Summary of Product Characteristics
last updated on the eMC:
08/11/2011
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 08/11/2011 and displayed until Current
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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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Change to section 4.8 - Undesirable Effects
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Change to section 5.2 - Pharmacokinetic Properties
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Change to section 6. 3 - Shelf Life
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| Date of revision of text on the SPC: 19-Oct-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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4.2 & 5.2: Sentences sentences related to hard capsules issued from the Topiramate referral. Typographical error - one "sentence" has been removed
4.8: Table 1: "Psychiatric disorders - no ADR hallucination auditory included" is changed to "Psychiatric disorders - an ADR hallucination auditory is added to comply with the Topiramate referral".
6.3: Shelf-life: 2 years has been changed to 2 years for 25mg strength with blister and vials and 50mg, 100mg & 200mg strengths with vial as primary packaging. 3 years for Topiramate 50mg, 100mg and 200mg strengths with blister as primary packaging approved through the variation no. DE/H/1031/002-004/IB/005.
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Updated on 04/11/2009 and displayed until 08/11/2011
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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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