Tyenne

Medicinal product

(Invented) name

Tyenne

Active substance (s)

Tocilizumabas

Strength

162 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)

L04AC07, Tocilizumab

Marketing authorisation holder

Fresenius Kabi Deutschland GmbH, Vokietija

Date of authorisation

2023-09-15

Date of renewal

Documents

TYENNE paciento įspėjamoji kortelė.pdf

TYENNE brošiūra sveikatos priežiūros specialistui.pdf

TYENNE dozavimo gidas sveikatos prieziuros specialistui.pdf

TYENNE brošiūra pacientui.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 syringe	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
111697	97810	1097810	užpildytas švirkštas	N1		Receptinis	EU/1/23/1754/007	Netiekiama	-	-	No	-	-
111698	97811	1097811	užpildytas švirkštas	N4		Receptinis	EU/1/23/1754/008	Tiekiama	2024-11-24	-	No	-	-
111699	97812	1097812	užpildytas švirkštas	N12		Receptinis	EU/1/23/1754/009	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-09-15	Registruotas