Is Pomalidomide registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 17 valid registrations of Pomalidomide, including IMNOVID 1 mg capsule (1 mg, Capsule, SAR 27953.30); IMNOVID 2 mg capsule (2 mg, Capsule, SAR 27953.30); IMNOVID 3 mg capsule (3 mg, Capsule, SAR 29031.45); IMNOVID 4 mg capsule (4 mg, Capsule, SAR 29031.45); Pomado (4 mg, Capsule, hard, SAR 21773.60).

Is Pomalidomide approved by the US FDA?

Drugs@FDA lists 12 application product lines for Pomalidomide, including POMALYST (Prescription); POMALIDOMIDE (Prescription); POMALIDOMIDE (Prescription); POMALIDOMIDE (Prescription); POMALIDOMIDE (Prescription).

Is Pomalidomide authorised in the European Union?

EMA lists 6 centrally authorised medicines containing Pomalidomide: Imnovid (previously Pomalidomide Celgene), Pomalidomide Viatris, Pomalidomide Zentiva, Pomalidomide Krka, Pomalidomide Accord, Pomalidomide Teva.

Are there safety signals or safety updates for Pomalidomide?

EMA PRAC: 2 entries; US FDA: 1 entry; MHRA: 2 entries (latest 2020-12-03).

Active substance

Pomalidomide

SFDA 21
US FDA 12
EMA 6
Health Canada 24
Safety 5

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
IMNOVID 1 mg capsule	1 mg	Capsule · Oral use	21 Blister	SAR 27953.30	NCE · Prescription	Bristol-Myers Squibb / Pharma EEIG	Valid
IMNOVID 2 mg capsule	2 mg	Capsule · Oral use	21 Blister	SAR 27953.30	NCE · Prescription	Bristol-Myers Squibb / Pharma EEIG	Valid
IMNOVID 3 mg capsule	3 mg	Capsule · Oral use	21 Blister	SAR 29031.45	NCE · Prescription	Bristol-Myers Squibb / Pharma EEIG	Valid
IMNOVID 4 mg capsule	4 mg	Capsule · Oral use	21 Blister	SAR 29031.45	NCE · Prescription	Bristol Myers Squibb Pharma EEIG	Valid
Pomado	4 mg	Capsule, hard · Oral use	21 Blister	SAR 21773.60	Generic · Prescription	Alrazi Pharmaceutical Industries Factory Co	Valid
Pomalidomide BOS	4 mg	Capsule · Oral use	21 Blister	SAR 15686.05	Generic · Prescription	Boston Oncology Arabia	Valid
Pomalidomide BOS	3 mg	Capsule · Oral use	21 Blister	SAR 15686.05	Generic · Prescription	Boston Oncology Arabia	Valid
Pomalidomide BOS	2 mg	Capsule · Oral use	21 Blister	SAR 12482.23	Generic · Prescription	Boston Oncology Arabia	Valid
Pomalidomide BOS	1 mg	Capsule · Oral use	21 Blister	SAR 15103.50	Generic · Prescription	Boston Oncology Arabia	Valid
Pomalidomide SPC	1 mg	Capsule, hard · Oral use	21 Blister	SAR 22712.05	Generic · Prescription	SUDAIR PHARMA COMPANY	Valid
Pomalidomide SPC	2 mg	Capsule, hard · Oral use	21 Blister	SAR 22712.05	Generic · Prescription	SUDAIR PHARMA COMPANY	Valid
Pomalidomide SPC	3 mg	Capsule, hard · Oral use	21 Blister	SAR 23588.05	Generic · Prescription	SUDAIR PHARMA COMPANY	Valid
Pomalidomide SPC	4 mg	Capsule, hard · Oral use	21 Blister	SAR 23588.05	Generic · Prescription	SUDAIR PHARMA COMPANY	Valid
Pomalidomide SPC	1 mg	Capsule, hard · Oral use	21 Bottle	SAR 22712.05	Generic · Prescription	SUDAIR PHARMA COMPANY	Valid
Pomalidomide SPC	2 mg	Capsule, hard · Oral use	21 Bottle	SAR 22712.05	Generic · Prescription	SUDAIR PHARMA COMPANY	Valid
Pomalidomide SPC	3 mg	Capsule, hard · Oral use	21 Bottle	SAR 23588.05	Generic · Prescription	SUDAIR PHARMA COMPANY	Valid
Pomalidomide SPC	4 mg	Capsule, hard · Oral use	21 Bottle	SAR 23588.05	Generic · Prescription	SUDAIR PHARMA COMPANY	Valid
IMNOVID 1 mg capsule	1 mg	Capsule · Oral use	21 Blister	SAR 34941.60	NCE · Prescription	CELGENE EUROPE Ltd	Withdrawn by MAH · Not Marketed
IMNOVID 2 mg capsule	2 mg	Capsule · Oral use	21 Blister	SAR 34941.60	NCE · Prescription	CELGENE EUROPE Ltd	Withdrawn by MAH · Not Marketed
IMNOVID 3 mg capsule	3 mg	Capsule · Oral use	21 Blister	SAR 36289.30	NCE · Prescription	CELGENE EUROPE Ltd	Withdrawn by MAH · Not Marketed
IMNOVID 4 mg capsule	4 mg	Capsule · Oral use	21 Blister	SAR 36289.30	NCE · Prescription	CELGENE EUROPE Ltd	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

AMYLOIDOSIS - LIGHT CHAIN; MULTIPLE MYELOMA

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

Product	Strength	Form · route	Applicant	Status	First approved
POMALYST	1MG; 2MG; 3MG; 4MG	capsule · oral	BRISTOL	Prescription	8 Feb 2013
POMALIDOMIDE	1MG; 2MG; 3MG; 4MG	capsule · oral	BRECKENRIDGE	Prescription	30 Oct 2020
POMALIDOMIDE	1MG; 2MG; 3MG; 4MG	capsule · oral	EUGIA PHARMA	Prescription	30 Oct 2020
POMALIDOMIDE	1MG; 2MG; 3MG; 4MG	capsule · oral	TEVA PHARMS USA	Prescription	4 May 2022
POMALIDOMIDE	1MG; 2MG; 3MG; 4MG	capsule · oral	APOTEX	Prescription	11 Jun 2024
POMALIDOMIDE	1MG; 2MG; 3MG; 4MG	capsule · oral	HETERO LABS LTD V	Prescription	26 Sep 2024
POMALIDOMIDE	1MG; 2MG; 3MG; 4MG	capsule · oral	SPIL	Prescription	31 Aug 2026
POMALIDOMIDE	1MG; 2MG; 3MG; 4MG	capsule · oral	DR REDDYS	Prescription	31 Aug 2026
POMALIDOMIDE	1MG; 2MG; 3MG; 4MG	capsule · oral	CIPLA	Prescription	31 Aug 2026
POMALIDOMIDE	1MG; 2MG; 3MG; 4MG	capsule · oral	SANDOZ	Prescription	31 Aug 2026
POMALIDOMIDE	2MG; 3MG; 4MG	capsule · oral	MSN	Prescription	2 Sep 2026
POMALIDOMIDE	1MG; 2MG; 3MG; 4MG	capsule · oral	MYLAN	Discontinued	26 Jan 2022

EMA European Union — centrally authorised medicines

Imnovid (previously Pomalidomide Celgene) Bristol-Myers Squibb Pharma EEIG · Authorised · authorised 5 Aug 2013 · ATC L04AX06

Therapeutic indication (EMA)

Imnovid in combination with bortezomib and dexamethasone is indicated in the treatment of adult patients with multiple myeloma who have received at least one prior treatment regimen including lenalidomide. Imnovid in combination with dexamethasone is indicated in the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior treatment regimens, including both lenalidomide and bortezomib, and have demonstrated disease progression on the last therapy.

Pomalidomide Viatris Viatris Limited · Authorised · authorised 16 Feb 2024 · ATC L04AX06

Therapeutic indication (EMA)

Pomalidomide Viatris in combination with bortezomib and dexamethasone is indicated in the treatment of adult patients with multiple myeloma who have received at least one prior treatment regimen including lenalidomide.Pomalidomide Viatris in combination with dexamethasone is indicated in the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior treatment regimens, including both lenalidomide and bortezomib, and have demonstrated disease progression on the last therapy.

Pomalidomide Zentiva Zentiva k.s. · Authorised · authorised 24 Jul 2024 · ATC L04AX06

Therapeutic indication (EMA)

Treatment of adults with multiple myeloma who have received at least one prior treatment regimen including lenalidomide. Pomalidomide Zentiva in combination with dexamethasone is indicated in the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior treatment regimens, including both lenalidomide and bortezomib, and have demonstrated disease progression on the last therapy.

Pomalidomide Krka Krka, d.d., Novo mesto · Authorised · authorised 24 Jul 2024 · ATC L04AX06

Therapeutic indication (EMA)

Pomalidomide Krka in combination with bortezomib and dexamethasone is indicated in the treatment of adult patients with multiple myeloma who have received at least one prior treatment regimen including lenalidomide. Pomalidomide Krka in combination with dexamethasone is indicated in the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior treatment regimens, including both lenalidomide and bortezomib, and have demonstrated disease progression on the last therapy.

Pomalidomide Accord Accord Healthcare S.L.U. · Authorised · authorised 26 Jul 2024 · ATC L04AX06

Therapeutic indication (EMA)

Pomalidomide Accord in combination with bortezomib and dexamethasone is indicated in the treatment of adult patients with multiple myeloma who have received at least one prior treatment regimen including lenalidomide. Pomalidomide Accord in combination with dexamethasone is indicated in the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior treatment regimens, including both lenalidomide and bortezomib, and have demonstrated disease progression on the last therapy.

Pomalidomide Teva Teva GmbH · Authorised · authorised 14 Nov 2024 · ATC L04AX06

Therapeutic indication (EMA)

Pomalidomide Teva in combination with bortezomib and dexamethasone is indicated in the treatment of adult patients with multiple myeloma who have received at least one prior treatment regimen including lenalidomide. Pomalidomide Teva in combination with dexamethasone is indicated in the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior treatment regimens, including both lenalidomide and bortezomib, and have demonstrated disease progression on the last therapy.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
APO-POMALIDOMIDE	02520427	1 MG	CAPSULE · ORAL	APOTEX INC
APO-POMALIDOMIDE	02520435	2 MG	CAPSULE · ORAL	APOTEX INC
APO-POMALIDOMIDE	02520443	3 MG	CAPSULE · ORAL	APOTEX INC
APO-POMALIDOMIDE	02520451	4 MG	CAPSULE · ORAL	APOTEX INC
JAMP POMALIDOMIDE	02538059	1 MG	CAPSULE · ORAL	JAMP PHARMA CORPORATION
JAMP POMALIDOMIDE	02538075	2 MG	CAPSULE · ORAL	JAMP PHARMA CORPORATION
JAMP POMALIDOMIDE	02538083	3 MG	CAPSULE · ORAL	JAMP PHARMA CORPORATION
JAMP POMALIDOMIDE	02538091	4 MG	CAPSULE · ORAL	JAMP PHARMA CORPORATION
NAT-POMALIDOMIDE	02506394	1 MG	CAPSULE · ORAL	NATCO PHARMA (CANADA) INC
NAT-POMALIDOMIDE	02506408	2 MG	CAPSULE · ORAL	NATCO PHARMA (CANADA) INC
NAT-POMALIDOMIDE	02506416	3 MG	CAPSULE · ORAL	NATCO PHARMA (CANADA) INC
NAT-POMALIDOMIDE	02506424	4 MG	CAPSULE · ORAL	NATCO PHARMA (CANADA) INC
POMALYST	02419580	1 MG	CAPSULE · ORAL	BRISTOL-MYERS SQUIBB CANADA
POMALYST	02419599	2 MG	CAPSULE · ORAL	BRISTOL-MYERS SQUIBB CANADA
POMALYST	02419602	3 MG	CAPSULE · ORAL	BRISTOL-MYERS SQUIBB CANADA
POMALYST	02419610	4 MG	CAPSULE · ORAL	BRISTOL-MYERS SQUIBB CANADA
REDDY-POMALIDOMIDE	02504073	1 MG	CAPSULE · ORAL	DR REDDY'S LABORATORIES LTD
REDDY-POMALIDOMIDE	02504081	2 MG	CAPSULE · ORAL	DR REDDY'S LABORATORIES LTD
REDDY-POMALIDOMIDE	02504103	3 MG	CAPSULE · ORAL	DR REDDY'S LABORATORIES LTD
REDDY-POMALIDOMIDE	02504111	4 MG	CAPSULE · ORAL	DR REDDY'S LABORATORIES LTD
SANDOZ POMALIDOMIDE	02523973	1 MG	CAPSULE · ORAL	SANDOZ CANADA INCORPORATED
SANDOZ POMALIDOMIDE	02523981	2 MG	CAPSULE · ORAL	SANDOZ CANADA INCORPORATED
SANDOZ POMALIDOMIDE	02524007	3 MG	CAPSULE · ORAL	SANDOZ CANADA INCORPORATED
SANDOZ POMALIDOMIDE	02524015	4 MG	CAPSULE · ORAL	SANDOZ CANADA INCORPORATED

Safety signals and safety-related labeling changes

US FDA 3 Dec 2020 POMALYST — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 3 Sep 2020 PRAC signal: Progressive multifocal leukoencephalopathy (PML)
Action for MAH: update of the product information: Yes
EMA PRAC 17 Apr 2020 PRAC signal: Progressive multifocal leukoencephalopathy (PML)
Action for MAH: update of the product information: No
MHRA 10 May 2016 Pomalidomide (Imnovid▼): risk of hepatitis B reactivation
Before starting treatment with pomalidomide, establish hepatitis B virus status in all patients.
MHRA 20 May 2015 Pomalidomide (Imnovid▼): risks of cardiac failure, interstitial lung disease and hepatotoxicity
New monitoring instructions to detect these side effects as soon as possible.

All safety entries for pomalidomide →

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.