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: 18-Mar-2010 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 6.5:
15ml glass bottle (amber III glass) mounted with an atomiser/metering unit which dispenses 0.015g (mean spray weight) of spray at each delivery.
The atomiser comprises a polypropylene body, stainless steel spring, a high-density polyethylene piston, a polyethylene terephthalate dip tube and other plastic components. has been changed to:
15ml glass bottle (amber type III glass) mounted with an atomiser/metering unit which delivers 25μg Oxymetazoline Hydrochloride per spray.
The atomiser comprises of a polypropylene body, stainless steel spring, a high-density polyethylene piston, a polyethylene terephthalate dip tube and other plastic components.
Section 10: June 2009 has been changed to March 2010
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Updated on 17/08/2009 and displayed until 04/08/2010
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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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| Date of revision of text on the SPC: 05-Jun-2009 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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4.2 Posology and method of administration
Nasal spray: for topical nasal use.
Adults and children over 12 years: 1-2 sprays per nostril every 6-8 hours.
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Updated on 26/10/2007 and displayed until 17/08/2009
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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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