MAVENCLAD 10 mg Tablets * Pharmacy Only: Prescription
Company:
MerckStatus:
No Recent UpdateLegal 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
File name
6297212fa48ee.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
629720fd18900.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
627b959779719.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_1651639428.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_1651639027.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_1646981571.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_1646981435.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_1642500775.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_1642500253.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_1614263005.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_1579267730.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_1579267636.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_1534763004.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)