Repatha

Medicinal product

(Invented) name

Repatha

Active substance (s)

Evolokumabas

Strength

140 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)

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 syringe	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
63293	77710	1077710	užpildytas švirkštas	N1		Receptinis	EU/1/15/1016/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2015-07-17	Registruotas