Xenical

Medicinal product

(Invented) name

Xenical

Active substance (s)

Orlistatas

Strength

120 mg

Pharmaceutical form

kietosios kapsulės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

A08AB01, Orlistat

Marketing authorisation holder

Cheplapharm Arzneimittel GmbH, Vokietija

Date of authorisation

1998-07-29

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

capsules, hard	1 vnt.
Orlistatas	120 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
28895	31407	1031407	lizdinė plokštelė	N21		Receptinis	EU/1/98/071/001	Netiekiama	-	-	No	-	-
9747	14357	1014357	lizdinė plokštelė	N42		Receptinis	EU/1/98/071/002	Netiekiama	-	-	No	-	-
28896	31408	1031408	lizdinė plokštelė	N84		Receptinis	EU/1/98/071/003	Netiekiama	-	-	No	-	-
28897	31409	1031409	buteliukas	N21		Receptinis	EU/1/98/071/004	Netiekiama	-	-	No	-	-
28898	31410	1031410	buteliukas	N42		Receptinis	EU/1/98/071/005	Netiekiama	-	-	No	-	-
28899	31411	1031411	buteliukas	N84		Receptinis	EU/1/98/071/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
1998-07-29	Registruotas