MAVENCLAD 10 mg Tablets
*Company:
MerckStatus:
UpdatedLegal 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
Updated on 12 May 2025
File name
Mavenclad 10mg ROI current TW4892471 v11.0.pdf
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- 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
Updated section 4.6 relating to excretion of cladribine in breast milk.
Internal reference number: TW4892471
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
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
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
File name
20826-Merck-Mavenclad-Prescribers_guide-IE_v02.01 - Final version.pdf
Reasons for updating
- Add New Doc
File name
20826-Merck-Mavenclad-Patient_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
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.
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.
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
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
Merck
Address:
Merck Serono (Ireland) Limited, 4045 Kingswood Road, Citywest Business Campus, Dublin 24, IrelandMedical Information E-mail:
medinfo.uk@merckgroup.comTelephone:
+353 1 468 7590Fax:
+353 1 466 3446Medical Information Facsimile:
+44 (0)208 818 7274Medical Information Direct Line:
+44 (0)208 818 7373