Venclyxto 10mg, 50mg and 100mg Film-coated Tablets
*Company:
AbbVie LimitedStatus:
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 03 April 2024
File name
SmPC_Venclyxto_10-50-100mg Film-coated Tablets_MURADO CSR 5.1_21Mar2024.pdf
Reasons for updating
- 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
Section 5.1 Pharmacodynamic properties of the SmPC was updated to reflect the final MURANO CSR as follows: - Addition of a new sub-section: “Final overall survival analysis (86-month follow-up)" after the 5-year subgroup Forest plot (current Figure 4)/ Addition of the final OS analysis text and updated figure in the new sub-section, including a statement that the OS analysis is not type I error-controlled/ Deletion of the 5-year OS KM curve (Figure 3) and associated text in the 5-year sub-section, while maintaining the 5-year OS data in Table 11
File name
IE-VNCLY-230006 Venclyxto Patient Alert Card_Approved.pdf
Reasons for updating
- Replace File
Updated on 25 August 2023
File name
PIL_Venclyxto_10-50-100mg Film-coated Tablets_Renewal_11Aug2023.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 4 - possible side effects
- Removal of Black Inverted Triangle
Updated on 25 August 2023
File name
SmPC_Venclyxto_10-50-100mg Film-coated Tablets_Renewal_11Aug2023.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 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.1 - List of excipients
- Change to section 6.5 - Nature and contents of container
- Change to section 10 - Date of revision of the text
- Removal of Black Inverted Triangle
- Updated inline with QRD template and/or excipient guideline
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
The SmpC has been updated to reflect the removal of the inverted black triangle and additional monitoring statement as well as minor QRD amendments throughout the SPC.
Updated on 24 October 2022
File name
SPC_Venclyxto_CLL14_5 year data update_20th_October.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- 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
Updates made to section 5.1 of the SmPC on the Clinical efficacy and safety data and other minor typographical errors in section 4.2 and 4.8
Updated on 29 March 2022
File name
PL_Venclyxto 10-50 tablets_TIB corrections_22Mar2022.pdf
Reasons for updating
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
Free text change information supplied by the pharmaceutical company
Grammatical and formatting changes made to Package Leaflet
Updated on 29 March 2022
File name
SmPC_Venclyxto 10-50 tablets_TIB corrections_22Mar2022.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 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic 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
Grammatical and typographical changes made to a variey of sections in the SmPC and PL
Rounding correction in Table 12
Updated on 20 December 2021
File name
Venclyxto 10-50-100mg Film-coated Tablets_AML Corrigendum_SmPC.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
File name
2. Abbvie_Venclyxto Patient Card_August 2021.pdf
Reasons for updating
- Add New Doc
Updated on 25 June 2021
File name
Venclyxto 10-50-100mg Film-coated Tablets_TLS+AML Update_SmPC.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- 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 25 June 2021
File name
Venclyxto 10-50-100mg Film-coated Tablets_TLS+AML Update_PL.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 6 - date of revision
Updated on 21 May 2021
File name
Venclyxto 10-50-100mg Film-coated Tablets_AML_SmPC_May 2021.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- 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 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
- 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 21 May 2021
File name
Venclyxto 10-50-100mg Film-coated Tablets_AML_PL_May 2021.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 02 March 2021
File name
Venclyxto 10-50-100mg Film-coated Tablets_MURANO 5-year Data_SmPC_February 2021.pdf
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)
Updated on 15 April 2020
File name
Venclyxto 10-50-100mg Film-coated Tablets_PSUR 5_PL_April 2020.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 15 April 2020
File name
Venclyxto 10-50-100mg Film-coated Tablets_PSUR 5_SmPC_April 2020.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 12 March 2020
File name
Venclyxto 10-50-100mg Film-coated Tablets_1st Line CLL_SmPC_March 2020.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- 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)
Updated on 12 March 2020
File name
Venclyxto 10-50-100mg Film-coated Tablets_1st Line CLL_PL_March 2020.pdf
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 3 - dose and frequency
Updated on 16 July 2019
File name
Venclyxto 10-50-100mg Film-coated Tablets_Hepatic Impairment Update_PL_June 2019.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
Updated on 16 July 2019
File name
Venclyxto 10-50-100mg Film-coated Tablets_Hepatic Impairment Update_SmPC_June 2019.pdf
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 02 July 2019
File name
Venclyxto 10-50-100mg Film-coated Tablets_Hepatic Impairment Update_PL_June 2019.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Updated on 02 July 2019
File name
Venclyxto 10-50-100mg Film-coated Tablets_Hepatic Impairment Update_SmPC_June 2019.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 17 December 2018
File name
Venclyxto 10-50-100mg Film-coated Tablets_M13-982 CSR_PL_December 2018.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
Updated on 17 December 2018
File name
Venclyxto 10-50-100mg Film-coated Tablets_M13-982 CSR_SmPC_December 2018.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 21 November 2018
File name
Venclyxto 10-50-100mg Film-coated Tablets_MURANO + SO_PL_November 2018_NOT MARKETED.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 3 - how to take/use
- Change to date of revision
Updated on 21 November 2018
File name
Venclyxto 10-50-100mg Film-coated Tablets_MURANO + SO_SmPC_November 2018_NOT MARKETED.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- 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
4.1. Therapeutic Indication
Addition of Venclyxto in combination with rituximab is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy.
4.2. Posology and Method of Administration
Post-titration dose for venetoclax in combination with rituximab included in section 4.2
4.8. Undesirable EffectsData from M14-032 and MURANO added to Section 4.8. Grade ≥3 Adverse Events tabulated.
5.1. Pharmacodynamic Properties
Clinical efficacy and safet sectiojn updated.
10. Date of Revision of Text
Updated to 11/2018.
Updated on 08 October 2018
File name
Venclyxto 10-50-100mg Film-coated Tablets_SmPC_Shelf Life Extension_October 2018_NOT MARKETED.pdf
Reasons for updating
- Change to section 6.3 - Shelf life
- 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 following is a summary of the changes:
6.3. Shelf Life
Venclyxto 100 mg film-coated tablets
3 years.
10. Date of Revision of Text
Updated to 10/2018.
Updated on 10 September 2018
File name
Venclyxto 10-50-100mg Film-coated Tablets_PSUR Update_SmPC_August 2018_NOT MARKETED.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- 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 following is summary of the changes:
4.4. Special warnings and precautions for use
Include ‘sepsis’ under the neutropenia subsection.
4.8. Undesireable effects
Include ‘sepsis’ with frequency calculated by MAH
10. Date of Revision of Text
Updated to 08/2018.
Updated on 18 July 2018
File name
Venclyxto 10-50-100mg Film-coated Tablets_MAH Transfer_SmPC_May 2018_NOT MARKETED.pdf
Reasons for updating
- File format updated to PDF
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 08 June 2018
File name
Venclyxto 10-50-100mg Film-coated Tablets_MAH Transfer_SmPC_May 2018_NOT MARKETED.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)
Free text change information supplied by the pharmaceutical company
SmPC was updated to reflect approval of Type IB variation to transfer EU MA from UK to Germany due to Brexit for Venclyxto 10mg, 50mg & 100mg Film-coated Tablets.
The following is summary of the changes:
7. Marketing Authorisation Holder
Updated to AbbVie Deutschland GmbH & Co. KG, Knollstrasse, 67061 Ludwigshafen, Germany
10. Date of Revision of Text
Updated to 05/2018.
Updated on 08 June 2018
File name
Venclyxto 10-50-100mg Film-coated Tablets_MAH Transfer_PIL_May 2018_NOT MARKETED.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 27 March 2018
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 27 March 2018
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
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.1 - List of excipients
- Change to section 6.5 - Nature and contents of container
- 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
Updated on 26 March 2018
File name
PIL_17006_408.pdf
Reasons for updating
- New PIL for new product
Updated on 26 March 2018
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 4 - possible side effects
- Change to section 6 - what the product contains
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Updated on 03 May 2017
Reasons for updating
- 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
Updated on 14 December 2016
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
Updated on 12 December 2016
Reasons for updating
- New PIL for new product