Bisramex

Medicinal product

(Invented) name

Bisramex

Active substance (s)

Ramiprilis/Bizoprololio fumaratas

Strength

10 mg/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)

C09BX05, ramipril and bisoprolol

Marketing authorisation holder

Teva B.V., Nyderlandai

Date of authorisation

2025-04-07

Date of renewal

Documents

5749-50-51-52_pakuotes lapelis_2025-04-07.docx

5749-5750-5751-5752_Bisramex.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10b

Procedure number

PL/H/0757/006/E/001

Marketing authorisation procedure

Kartotinė procedūra

Qualitative and quantitative composition

Kapsulėje yra	1 vnt.
Ramiprilis	10 mg
Bizoprololio fumaratas	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
117131	103231	1103231	lizdinė plokštelė	N10		Receptinis	LT/1/25/5752/001	Netiekiama	-	-	No	-	-
117132	103232	1103232	lizdinė plokštelė	N30		Receptinis	LT/1/25/5752/002	Netiekiama	-	-	No	-	-
117133	103233	1103233	lizdinė plokštelė	N60		Receptinis	LT/1/25/5752/003	Netiekiama	-	-	No	-	-
117134	103234	1103234	lizdinė plokštelė	N100		Receptinis	LT/1/25/5752/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-04-07	Registruotas