Vaxchora

Medicinal product

(Invented) name

Vaxchora

Active substance (s)

V. cholerae CVD 103-HgR padermė

Strength

4×10(x8) iki 2×10(x9) gyvyb. ląst.

Pharmaceutical form

šnypštieji milteliai ir milteliai geriamajai suspensijai

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

J07AE02, Cholera, live attenuated

Marketing authorisation holder

Bavarian Nordic A/S, Danija

Date of authorisation

2020-04-01

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

Effervescent powder and powder for oral suspension	1 dozėje
V. cholerae CVD 103-HgR padermė	4×10(x8) iki 2×10(x9) gyvyb. ląst.

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
103773	89875	1089875	paketėlis	N1 (1 dozė: 4,5 g (buferinė medžiaga) +2 g)		Receptinis	EU/1/20/1423/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2020-04-01	Registruotas