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Exelon 1.5 mg, 3.0 mg, 4.5 mg, 6.0 mg hard capsules

*
Pharmacy Only: Prescription

  • Company:

    Novartis Ireland Limited

  • Status:

    No Recent Update

  • Legal Category:

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

  • Active Ingredient(s):

    Rivastigmine Hydrogen Tartrate

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

Updated on 26 May 2023

File name

Exelon Hard Caps_REG PIL_PF23-0102_14.04.2023_clean_Barcelona.pdf

Reasons for updating

  • New PIL for new product

Updated on 26 May 2023

File name

Exelon Hard Caps_REG SPC_PF23-0102_14.04.2023_clean.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

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

Updated on 23 November 2022

File name

EXELON-Caps REGPIL PF22-0227_Clean_Nov 2022.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation number

Updated on 23 November 2022

File name

Exelon Hard Caps_REG SPC_PF22-0227_Nov 2022_clean.pdf

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • Change to section 8 - Marketing authorisation number(s)

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

Updated on 19 January 2022

File name

Exelon Hard Caps_REG PIL_PF21161_10.05.2021_Clean.pdf

Reasons for updating

  • Change to name of manufacturer

Updated on 09 August 2021

File name

Exelon Caps REGSPC PF 20-0265_ Nov 2020 Clean.pdf

Reasons for updating

  • Change to section 5.2 - Pharmacokinetic properties

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

Updated on 10 December 2019

File name

Exelon Caps REGPIL PF 18-0110 April 2018 IPHA.pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 10 December 2019

File name

Exelon Caps PIL 1139630_A18_IE_p2_LFT_X-4 RA approved 25.06.2018 IPHA.pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 09 May 2019

File name

Exelon Caps PIL 1139630_A18_IE_p2_LFT_X-4 RA approved 25.06.2018 IPHA.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 08 April 2019

File name

Exelon Hard Caps REGSPC May 2018_IPHA.pdf

Reasons for updating

  • File format updated to PDF

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

Updated on 22 January 2019

File name

PIL_8505_142.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number

Updated on 21 May 2018

File name

Exelon Hard Caps REGSPC May 2018_Clean.docx

Reasons for updating

  • 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

Address change BREXIT

Updated on 08 February 2018

Reasons for updating

  • New SPC for new product

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

Updated on 08 February 2018

Reasons for updating

  • Improved presentation of SPC
  • Change from individual to joint SPC

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

Free text change information supplied by the pharmaceutical company

SmPCs have been combined, some typographical changes have been made

Updated on 19 May 2016

File name

PIL_8505_142.pdf

Reasons for updating

  • New PIL for new product

Updated on 19 May 2016

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 03 September 2015

Reasons for updating

  • Change to MA holder contact details
  • Addition of information on reporting a side effect.

Updated on 28 April 2015

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 14 March 2014

Reasons for updating

  • Removal/change of distributor

Updated on 28 May 2013

Reasons for updating

  • Change to further information section

Updated on 06 March 2013

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to storage instructions
  • Correction of spelling/typing errors

Updated on 05 March 2013

Reasons for updating

  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change to storage instructions
  • Change to information about pregnancy or lactation

Updated on 26 September 2012

Reasons for updating

  • Addition of information on alternative format leaflets

Updated on 08 August 2012

Reasons for updating

  • Change to section 10 - Date of revision of the text
  • Joint SPC superseded by SPCs for individual presentations

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

Free text change information supplied by the pharmaceutical company

Update to Revision Date

Updated on 16 April 2009

Reasons for updating

  • Change to side-effects

Updated on 24 February 2009

Reasons for updating

  • Change to section 4.8 - Undesirable effects

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

Free text change information supplied by the pharmaceutical company

4.8 updated to include additional AE's observed with the transdermal patches

Updated on 03 September 2008

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 9 - Date of renewal of authorisation
  • 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

 Changes to Sections 4.2, 4.5 , 4.7 , 4.8,  and 9 and 10. following renewal assessment.

Updated on 10 November 2006

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties

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

Free text change information supplied by the pharmaceutical company

Update to Sections 4.4 and 4.8 of the SPC and section 4 of the PIL in relation to vomiting associated with oesophageal rupture and elevated liver function tests.

In addition, some clarifications have been introduced in section 5.1 of the SPC

Updated on 18 May 2006

Reasons for updating

  • Change to, or new use for medicine

Updated on 31 March 2006

Reasons for updating

  • Change to section 4.1 - Therapeutic indications

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

Updated on 25 August 2004

Reasons for updating

  • New PIL for medicines.ie

Updated on 10 July 2003

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.1 - List of excipients
  • Change to section 9 - Date of renewal of authorisation
  • 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 30 June 2003

Reasons for updating

  • New SPC for medicines.ie

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