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

  • Name:

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

  • Company:
    info
  • Active Ingredients:

    Venetoclax

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 15/04/20

files-icon(Click to Download)
Summary of Product Characteristics last updated on medicines.ie: 15/4/2020
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.

Click on this link to Download PDF directly

AbbVie Limited

AbbVie Limited

Company Products

Medicine NameActive Ingredients
Medicine Name Chirocaine 1.25mg/ml solution for infusion Active Ingredients levobupivacaine hydrochloride
Medicine Name Chirocaine 2.5 mg/ml solution for injection/concentrate for solution for infusion Active Ingredients levobupivacaine hydrochloride
Medicine Name Chirocaine 5 mg/ml solution for injection/concentrate for solution for infusion Active Ingredients levobupivacaine hydrochloride
Medicine Name Chirocaine 7.5 mg/ml solution for injection/concentrate for solution for infusion Active Ingredients levobupivacaine hydrochloride
Medicine Name Duodopa intestinal gel Active Ingredients Carbidopa Monohydrate, Levodopa
Medicine Name Humira 20 mg solution for injection in pre-filled syringe Active Ingredients adalimumab
Medicine Name Humira 40 mg solution for injection in pre-filled syringe Active Ingredients adalimumab
Medicine Name Humira 40mg solution for injection in pre-filled pen Active Ingredients adalimumab
Medicine Name Humira 80 mg solution for injection in pre-filled pen Active Ingredients adalimumab
Medicine Name Kaletra 200 mg/50 mg film-coated tablets Active Ingredients Lopinavir, Ritonavir
Medicine Name Kaletra oral solution Active Ingredients Lopinavir, Ritonavir
Medicine Name Maviret 100 mg-40 mg film-coated tablets Active Ingredients Glecaprevir, Pibrentasvir
Medicine Name Norvir 100 mg powder for oral suspension Active Ingredients Ritonavir
Medicine Name Norvir 100mg Film-coated Tablets Active Ingredients Ritonavir
Medicine Name RINVOQ 15 mg prolonged-release tablets Active Ingredients Upadacitinib
Medicine Name Sevorane Active Ingredients Sevoflurane
Medicine Name Skyrizi 75 mg solution for injection in pre-filled syringe Active Ingredients Risankizumab
Medicine Name Synagis Solution for Injection Active Ingredients Palivizumab
Medicine Name Venclyxto 10mg, 50mg and 100mg Film-coated Tablets Active Ingredients Venetoclax
Medicine Name Zemplar 5 microgram/ml Solution for Injection Active Ingredients Paricalcitol
Medicine Name Zemplar capsules, soft Active Ingredients Paricalcitol
1 - 0 of 21 items.Total: Infinity pages

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.

Updated on 15 April 2020 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 15 April 2020 SmPC

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 SmPC

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 PIL

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 3 - dose and frequency

Updated on 16 July 2019 PIL

Reasons for updating

  • Change to section 4 - how to report a side effect

Updated on 16 July 2019 SmPC

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 2 July 2019 PIL

Reasons for updating

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

Updated on 2 July 2019 SmPC

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 PIL

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 SmPC

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 PIL

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 SmPC

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 8 October 2018 SmPC

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 SmPC

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 SmPC

Reasons for updating

  • File format updated to PDF

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

Updated on 8 June 2018 SmPC

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 8 June 2018 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 27 March 2018 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 27 March 2018 SmPC

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 PIL

Reasons for updating

  • New PIL for new product

Updated on 26 March 2018 PIL

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 3 May 2017 SmPC

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 SmPC

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 PIL

Reasons for updating

  • New PIL for new product