Bomyntra

Medicinal product

(Invented) name

Bomyntra

Active substance (s)

Denozumabas

Strength

120 mg

Pharmaceutical form

injekcinis tirpalas užpildytame švirkšte

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

Užpildytame švirkšte (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
118149	104257	1104257	užpildytas švirkštas	N1		Receptinis	EU/1/25/1953/004	Netiekiama	-	-	No	-	-
118150	104258	1104258	užpildytas švirkštas	N3		Receptinis	EU/1/25/1953/005	Netiekiama	-	-	No	-	-
118151	104259	1104259	užpildytas švirkštas	N4		Receptinis	EU/1/25/1953/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-07-17	Registruotas