DRO SPAZ

Medicinal product

(Invented) name

DRO SPAZ

Active substance (s)

Drotaverino hidrochloridas

Strength

20 mg/ml

Pharmaceutical form

injekcinis tirpalas

Route (s) of administration

leisti į veną, leisti į raumenis

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

A03AD02, Drotaverine

Marketing authorisation holder

UAB Actiofarma, Lietuva

Date of authorisation

2019-02-08

Date of renewal

Documents

0831-001_DRO SPAZ_2021-05-18.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

Procedure number

Marketing authorisation procedure

Lygiagretus importas

Qualitative and quantitative composition

1 ml tirpalo yra	1 ml
Drotaverino hidrochloridas	20 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
100910	87021	1087021	ampulė	N10 - 2 ml		Receptinis	LT/L/19/0831/001	Netiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
	Išregistruotas
2019-02-08	Registruotas