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Methotrexate Orion 10 mg tablets

  • Name:

    Methotrexate Orion 10 mg tablets

  • Company:
    info
  • Active Ingredients:

    Methotrexate disodium

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 14/04/21

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Summary of Product Characteristics last updated on medicines.ie: 14/4/2021

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Orion Pharma (Ireland) Ltd

Orion Pharma (Ireland) Ltd

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Medicine Name Indivina 2 mg/5 mg tablets Active Ingredients Estradiol valerate, Medroxyprogesterone Acetate
Medicine Name Methotrexate Orion 10 mg tablets Active Ingredients Methotrexate disodium
Medicine Name Methotrexate Orion 2.5 mg tablets Active Ingredients Methotrexate disodium
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Medicine Name Stalevo 200 mg/50 mg/200 mg film-coated tablets Active Ingredients Carbidopa, Entacapone, Levodopa
Medicine Name Stalevo 50 mg/12.5 mg/200 mg film-coated tablets Active Ingredients Carbidopa, Entacapone, Levodopa
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1 - 0 of 23 items.Total: Infinity pages

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 14 April 2021 SPC

Reasons for updating

  • Correction of spelling/typing errors

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

Free text change information supplied by the pharmaceutical company

Correction of typing errors

Updated on 14 April 2021 SPC

Reasons for updating

  • Change to section 9 - Date of first authorisation/renewal of the 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

The marketing authorisation has been renewed, so the date of the revision of text has been updated. 

Updated on 14 April 2021 PIL

Reasons for updating

  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

The marketing authorisation has been renewed, so the date of the revision of text has been updated.  

Updated on 27 August 2020 PIL

Reasons for updating

  • Change to section 6 - what the product looks like and pack contents

Free text change information supplied by the pharmaceutical company

Addition of a blister pack of 4 tablets to pack sizes for Methotrexate Orion 10mg Tablets.

Updated on 27 August 2020 SPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

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

Free text change information supplied by the pharmaceutical company

Addition of a blister pack of 4 tablets to pack sizes.

Updated on 5 August 2020 PIL

Reasons for updating

  • New PIL for new product

Free text change information supplied by the pharmaceutical company

The leaflet has been updated to include an alternative closure to the bottle (section 6.5).

Updated on 5 August 2020 SPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

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

Free text change information supplied by the pharmaceutical company

The SPC has been updated to include an alternative closure to the bottle (section 6.5).

Updated on 8 June 2020 Ed-Both

Reasons for updating

  • Add New Doc

Updated on 8 June 2020 Ed-HCP

Reasons for updating

  • Add New Doc

Free text change information supplied by the pharmaceutical company

Checklist for Physicians who prescribe Methotrexate - Information to minimise the risk of potentially fatal dosing errors

Updated on 8 June 2020 Ed-HCP

Reasons for updating

  • Add New Doc

Free text change information supplied by the pharmaceutical company

Checklist for Community Pharmacists who dispense Methotrexate- Information to minimise the risk of potentially fatal dosing errors

Updated on 8 June 2020 Ed-HCP

Reasons for updating

  • Add New Doc

Free text change information supplied by the pharmaceutical company

Checklist for Hospital Pharmacists who dispense Methotrexate- Information to minimise the risk of potentially fatal dosing errors

Updated on 25 November 2019 SPC

Reasons for updating

  • New SPC for new product

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

Free text change information supplied by the pharmaceutical company

This is the first publication of an SmPC for Methotrexate Orion 10mg tablets.

  • Checklist for Hospital Pharmacists who dispense MethotrexateRisk Minimisation Materials

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  • Checklist for Community Pharmacists who dispense MethotrexateRisk Minimisation Materials

    files-icon(Click to Download)

  • Checklist for Physicians who prescribe MethotrexateRisk Minimisation Materials

    files-icon(Click to Download)