Vyndaqel

Medicinal product

(Invented) name

Vyndaqel

Active substance (s)

Tafamidis

Strength

61 mg

Pharmaceutical form

minkštosios kapsulės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

N07XX08, Tafamidis

Marketing authorisation holder

Pfizer Europe MA EEIG, Belgija

Date of authorisation

2011-11-16

Date of renewal

Documents

Vyndaqel 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, soft	1 vnt.
Tafamidis	61 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
103360	89462	1089462	dalomoji lizdinė plokštelė	N30x1		Receptinis	EU/1/11/717/003	Tiekiama	-	-	No	-	-
103361	89463	1089463	dalomoji lizdinė plokštelė	N90x1 (3x30x1)		Receptinis	EU/1/11/717/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2011-11-16	Registruotas