Tyenne

Medicinal product

(Invented) name

Tyenne

Active substance (s)

Tocilizumabas

Strength

162 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)

L04AC07, Tocilizumab

Marketing authorisation holder

Fresenius Kabi Deutschland GmbH, Vokietija

Date of authorisation

2023-09-15

Date of renewal

Documents

TYENNE brošiūra pacientui.pdf

TYENNE paciento įspėjamoji kortelė.pdf

TYENNE dozavimo gidas sveikatos prieziuros specialistui.pdf

TYENNE brošiūra sveikatos priežiūros specialistui.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 or infusion in pre-filled pen	0.9 ml
Tocilizumabas	162 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
111700	97813	1097813	užpildytas švirkštiklis	N1		Receptinis	EU/1/23/1754/010	Netiekiama	-	-	No	-	-
111701	97814	1097814	užpildytas švirkštiklis	N4		Receptinis	EU/1/23/1754/011	Netiekiama	2024-10-22	2025-07-01	No	-	-
111702	97815	1097815	užpildytas švirkštiklis	N12 (3×4)		Receptinis	EU/1/23/1754/012	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-09-15	Registruotas