Tobrex

Medicinal product

(Invented) name

Tobrex

Active substance (s)

Tobramicinas

Strength

3 mg/ml

Pharmaceutical form

akių lašai (tirpalas)

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

1992-03-05

Date of renewal

2013-01-10

Documents

0004 Tobrex akiu lasai II PL 2025 02 01.docx

0004 Pakuotės lapelis 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 ml tirpalo yra	1 ml
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
11876	16300	1016300	talpyklė su lašintuvu	5 ml N1		Receptinis	LT/1/92/0004/001	Tiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2013-01-10	Perregistruotas
1992-03-05	Registruotas