CAMZYOS

Medicinal product

(Invented) name

CAMZYOS

Active substance (s)

Mavakamtenas

Strength

5 mg

Pharmaceutical form

kietosios kapsulės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

C01EB24, mavacamten

Marketing authorisation holder

Bristol-Myers Squibb Pharma EEIG, Airija

Date of authorisation

2023-06-26

Date of renewal

Documents

Camzyos paciento kortele.pdf

Camzyos mokomoji medziaga pacientui.pdf

Camzyos mokomoji medziaga sveikatos prieziuros specialistams.pdf

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

Capsule, hard	1 vnt.
Mavakamtenas	5 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
111198	97309	1097309	lizdinė plokštelė	N14		Receptinis	EU/1/23/1716/003	Netiekiama	-	-	No	-	-
111199	97310	1097310	lizdinė plokštelė	N28		Receptinis	EU/1/23/1716/004	Netiekiama	-	-	No	-	-
111506	97619	1097619	lizdinė plokštelė	N98		Receptinis	EU/1/23/1716/010	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-06-26	Registruotas