SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|
| VENCLEXTA 10 mg / 50 mg / 100 mg film-coated tablet | 10, 50, 100 mg | Film-coated tablet · Oral use | 42 Blister | SAR 6695.15 | NCE · Prescription | ABBVIE Inc. | Valid |
| VENCLEXTA 100 mg film-coated tablet | 100 mg | Film-coated tablet · Oral use | 120 Blister | SAR 31020.00 | NCE · Prescription | ABBVIE Inc. | Valid |
| VENCLEXTA 10 mg film-coated tablet | 10 mg | Film-coated tablet · Oral use | 14 Blister | SAR 452.25 | NCE · Prescription | ABBVIE Inc. | Withdrawn by MAH · Not Marketed |
| VENCLEXTA 50 mg film-coated tablet | 50 mg | Film-coated tablet · Oral use | 7 Blister | SAR 1130.90 | NCE · Prescription | ABBVIE Inc. | Withdrawn by MAH · Not Marketed |
Indications — CHI Daman Drug Formulary
ADULT ACUTE MYELOID LEUKAEMIA (AML); AMYLOIDOSIS - LIGHT CHAIN; CHRONIC LYMPHOCYTIC LEUKEMIA (CLL); LYMPHOPLASMACYTIC LYMPHOMA
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|
| VENCLEXTA | 10MG; 50MG; 100MG | tablet · oral | ABBVIE | Prescription | 11 Apr 2016 |
| VENETOCLAX | 10MG; 50MG; 100MG | tablet · oral | DR REDDYS | Prescription | 15 May 2026 |
EMA European Union — centrally authorised medicines
Venclyxto AbbVie Deutschland GmbH & Co. KG · Authorised · authorised 4 Dec 2016 · ATC L01XX52
Therapeutic indication (EMA)
Venclyxto is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL): in combination with acalabrutinib with or without obinutuzumab in combination with obinutuzumab in combination with ibrutinib Venclyxto in combination with rituximab is indicated for the treatment of adult patients with CLL who have received at least one prior therapy. Venclyxto monotherapy is indicated for the treatment of CLL: in the presence of 17p deletion or TP53 mutation in adult patients who are unsuitable for or have failed a B cell receptor pathway inhibitor, or in the absence of 17p deletion or TP53 mutation in adult patients who have failed both chemoimmunotherapy and a B cell receptor pathway inhibitor. Venclyxto in combination with a hypomethylating agent is indicated for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for intensive chemotherapy.
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|
| VENCLEXTA | 02458039 | 10 MG | TABLET · ORAL | ABBVIE CORPORATION |
| VENCLEXTA | 02458047 | 50 MG | TABLET · ORAL | ABBVIE CORPORATION |
| VENCLEXTA | 02458055 | 100 MG | TABLET · ORAL | ABBVIE CORPORATION |
| VENCLEXTA | 02458063 | 10 MG; 100 MG; 50 MG | KIT; TABLET · ORAL | ABBVIE CORPORATION |
Safety signals and safety-related labeling changes
- US FDA 20 May 2026 VENCLEXTA — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - MHRA 10 Dec 2021 Venetoclax (Venclyxto▼): updated recommendations on tumour lysis syndrome (TLS)
Fatal cases of tumour lysis syndrome (TLS) have been reported, some occurring in patients with chronic lymphocytic leukaemia receiving the lowest venetoclax dose used in the dose-titration schedule. For all patients, it is important to strictly adhere to the dose-titration schedule and to the measures to minimise the risk of TLS as outlined in the updated Summary of Product Characteristics (SmPC).
All safety entries for venetoclax →
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.