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Targretin Capsules

  • Name:

    Targretin Capsules

  • Company:
    info
  • Active Ingredients:

    Bexarotene

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 03/07/20

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XPIL

Summary of Product Characteristics last updated on medicines.ie: 3/7/2020

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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 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
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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 3 July 2020 SPC

Reasons for updating

  • 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

 

Documented changes

Sections of the SmPC

Changes/updates

Section 7. Marketing Authorisation Holder

Eisai GmbH

Lyoner Straße 36

60528 Frankfurt am Main

Germany

 

Has changed to:

Eisai GmbH

Edmund-Rumpler-Straße 3   

60549 Frankfurt am Main

Germany

Section 10 Date of Revision of the Text

Date of revision of text has been updated to 26 May 2020

Updated on 3 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

Free text change information supplied by the pharmaceutical company

Documented changes

Sections of the PIL

Changes/updates

Section 6 Contents of the pack and other information

Eisai GmbH

Lyoner Straße 36

60528 Frankfurt am Main

Germany

 

Has changed to:

Eisai GmbH

Edmund-Rumpler-Straße 3   

60549 Frankfurt am Main

Germany

 

The date of revision of text has been updated to 05/2020  

Updated on 27 February 2019 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 26 February 2019 SPC

Reasons for updating

  • 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Documented changes

Sections of the SmPC

Changes/updates

Section 7

Marketing Authorisation Holder details have been updated:

Eisai GmbH

Lyoner Straße 36

60528 Frankfurt am Main

Germany

E-mail: medinfo_de@eisai.net

Section 10

The date of revision of text has been updated to 11/2018

Updated on 5 July 2018 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions

Updated on 3 July 2018 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions

Updated on 9 May 2018 SPC

Reasons for updating

  • New SPC for new product

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

Updated on 9 May 2018 SPC

Reasons for updating

  • New SPC for new product

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

Updated on 8 May 2018 SPC

Reasons for updating

  • New SPC for new product

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

Updated on 4 May 2018 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision

Updated on 3 May 2018 SPC

Reasons for updating

  • New SPC for new product

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

Updated on 30 April 2018 SPC

Reasons for updating

  • New SPC for new product

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

Updated on 30 April 2018 SPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

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

Free text change information supplied by the pharmaceutical company

Documented changes

Sections of the SmPC

Changes/updates

Section 4.4

The following text has been added:

Psychiatric disorders
Depression, depression aggravated, anxiety, and mood alterations have been reported in patients treated with systemic retinoids, including bexarotene. Particular care should be taken in patients with a history of depression. Patients should be monitored for signs of depression and referred for appropriate treatment if necessary. Awareness by family or friends may be useful to detect mental health deterioration.

Section 4.8

Change to the formating of the tabulated adverse events

Section 10

Date of revision updated to 22 March 2018

Updated on 28 November 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 28 November 2017 PIL

Reasons for updating

  • Change to MA holder contact details
  • Improved presentation of PIL
  • Change to section 6 - date of revision

Updated on 10 September 2015 PIL

Reasons for updating

  • Change to date of revision
  • Change to MA holder contact details

Updated on 9 June 2015 SPC

Reasons for updating

  • New SPC for new product

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

Updated on 3 June 2015 PIL

Reasons for updating

  • Change to drug interactions
  • Change to date of revision

Updated on 25 June 2012 PIL

Reasons for updating

  • New PIL for medicines.ie
  • PIL Submitted in error