Tezspire

Medicinal product

(Invented) name

Tezspire

Active substance (s)

Tezepelumabas

Strength

210 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)

R03DX11, tezepelumab

Marketing authorisation holder

AstraZeneca AB, Švedija

Date of authorisation

2022-09-19

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	1.91 ml
Tezepelumabas	210 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
110422	96532	1096532	užpildytas švirkštiklis	N1		Receptinis	EU/1/22/1677/003	Netiekiama	-	-	No	-	-
110890	97001	1097001	užpildytas švirkštiklis	N3 (3×1)		Receptinis	EU/1/22/1677/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-09-19	Registruotas