Summary of Product Characteristics
last updated on the eMC:
19/08/2010
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 19/08/2010 and displayed until Current
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Reasons for adding or updating:
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Change to section 1 -Name of the Medicinal product
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Change to section 4.2 - Posology and method of administration
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Change to section 4.3 - Contraindications
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Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
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Change to section 9 - Date of first Authorisation/renewal of the Authorisation
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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-May-2010 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 1 - Product name changed to Vicks Sinex Soother Nasal Spray
Section 4.2 - Posology changed to: Adults and children over 12 years: 1-2 sprays up each nostril maximum 2-3 times daily.
Not recommended for use in children under 12yrs.
Section 4.3 - Where there is demonstrated hypersensitivity or idiosyncrasy to any ingredient in the product has been replaced with
In case of hypersensitivity to the active substance or to any of the excipients.
by children under 6 years of age has been replaced with by children under 12 years of age
Section 8 - Marketing Authoristion Number has been changed to PL 00129/0356
Section 9 - Date of First Authorisation has been changed to 17/05/2010
Section 10 - Revision of text has been changed to 17/05/2010
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Updated on 26/10/2007 and displayed until 19/08/2010
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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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