AJOVY

Medicinal product

(Invented) name

AJOVY

Active substance (s)

Fremanezumabas

Strength

225 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)

N02CD03, fremanezumab

Marketing authorisation holder

Teva GmbH, Vokietija

Date of authorisation

2019-03-28

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	1.5 ml
Fremanezumabas	225 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
103195	89296	1089296	užpildytas švirkštiklis	1,5 ml N1		Receptinis	EU/1/19/1358/003	Tiekiama	-	-	No	-	-
103196	89297	1089297	užpildytas švirkštiklis	1,5 ml N3		Receptinis	EU/1/19/1358/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2019-03-28	Registruotas