Rolcya

Medicinal product

(Invented) name

Rolcya

Active substance (s)

Denozumabas

Strength

60 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

Sandoz GmbH, Austrija

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 ml tirpalo) yra	1 ml
Denozumabas	60 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
118145	104253	1104253	užpildytas švirkštas	1 ml N1 (su apsauga)		Receptinis	EU/1/25/1958/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-07-17	Registruotas