Tobramycin/Dexamethasone Ingen Pharma

Medicinal product

(Invented) name

Tobramycin/Dexamethasone Ingen Pharma

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 Ingen Pharma, Latvija

Date of authorisation

2018-05-24

Date of renewal

2023-06-29

Documents

Tobramycin_Dexametazone_viesas_AR.pdf

4224 Pakuotės lapelis 2024 03 28.docx

4224 Tobramycin_Dexam Ingen Pharma RPP 2024 03 28.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

Marketing authorisation procedure

Nacionalinė 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
99495	85602	1085602	talpyklė su lašintuvu	5 ml N1		Receptinis	LT/1/18/4224/001	Netiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2023-06-29	Perregistruotas
2018-05-24	Registruotas