Pregabalin Viatris [Pregabalin Mylan]

Medicinal product

(Invented) name

Pregabalin Viatris [Pregabalin Mylan]

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

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	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
62754	77167	1077167	lizdinė plokštelė	N14		Receptinis	EU/1/15/997/040	Netiekiama	-	-	No	-	-
62755	77168	1077168	lizdinė plokštelė	N56		Receptinis	EU/1/15/997/041	Netiekiama	-	-	No	-	-
62756	77169	1077169	lizdinė plokštelė	N100		Receptinis	EU/1/15/997/042	Netiekiama	-	-	No	-	-
62757	77170	1077170	dalomoji lizdinė plokštelė	N56x1		Receptinis	EU/1/15/997/043	Netiekiama	-	-	No	-	-
62758	77171	1077171	dalomoji lizdinė plokštelė	N100x1		Receptinis	EU/1/15/997/044	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2015-06-25	Registruotas