Pregabalin Viatris [Pregabalin Mylan]

Medicinal product

(Invented) name

Pregabalin Viatris [Pregabalin Mylan]

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

Viatris Limited, Airija

Date of authorisation

2015-06-25

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	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
62749	77162	1077162	lizdinė plokštelė	N21		Receptinis	EU/1/15/997/035	Netiekiama	-	-	No	-	-
62750	77163	1077163	lizdinė plokštelė	N84		Receptinis	EU/1/15/997/036	Netiekiama	-	-	No	-	-
62751	77164	1077164	lizdinė plokštelė	N100		Receptinis	EU/1/15/997/037	Netiekiama	-	-	No	-	-
62752	77165	1077165	dalomoji lizdinė plokštelė	N84x1		Receptinis	EU/1/15/997/038	Netiekiama	-	-	No	-	-
62753	77166	1077166	dalomoji lizdinė plokštelė	N100x1		Receptinis	EU/1/15/997/039	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2015-06-25	Registruotas