Quetiapine Fair-Med

Medicinal product

(Invented) name

Quetiapine Fair-Med

Active substance (s)

Kvetiapinas+Kvetiapinas+Kvetiapinas

Strength

25 mg + 100 mg + 200 mg

Pharmaceutical form

plėvele dengtos tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

N05AH04, Quetiapine

Marketing authorisation holder

FAIR-MED HEALTHCARE GmbH, Vokietija

Date of authorisation

2012-12-17

Date of renewal

Documents

3161_1_33 Quetiapine Fair_Med RPP keit.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

Procedure number

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje (25 mg) yra	1 vnt.
Kvetiapinas	25 mg
Tabletėje (100 mg) yra	1 vnt.
Kvetiapinas	100 mg
Tabletėje (200 mg) yra	1 vnt.
Kvetiapinas	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
44550	58345	1058345	lizdinė plokštelė	N6 (25 mg) + N3 (100 mg) + N1 (200 mg)		Receptinis	LT/1/12/3161/033	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2016-03-23	Išregistruotas
2012-12-17	Registruotas