Zonegran 50 mg hard capsules
- Name:
Zonegran 50 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: 12/03/21
(Click to Download)Click on this link to Download PDF directly
Eisai Ltd
Company Products
| Medicine Name | Active Ingredients |
|---|---|
| Medicine Name Fycompa 0.5 mg/ml oral suspension | Active Ingredients Perampanel |
| Medicine Name Fycompa tablets | Active Ingredients Perampanel |
| Medicine Name Gliadel | Active Ingredients Carmustine |
| Medicine Name Halaven 0.44 mg/ml solution for injection | Active Ingredients Eribulin mesylate |
| Medicine Name Inovelon Oral Suspension | Active Ingredients Rufinamide |
| Medicine Name Inovelon Tablets | Active Ingredients Rufinamide |
| Medicine Name Lenvima (lenvatinib) | Active Ingredients Lenvatinib mesilate |
| Medicine Name Targretin Capsules | Active Ingredients Bexarotene |
| Medicine Name Zonegran 100 mg hard capsules | Active Ingredients Zonisamide |
| Medicine Name Zonegran 25 mg hard capsules | Active Ingredients Zonisamide |
| Medicine Name Zonegran 50 mg hard capsules | Active Ingredients Zonisamide |
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 12 March 2021 PIL
Reasons for updating
- Change to section 6 - manufacturer
- Change to other sources of information section
Free text change information supplied by the pharmaceutical company
Update manufacturing site details: Removing Hatfield site and leaving Eisai GmbH Germany site.
Update contact details to: United Kingdom (Northern Ireland)
Eisai GmbH -Tel: +49 (0) 69 66 58 50 (Germany)
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
- New individual PIL (was previously included in a combined PIL)
- 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 included 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)
Free text change information supplied by the pharmaceutical company
New individual SPC (was previously inlcuded in joint SPC)
Updated on 2 July 2020 PIL
Reasons for updating
- New PIL for new product