interaction with other medicinal products and other forms of interaction
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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: 01-Sep-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.4 - Extra paragraph relating to the elderly
Section 4.5 - additional sub sections 2) and 3) added
Section 4.8 - revisions to wording
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Updated on 23/09/2010 and displayed until 01/11/2010
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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 4.5 - Interaction with other medicinal products and other forms of interaction
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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: 01-Sep-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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all revisons due to safety update.
Section 4.4 - additional information added
Section 4.5 - additional information added
Section 4.8 - additonal information/headings added
Section 10 - date of revison changes to 01 September 2010
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Updated on 21/12/2009 and displayed until 23/09/2010
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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 4.8 - Undesirable Effects
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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: 27-Nov-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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In section 4.1 added - Children 6 months - 18 years
In section 4.2 heading amended to read - Adults (including elderly) and adolescents (12 years and older)
In section 4.2 heading amended to read - Children/infants (6 months to 11 years) and additional information included in section
In section 4.8 added at the end a statement relating to safety of ranitidine in children 0 - 16 years.
In section 5.1 added at the end a statement concerning clinical data.
In section 5.2 added information on Special Patient Polulations and Neonates (under 1 month)
In section 10 - revision date added
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Updated on 16/10/2009 and displayed until 21/12/2009
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Reasons for adding or updating:
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| Date of revision of text on the SPC: |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| None provided |
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