TOBRADEX

Medicinal product

(Invented) name

TOBRADEX

Active substance (s)

Tobramicinas/Deksametazonas

Strength

3 mg/1 mg/ml

Pharmaceutical form

akių lašai (suspensija)

Route (s) of administration

vartoti ant akių

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

S01CA01, Dexamethasone and antiinfectives

Marketing authorisation holder

UAB Adeofarma, Lietuva

Date of authorisation

2016-06-07

Date of renewal

Documents

0384-01_Tobradex_PZPL.doc

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

Procedure number

Marketing authorisation procedure

Lygiagretus importas

Qualitative and quantitative composition

Viename ml suspensijos yra	1 ml
Tobramicinas	3 mg
Deksametazonas	1 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
65986	80500	1080500	talpyklė su lašintuvu	5 ml N1		Receptinis	LT/L/16/0384/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
	Išregistruotas
2016-06-07	Registruotas