Prasugrel Viatris [Prasugrel Mylan]

Medicinal product

(Invented) name

Prasugrel Viatris [Prasugrel Mylan]

Active substance (s)

Prazugrelis

Strength

5 mg

Pharmaceutical form

plėvele dengtos tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

B01AC22, Prasugrel

Marketing authorisation holder

Viatris Limited, Airija

Date of authorisation

2018-05-16

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Film-coated tablet	1 vnt.
Prazugrelis	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
99502	85609	1085609	buteliukas	N28		Receptinis	EU/1/18/1273/001	Netiekiama	-	-	No	-	-
101391	87494	1087494	buteliukas	N30		Receptinis	EU/1/18/1273/003	Netiekiama	-	-	No	-	-
102544	88645	1088645	lizdinė plokštelė	N28		Receptinis	EU/1/18/1273/005	Netiekiama	-	-	No	-	-
102545	88646	1088646	lizdinė plokštelė	N30		Receptinis	EU/1/18/1273/006	Netiekiama	-	-	No	-	-
102546	88647	1088647	lizdinė plokštelė	N84		Receptinis	EU/1/18/1273/007	Netiekiama	-	-	No	-	-
102547	88648	1088648	lizdinė plokštelė	N98		Receptinis	EU/1/18/1273/008	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-05-16	Registruotas