Zonegran 100 mg hard capsules
- Name:
Zonegran 100 mg hard capsules
- Company:
Eisai Ltd
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may be renewed (B)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 26/01/21

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Eisai Ltd

Company Products
When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
Updated on 26 January 2021 PIL
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Updated on 26 January 2021 SPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Update to Section 4.4: Update to “Metabolic acidosis” warning: additional data stating: “Metabolic acidosis has the potential to lead to hyperammonaemia, which has been reported with or without encephalopathy during zonisamide treatment…”
Updated on 2 July 2020 PIL
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 2 July 2020 SPC
Reasons for updating
- New individual SPC (was previously included in combined SPC)
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
New individual SmPc (was previously inlcuded in combined SmPC)
SPC Section affected |
Change |
Section 7 Marketing Authorisation Holder |
Change of MAH address details:
From :
Eisai GmbH Lyoner Straße 36 60528 Frankfurt am Main Germany
Amended to:
Eisai GmbH Edmund-Rumpler-Straße 3 60549 Frankfurt am Main Germany
|
Section 10 Date of Revision of the Text |
Amended to 26 May 2020 |
Updated on 2 July 2020 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 2 July 2020 PIL
Reasons for updating
- New PIL for new product