Pregabalin Zentiva k.s

Medicinal product

(Invented) name

Pregabalin Zentiva k.s

Active substance (s)

Pregabalinas

Strength

300 mg

Pharmaceutical form

kietosios kapsulės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

Yes

ATC code (s)

N02BF02, Pregabalin

Marketing authorisation holder

Zentiva k.s., Čekija

Date of authorisation

2017-02-27

Date of renewal

Documents

Search in EMA Europe

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Capsule, hard	1 vnt.
Pregabalinas	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
67865	82423	1082423	lizdinė plokštelė	N14		Receptinis	EU/1/16/1166/026	Netiekiama	-	-	No	-	-
67866	82424	1082424	lizdinė plokštelė	N56		Receptinis	EU/1/16/1166/027	Netiekiama	-	-	No	-	-
67867	82425	1082425	lizdinė plokštelė	N100		Receptinis	EU/1/16/1166/028	Netiekiama	-	-	No	-	-
99666	85773	1085773	lizdinė plokštelė	N98		Receptinis	EU/1/16/1166/036	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-02-28	Išregistruotas
2017-02-27	Registruotas