EVENITY

Medicinal product

(Invented) name

EVENITY

Active substance (s)

Romosozumabas

Strength

105 mg

Pharmaceutical form

injekcinis tirpalas užpildytame švirkštiklyje

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 pen	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
102960	89061	1089061	užpildytas švirkštiklis	1,17 ml N2		Receptinis	EU/1/19/1411/001	Netiekiama	-	-	No	-	-
102962	89063	1089063	užpildytas švirkštiklis	1,17 ml N6 (3x2)		Receptinis	EU/1/19/1411/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2019-12-09	Registruotas