Venclyxto 10mg, 50mg and 100mg Film-coated Tablets *

  • Company:

    AbbVie Limited
  • Status:

    No Recent Update
  • Legal Category:

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

    This medicinal product is subject to additional monitoring.

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

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.

EDM Updated on 23 August 2021

File name

2. Abbvie_Venclyxto Patient Card_August 2021_1629728342.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_1624615288.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_1624615171.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_1621589916.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_1621589692.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_1614681633.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_1586962039.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_1586961945.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_1584051320.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_1584050445.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_1563278900.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_1563279751.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_1562074772.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_1562074820.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_1545046183.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_1545046219.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_1542803232.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_1542803075.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_1538994876.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_1536571452.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

$0SmPC for Venclyxto 10mg, 50mg & 100mg Film-coatedTablets updated to reflect approval of TypeII variation to  update section 4.5 ofSmPC concerning Drug-Drug Interation (DDI) in line with the updated CCDSchanges. Additionally editorial changes were made throughout all the annexes(SmPC/Labelling/PIL).$0$0 $0$0The following is summary of changes:$0$0 $0$0Section4.2 Posology and method of administration $0$0Minor editorial changes implemented.$0$0 $0$0Section4.4 Special warnings and precautions for use$0$0Minor editorial changes implemented.$0$0 $0$0Section4.5 Interaction with other medicinal products and other forms of interaction$0$0Updateconcerning Drug-Drug Interation (DDI) in line with the CCDS changes.$0$0 $0$0Section 4.6 Fertility, pregnancyand lactation$0$0Minor editorial changes implemented.$0$0 $0$0Section4.7 Effects on ability to drive and use machines$0$0Minor editorial changes implemented.$0$0 $0$0Section4.8 Undesirable effects$0$0Minor editorial changes implemented.$0$0 $0$0Section5.1 Pharmacodynamic properties$0$0Minor editorial changes implemented.$0$0 $0$0Section5.2 Pharmacokinetic properties$0$0Minor editorial changes implemented.$0$0 $0$0Section6.1 List of excipients$0$0Minor editorial changes implemented.$0$0 $0$0Section6.5 Nature and contents of container$0$0Minor editorial changes implemented.$0$0 $0$0Section9. Date of First Authorisation / Renewal of the Authorisation$0$0Added date of latest renewal.$0$0 $0$0Section10. Date of revision of the text$0$0Updated to March 2018.$0

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

Add ATC Code LO1XX52 to Section 5.1 of SmPC

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

None provided

Updated on 12 December 2016

Reasons for updating

  • New PIL for new product