Emgality

Medicinal product

(Invented) name

Emgality

Active substance (s)

Galkanezumabas

Strength

120 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)

N02CD02, Galcanezumab

Marketing authorisation holder

Eli Lilly Nederland B.V., Nyderlandai

Date of authorisation

2018-11-14

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
Galkanezumabas	120 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
100484	86592	1086592	užpildytas švirkštas	N1		Receptinis	EU/1/18/1330/003	Netiekiama	-	-	No	-	-
100485	86593	1086593	užpildytas švirkštas	N3		Receptinis	EU/1/18/1330/004	Netiekiama	-	-	No	-	-
100987	87098	1087098	užpildytas švirkštas	N2		Receptinis	EU/1/18/1330/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-11-14	Registruotas