Thiamine Kabi

Medicinal product

(Invented) name

Thiamine Kabi

Active substance (s)

Tiamino hidrochloridas

Strength

50 mg/ml

Pharmaceutical form

injekcinis ar infuzinis tirpalas

Route (s) of administration

leisti į veną, leisti į raumenis, leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

A11DA01, Thiamine (vit B1)

Marketing authorisation holder

Fresenius Kabi Polska Sp.z.o.o., Lenkija

Date of authorisation

2025-10-31

Date of renewal

Documents

5879_Thiamine Kabi.docx

5879_pakuotes lapelis_2025-10-31.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10a

Procedure number

NL/H/5949/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml tirpalo yra	1 ml
Tiamino hidrochloridas	50 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
119003	105109	1105109	ampulė	2 ml N1		Receptinis	LT/1/25/5879/001	Netiekiama	-	-	No	-	-
119004	105110	1105110	ampulė	2 ml N5		Receptinis	LT/1/25/5879/002	Netiekiama	-	-	No	-	-
119005	105111	1105111	ampulė	2 ml N10		Receptinis	LT/1/25/5879/003	Netiekiama	-	-	No	-	-
119006	105112	1105112	ampulė	2 ml N50		Receptinis	LT/1/25/5879/004	Netiekiama	-	-	No	-	-
119007	105113	1105113	ampulė	10 ml N1		Receptinis	LT/1/25/5879/005	Netiekiama	-	-	No	-	-
119008	105114	1105114	ampulė	10 ml N5		Receptinis	LT/1/25/5879/006	Netiekiama	-	-	No	-	-
119009	105115	1105115	ampulė	10 ml N10		Receptinis	LT/1/25/5879/007	Netiekiama	-	-	No	-	-
119010	105116	1105116	ampulė	10 ml N50		Receptinis	LT/1/25/5879/008	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-10-31	Registruotas