Cyltezo

Medicinal product

(Invented) name

Cyltezo

Active substance (s)

Adalimumabas

Strength

40 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)

L04AB04, Adalimumab

Marketing authorisation holder

Boehringer Ingelheim International GmbH, Vokietija

Date of authorisation

2017-11-10

Date of renewal

Documents

Search in EMA Europe

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(4)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Solution for injection in pre-filled syringe	0.8 ml
Adalimumabas	40 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
98341	84443	1084443	užpildytas švirkštas	0,8 ml ir 2 alkoholiu suvilgyti tamponai N1		Receptinis	EU/1/17/1240/001	Netiekiama	-	-	No	-	-
98342	84444	1084444	užpildytas švirkštas	0,8 ml ir 2 alkoholiu suvilgyti tamponai N2		Receptinis	EU/1/17/1240/002	Netiekiama	-	-	No	-	-
98343	84445	1084445	užpildytas švirkštas	0,8 ml ir 4 alkoholiu suvilgyti tamponai N4		Receptinis	EU/1/17/1240/003	Netiekiama	-	-	No	-	-
98344	84446	1084446	užpildytas švirkštas	0,8 ml ir 6 alkoholiu suvilgyti tamponai N6		Receptinis	EU/1/17/1240/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2019-01-17	Išregistruotas
2017-11-10	Registruotas