Pregabalin Zentiva

Medicinal product

(Invented) name

Pregabalin Zentiva

Active substance (s)

Pregabalinas

Strength

225 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

2015-07-17

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Hard capsule	1 vnt.
Pregabalinas	225 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
63166	77581	1077581	lizdinė plokštelė	N14		Receptinis	EU/1/15/1021/023	Netiekiama	-	-	No	-	-
63167	77582	1077582	lizdinė plokštelė	N56		Receptinis	EU/1/15/1021/024	Netiekiama	-	-	No	-	-
63168	77583	1077583	lizdinė plokštelė	N100		Receptinis	EU/1/15/1021/025	Netiekiama	-	-	No	-	-
99650	85757	1085757	lizdinė plokštelė	N98		Receptinis	EU/1/15/1021/035	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2015-07-17	Registruotas