Propafenone Accord

Medicinal product

(Invented) name

Propafenone Accord

Active substance (s)

Propafenono hidrochloridas

Strength

300 mg

Pharmaceutical form

plėvele dengtos tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

C01BC03, Propafenone

Marketing authorisation holder

Accord Healthcare B.V., Nyderlandai

Date of authorisation

2017-07-27

Date of renewal

2023-12-11

Documents

4119 Propafenone Accord II PL 2025 02 14.docx

4119 Pakuotės lapelis 2025 02 14.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

AT/H/0657/002/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra:	1 vnt.
Propafenono hidrochloridas	300 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
97509	83603	1083603	lizdinė plokštelė	N20		Receptinis	LT/1/17/4119/006	Netiekiama	-	-	No	-	-
97510	83604	1083604	lizdinė plokštelė	N30		Receptinis	LT/1/17/4119/007	Netiekiama	-	-	No	-	-
97511	83605	1083605	lizdinė plokštelė	N60		Receptinis	LT/1/17/4119/008	Netiekiama	2025-07-03	2025-09-01	No	-	-
97512	83606	1083606	lizdinė plokštelė	N90		Receptinis	LT/1/17/4119/009	Netiekiama	-	-	No	-	-
97513	83607	1083607	lizdinė plokštelė	N100		Receptinis	LT/1/17/4119/010	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-12-11	Perregistruotas
2017-07-27	Registruotas