Tobrex

Medicinal product

(Invented) name

Tobrex

Active substance (s)

Tobramicinas

Strength

3 mg/g

Pharmaceutical form

akių tepalas

Route (s) of administration

vartoti ant akių

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

S01AA12, Tobramycin

Marketing authorisation holder

SIA Novartis Baltics, Latvija

Date of authorisation

1996-07-11

Date of renewal

2013-01-10

Documents

0004 Pakuotės lapelis 2025 02 01.docx

0004 Tobrex akiu tepalas II PL 2025 02 01.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

1 g tepalo yra	1 g
Tobramicinas	3 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
7672	12608	1012608	tūbelė	3,5 g; N1		Receptinis	LT/1/92/0004/002	Tiekiama	2025-08-26	-	No	-	-	Download

Stadijos

Data	Stadija
2013-01-10	Perregistruotas
1996-07-11	Registruotas