Summary of Product Characteristics
last updated on the eMC:
04/08/2010
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 04/08/2010 and displayed until Current
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Reasons for adding or updating:
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Change to section 6. 5 - Nature and Contents of Container
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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: 14-Dec-2009 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 6.5: 100ml, 120ml, 125ml, 150ml or 200ml Brown Type III Coated Amber Glass Bottles With Urea Formaldehyde Or Polypropylene Caps, Each With A Cellulose/Aluminium/Melinex Wad Liner has been changed to:
100ml, 120ml, 125ml, 150ml or 200ml Brown Type III Coated Amber Glass Bottles with two piece crab claw seal (polypropylene) child resistant closure. Composed of two parts; an outer and inner part. The outer part does not come into contact with the product, whereas the inner part is in contact with the product. Not all pack sizes may be marketed
Section 10: June 1998 has been changed to December 2009
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Updated on 02/11/2007 and displayed until 04/08/2010
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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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