Progesterone Besins

Medicinal product

(Invented) name

Progesterone Besins

Active substance (s)

Progesteronas

Strength

400 mg

Pharmaceutical form

makšties minkštosios kapsulės

Route (s) of administration

vartoti į makštį

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

G03DA04, Progesterone

Marketing authorisation holder

Besins Healthcare Ireland Limited, Airija

Date of authorisation

2025-03-03

Date of renewal

Documents

5721 Pakuotės lapelis 2025 11 06.docx

5721 Progesterone Besins RPP 2025 11 06.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

SE/H/2023/002/E/002

Marketing authorisation procedure

Kartotinė procedūra

Qualitative and quantitative composition

Kapsulėje yra	1 vnt.
Progesteronas	400 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
116819	102923	1102923	buteliukas	N15		Receptinis	LT/1/25/5721/001	Netiekiama	-	2026-09-30	No	-	-
119224	105328	1105328	lizdinė plokštelė	N15		Receptinis	LT/1/25/5721/002	Netiekiama	-	-	No	-	-
119225	105329	1105329	lizdinė plokštelė	N30		Receptinis	LT/1/25/5721/003	Netiekiama	-	-	No	-	-
119226	105330	1105330	lizdinė plokštelė	N45		Receptinis	LT/1/25/5721/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-03-03	Registruotas