POLYGYNAX

This brand name is authorized in Nigeria. It is also authorized in Croatia, Cyprus, Ecuador, Estonia, France, Hong Kong SAR China, Lithuania, Malta, Mexico, Romania, Singapore, Tunisia.

Active ingredients

The drug POLYGYNAX contains a combination of these active pharmaceutical ingredients (APIs):

1	Neomycin UNII 057Y626693 - NEOMYCIN SULFATE
	Neomycin is an aminoglycoside antibiotic and acts by binding to polysomes, inhibiting protein synthesis and generating errors in the transcription of the genetic code.
	Read more about Neomycin
2	Polymyxin B UNII 19371312D4 - POLYMYXIN B SULFATE
	Polymixin B is bactericidal against a wide range of gram negative bacilli. It exerts a bactericidal effect by binding to acid phospholipids in the cell wall and membranes of the bacterium, thereby rendering ineffective the osmotic barrier normally provided by the cell membrane.
	Read more about Polymyxin B
3	Nystatin UNII BDF1O1C72E - NYSTATIN
	Nystatin is an antifungal antibiotic active against a wide range of yeasts and yeast-like fungi, including Candida albicans.
	Read more about Nystatin

Packages

This drug has been approved in Nigeria as follows:

Identifier	Form	Presentation	Description	Approval
04-3009	Vaginal capsule	Polygynax Capsule CAP 100,000 IU; 35 mg; 35,000 IU 2 x 6's	Each Vaginal Capsule contains: Neomycin (as Neomycin Sulfate) 35 mg, Polymyxin B Sulfate 35,000 IU, Nystatin 100,000 IU	09/02/2021

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
POLYGYNAX Vaginal capsule	MPI, EU: SmPC

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC Group		Classification
G01AA51	Nystatin, combinations	G Genito urinary system and sex hormones → G01 Gynecological antiinfectives and antiseptics → G01A ANTIINFECTIVES AND ANTISEPTICS, EXCL. COMBINATIONS WITH CORTICOSTEROIDS → G01AA Antibiotics
Discover more medicines within G01AA51

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country	Identification scheme	Identifier(s)
EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	26.011-10-04
EE	Ravimiamet	1127001, 1128181
FR	Base de données publique des médicaments	66085108, 68739115
HK	Department of Health Drug Office	29091
HR	Agencija za lijekove i medicinske proizvode	HR-H-155352773
LT	Valstybinė vaistų kontrolės tarnyba	1006309, 1014582, 1073846, 1079847, 1083704, 1085845, 1086395, 1092801
MT	Medicines Authority	MA093/00401
MX	Comisión Federal para la Protección contra Riesgos Sanitarios	081M2004
NG	Registered Drug Product Database	04-3009
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W01949002, W64599001
SG	Health Sciences Authority	07745P
TN	Direction de la Pharmacie et du Médicament	1763031