Biodacyna

Medicinal product

(Invented) name

Biodacyna

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

Pharmaceutical Works POLPHARMA S.A., Lenkija

Date of authorisation

2002-02-06

Date of renewal

2012-06-15

Documents

2973 Biodacyna inj PCS PL 2023_04_24.docx

2973 Pakuotės lapelis 2023 04 24.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

1 ml 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
52589	66512	1066512	ampulė	2 ml N1		Receptinis	LT/1/02/2973/005	Tiekiama	-	-	No	-	-
52593	66516	1066516	ampulė	4 ml N1		Receptinis	LT/1/02/2973/006	Tiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2012-06-15	Perregistruotas
2002-02-06	Registruotas