Hyrimoz

Medicinal product

(Invented) name

Hyrimoz

Active substance (s)

Adalimumabas

Strength

40 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)

L04AB04, Adalimumab

Marketing authorisation holder

Sandoz GmbH, Austrija

Date of authorisation

2018-07-26

Date of renewal

Documents

Hyrimoz paciento priminimo kortele vaikams.pdf

Hyrimoz paciento priminimo kortele suaugusiems.pdf

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Stage

Registruotas

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 pen	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
99926	86034	1086034	užpildytas švirkštiklis	0,8 ml N1 (SensoReady)		Receptinis	EU/1/18/1286/004	Netiekiama	-	-	No	-	-
99927	86035	1086035	užpildytas švirkštiklis	0,8 ml N2 (SensoReady)		Receptinis	EU/1/18/1286/005	Netiekiama	-	-	No	-	-
99928	86036	1086036	užpildytas švirkštiklis	0,8 ml N6 (3×2) (SensoReady)		Receptinis	EU/1/18/1286/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-07-26	Registruotas