Pregabalin Zentiva k.s

Medicinal product

(Invented) name

Pregabalin Zentiva k.s

Active substance (s)

Pregabalinas

Strength

100 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	100 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
67853	82411	1082411	lizdinė plokštelė	N21		Receptinis	EU/1/16/1166/014	Netiekiama	-	-	No	-	-
67854	82412	1082412	lizdinė plokštelė	N84		Receptinis	EU/1/16/1166/015	Netiekiama	-	-	No	-	-
67855	82413	1082413	lizdinė plokštelė	N100		Receptinis	EU/1/16/1166/016	Netiekiama	-	-	No	-	-
99662	85769	1085769	lizdinė plokštelė	N98		Receptinis	EU/1/16/1166/032	Netiekiama	-	-	No	-	-

Stadijos

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