MAVENCLAD 10 mg Tablets

*
Pharmacy Only: Prescription
  • Company:

    Merck
  • Status:

    No Recent Update
  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)
  • Active Ingredient(s):

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

EDM Updated on 12 November 2024

File name

20887-Merck-Mavenclad-Patient guide_IE-v03.01.pdf

Reasons for updating

  • Replace File

Free text change information supplied by the pharmaceutical company

Dosage scheme update

EDM Updated on 12 November 2024

File name

20887-Merck-Mavenclad-Prescribers guide-IE_v03.01.pdf

Reasons for updating

  • Replace File

Free text change information supplied by the pharmaceutical company

Dosage scheme update

Updated on 28 August 2024

File name

SmPC Mavenclad 10mg NI and ROI TW4277856 current v10.0.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.1 - Pharmacodynamic properties

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

Free text change information supplied by the pharmaceutical company

Update of the product information to include additional information on the possibility of serious infections. 

Internal reference No.: TW 4277856

Updated on 28 August 2024

File name

PIL Mavenclad 10mg IE NI TW4277856 current.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions

Free text change information supplied by the pharmaceutical company

Update of the product information to include additional information on the possibility of serious infections. 

Internal reference No.: TW 4277856

EDM Updated on 19 February 2024

File name

20826-Merck-Mavenclad-Patient_guide_IE-v02.01 - Final version.pdf

Reasons for updating

  • Add New Doc

EDM Updated on 19 February 2024

File name

20826-Merck-Mavenclad-Prescribers_guide-IE_v02.01 - Final version.pdf

Reasons for updating

  • Add New Doc

Updated on 22 January 2024

File name

SPC-Mavenclad 10mg NI and ROI TW4062072 current v9.0.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation

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

Updated on 22 January 2024

File name

PIL-Mavenclad 10mg IE NI TW4062072 current.pdf

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility

EDM Updated on 01 June 2022

File name

Final-Merck-Mavenclad-Patient_guide_HPRAv2.pdf

Reasons for updating

  • Add New Doc

Free text change information supplied by the pharmaceutical company

Approved educational materials, updated for liver injury update for Mavenclad.  

EDM Updated on 01 June 2022

File name

Merck-Mavenclad-Prescribers_guide-HPRA_Final_May_2022.pdf

Reasons for updating

  • Add New Doc

Free text change information supplied by the pharmaceutical company

Approved educational materials, updated for liver injury update for Mavenclad.  

Updated on 11 May 2022

File name

SPC_Mavenclad 10mg NI and ROI TW3067610 current v8.0.pdf

Reasons for updating

  • Change due to harmonisation of SPC

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

Free text change information supplied by the pharmaceutical company

Typo error rectified.

Updated on 04 May 2022

File name

SPC_Mavenclad 10mg NI and ROI TW3067610 current v8.0.pdf

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • 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 Summary of Product Characteristics has changed with editorial changes throughout.

Internal Reference number: TW 3067610

Updated on 04 May 2022

File name

PIL_Mavenclad 10mg IE NI TW3067610 current.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

The PIL has changed with editorial changes.

Internal Reference number: TW 3067610

Updated on 11 March 2022

File name

SPC_Mavenclad 10mg NI and ROI TW2914633 current v7.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

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

Free text change information supplied by the pharmaceutical company

Update of section 4.4 of the SmPC to include a warning on liver function

Update of section 4.8 of the SmPC to include the adverse reaction liver injury

Internal Reference: TW2914633

Updated on 11 March 2022

File name

PIL_Mavenclad 10mg IE NI TW2914633 current.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects

Free text change information supplied by the pharmaceutical company

Change to section 2 - what you need to know - warnings and precautions

Change to section 4 - possible side effects 

Internal reference: TW2914633

Updated on 18 January 2022

File name

Mavenclad 10mg IE NI TW2704419 current.pdf

Reasons for updating

  • Change to section 4 - possible side effects

Free text change information supplied by the pharmaceutical company

To include the adverse reaction Hypersensitivity

Updated on 18 January 2022

File name

Mavenclad 10mg NI and ROI TW2704419 current v6.0.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects

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

Free text change information supplied by the pharmaceutical company

Update of section 4.2 of the SmPC to provide clarification on the delay of treatment course in year 2

Update of section 4.8 of the SmPC to include the adverse reaction Hypersensitivity

Updated on 25 February 2021

File name

Mavenclad 10mg UK and ROI TW2759994 current v5.pdf

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

File name

Mavenclad 10mg UK and ROI TW2292761 current v4.0.pdf

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

File name

PIL for eMC and IPHA.pdf

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 20 August 2018

File name

Mavenclad 10mg UK and ROI TW1735675 current v3.0.pdf

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

File name

EU SPC Cladribine MA transfer 2018-05-11 en TW1735675.docx

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

File name

Mavenclad PIL TW1735675.pdf

Reasons for updating

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

Updated on 18 December 2017

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

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

File name

PIL_17288_268.pdf

Reasons for updating

  • New PIL for new product

Updated on 11 September 2017

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