Progesterone Besins

Medicinal product

(Invented) name

Progesterone Besins

Active substance (s)

Progesteronas

Strength

300 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

2023-05-23

Date of renewal

2025-05-19

Documents

5184 Pakuotės lapelis 2025 10 08.docx

5184 Progesterone Besins 300mg RPP 2025 10 08.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

SE/H/2242/001/E/001

Marketing authorisation procedure

Kartotinė procedūra

Qualitative and quantitative composition

Kapsulėje yra:	1 vnt.
Progesteronas	300 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
111025	97136	1097136	buteliukas	N15		Receptinis	LT/1/23/5184/001	Netiekiama	-	-	No	-	-
118932	105038	1105038	lizdinė plokštelė	N15		Receptinis	LT/1/23/5184/002	Netiekiama	-	-	No	-	-
118933	105039	1105039	lizdinė plokštelė	N30		Receptinis	LT/1/23/5184/003	Netiekiama	-	-	No	-	-
118934	105040	1105040	lizdinė plokštelė	N45		Receptinis	LT/1/23/5184/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-05-19	Perregistruotas
2023-05-23	Registruotas