Hukyndra

Medicinal product

(Invented) name

Hukyndra

Active substance (s)

Adalimumabas

Strength

80 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

Search in EMA Europe

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	80 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
114924	101031	1101031	užpildytas švirkštiklis	0,8 ml N1 (alkoholiu suvilgytas tamponas)		Receptinis	EU/1/21/1589/008	Netiekiama	-	2025-12-31	Yes	2025-05-30	2025-12-31
114925	101032	1101032	užpildytas švirkštiklis	0,8 ml N3 (3 alkoholiu suvilgyti tamponai)		Receptinis	EU/1/21/1589/009	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-11-15	Registruotas