Dovprela

Medicinal product

(Invented) name

Dovprela

Active substance (s)

Pretomanidas

Strength

200 mg

Pharmaceutical form

tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

J04AK08, pretomanid

Marketing authorisation holder

Mylan IRE Healthcare Limited, Airija

Date of authorisation

2020-07-31

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Tablet	1 vnt.
Pretomanidas	200 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
104865	90966	1090966	lizdinė plokštelė	N14		Receptinis	EU/1/20/1437/001	Netiekiama	-	-	No	-	-
104866	90967	1090967	dalomoji lizdinė plokštelė	N14×1		Receptinis	EU/1/20/1437/002	Netiekiama	-	-	No	-	-
104898	90999	1090999	buteliukas	N26		Receptinis	EU/1/20/1437/003	Netiekiama	-	-	No	-	-
104867	90968	1090968	lizdinė plokštelė	N182		Receptinis	EU/1/20/1437/004	Netiekiama	-	-	No	-	-
104868	90969	1090969	dalomoji lizdinė plokštelė	N182×1		Receptinis	EU/1/20/1437/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2020-07-31	Registruotas