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Erdotin 300mg Capsules

  • Name:

    Erdotin 300mg Capsules

  • Company:
    info
  • Active Ingredients:

    Erdosteine

  • 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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Summary of Product Characteristics last updated on medicines.ie: 27/6/2019

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Galen Pharma Ireland Limited

Galen Limited

Company Products

Medicine NameActive Ingredients
Medicine Name Erdotin 300mg Capsules Active Ingredients Erdosteine
Medicine Name Kapake 15mg/500mg Tablets Active Ingredients Codeine Phosphate Hemihydrate, Paracetamol
Medicine Name Kapake 30mg/500mg Tablets Active Ingredients Codeine Phosphate, Paracetamol DC
Medicine Name Laxido Orange, powder for oral solution Active Ingredients Macrogol 3350, Potassium Chloride, Sodium Chloride, Sodium Hydrogen Carbonate
Medicine Name Laxido Paediatric Plain, 6.9 g sachet, powder for oral solution. Active Ingredients Macrogol 3350, Potassium Chloride, Sodium Chloride, Sodium Hydrogen Carbonate
Medicine Name PENTHROX 3mL inhalation vapour, liquid Active Ingredients Methoxyflurane
Medicine Name THORENS 10 000 I.U. /ml oral drops, solution Active Ingredients Colecalciferol (Vitamin D3)
Medicine Name THORENS 25 000 I.U. /2.5 ml oral solution Active Ingredients Colecalciferol (Vitamin D3)
Medicine Name Tramake 100mg Tablets Active Ingredients Tramadol Hydrochloride
Medicine Name Tramake 50mg Tablets Active Ingredients Tramadol Hydrochloride
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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 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 SmPC

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 SmPC

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 SmPC

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 SmPC

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 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 10 July 2015 SmPC

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 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 SmPC

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 PIL

Reasons for updating

  • Change to MA holder contact details

Updated on 24 May 2012 SmPC

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 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 SmPC

Reasons for updating

  • New SPC for new product

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