POLYGYNAX

Medicinal product

(Invented) name

POLYGYNAX

Active substance (s)

Neomicino sulfatas/Polimiksino B sulfatas/Nistatinas

Strength

35000 TV/35000 TV/100000 TV

Pharmaceutical form

makšties minkštosios kapsulės

Route (s) of administration

vartoti į makštį

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

G01AA51, Nystatin, combinations

Marketing authorisation holder

LABORATOIRE INNOTECH INTERNATIONAL, Prancūzija

Date of authorisation

1994-12-20

Date of renewal

2009-05-13

Documents

1574 POLYGYNAX maksties kaps RPP 2025 04 30.docx

1574 Pakuotės lapelis 2025 04 30.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10b

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

Kapsulėje yra	1 vnt.
Neomicino sulfatas	35000 TV
Polimiksino B sulfatas	35000 TV
Nistatinas	100000 TV

Packages

PAKID	NPAKID	NPAKID-7	Pack type	Pack size	Type of packaging	Proposed dispensing/classification	Marketing authorisation no.	Supply status	From	To	Package is in foreign language	From	To	Mock-up
358	6309	1006309	lizdinė plokštelė	N6		Receptinis	LT/1/94/1574/001	Tiekiama	-	-	No	-	-
9976	14582	1014582	lizdinė plokštelė	N12		Receptinis	LT/1/94/1574/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2009-05-13	Perregistruotas
1994-12-20	Registruotas