Emgality

Medicinal product

(Invented) name

Emgality

Active substance (s)

Galkanezumabas

Strength

120 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)

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 pen	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
100486	86594	1086594	užpildytas švirkštiklis	N1		Receptinis	EU/1/18/1330/001	Netiekiama	-	-	No	-	-
100487	86595	1086595	užpildytas švirkštiklis	N3		Receptinis	EU/1/18/1330/002	Netiekiama	-	-	No	-	-
100986	87097	1087097	užpildytas švirkštiklis	N2		Receptinis	EU/1/18/1330/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-11-14	Registruotas