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

UAB Lex ano, Lietuva

Date of authorisation

2024-01-12

Date of renewal

Documents

2054_OTIPAX_PL_2024-01-12.docx

2054_OTIPAX_PZ_2024-01-12.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

Procedure number

Marketing authorisation procedure

Lygiagretus importas

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
112555	98675	1098675	buteliukas	16 g, N1		Nereceptinis	LT/L/24/2054/001	Tiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2024-01-12	Registruotas