Amiodarone Hikma

Medicinal product

(Invented) name

Amiodarone Hikma

Active substance (s)

Amjodarono hidrochloridas

Strength

50 mg/ml

Pharmaceutical form

injekcinis tirpalas

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

C01BD01, Amiodarone

Marketing authorisation holder

UAB Adeofarma, Lietuva

Date of authorisation

2021-09-23

Date of renewal

Documents

1593-001_Amiodarone Hikma 50mg-ml_inj_tirp_PZPL_2021-09-23.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

Procedure number

Marketing authorisation procedure

Lygiagretus importas

Qualitative and quantitative composition

1 ml tirpalo yra	1 ml
Amjodarono hidrochloridas	50 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
107269	93373	1093373	ampulė	3 ml N10	ASPĮ	Receptinis	LT/L/21/1593/001	Tiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2021-09-23	Registruotas