Biodacyna

Medicinal product

(Invented) name

Biodacyna

Active substance (s)

Amikacinas

Strength

125 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

Pharmaceutical Works POLPHARMA S.A., Lenkija

Date of authorisation

2002-02-06

Date of renewal

2012-06-15

Documents

2973_4_6 Biodacyna inj PZ PL 180920.docx

2973_4_6 Pakuotės lapelis 180920.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

1 ml injekcinio tirpalo yra	1 ml
Amikacinas	125 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
52587	66510	1066510	ampulė	2 ml N1		Receptinis	LT/1/02/2973/004	Netiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2019-05-08	Išregistruotas
2012-06-15	Perregistruotas
2002-02-06	Registruotas