Betadine

Medicinal product

(Invented) name

Betadine

Active substance (s)

Povidonas, joduotas

Strength

100 mg/g

Pharmaceutical form

tepalas

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 Pakuotės lapelis tepalas 2024 07 22.docx

1802 Betadine tepalas PCS PL 2024 07 22.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10a

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

1 g tepalo yra	1 g
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
1787	7469	1007469	tūbelė	20 g N1		Nereceptinis	LT/1/96/1802/001	Tiekiama	-	-	No	-	-	Download
62436	76844	1076844	tūbelė	100 g N1		Nereceptinis	LT/1/96/1802/006	Tiekiama	-	-	No	-	-

Stadijos

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