Betadine

Medicinal product

(Invented) name

Betadine

Active substance (s)

Povidonas, joduotas

Strength

100 mg/ml

Pharmaceutical form

odos tirpalas

Route (s) of administration

vartoti ant odos

Legal status for supply

Nereceptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

D08AG02, Povidone-iodine

Marketing authorisation holder

Egis Pharmaceuticals PLC, Vengrija

Date of authorisation

1996-03-29

Date of renewal

2009-12-17

Documents

1802 Betadine odos tirp PL 2024 07 22, rastas VRA_10399.docx

1802 Pakuotės lapelis odos tirp 2024 07 22, rastas VRA_10399.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10a

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

1 ml tirpalo yra	1 ml
Povidonas, joduotas	100 mg

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
1786	7468	1007468	buteliukas	30 ml N1		Nereceptinis	LT/1/96/1802/002	Tiekiama	-	-	No	-	-	Download
13470	17769	1017769	buteliukas	120 ml N1		Nereceptinis	LT/1/96/1802/003	Tiekiama	-	-	No	-	-
13471	17770	1017770	buteliukas	1000 ml N1		Nereceptinis	LT/1/96/1802/004	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2009-12-17	Perregistruotas
1996-03-29	Registruotas