DRONEDARONE HYDROCHLORIDE

Details

Stereochemistry	ACHIRAL
Molecular Formula	C31H44N2O5S.ClH
Molecular Weight	593.217
Optical Activity	NONE
Defined Stereocenters	0 / 0
E/Z Centers	0
Charge	0

SHOW SMILES / InChI

Structure Search

SMILES

Cl.CCCCN(CCCC)CCCOC1=CC=C(C=C1)C(=O)C2=C(CCCC)OC3=C2C=C(NS(C)(=O)=O)C=C3

InChI

InChIKey=DWKVCQXJYURSIQ-UHFFFAOYSA-N

InChI=1S/C31H44N2O5S.ClH/c1-5-8-12-29-30(27-23-25(32-39(4,35)36)15-18-28(27)38-29)31(34)24-13-16-26(17-14-24)37-22-11-21-33(19-9-6-2)20-10-7-3;/h13-18,23,32H,5-12,19-22H2,1-4H3;1H

HIDE SMILES / InChI

Molecular Formula	C31H44N2O5S
Molecular Weight	556.756
Charge	0
Count

Stereochemistry	ACHIRAL
Additional Stereochemistry	No
Defined Stereocenters	0 / 0
E/Z Centers	0
Optical Activity	NONE

Molecular Formula	ClH
Molecular Weight	36.461
Charge	0
Count

Stereochemistry	ACHIRAL
Additional Stereochemistry	No
Defined Stereocenters	0 / 0
E/Z Centers	0
Optical Activity	NONE

Description
Sources: http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022425lbl.pdf
Curator's Comment: description was created based on several sources, including: https://www.drugs.com/ppa/dronedarone.html | https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7fa41601-7fb5-4155-8e50-2ae903f0d2d6 | http://www.rxlist.com/multaq-drug.htm

Dronedarone is an antiarrhythmic that is FDA approved for the treatment of atrial fibrillation in patients in sinus rhythm with a history of paroxysmal or persistent atrial fibrillation (AF). Dronedarone is multichannel blocker. Common adverse reactions include abdominal pain, diarrhea, indigestion, nausea, vomiting, asthenia and raised serum creatinine. Dronedarone has potentially important pharmacodynamics interactions: Digoxin: Consider discontinuation or halve dose of digoxin before treatment and monitor; Calcium channel blockers (CCB): Initiate CCB with low dose and increase after ECG verification of tolerability; Beta-blockers: May provoke excessive bradycardia, Initiate with low dose and increase after ECG verification of tolerability.

CNS Activity

Originator

Approval Year

Targets

Primary Target	Pharmacology	Potency
Inward rectifier potassium channel 2 5 Target ID: CHEMBL1914276 Sources: https://www.ncbi.nlm.nih.gov/pubmed/25182566	Blocker 534
Potassium/sodium hyperpolarization-activated cyclic nucleotide-gated channel 4 14 Target ID: CHEMBL1250417 Sources: https://www.ncbi.nlm.nih.gov/pubmed/21279331	Blocker 534	1.0 µM [IC50]
Cytochrome P450 3A4 126 Target ID: CHEMBL340 Sources: https://www.ncbi.nlm.nih.gov/pubmed/17389667 \| http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022425lbl.pdf	Substrate 656

Conditions

Condition	Modality	Targets	Highest Phase	Product
Atrial fibrillation 131 Sources: http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022425lbl.pdf	Primary		Approved 8360	MULTAQ Approved Use MULTAQ® is indicated to reduce the risk of hospitalization for atrial fibrillation in patients in sinus rhythm with a history of paroxysmal or persistent atrial fibrillation (AF) [see Clinical Studies (14) Launch Date 1.24640638E12
Atrial flutter 6 Sources: http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022425lbl.pdf	Primary		Approved 8360	MULTAQ Approved Use MULTAQ® is indicated to reduce the risk of hospitalization for atrial fibrillation in patients in sinus rhythm with a history of paroxysmal or persistent atrial fibrillation (AF) [see Clinical Studies (14) Launch Date 1.24640638E12

C_max

Value	Dose	Co-administered	Analyte	Population
96.2 ng/mL EXPERIMENT https://onlinelibrary.wiley.com/doi/full/10.1046/j.1472-8206.2003.00216.x	1600 mg single, oral dose: 1600 mg route of administration: Oral experiment type: SINGLE co-administered: METOPROLOL	METOPROLOL	DRONEDARONE plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN

AUC

Value	Dose	Co-administered	Analyte	Population
1386 ng × h/mL EXPERIMENT https://onlinelibrary.wiley.com/doi/full/10.1046/j.1472-8206.2003.00216.x	1600 mg single, oral dose: 1600 mg route of administration: Oral experiment type: SINGLE co-administered: METOPROLOL	METOPROLOL	DRONEDARONE plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN

T_1/2

Value	Dose	Co-administered	Analyte	Population
12 h EXPERIMENT https://onlinelibrary.wiley.com/doi/full/10.1046/j.1472-8206.2003.00216.x	1600 mg single, oral dose: 1600 mg route of administration: Oral experiment type: SINGLE co-administered: METOPROLOL	METOPROLOL	DRONEDARONE plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN

Doses

Dose	Population	Adverse events
400 mg 2 times / day steady, oral Recommended Dose: 400 mg, 2 times / day Route: oral Route: steady Dose: 400 mg, 2 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022425lbl.pdf	unhealthy, 20-97 years n = 3282 Health Status: unhealthy Condition: atrial fibrillation \| atrial flutter Age Group: 20-97 years Sex: M+F Population Size: 3282 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022425lbl.pdf	Disc. AE: Gastrointestinal disorders, QT interval prolonged... AEs leading to discontinuation/dose reduction: Gastrointestinal disorders (3.2%) QT interval prolonged (1.5%) Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022425lbl.pdf
1600 mg 2 times / day multiple, oral Highest studied dose Dose: 1600 mg, 2 times / day Route: oral Route: multiple Dose: 1600 mg, 2 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022425lbl.pdf https://pubmed.ncbi.nlm.nih.gov/17056831	healthy, 21-40 years Health Status: healthy Age Group: 21-40 years Sex: M Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022425lbl.pdf https://pubmed.ncbi.nlm.nih.gov/17056831	Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022425lbl.pdf https://pubmed.ncbi.nlm.nih.gov/17056831
400 mg 2 times / day steady, oral Recommended Dose: 400 mg, 2 times / day Route: oral Route: steady Dose: 400 mg, 2 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf Page: p. 103	unhealthy, adult n = 989 Health Status: unhealthy Condition: atrial fibrillation \| atrial flutter Age Group: adult Sex: M+F Population Size: 989 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf Page: p. 103	Disc. AE: Diarrhea, Nausea... AEs leading to discontinuation/dose reduction: Diarrhea (6.7%) Nausea (3.9%) Abdominal pain upper (2%) Abdominal pain (1.9%) Vomiting (1.7%) Dyspepsia (1.3%) Nasopharyngitis (3.7%) Upper respiratory tract infection (2.9%) Dizziness (3.4%) Blood creatinine increased (2.5%) Hepatic enzyme increased (1.2%) Blood urea increased (0.4%) Bradycardia (2.6%) Palpitations (1.1%) Cardiac failure congestive (1.3%) Cardiac failure (0.8%) Fatigue (2.7%) Oedema peripheral (4.2%) Back pain (3.3%) Arthralgia (3.1%) Pain in extremity (2.1%) Cough (2.2%) Dyspnoea (2.3%) Vertigo (1.3%) Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf Page: p. 103
400 mg 2 times / day steady, oral Dose: 400 mg, 2 times / day Route: oral Route: steady Dose: 400 mg, 2 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022425lbl.pdf	unhealthy, adult Health Status: unhealthy Condition: NYHA Class IV heart failure \| NYHA Class II - III heart failure Age Group: adult Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022425lbl.pdf	Other AEs: Heart failure... Other AEs: Heart failure (grade 5) Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022425lbl.pdf
600 mg 2 times / day multiple, oral Dose: 600 mg, 2 times / day Route: oral Route: multiple Dose: 600 mg, 2 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf Page: p. 103	unhealthy, adult n = 66 Health Status: unhealthy Condition: atrial fibrillation \| atrial flutter Age Group: adult Sex: M+F Population Size: 66 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf Page: p. 103	Disc. AE: Diarrhea, Vomiting... AEs leading to discontinuation/dose reduction: Diarrhea (7.6%) Vomiting (1.5%) Dyspepsia (3%) Abdominal pain (1.5%) Nasopharyngitis (4.5%) Electrocardiogram QT prolonged (1.5%) Blood creatinine increased (1.5%) Hepatic enzyme increased (4.5%) Blood urea increased (3%) Bradycardia (1.5%) Palpitations (6.1%) Cardiac failure congestive (4.5%) Cardiac failure (4.5%) Fatigue (4.5%) Cough (1.5%) Hypokalemia (3%) Vertigo (4.5%) Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf Page: p. 103
800 mg 2 times / day multiple, oral Dose: 800 mg, 2 times / day Route: oral Route: multiple Dose: 800 mg, 2 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf Page: p. 103	unhealthy, adult n = 62 Health Status: unhealthy Condition: atrial fibrillation \| atrial flutter Age Group: adult Sex: M+F Population Size: 62 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf Page: p. 103	Disc. AE: Diarrhea, Nausea... AEs leading to discontinuation/dose reduction: Diarrhea (29%) Nausea (8.1%) Vomiting (3.2%) Abdominal pain (3.2%) Influenza (3.2%) Upper respiratory tract infection (1.6%) Dizziness (4.8%) Electrocardiogram QT prolonged (3.2%) Hepatic enzyme increased (1.6%) Blood urea increased (3.2%) Bradycardia (6.5%) Palpitations (4.8%) Cardiac failure congestive (1.6%) Cardiac failure (1.6%) Fatigue (3.2%) Atrial tachycardia (4.8%) Cough (4.8%) Vertigo (3.2%) Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf Page: p. 103

AEs

Overview

CYP3A4	CYP2C9	CYP2D6	hERG
inhibitor 1579	inducer 383 inhibitor 1752	substrate 1193 inhibitor 1837	inhibitor 1599

OverviewOther

Other Inhibitor	Other Substrate	Other Inducer
CYP1A2 1509 CYP2C19 1463 CYP2E1 876 P-gp 1437 OAT1 595 OAT3 636 OCT1 506 OATP1B1 781 OATP1B3 700	CYP3A 189 CYP1A2 1032 P-gp 1527	CYP1A2 689 CYP2A6 79 CYP3A 126 CYP2C8 168 CYP2C19 290

Drug as perpetrator

Target	Modality	Activity	Clinical evidence
OATP1B1 796	inhibitor 3240 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022425s029lbl.pdf#page=13 Page: 13.0	likely
OATP1B3 709	inhibitor 3240 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022425s029lbl.pdf#page=13 Page: 13.0	likely
CYP3A4 1909	inhibitor 3240 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_ClinPharm_P1.pdf#page=76 Page: 76,89,194	moderate [Ki 8.12 uM]	yes (co-administration study) Comment: dronedarone increased verapamil exposure by 1.4- fold, and nisoldipine exposure by 1.5- fold; dronedarone increased simvastatin, a sensitive CYP3A substrate, and simvastatin acid exposure by 4- fold and 2- fold, respectively; Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_ClinPharm_P1.pdf#page=76 Page: 76,89,194
CYP1A2 1673	inducer 1542 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_ClinPharm_P1.pdf#page=76 Page: 76.0	no
CYP2A6 736	inducer 1542 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_ClinPharm_P1.pdf#page=76 Page: 76.0	no
CYP2C19 1537	inducer 1542 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_ClinPharm_P1.pdf#page=76 Page: 76.0	no
CYP2C8 955	inducer 1542 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_ClinPharm_P1.pdf#page=76 Page: 76.0	no
CYP2C9 1803	inducer 1542 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_ClinPharm_P1.pdf#page=76 Page: 76.0	no
CYP3A 295	inducer 1542 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_ClinPharm_P1.pdf#page=76 Page: 76.0	no
CYP1A2 1673	inhibitor 3240 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_ClinPharm_P1.pdf#page=76 Page: 76.0	not significant
CYP2C19 1537	inhibitor 3240 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_ClinPharm_P1.pdf#page=76 Page: 76.0	not significant
CYP2E1 964	inhibitor 3240 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_ClinPharm_P1.pdf#page=76 Page: 76.0	not significant
OAT1 599	inhibitor 3240 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022425s029lbl.pdf#page=13 Page: 13.0	not significant
OAT3 638	inhibitor 3240 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022425s029lbl.pdf#page=13 Page: 13.0	not significant
OCT1 523	inhibitor 3240 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022425s029lbl.pdf#page=13 Page: 13.0	not significant
CYP2C9 1803	inhibitor 3240 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_ClinPharm_P1.pdf#page=76 Page: 76.0	not significant	weak (co-administration study) Comment: dronedarone increased S-warfarin exposure by 1.2- fold Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_ClinPharm_P1.pdf#page=76 Page: 76.0
P-gp 1626	inhibitor 3240 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_ClinPharm_P1.pdf#page=76 Page: 76,90	strong [IC50 0.97 uM]	yes (co-administration study) Comment: IC50 value obtained using vincristine as substrate; increased S-warfarin exposure by 1.2- fold Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_ClinPharm_P1.pdf#page=76 Page: 76,90
CYP2D6 1875	inhibitor 3240 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_ClinPharm_P1.pdf#page=76 Page: 76,89,194	weak [Ki 4.37 uM]	yes (co-administration study) Comment: dronedarone increased metoprolol exposure by 1.6- and 2.3- fold, respectively; increased propranolol exposure by 1.3- fold; Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_ClinPharm_P1.pdf#page=76 Page: 76,89,194

Drug as victim

Target	Modality	Activity	Clinical evidence
CYP3A 189	substrate 3326 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_ClinPharm_P1.pdf#page=76 Page: 76,89	major	yes (co-administration study) Comment: administration of ketoconazole resulted in a 17- to 25- fold increase in dronedarone exposure; administration with rifampicin decreased dronedarone exposure by 80% Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_ClinPharm_P1.pdf#page=76 Page: 76,89
CYP1A2 1032	substrate 3326 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_ClinPharm_P1.pdf#page=76 Page: 76.0	no
CYP2D6 1193	substrate 3326 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_ClinPharm_P1.pdf#page=76 Page: 76.0	no
P-gp 1527	substrate 3326 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_ClinPharm_P1.pdf#page=76 Page: 76.0	unlikely

Tox targets

Target	Modality	Activity	Metabolite	Clinical evidence
hERG 1632	inhibitor 1613 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_Pharm_P1.pdf#page=59 Page: 59.0

Sourcing

Vendor/Aggregator	ID	URL
ChEBI	CHEBI:50659	https://www.ebi.ac.uk/chebi/searchId.do?chebiId=CHEBI:50659
ChemicalBook	CB11117179	https://www.chemicalbook.com/ChemicalProductProperty_EN_CB11117179
MolPort	MolPort-006-170-000	https://www.molport.com/shop/molecule-link/MolPort-006-170-000
ZINC	ZINC000049933061	http://zinc15.docking.org/substances/ZINC000049933061
eMolecules	30152747	https://www.emolecules.com/cgi-bin/more?vid=30152747

PubMed

Title	Date	PubMed
Hemodynamic and antiadrenergic effects of dronedarone and amiodarone in animals with a healed myocardial infarction.	2000 Sep	10975596
Mechanisms of action of antiarrhythmic drugs relative to the origin and perpetuation of cardiac arrhythmias.	2001 Jan	11452339
Electrophysiological effects of dronedarone (SR 33589), a noniodinated amiodarone derivative in the canine heart: comparison with amiodarone.	2001 Jul	11429385
Newer antiarrhythmic drugs.	2001 May-Jun	11516042
Chronic and acute effects of dronedarone on the action potential of rabbit atrial muscle preparations: comparison with amiodarone.	2002 May	11973411
Electrophysiologic characterization of dronedarone in guinea pig ventricular cells.	2003 Feb	12548079
Involvement of nitric oxide in amiodarone- and dronedarone-induced coronary vasodilation in guinea pig heart.	2004 Aug 2	15288583
Pharmacokinetic and pharmacodynamic interactions between metoprolol and dronedarone in extensive and poor CYP2D6 metabolizers healthy subjects.	2004 Feb	14748763
Theoretical possibilities for the development of novel antiarrhythmic drugs.	2004 Jan	14754422
A benefit-risk assessment of class III antiarrhythmic agents.	2004 Nov	15500415
Antiarrhythmic drugs in patients with implantable cardioverter-defibrillators.	2005	16259525
[Atrial fibrillation: choice of the method of pharmacological cardioversion].	2005	15798717
Dronedarone administration prevents body weight gain and increases tolerance of the heart to ischemic stress: a possible involvement of thyroid hormone receptor alpha1.	2005 Jan	15687816
This DAFNE is definitely not that DAFNE.	2005 May 25	15882687
[Dronedarone establishes and maintains control of sinus rhythm].	2006 Aug 23	16972539
Do we need pharmacological therapy for atrial fibrillation in the ablation era?	2006 Dec	17340189
Amiodarone inhibits thyroidal iodide transport in vitro by a cyclic adenosine 5'-monophosphate- and iodine-independent mechanism.	2006 Jun	16527845
Topics on the Na+/Ca2+ exchanger: pharmacological characterization of Na+/Ca2+ exchanger inhibitors.	2006 Sep	16990699
Medical management of atrial fibrillation: state of the art.	2006 Sep	16939435
Dronedarone: an amiodarone analog for the treatment of atrial fibrillation and atrial flutter.	2007 Apr	17389667
Dronedarone: in quest of the ideal antiarrhythmic drug.	2007 Fall	18059201
New antiarrhythmic treatment of atrial fibrillation.	2007 Jul	17605649
Na+/Ca2+ exchange inhibitors: a new class of calcium regulators.	2007 Sep	17896959
Clinical trials update from the Heart Failure Society of America and the American Heart Association meetings in 2008: SADHART-CHF, COMPARE, MOMENTUM, thyroid hormone analogue study, HF-ACTION, I-PRESERVE, beta-interferon study, BACH, and ATHENA.	2009 Feb	19168521
Benzofuran derivatives and the thyroid.	2009 Jan	18727707
The role of thyroid hormone nuclear receptors in the heart: evidence from pharmacological approaches.	2010 Mar	19096930

Patents

Sample Use Guides

In Vivo Use Guide

One tablet of 400 mg twice a day with morning and evening meals.

Route of Administration: Oral

In Vitro Use Guide

In isolated ventricular myocytes, dronedarone inhibited rapidly activating delayed-rectifier K+ current (I(Kr)) (median inhibitory concentration [IC50] /= 30 uM).

Substance Class	Chemical Created by `admin` on `Wed Jul 05 23:10:25 UTC 2023` Edited by `admin` on `Wed Jul 05 23:10:25 UTC 2023`
Record UNII	FA36DV299Q
Record Status	`Validated (UNII)`
Record Version

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Name

Type

Language

DRONEDARONE HYDROCHLORIDE

Official Name

English

MULTAQ

Brand Name

English

SR33598B

Code

English

DRONEDARONE HCL

Common Name

English

Methanesulfonamide, N-[2-butyl-3-[4-[3-(dibutylamino)propoxy]benzoyl]-5-benzofuranyl]-, monohydrochloride

Common Name

English

DRONEDARONE HYDROCHLORIDE [EP MONOGRAPH]

Common Name

English

DRONEDARONE HYDROCHLORIDE [MI]

Common Name

English

DRONEDARONE HYDROCHLORIDE [USP-RS]

Common Name

English

DRONEDARONE HYDROCHLORIDE [USP MONOGRAPH]

Common Name

English

Dronedarone hydrochloride [WHO-DD]

Common Name

English

DRONEDARONE HYDROCHLORIDE [MART.]

Common Name

English

SR-33598B

Code

English

DRONEDARONE HYDROCHLORIDE [USAN]

Common Name

English

N-(2-BUTYL-3-(4-(3-(DIBUTYLAMINO)PROPROXY)BENZOYL)BENZOFURAN-5-YL) METHANESULFONAMIDE-, MONOHYDROCHLORIDE

Common Name

English

DRONEDARONE HYDROCHLORIDE [ORANGE BOOK]

Common Name

English

Classification Tree Code System Code

EMA ASSESSMENT REPORTS

MULTAQ (AUTHORIZED ATRIAL FIBRILLATION)