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Targretin Capsules

*
Pharmacy Only: Prescription

  • Company:

    Eisai Ltd

  • Status:

    No Recent Update

  • Legal Category:

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

  • Active Ingredient(s):

    Bexarotene

    *Additional information is available within the SPC or upon request to the company

Updated on 19 January 2023

File name

ROI Targretin SmPC.pdf

Reasons for updating

  • Document format updated

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

Updated on 19 May 2021

File name

ROI Targretin SmPC.pdf

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

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

Updated on 19 May 2021

File name

ROI Targretin PIL.pdf

Reasons for updating

  • Change to section 6 - date of revision

Updated on 12 March 2021

File name

ROI Targretin PIL.pdf

Reasons for updating

  • 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

Following name and address removed as a Manufacturer

                Eisai Manufacturing Ltd.

                Mosquito Way

                Hatfield

                AL10 9SN

                United Kingdom

 

The date of revision of text has been updated to 03/2021

Updated on 03 July 2020

File name

ROI Targretin SmPC 26 May 2020.pdf

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 03 July 2020

File name

ROI Targretin PIL 26 May 2020.pdf

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

File name

Targretin PIL_ROI (draft).pdf

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

File name

Targretin SmPC_ROI (draft).pdf

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 05 July 2018

File name

ROI Targretin PIL.pdf

Reasons for updating

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

Updated on 03 July 2018

File name

ROI Targretin PIL.pdf

Reasons for updating

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

Updated on 09 May 2018

File name

ROI_Targretin_SmPC.docx

Reasons for updating

  • New SPC for new product

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

Updated on 09 May 2018

File name

ROI_Targretin_SmPC.docx

Reasons for updating

  • New SPC for new product

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

Updated on 08 May 2018

File name

ROI_Targretin_SmPC.docx

Reasons for updating

  • New SPC for new product

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

Updated on 04 May 2018

File name

ROI Targretin PIL.pdf

Reasons for updating

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

Updated on 03 May 2018

File name

ROI_Targretin_SmPC.docx

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

File name

ROI_Targretin_SmPC.docx

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

File name

ROI_Targretin_SmPC.docx

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

File name

PIL_15396_276.pdf

Reasons for updating

  • New PIL for new product

Updated on 28 November 2017

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

Reasons for updating

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

Updated on 09 June 2015

Reasons for updating

  • New SPC for new product

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

Updated on 03 June 2015

Reasons for updating

  • Change to drug interactions
  • Change to date of revision

Updated on 25 June 2012

Reasons for updating

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