Summary of Product Characteristics
last updated on the eMC:
07/08/2008
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 07/08/2008 and displayed until Current
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Reasons for adding or updating:
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Change to section 6. 3 - Shelf Life
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| Date of revision of text on the SPC: 25-Jul-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| In section 6.3 the expiry date for EpiPen 0.15mg has been changed from 20 months to 18 months.
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Updated on 17/04/2008 and displayed until 07/08/2008
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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: 03/2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.2 - The following information has been added to the EpiPen Jr SPC:
The repeated injection may be administered after about 5 - 15 minutes.
As EpiPen Jr. is designed as emergency treatment only, the patient should be advised always to seek medical help immediately.
EpiPen Jr. Auto-Injector 0.15 mg is recommended for children weighing 15 - 30 kg. For children weighing more than 30 kg, EpiPen Auto-Injector 0.3 mg (adult formulation) is recommended.
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Updated on 13/03/2007 and displayed until 17/04/2008
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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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