Is Lenalidomide registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 23 valid registrations of Lenalidomide, including LENALIDOMIDE SPC 10 mg Capsule (10 mg, Capsule, hard, SAR 14505.90); LENALIDOMIDE SPC 25 mg Capsule (25 mg, Capsule, hard, SAR 16804.35); LENALIDOMIDE SPC 5 mg Capsule (5 mg, Capsule, hard, SAR 13834.90); LIDOVA 10 mg capsule (10 mg, Capsule, hard, SAR 11749.75); LIDOVA 25 mg capsule (25 mg, Capsule, hard, SAR 13611.50).

Is Lenalidomide approved by the US FDA?

Drugs@FDA lists 21 application product lines for Lenalidomide, including REVLIMID (Prescription); LENALIDOMIDE (Prescription); LENALIDOMIDE (Prescription); LENALIDOMIDE (Prescription); LENALIDOMIDE (Prescription).

Is Lenalidomide authorised in the European Union?

EMA lists 5 centrally authorised medicines containing Lenalidomide: Revlimid, Lenalidomide Accord, Lenalidomide Mylan, Lenalidomide Krka (previously Lenalidomide Krka d.d. Novo mesto), Lenalidomide Krka d.d. Novo mesto (previously Lenalidomide Krka).

Is Lenalidomide on the WHO Model List of Essential Medicines?

Yes — 8.2.3. Immunomodulators (complementary list): Plasma cell myeloma.

Are there safety signals or safety updates for Lenalidomide?

EMA PRAC: 7 entries; US FDA: 1 entry; MHRA: 3 entries (latest 2022-05-24).

Active substance

Lenalidomide

SFDA 28
US FDA 21
EMA 7
Health Canada 42
WHO EML 1
Safety 11

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
LENALIDOMIDE SPC 10 mg Capsule	10 mg	Capsule, hard · Oral use	21 Blister	SAR 14505.90	Generic · Prescription	SUDAIR PHARMA COMPANY	Valid
LENALIDOMIDE SPC 25 mg Capsule	25 mg	Capsule, hard · Oral use	21 Blister	SAR 16804.35	Generic · Prescription	SUDAIR PHARMA COMPANY	Valid
LENALIDOMIDE SPC 5 mg Capsule	5 mg	Capsule, hard · Oral use	21 Blister	SAR 13834.90	Generic · Prescription	SUDAIR PHARMA COMPANY	Valid
LIDOVA 10 mg capsule	10 mg	Capsule, hard · Oral use	21 Blister	SAR 11749.75	Generic · Prescription	SAJA-SAUDI ARABIAN JAPANESE PHARMACEUTICAL CO	Valid
LIDOVA 25 mg capsule	25 mg	Capsule, hard · Oral use	21 Blister	SAR 13611.50	Generic · Prescription	SAJA-SAUDI ARABIAN JAPANESE PHARMACEUTICAL CO	Valid
LIDOVA 5 mg capsule	5 mg	Capsule, hard · Oral use	21 Blister	SAR 11206.25	Generic · Prescription	SAJA-SAUDI ARABIAN JAPANESE PHARMACEUTICAL CO	Valid
Lammalid	5 mg	Capsule, hard · Oral use	21 Blister	SAR 11206.25	Generic · Prescription	MS Pharma Saudi (MSPS)	Valid
Lammalid	10 mg	Capsule, hard · Oral use	21 Blister	SAR 11749.75	Generic · Prescription	MS Pharma Saudi (MSPS)	Valid
Lammalid	15 mg	Capsule, hard · Oral use	21 Blister	SAR 11749.75	Generic · Prescription	MS Pharma Saudi (MSPS)	Valid
Lammalid	25 mg	Capsule, hard · Oral use	21 Blister	SAR 13611.50	Generic · Prescription	MS Pharma Saudi (MSPS)	Valid
Lenalidomide BOS	5 mg	Capsule · Oral use	21 Blister	SAR 7844.35	Generic · Prescription	Boston Oncology Arabia	Valid
Lenalidomide BOS	10 mg	Capsule · Oral use	21 Blister	SAR 8224.85	Generic · Prescription	Boston Oncology Arabia	Valid
Lenalidomide BOS	15 mg	Capsule · Oral use	21 Blister	SAR 8224.85	Generic · Prescription	Boston Oncology Arabia	Valid
Lenalidomide BOS	25 mg	Capsule · Oral use	21 Blister	SAR 9528.05	Generic · Prescription	Boston Oncology Arabia	Valid
Lenalidomide SPC	15 mg	Capsule, hard · Oral use	21 Blister	SAR 14505.90	Generic · Prescription	SUDAIR PHARMA COMPANY	Valid
Lenalidomide SPC	20 mg	Capsule, hard · Oral use	21 Blister	SAR 14505.90	Generic · Prescription	SUDAIR PHARMA COMPANY	Valid
Lenamid	25 mg	Capsule, hard · Oral use	21 Blister	SAR 13611.50	Generic · Prescription	Saudi Amarox	Valid
Lenamid	10 mg	Capsule, hard · Oral use	21 Blister	SAR 11749.75	Generic · Prescription	Saudi Amarox	Valid
Lenamid	5 mg	Capsule, hard · Oral use	21 Blister	SAR 11206.25	Generic · Prescription	Saudi Amarox	Valid
SOTIRA 10MG CAPSULE	10 mg	Capsule, hard · Oral use	21 Blister	SAR 13055.30	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
SOTIRA 15MG CAPSULE	15 mg	Capsule, hard · Oral use	21 Blister	SAR 13773.35	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
SOTIRA 25MG CAPSULE	25 mg	Capsule, hard · Oral use	21 Blister	SAR 15123.90	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
SOTIRA 5MG CAPSULE	5 mg	Capsule, hard · Oral use	21 Blister	SAR 12451.40	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
Lenalidomide SPC	2.5 mg	Capsule, hard · Oral use	21 Blister	SAR 7236.75	Generic · Prescription	SUDAIR PHARMA COMPANY	Withdrawn by MAH · Not Marketed
REVLIMID 10 mg capsule	10 mg	Capsule, hard · Oral use	21 Blister	SAR 17853.40	NCE · Prescription	CELGENE INTERNATIONAL	Withdrawn by MAH · Not Marketed

3 more — full table

Indications — CHI Daman Drug Formulary

AMYLOIDOSIS - LIGHT CHAIN; CHRONIC LYMPHOCYTIC LEUKEMIA (CLL); DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL); FOLLICULAR LYMPHOMA; MANTLE CELL LYMPHOMA; MARGINAL ZONE LYMPHOMA; MULTIPLE MYELOMA; MYELODYSPLASTIC SYNDROMES; MYELOFIBROSIS-SYMPTOMATIC, LOW-RISK; T-CELL LYMPHOMA

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

Product	Strength	Form · route	Applicant	Status	First approved
REVLIMID	5MG; 10MG; 15MG; 25MG; 2.5MG; 20MG	capsule · oral	BRISTOL MYERS SQUIBB	Prescription	27 Dec 2005
LENALIDOMIDE	5MG; 10MG; 15MG; 25MG; 2.5MG; 20MG	capsule · oral	ARROW INTL	Prescription	21 May 2021
LENALIDOMIDE	2.5MG; 20MG; 5MG; 10MG; 15MG; 25MG	capsule · oral	DR REDDYS	Prescription	14 Oct 2021
LENALIDOMIDE	5MG; 10MG; 15MG; 25MG; 2.5MG; 20MG	capsule · oral	APOTEX	Prescription	30 Aug 2022
LENALIDOMIDE	5MG; 10MG; 15MG; 25MG; 2.5MG; 20MG	capsule · oral	MYLAN	Prescription	30 Aug 2022
LENALIDOMIDE	5MG; 10MG; 15MG; 25MG; 2.5MG; 20MG	capsule · oral	ALVOGEN	Prescription	31 Aug 2022
LENALIDOMIDE	5MG; 10MG; 15MG; 25MG; 20MG	capsule · oral	CIPLA	Prescription	6 Sep 2022
LENALIDOMIDE	5MG; 10MG; 15MG; 25MG; 2.5MG; 20MG	capsule · oral	ZYDUS PHARMS	Prescription	12 Sep 2022
LENALIDOMIDE	5MG; 10MG; 15MG; 25MG; 2.5MG; 20MG	capsule · oral	SUN PHARM	Prescription	8 Feb 2023
LENALIDOMIDE	2.5MG; 5MG; 10MG; 15MG; 20MG; 25MG	capsule · oral	EUGIA PHARMA	Prescription	6 Mar 2023
LENALIDOMIDE	2.5MG	capsule · oral	CIPLA	Prescription	6 Mar 2023
LENALIDOMIDE	2.5MG; 5MG; 10MG; 15MG; 20MG; 25MG	capsule · oral	HETERO LABS LTD V	Prescription	11 May 2023
LENALIDOMIDE	2.5MG; 5MG; 10MG; 15MG; 20MG; 25MG	capsule · oral	QILU	Prescription	22 Feb 2024
LENALIDOMIDE	2.5MG; 5MG; 10MG; 15MG; 20MG; 25MG	capsule · oral	NOVUGEN	Prescription	11 Sep 2024
LENALIDOMIDE	2.5MG; 5MG; 10MG; 15MG; 20MG; 25MG	capsule · oral	AMNEAL	Prescription	31 Jan 2025
LENALIDOMIDE	2.5MG; 5MG; 10MG; 15MG; 20MG; 25MG	capsule · oral	BIOCON PHARMA	Prescription	3 Mar 2025
LENALIDOMIDE	2.5MG; 5MG; 10MG; 15MG; 20MG; 25MG	capsule · oral	DEVA HOLDING AS	Prescription	22 May 2025
LENALIDOMIDE	2.5MG; 5MG; 10MG; 15MG; 20MG; 25MG	capsule · oral	LUPIN	Prescription	16 Sep 2025
LENALIDOMIDE	2.5MG; 5MG; 10MG; 15MG; 20MG; 25MG	capsule · oral	ACCORD HLTHCARE	Prescription	14 Nov 2025
LENALIDOMIDE	5MG; 10MG; 15MG; 20MG; 25MG	capsule · oral	CIPLA	Prescription	2 Feb 2026
LENALIDOMIDE	10MG; 25MG; 20MG; 15MG; 2.5MG; 5MG	capsule · oral	TORRENT	Discontinued	17 Feb 2023

EMA European Union — centrally authorised medicines

Revlimid Bristol-Myers Squibb Pharma EEIG · Authorised · authorised 14 Jun 2007 · ATC L04AX04

Therapeutic indication (EMA)

Multiple myeloma Revlimid as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. Revlimid as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4.2) is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant. Revlimid in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. Myelodysplastic syndromes Revlimid as monotherapy is indicated for the treatment of adult patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate. Mantle cell lymphoma Revlimid as monotherapy is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma. Follicular lymphoma Revlimid in combination with rituximab (anti-CD20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (Grade 1 – 3a).

Lenalidomide Accord Accord Healthcare S.L.U. · Authorised · authorised 20 Sep 2018 · ATC L04AX04

Therapeutic indication (EMA)

Multiple myelomaLenalidomide Accord as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. Lenalidomide Accord as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4.2) is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant. Lenalidomide Accord in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. Follicular lymphomaLenalidomide Accord in combination with rituximab (anti-CD20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (Grade 1 – 3a).

Lenalidomide Mylan Mylan Pharmaceuticals Limited · Authorised · authorised 18 Dec 2020 · ATC L04AX07

Therapeutic indication (EMA)

Multiple myeloma Lenalidomide Mylan as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. Lenalidomide Mylan as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant. Lenalidomide Mylan in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. Follicular lymphoma Lenalidomide Mylan in combination with rituximab (anti-CD20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (Grade 1-3a).

Lenalidomide Krka (previously Lenalidomide Krka d.d. Novo mesto) Krka, d.d., Novo mesto · Authorised · authorised 11 Feb 2021 · ATC L04AX04

Therapeutic indication (EMA)

Multiple myelomaLenalidomide Krka as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. Lenalidomide Krka as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4.2) is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant. Lenalidomide Krka in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. Myelodysplastic syndromesLenalidomide Krka as monotherapy is indicated for the treatment of adult patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate.Mantle cell lymphomaLenalidomide Krka as monotherapy is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (see sections 4.4 and 5.1). Follicular lymphomaLenalidomide Krka in combination with rituximab (anti-CD20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (Grade 1 – 3a). Multiple myelomaLenalidomide Krka as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. Lenalidomide Krka as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4.2) is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant. Lenalidomide Krka in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. Myelodysplastic syndromesLenalidomide Krka as monotherapy is indicated for the treatment of adult patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate. Mantle cell lymphomaLenalidomide Krka as monotherapy is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (see sections 4.4 and 5.1). Follicular lymphomaLenalidomide Krka in combination with rituximab (anti-CD20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (Grade 1 – 3a).

Lenalidomide Krka d.d. Novo mesto (previously Lenalidomide Krka) Krka, d.d., Novo mesto · Authorised · authorised 11 Feb 2021 · ATC L04AX04

Therapeutic indication (EMA)

Multiple myelomaLenalidomide krka d.d. Novo mesto as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. Lenalidomide krka d.d. Novo mesto as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4.2) is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant. Lenalidomide krka d.d. Novo mesto in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. Follicular lymphomaLenalidomide krka d.d. Novo mesto in combination with rituximab (anti-CD20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (Grade 1 – 3a). Multiple myelomaLenalidomide krka d.d. Novo mesto as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. Lenalidomide krka d.d. Novo mesto as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4.2) is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant. Lenalidomide krka d.d. Novo mesto in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. Follicular lymphomaLenalidomide krka d.d. Novo mesto in combination with rituximab (anti-CD20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (Grade 1 – 3a).

Lenalidomide Celgene Europe Celgene Europe Limited · Application withdrawn

Lenalidomide Krka d.d. Krka, d.d., Novo mesto · Withdrawn · authorised 11 Feb 2021 · ATC L04AX04

Therapeutic indication (EMA)

Multiple myeloma Lenalidomide Krka d.d. as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. Lenalidomide Krka d.d. as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4.2) is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant. Lenalidomide Krka d.d. in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. Myelodysplastic syndromes Lenalidomide Krka d.d. as monotherapy is indicated for the treatment of adult patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate. Follicular lymphoma Lenalidomide Krka d.d. in combination with rituximab (anti-CD20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (Grade 1 – 3a).

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
APO-LENALIDOMIDE	02507927	2.5 MG	CAPSULE · ORAL	APOTEX INC
APO-LENALIDOMIDE	02507935	5 MG	CAPSULE · ORAL	APOTEX INC
APO-LENALIDOMIDE	02507943	10 MG	CAPSULE · ORAL	APOTEX INC
APO-LENALIDOMIDE	02507951	15 MG	CAPSULE · ORAL	APOTEX INC
APO-LENALIDOMIDE	02507978	20 MG	CAPSULE · ORAL	APOTEX INC
APO-LENALIDOMIDE	02507986	25 MG	CAPSULE · ORAL	APOTEX INC
JAMP LENALIDOMIDE	02506130	2.5 MG	CAPSULE · ORAL	JAMP PHARMA CORPORATION
JAMP LENALIDOMIDE	02506149	5 MG	CAPSULE · ORAL	JAMP PHARMA CORPORATION
JAMP LENALIDOMIDE	02506157	10 MG	CAPSULE · ORAL	JAMP PHARMA CORPORATION
JAMP LENALIDOMIDE	02506165	15 MG	CAPSULE · ORAL	JAMP PHARMA CORPORATION
JAMP LENALIDOMIDE	02506173	20 MG	CAPSULE · ORAL	JAMP PHARMA CORPORATION
JAMP LENALIDOMIDE	02506181	25 MG	CAPSULE · ORAL	JAMP PHARMA CORPORATION
NAT-LENALIDOMIDE	02493837	2.5 MG	CAPSULE · ORAL	NATCO PHARMA (CANADA) INC
NAT-LENALIDOMIDE	02493845	5 MG	CAPSULE · ORAL	NATCO PHARMA (CANADA) INC
NAT-LENALIDOMIDE	02493861	10 MG	CAPSULE · ORAL	NATCO PHARMA (CANADA) INC
NAT-LENALIDOMIDE	02493888	15 MG	CAPSULE · ORAL	NATCO PHARMA (CANADA) INC
NAT-LENALIDOMIDE	02493896	20 MG	CAPSULE · ORAL	NATCO PHARMA (CANADA) INC
NAT-LENALIDOMIDE	02493918	25 MG	CAPSULE · ORAL	NATCO PHARMA (CANADA) INC
REDDY-LENALIDOMIDE	02483017	5 MG	CAPSULE · ORAL	DR REDDY'S LABORATORIES LTD
REDDY-LENALIDOMIDE	02483025	10 MG	CAPSULE · ORAL	DR REDDY'S LABORATORIES LTD
REDDY-LENALIDOMIDE	02483033	15 MG	CAPSULE · ORAL	DR REDDY'S LABORATORIES LTD
REDDY-LENALIDOMIDE	02483041	20 MG	CAPSULE · ORAL	DR REDDY'S LABORATORIES LTD
REDDY-LENALIDOMIDE	02483068	25 MG	CAPSULE · ORAL	DR REDDY'S LABORATORIES LTD
REDDY-LENALIDOMIDE	02484714	2.5 MG	CAPSULE · ORAL	DR REDDY'S LABORATORIES LTD
REVLIMID	02304899	5 MG	CAPSULE · ORAL	BRISTOL-MYERS SQUIBB CANADA

17 more — full table

WHO WHO Model List of Essential Medicines (2025)

8.2.3. Immunomodulators · complementary
Plasma cell myeloma
Oral > Solid: 25 mg

Safety signals and safety-related labeling changes

US FDA 24 May 2022 REVLIMID — 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 17 May 2018 PRAC signal: Progressive multifocal leukoencephalopathy (PML)
Action for MAH: update of the product information: Yes
EMA PRAC 11 Jan 2018 PRAC signal: Progressive multifocal leukoencephalopathy (PML)
Action for MAH: update of the product information: No
EMA PRAC 12 Jan 2017 PRAC signal: Hemophagocytic lymphohistiocytosis (HLH)
Action for MAH: update of the product information: No
EMA PRAC 2 Sep 2016 PRAC signal: Hemophagocytic lymphohistiocytosis (HLH)
Action for MAH: update of the product information: No
EMA PRAC 10 Sep 2015 PRAC signal: Pulmonary alveolar haemorrhage
Action for MAH: update of the product information: No
EMA PRAC 7 May 2015 PRAC signal: Pulmonary alveolar haemorrhage
Action for MAH: update of the product information: No
MHRA 11 Dec 2014 Lenalidomide (Revlimid): risk of serious hepatic adverse drug reactions
Routine monitoring of liver function now recommended.
MHRA 11 Dec 2014 Lenalidomide (Revlimid▼): update on risk of second primary malignancy
Healthcare professionals should consider the possibility of second primary malignancy in patients treated with lenalidomide.
MHRA 11 Dec 2014 Lenalidomide: risk of thrombosis and thromboembolism
Patients receiving lenalidomide for management of multiple myeloma should be closely monitored for evidence of arterial and venous thromboembolic events.
EMA PRAC 4 Dec 2014 PRAC signal: Parkinson’s disease
Action for MAH: update of the product information: No

All safety entries for lenalidomide →

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.