Tramadol Basi

Medicinal product

(Invented) name

Tramadol Basi

Active substance (s)

Tramadolio hidrochloridas

Strength

50 mg/ml

Pharmaceutical form

injekcinis 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)

N02AX02, Tramadol

Marketing authorisation holder

Laboratórios Basi-Indústria Farmacêutica, S.A., Portugalija

Date of authorisation

2024-01-05

Date of renewal

Documents

5322 Tramadol Basi PCS PL 2024 07 13.docx

5322 Pakuotės lapelis 2024 07 13.docx

Stage

Registruotas

Controlled?

Yes

Controlled substance type

Narkotinis

Legal basis

10(1)

Procedure number

PT/H/2808/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml tirpalo yra:	1 ml
Tramadolio 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
112498	98618	1098618	ampulė	2 ml N10		Receptinis	LT/1/24/5322/001	Netiekiama	-	-	No	-	-
112499	98619	1098619	ampulė	2 ml N50		Receptinis	LT/1/24/5322/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-01-05	Registruotas