CAMZYOS

Medicinal product

(Invented) name

CAMZYOS

Active substance (s)

Mavakamtenas

Strength

10 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 mokomoji medziaga pacientui.pdf

Camzyos mokomoji medziaga sveikatos prieziuros specialistams.pdf

Camzyos paciento kortele.pdf

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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	10 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
111200	97311	1097311	lizdinė plokštelė	N14		Receptinis	EU/1/23/1716/005	Netiekiama	-	-	No	-	-
111201	97312	1097312	lizdinė plokštelė	N28		Receptinis	EU/1/23/1716/006	Netiekiama	-	-	No	-	-
111507	97620	1097620	lizdinė plokštelė	N98		Receptinis	EU/1/23/1716/011	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-06-26	Registruotas