Hukyndra

Medicinal product

(Invented) name

Hukyndra

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

STADA Arzneimittel AG, Vokietija

Date of authorisation

2021-11-15

Date of renewal

Documents

Hukyndra paciento priminimo kortele vaikams.pdf

Hukyndra paciento priminimo kortele suagusiems.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	0.4 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
107571	93676	1093676	užpildytas švirkštiklis	N1 (alkoholiu suvilgytas tamponas)		Receptinis	EU/1/21/1589/004	Netiekiama	-	-	No	-	-
107572	93677	1093677	užpildytas švirkštiklis	N2 (2 alkoholiu suvilgyti tamponai)		Receptinis	EU/1/21/1589/005	Netiekiama	2025-04-07	2026-06-30	Yes	2026-04-09	2026-06-30
107573	93678	1093678	užpildytas švirkštiklis	N6 (6 alkoholiu suvilgyti tamponai)		Receptinis	EU/1/21/1589/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-11-15	Registruotas