EVENITY

Medicinal product

(Invented) name

EVENITY

Active substance (s)

Romosozumabas

Strength

105 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)

M05BX06, Romosozumab

Marketing authorisation holder

UCB Pharma S.A., Belgija

Date of authorisation

2019-12-09

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Solution for injection in pre-filled syringe	1.17 ml
Romosozumabas	105 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
102963	89064	1089064	užpildytas švirkštas	1,17 ml N2		Receptinis	EU/1/19/1411/003	Netiekiama	-	-	No	-	-
102964	89065	1089065	užpildytas švirkštas	1,17 ml N6 (3x2)		Receptinis	EU/1/19/1411/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2019-12-09	Registruotas