Repatha

Medicinal product

(Invented) name

Repatha

Active substance (s)

Evolokumabas

Strength

140 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)

C10AX13, Evolocumab

Marketing authorisation holder

Amgen Europe B.V., Nyderlandai

Date of authorisation

2015-07-17

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 ml
Evolokumabas	140 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
63294	77711	1077711	užpildytas švirkštiklis	N1 (SureClick)		Receptinis	EU/1/15/1016/002	Tiekiama	-	-	No	-	-
63295	77712	1077712	užpildytas švirkštiklis	N2 (SureClick)		Receptinis	EU/1/15/1016/003	Netiekiama	-	-	No	-	-
63296	77713	1077713	užpildytas švirkštiklis	N3 (SureClick)		Receptinis	EU/1/15/1016/004	Netiekiama	-	-	No	-	-
63297	77714	1077714	užpildytas švirkštiklis	N6 (3x2) (daugiadozė) (SureClick)		Receptinis	EU/1/15/1016/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2015-07-17	Registruotas