Is Talazoparib registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 3 valid registrations of Talazoparib, including TALZENNA (0.25 mg, Capsule, hard, SAR 5810.60); TALZENNA (1 mg, Capsule, hard, SAR 17431.90); Talzenna (0.1 mg, Capsule, hard, SAR 2656.10).

Is Talazoparib approved by the US FDA?

Drugs@FDA lists 2 application product lines for Talazoparib, including TALZENNA (Prescription); TALZENNA (Discontinued).

Is Talazoparib authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Talazoparib: Talzenna.

Are there safety signals or safety updates for Talazoparib?

US FDA: 2 entries (latest 2025-06-12).

Active substance

Talazoparib

SFDA 3
US FDA 2
EMA 1
Health Canada 2
Safety 2

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
TALZENNA	0.25 mg	Capsule, hard · Oral use	30 Bottle	SAR 5810.60	NCE · Prescription	PFIZER INC	Valid
TALZENNA	1 mg	Capsule, hard · Oral use	30 Bottle	SAR 17431.90	NCE · Prescription	PFIZER INC	Valid
Talzenna	0.1 mg	Capsule, hard · Oral use	30 Bottle	SAR 2656.10	NCE · Prescription	PFIZER INC	Valid

Indications — CHI Daman Drug Formulary

BREAST CANCER MET.HER-2 -VE; PROSTATE CANCER

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
TALZENNA	EQ 0.1MG BASE; EQ 0.25MG BASE; EQ 0.35MG BASE; EQ 0.5MG BASE; EQ 0.75MG BASE; EQ 1MG BASE	capsule · oral	PFIZER	Prescription	7 Mar 2024
TALZENNA	EQ 0.25MG BASE; EQ 1MG BASE; EQ 0.5MG BASE; EQ 0.75MG BASE; EQ 0.1MG BASE; EQ 0.35MG BASE	capsule · oral	PFIZER	Discontinued	16 Oct 2018

EMA European Union — centrally authorised medicines

Talzenna Pfizer Europe MA EEIG · Authorised · authorised 20 Jun 2019 · ATC L01XK04

Therapeutic indication (EMA)

Treatment with Talzenna should be initiated and supervised by a physician experienced in the use of anticancer medicinal products. Patient selection Breast cancer: Patients should be selected for the treatment of breast cancer with Talzenna based on the presence of deleterious or suspected deleterious germline BRCA mutations determined by an experienced laboratory using a validated test method. Genetic counselling for patients with BRCA mutations should be performed according to local regulations, as applicable. Prostate cancer: There is no requirement for tumour mutation testing for selection of patients with mCRPC for treatment with Talzenna.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
TALZENNA	02492032	0.25 MG	CAPSULE · ORAL	PFIZER CANADA ULC
TALZENNA	02555050	0.1 MG	CAPSULE · ORAL	PFIZER CANADA ULC

Safety signals and safety-related labeling changes

US FDA 12 Jun 2025 TALZENNA — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 12 Jun 2025 TALZENNA — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for talazoparib →

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.