Zypadhera

Medicinal product

(Invented) name

Zypadhera

Active substance (s)

Olanzapinas

Strength

300 mg

Pharmaceutical form

milteliai ir tirpiklis pailginto atpalaidavimo injekcinei suspensijai

Route (s) of administration

leisti į raumenis

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

N05AH03, Olanzapine

Marketing authorisation holder

Cheplapharm Registration GmbH, Vokietija

Date of authorisation

2008-11-19

Date of renewal

Documents

Zypadhera mokomoji medziaga sveikatos prieziuros specialistams.pdf

Zypadhera paruosimo mokomoji medziaga sveikatos prieziuros specialistams.pdf

Zypadhera paciento kortele.pdf

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Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Powder and solvent for prolonged release suspension for injection	1 vnt.
Olanzapinas	300 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
32721	5659	1005659	flakonas	milteliai, tirpiklio flakonas (3 ml) N1 (+hipoderminis švirkštas ir saugi adata N1, N3)		Receptinis	EU/1/08/479/002	Netiekiama	2025-01-09	2025-10-08	No	-	-

Stadijos

Data	Stadija
2008-11-19	Registruotas