PROPANORM

Medicinal product

(Invented) name

PROPANORM

Active substance (s)

Propafenono hidrochloridas

Strength

3,5 mg/ml

Pharmaceutical form

injekcinis ar infuzinis tirpalas

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

C01BC03, Propafenone

Marketing authorisation holder

PRO. MED. CS Praha a.s., Čekija

Date of authorisation

2012-10-12

Date of renewal

2019-01-17

Documents

0467 Pakuotės lapelis 2022 10 24.docx

0467 PROPANORM inj_inf PCS PL 2022 10 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
Propafenono hidrochloridas	3,5 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
50255	64132	1064132	ampulė	10 ml N10		Receptinis	LT/1/01/0467/003	Tiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2019-01-17	Perregistruotas
2012-10-12	Registruotas