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Erdotin 300mg Capsules

*
Pharmacy Only: Prescription

  • Company:

    Galen Pharma Ireland Limited

  • Status:

    No Recent Update

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

  • Active Ingredient(s):

    Erdosteine

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

Updated on 23 January 2023

File name

04-1.pdf

Reasons for updating

  • Document format updated

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 27 June 2019

File name

04-1.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number
  • Change to section 6 - date of revision

Updated on 27 June 2019

File name

04-1.pdf

Reasons for updating

  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 17 August 2018

File name

Erdotin IE SPC.pdf

Reasons for updating

  • File format updated to PDF

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 17 August 2018

File name

Erdotin IE SPC.pdf

Reasons for updating

  • File format updated to PDF

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 17 August 2018

File name

Erdotin UK SPC.pdf

Reasons for updating

  • File format updated to PDF

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 26 November 2015

File name

PIL_12409_531.pdf

Reasons for updating

  • New PIL for new product

Updated on 26 November 2015

Reasons for updating

  • Change to date of revision

Updated on 10 July 2015

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 10 July 2015

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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

In section 7 (Change in Marketing Authorisation Holder) - Change in the address of Edmond Pharma, who are the MA Holder, drug product manufacturer and manufacturer of the active substance.  The updated address is:

Edmond Pharma S.r.l.

Strada Statale dei Giovi 131

20037 Paderno Dugnano MI Italy

  • In section 4.8 (undesirable Effects) -     The inclusion of the ADR wording within the SPC.

Updated on 07 July 2015

Reasons for updating

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

Updated on 29 May 2012

Reasons for updating

  • Change to section 9 - Date of renewal of authorisation

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

In Section 9, Date of last renewal has been updated to 27th September 2011.

Updated on 28 May 2012

Reasons for updating

  • Change to MA holder contact details

Updated on 24 May 2012

Reasons for updating

  • Change to MA holder contact details
  • SPC retired pending re-submission

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 7, change to MA holder address.

Updated on 19 March 2010

Reasons for updating

  • Change to date of revision
  • Removal/change of distributor

Updated on 27 August 2007

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 27 August 2007

Reasons for updating

  • New PIL for new product