Gliadel

  • Name:

    Gliadel

  • Company:
    info
  • Active Ingredients:

    Carmustine

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 02/02/15

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XPIL

Summary of Product Characteristics last updated on medicines.ie: 9/2/2015
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Eisai Ltd

Eisai Ltd

Company Products

Medicine NameActive 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 Zebinix 200mg tablets Active Ingredients eslicarbazepine acetate
Medicine Name Zebinix 50 mg/ml Oral Suspension Active Ingredients eslicarbazepine acetate
Medicine Name Zebinix 800mg tablets Active Ingredients eslicarbazepine acetate
Medicine Name Zonegran capsules Active Ingredients Zonisamide
1 - 0 of 12 items.Total: Infinity pages

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 9 February 2015 SmPC

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 6.3 - Shelf life
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text
  • Change to MA holder contact details

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.8 - How to report a side effect has been added.

Section 6.3 - Shelf Life changed from 3 years to 4 years.

Section 7 - Change in Address of Marketing Authorisation Holder

From:
MGI PHARMA LIMITED
Holborn Gate, 1st Floor
330 High Holborn
London,WC1V 7QT
United Kingdom

To:

MGI PHARMA LIMITED
European Knowledge Centre
Mosquito Way
Hatfield
Hertfordshire
AL10 9SN
United Kingdom

Section 10 - Date of revision of the text has been updated.

·                 

Updated on 9 February 2015 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 2 February 2015 PIL

Reasons for updating

  • Change to date of revision
  • Change to marketing authorisation holder
  • Change to MA holder contact details
  • Change due to user-testing of patient information
  • Addition of information on reporting a side effect.

Updated on 2 February 2015 PIL

Reasons for updating

  • New PIL for new product

Updated on 21 November 2011 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

None provided

Updated on 17 October 2011 PIL

Reasons for updating

  • New PIL for medicines.ie