Wyost

Medicinal product

(Invented) name

Wyost

Active substance (s)

Denozumabas

Strength

120 mg

Pharmaceutical form

injekcinis tirpalas

Route (s) of administration

leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

M05BX04, Denosumab

Marketing authorisation holder

Sandoz GmbH, Austrija

Date of authorisation

2024-05-17

Date of renewal

Documents

Wyost paciento kortele.pdf

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Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(4)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Kiekviename flakone 1,7 ml tirpalo yra	1.7 ml
Denozumabas	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
113755	99872	1099872	flakonas	N1		Receptinis	EU/1/24/1812/001	Tiekiama	-	-	No	-	-
116524	102623	1102623	flakonas	N3		Receptinis	EU/1/24/1812/002	Netiekiama	-	-	No	-	-
116525	102624	1102624	flakonas	N4		Receptinis	EU/1/24/1812/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-05-17	Registruotas