Pregabalin Zentiva k.s

Medicinal product

(Invented) name

Pregabalin Zentiva k.s

Active substance (s)

Pregabalinas

Strength

200 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	200 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
67859	82417	1082417	lizdinė plokštelė	N21		Receptinis	EU/1/16/1166/020	Netiekiama	-	-	No	-	-
67860	82418	1082418	lizdinė plokštelė	N84		Receptinis	EU/1/16/1166/021	Netiekiama	-	-	No	-	-
67861	82419	1082419	lizdinė plokštelė	N100		Receptinis	EU/1/16/1166/022	Netiekiama	-	-	No	-	-
99664	85771	1085771	lizdinė plokštelė	N98		Receptinis	EU/1/16/1166/034	Netiekiama	-	-	No	-	-

Stadijos

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