Finlepsin

Medicinal product

(Invented) name

Finlepsin

Active substance (s)

Karbamazepinas

Strength

400 mg

Pharmaceutical form

pailginto atpalaidavimo tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

Yes

ATC code (s)

N03AF01, Carbamazepine

Marketing authorisation holder

Teva Pharma B.V., Nyderlandai

Date of authorisation

1998-11-27

Date of renewal

2013-07-31

Documents

0320 Pakuotės lapelis 400mg 2024 07 03.docx

0320 Finlepsin 400mg pailg atpal tab PCS PL 2024 07 03.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Karbamazepinas	400 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
15123	2612	1002612	lizdinė plokštelė	N50		Receptinis	LT/1/98/0320/004	Tiekiama	-	-	No	-	-	Download
15124	19323	1019323	lizdinė plokštelė	N100		Receptinis	LT/1/98/0320/005	Netiekiama	-	-	No	-	-
15125	19324	1019324	lizdinė plokštelė	N200		Receptinis	LT/1/98/0320/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2013-07-31	Perregistruotas
1998-11-27	Registruotas