Is Palbociclib registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 24 valid registrations of Palbociclib, including Chinasi (100 mg, Capsule, SAR 9738.00); Chinasi (125 mg, Capsule, SAR 9738.00); Cryptario (100 mg, Film-coated tablet, SAR 7980.95); Cryptario (75 mg, Film-coated tablet, SAR 7980.95); Cryptario (125 mg, Film-coated tablet, SAR 7980.95).

Is Palbociclib approved by the US FDA?

Drugs@FDA lists 3 application product lines for Palbociclib, including IBRANCE (Prescription); IBRANCE (Prescription); PALBOCICLIB (Discontinued).

Is Palbociclib authorised in the European Union?

EMA lists 2 centrally authorised medicines containing Palbociclib: Ibrance, Palbociclib Viatris.

Are there safety signals or safety updates for Palbociclib?

EMA PRAC: 5 entries; US FDA: 2 entries (latest 2026-06-24).

Active substance

Palbociclib

SFDA 24
US FDA 3
EMA 2
Health Canada 9
Safety 7

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Chinasi	100 mg	Capsule · Oral use	21 Bottle	SAR 9738.00	Generic · Prescription	MS Pharma Saudi (MSPS)	Valid
Chinasi	125 mg	Capsule · Oral use	21 Bottle	SAR 9738.00	Generic · Prescription	MS Pharma Saudi (MSPS)	Valid
Cryptario	100 mg	Film-coated tablet · Oral use	21 Blister	SAR 7980.95	Generic · Prescription	SAJA-SAUDI ARABIAN JAPANESE PHARMACEUTICAL CO	Valid
Cryptario	75 mg	Film-coated tablet · Oral use	21 Blister	SAR 7980.95	Generic · Prescription	SAJA-SAUDI ARABIAN JAPANESE PHARMACEUTICAL CO	Valid
Cryptario	125 mg	Film-coated tablet · Oral use	21 Blister	SAR 7980.95	Generic · Prescription	SAJA-SAUDI ARABIAN JAPANESE PHARMACEUTICAL CO	Valid
IBRANCE	75 mg	Film-coated tablet · Oral use	21 Blister	SAR 8551.00	NCE · Prescription	Pfizer Europe MA EEIG	Valid
IBRANCE	100 mg	Film-coated tablet · Oral use	21 Blister	SAR 8551.00	NCE · Prescription	Pfizer Europe MA EEIG	Valid
IBRANCE	125 mg	Film-coated tablet · Oral use	21 Blister	SAR 8551.00	NCE · Prescription	Pfizer Europe MA EEIG	Valid
IBRANCE 100 mg capsule	100 mg	Capsule · Oral use	21 Bottle	SAR 12172.95	NCE · Prescription	PFIZER	Valid
IBRANCE 125 mg capsule	125 mg	Capsule · Oral use	21 Bottle	SAR 12172.95	NCE · Prescription	PFIZER	Valid
IBRANCE 75 mg capsule	75 mg	Capsule · Oral use	21 Bottle	SAR 12172.95	NCE · Prescription	PFIZER	Valid
Innolib	125 mg	Capsule · Oral use	30 Blister	SAR 13911.95	Generic · Prescription	SUDAIR PHARMA COMPANY	Valid
Innolib	75 mg	Capsule · Oral use	30 Blister	SAR 13911.95	Generic · Prescription	SUDAIR PHARMA COMPANY	Valid
Innolib	100 mg	Capsule · Oral use	28 Blister	SAR 12984.45	Generic · Prescription	SUDAIR PHARMA COMPANY	Valid
Pabrolib	100 mg	Capsule, hard · Oral use	21 Bottle	SAR 10549.90	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
Pabrolib	75 mg	Capsule, hard · Oral use	21 Bottle	SAR 10549.90	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
Pabrolib	125 mg	Capsule, hard · Oral use	21 Bottle	SAR 10549.90	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
Palpocent	125 mg	Capsule · Oral use	21 Blister	SAR 9738.00	Generic · Prescription	Saudi Amarox	Valid
Palpocent	100 mg	Capsule · Oral use	21 Blister	SAR 9738.00	Generic · Prescription	Saudi Amarox	Valid
Palpocent	75 mg	Capsule · Oral use	21 Blister	SAR 9738.00	Generic · Prescription	Saudi Amarox	Valid
Papillio	75 mg	Capsule, hard · Oral use	21 Blister	SAR 11361.40	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
Papillio	100 mg	Capsule, hard · Oral use	21 Blister	SAR 11361.40	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
Papillio	125 mg	Capsule, hard · Oral use	21 Blister	SAR 11361.40	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
chinasi	75 mg	Capsule · Oral use	21 Bottle	SAR 9738.00	Generic · Prescription	MS Pharma Saudi (MSPS)	Valid

Indications — CHI Daman Drug Formulary

BREAST CANCER MET.HORMONAL; SOFT TISSUE SARCOMA - LEIOMYOSARCOMA & LIPOSARCOMA

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

Product	Strength	Form · route	Applicant	Status	First approved
IBRANCE	75MG; 100MG; 125MG	capsule · oral	PFIZER	Prescription	3 Feb 2015
IBRANCE	75MG; 100MG; 125MG	tablet · oral	PFIZER	Prescription	1 Nov 2019
PALBOCICLIB	75MG; 100MG; 125MG	tablet · oral	ZYDUS LIFESCIENCES	Discontinued	5 Jun 2024

EMA European Union — centrally authorised medicines

Ibrance Pfizer Europe MA EEIG · Authorised · authorised 9 Nov 2016 · ATC L01EF01

Therapeutic indication (EMA)

Ibrance is indicated for the treatment of hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer: in combination with an aromatase inhibitor; in combination with fulvestrant in women who have received prior endocrine therapy. In pre- or perimenopausal women, the endocrine therapy should be combined with a luteinizing hormone releasing hormone (LHRH) agonist.

Palbociclib Viatris Viatris Limited · Authorised · authorised 19 Jun 2026 · ATC L01EF01

Therapeutic indication (EMA)

Palbociclib Viatris is indicated for the treatment of hormone receptor (HR)‑positive, human epidermal growth factor receptor 2 (HER2)‑negative locally advanced or metastatic breast cancer. in combination with an aromatase inhibitor; in combination with fulvestrant in women who have received prior endocrine therapy (see section 5.1). In pre‑ or perimenopausal women, the endocrine therapy should be combined with a luteinizing hormone‑releasing hormone (LHRH) agonist.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
IBRANCE	02493535	75 MG	TABLET · ORAL	PFIZER CANADA ULC
IBRANCE	02493543	100 MG	TABLET · ORAL	PFIZER CANADA ULC
IBRANCE	02493551	125 MG	TABLET · ORAL	PFIZER CANADA ULC
PMS-PALBOCICLIB	02552124	75 MG	TABLET · ORAL	PHARMASCIENCE INC
PMS-PALBOCICLIB	02552132	100 MG	TABLET · ORAL	PHARMASCIENCE INC
PMS-PALBOCICLIB	02552140	125 MG	TABLET · ORAL	PHARMASCIENCE INC
TARO-PALBOCICLIB	02547635	75 MG	TABLET · ORAL	TARO PHARMACEUTICALS INC
TARO-PALBOCICLIB	02547643	100 MG	TABLET · ORAL	TARO PHARMACEUTICALS INC
TARO-PALBOCICLIB	02547651	125 MG	TABLET · ORAL	TARO PHARMACEUTICALS INC

Safety signals and safety-related labeling changes

US FDA 24 Jun 2026 IBRANCE — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 24 Jun 2026 IBRANCE — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 11 Jun 2026 PRAC signal: Progressive multifocal leukoencephalopathy (PML)
Action for MAH: update of the product information: No
EMA PRAC 7 Mar 2024 PRAC signal: Erythema multiforme
Action for MAH: update of the product information: Yes
EMA PRAC 28 Sep 2023 PRAC signal: Erythema multiforme
Action for MAH: update of the product information: No
EMA PRAC 31 Aug 2023 PRAC signal: Rhabdomyolysis by interaction with statins
Action for MAH: update of the product information: No
EMA PRAC 9 Jul 2020 PRAC signal: Cutaneous lupus erythematosus
Action for MAH: update of the product information: No

All safety entries for palbociclib →

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.