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Zonegran 50 mg hard capsules

  • Name:

    Zonegran 50 mg hard capsules

  • Company:
    info
  • Active Ingredients:

    Zonisamide

  • 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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Summary of Product Characteristics last updated on medicines.ie: 26/1/2021

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Eisai Ltd

Eisai Ltd

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Medicine Name Zonegran 50 mg hard capsules Active Ingredients Zonisamide
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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

  • 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