CAMZYOS

Medicinal product

(Invented) name

CAMZYOS

Active substance (s)

Mavakamtenas

Strength

15 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 sveikatos prieziuros specialistams.pdf

Camzyos mokomoji medziaga pacientui.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	15 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
111202	97313	1097313	lizdinė plokštelė	N14		Receptinis	EU/1/23/1716/007	Netiekiama	-	-	No	-	-
111203	97314	1097314	lizdinė plokštelė	N28		Receptinis	EU/1/23/1716/008	Netiekiama	-	-	No	-	-
111504	97617	1097617	lizdinė plokštelė	N98		Receptinis	EU/1/23/1716/012	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-06-26	Registruotas