Dretacen

Medicinal product

(Invented) name

Dretacen

Active substance (s)

Levetiracetamas

Strength

500 mg

Pharmaceutical form

plėvele dengtos tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

Yes

ATC code (s)

N03AX14, Levetiracetam

Marketing authorisation holder

UAB Actiofarma, Lietuva

Date of authorisation

2019-06-14

Date of renewal

Documents

0955-001-002_Dretacen_500 mg-2020-07-23-CL.DOCX

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

Procedure number

Marketing authorisation procedure

Lygiagretus importas

Qualitative and quantitative composition

tabletėje yra	1 vnt.
Levetiracetamas	500 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
101951	88053	1088053	lizdinė plokštelė	N30		Receptinis	LT/L/19/0955/001	Netiekiama	-	-	No	-	-	Download
101952	88054	1088054	lizdinė plokštelė	N60		Receptinis	LT/L/19/0955/002	Netiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
	Išregistruotas
2019-06-14	Registruotas