Amikacin Sopharma

Medicinal product

(Invented) name

Amikacin Sopharma

Active substance (s)

Amikacinas

Strength

250 mg/ml

Pharmaceutical form

injekcinis tirpalas

Route (s) of administration

leisti į veną, leisti į raumenis

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

J01GB06, Amikacin

Marketing authorisation holder

SOPHARMA AD, Bulgarija

Date of authorisation

2002-06-05

Date of renewal

2014-06-06

Documents

3574_1-4_Pakuotės lapelis_190923.docx

3574_1-4_Amikacin_Sopharma_inj_tirp_RPP_190923.doc

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10a

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

1 ml injekcinio tirpalo yra	1 ml
Amikacinas	250 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
59318	73544	1073544	ampulė	2 ml N10		Receptinis	LT/1/97/3574/001	Netiekiama	-	-	No	-	-	Download
59319	73545	1073545	ampulė	2 ml N100		Receptinis	LT/1/97/3574/002	Netiekiama	-	-	No	-	-
3660	5021	1005021	ampulė	4 ml N10		Receptinis	LT/1/97/3574/003	Netiekiama	-	-	No	-	-
3661	9089	1009089	ampulė	4 ml N100		Receptinis	LT/1/97/3574/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2020-08-31	Išregistruotas
2014-06-06	Perregistruotas
2002-06-05	Registruotas