Lubion

Medicinal product

(Invented) name

Lubion

Active substance (s)

Progesteronas

Strength

25 mg

Pharmaceutical form

injekcinis tirpalas

Route (s) of administration

leisti į raumenis, leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

G03DA04, Progesterone

Marketing authorisation holder

IBSA Farmaceutici Italia Srl, Italija

Date of authorisation

2021-02-10

Date of renewal

2025-05-05

Documents

4673_Lubion_perr2025-05-05.docx

4673_pakuotes lapelis_2025-05-05.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

AT/H/1015/002/E/001

Marketing authorisation procedure

Kartotinė procedūra

Qualitative and quantitative composition

Flakone (1,112 ml injekcinio tirpalo) yra:	1.12 ml
Progesteronas	25 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
105816	91916	1091916	flakonas	N1		Receptinis	LT/1/21/4673/001	Netiekiama	-	-	No	-	-
105817	91917	1091917	flakonas	N7		Receptinis	LT/1/21/4673/002	Tiekiama	-	-	No	-	-
105818	91918	1091918	flakonas	N14		Receptinis	LT/1/21/4673/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-05-05	Perregistruotas
2021-02-10	Registruotas