Repatha

Medicinal product

(Invented) name

Repatha

Active substance (s)

Evolokumabas

Strength

420 mg

Pharmaceutical form

injekcinė suspensija užtaise

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 cartridge	3.5 ml
Evolokumabas	420 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
67912	82472	1082472	užtaisas	N1 (+automatinis mini dozatorius)		Receptinis	EU/1/15/1016/006	Netiekiama	-	-	No	-	-
67913	82473	1082473	užtaisas	N3 (3x1) (+3x1 automatiniai mini dozatoriai) (daugiadozė)		Receptinis	EU/1/15/1016/007	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2015-07-17	Registruotas