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

UAB Limedika, Lietuva

Date of authorisation

2017-05-09

Date of renewal

Documents

0496_001 TOBREX_akiu lasai tirpalas.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

Procedure number

Marketing authorisation procedure

Lygiagretus importas

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
68249	82816	1082816	talpyklė su lašintuvu	5 ml N1		Receptinis	LT/L/17/0496/001	Netiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2017-05-09	Registruotas