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

Lex ano, UAB, Lietuva

Date of authorisation

2015-04-17

Date of renewal

Documents

0263_01 TOBREX RO_PZ_PL.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

Procedure number

Marketing authorisation procedure

Lygiagretus importas

Qualitative and quantitative composition

Viename grame akių 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
61825	76195	1076195	tūbelė	3,5 g N1		Receptinis	LT/L/15/0263/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
	Išregistruotas
2015-04-17	Registruotas