Bomyntra

Medicinal product

(Invented) name

Bomyntra

Active substance (s)

Denozumabas

Strength

120 mg

Pharmaceutical form

injekcinis tirpalas flakone

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

Fresenius Kabi Deutschland GmbH, Vokietija

Date of authorisation

2025-07-17

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(4)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

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
118146	104254	1104254	flakonas	N1		Receptinis	EU/1/25/1953/001	Netiekiama	-	-	No	-	-
118147	104255	1104255	flakonas	N3		Receptinis	EU/1/25/1953/002	Netiekiama	-	-	No	-	-
118148	104256	1104256	flakonas	N4		Receptinis	EU/1/25/1953/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-07-17	Registruotas