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 Lex ano, Lietuva

Date of authorisation

2022-09-22

Date of renewal

Documents

1737-001_TOBREX 3mg_ml_akiu_lasai_tirp_PZPL_2022-09-22.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
109477	95583	1095583	talpyklė su lašintuvu	5 ml N1		Receptinis	LT/L/22/1737/001	Netiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2022-09-22	Registruotas