Tobramycin/Dexamethasone ELVIM

Medicinal product

(Invented) name

Tobramycin/Dexamethasone ELVIM

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

SIA ELVIM, Latvija

Date of authorisation

2022-12-19

Date of renewal

Documents

5083 Tobramycin_Dexamethasone_ELVIM.docx

5083 pakuotes lapelis_2022-12-19.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

LV/H/0207/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 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
109987	96097	1096097	buteliukas	5 ml su lašintuvu N1		Receptinis	LT/1/22/5083/001	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-12-19	Registruotas