Erdotin 300mg Capsules
- Name:
Erdotin 300mg Capsules
- Company:
Galen Pharma Ireland Limited
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may be renewed (B)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 27/06/19

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Galen Pharma Ireland Limited

Company Products
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 27 June 2019 PIL
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 SPC
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 SPC
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 SPC
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 SPC
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 PIL
Reasons for updating
- New PIL for new product
Updated on 26 November 2015 PIL
Reasons for updating
- Change to date of revision
Updated on 10 July 2015 SPC
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 SPC
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
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 7 July 2015 PIL
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 SPC
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
Updated on 28 May 2012 PIL
Reasons for updating
- Change to MA holder contact details
Updated on 24 May 2012 SPC
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
Updated on 19 March 2010 PIL
Reasons for updating
- Change to date of revision
- Removal/change of distributor
Updated on 27 August 2007 PIL
Reasons for updating
- New PIL for new product
Updated on 27 August 2007 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)