Ramostin

Medicinal product

(Invented) name

Ramostin

Active substance (s)

Rozuvastatinas/Ramiprilis

Strength

20 mg/5 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)

C10BX17, rosuvastatin and ramipril

Marketing authorisation holder

Egis Pharmaceuticals PLC, Vengrija

Date of authorisation

2021-07-23

Date of renewal

Documents

4787_4790 Pakuotės lapelis 2024 05 04.docx

4787_4790 Ramostin PL 2024 05 04.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10b

Procedure number

HU/H/0674/003/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Kapsulėje yra	1 vnt.
Rozuvastatinas	20 mg
Ramiprilis	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
106898	93001	1093001	lizdinė plokštelė	N30		Receptinis	LT/1/21/4789/001	Tiekiama	-	-	No	-	-
106899	93002	1093002	lizdinė plokštelė	N60		Receptinis	LT/1/21/4789/002	Netiekiama	-	-	No	-	-
106900	93003	1093003	lizdinė plokštelė	N90		Receptinis	LT/1/21/4789/003	Netiekiama	-	-	No	-	-
106901	93004	1093004	lizdinė plokštelė	N100		Receptinis	LT/1/21/4789/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-07-23	Registruotas