OTIPAX

Medicinal product

(Invented) name

OTIPAX

Active substance (s)

Fenazonas/Lidokaino hidrochloridas

Strength

40 mg/10 mg/g

Pharmaceutical form

ausų lašai (tirpalas)

Route (s) of administration

vartoti į ausis

Legal status for supply

Nereceptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

S02DA30, Combinations

Marketing authorisation holder

Biocodex, Prancūzija

Date of authorisation

1995-10-04

Date of renewal

2008-06-02

Documents

1174 Pakuotės lapelis 2024 07 01.docx

1174 OTIPAX RPP 2024 07 01.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10c

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

1 g tirpalo yra	1 g
Fenazonas	40 mg
Lidokaino hidrochloridas	10 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
1156	6980	1006980	buteliukas	15 ml (16 g), N1		Nereceptinis	LT/1/95/1174/001	Tiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2008-06-02	Perregistruotas
1995-10-04	Registruotas