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MAVENCLAD 10 mg Tablets

  • Name:

    MAVENCLAD 10 mg Tablets

  • Company:
    info
  • Active Ingredients:

    Cladribine

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 17/01/20

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Summary of Product Characteristics last updated on medicines.ie: 25/2/2021

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Merck

Merck

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Medicine Name MAVENCLAD 10 mg Tablets Active Ingredients Cladribine
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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 25 February 2021 SPC

Reasons for updating

  • Change to section 6.3 - Shelf life

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

Free text change information supplied by the pharmaceutical company

Change in shelf-life from 3 to 4 years. 

(Company ref: TW2759994)

Updated on 17 January 2020 SPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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 17 January 2020 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - driving and using machines
  • Change to section 6 - date of revision

Updated on 7 June 2019 Ed-Ptnt

Reasons for updating

  • Add New Doc

Updated on 20 August 2018 SPC

Reasons for updating

  • Correction of spelling/typing errors

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

Updated on 10 July 2018 SPC

Reasons for updating

  • 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 not be renewed (A)

Updated on 10 July 2018 PIL

Reasons for updating

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

Updated on 23 April 2018 Ed-HCP

Reasons for updating

  • Add New Doc

Updated on 18 December 2017 SPC

Reasons for updating

  • New SPC for new product

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

Updated on 18 December 2017 SPC

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties
  • 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

$0- In section 5.1 (Pharmacodynamic properties), text has been changed to  Pharmacotherapeutic group: SelectiveImmunosuppressants, ATC code:  L04AA40.$0$0- In section 10 (Date of revision of the text),  has changed to 12/2017. $0

Updated on 11 September 2017 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

None provided

Updated on 11 September 2017 PIL

Reasons for updating

  • New PIL for new product

  • MAVENCLAD 10mg Tabs (cladribine)-Prescriber GuideRisk Minimisation Materials

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  • MAVENCLAD 10mg Tablets (cladribine)-Patient GuideRisk Minimisation Materials

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