Dolmen

Medicinal product

(Invented) name

Dolmen

Active substance (s)

Deksketoprofenas

Strength

25 mg

Pharmaceutical form

geriamasis tirpalas paketėlyje

Route (s) of administration

vartoti per burną

Legal status for supply

Nereceptinis/Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

M01AE17, Dexketoprofen

Marketing authorisation holder

Menarini International Operations Luxembourg S.A., Liuksemburgas

Date of authorisation

2017-04-27

Date of renewal

2021-02-10

Documents

0539 Pakuotės lapelis ger tirp paket Rp 2023 03 17.docx

0539 Dolmen 25 ger tirp paket OTC PCS PL 2023 03 17.docx

0539 Pakuotės lapelis ger tirp paket OTC 2023 03 17.docx

0539 Dolmen 25 ger tirp paket Rp PCS PL 2023 03 17.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

ES/H/0101/006/MR

Marketing authorisation procedure

Savitarpio pripažinimo procedūra

Qualitative and quantitative composition

Paketėlyje yra	10 ml
Deksketoprofenas	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
68132	82698	1082698	paketėlis	10 ml N20		Receptinis	LT/1/06/0539/037	Netiekiama	-	-	No	-	-
98151	84249	1084249	paketėlis	10 ml N2		Nereceptinis	LT/1/06/0539/038	Netiekiama	-	-	No	-	-
98152	84250	1084250	paketėlis	10 ml N4		Nereceptinis	LT/1/06/0539/039	Netiekiama	-	-	No	-	-
98153	84251	1084251	paketėlis	10 ml N10		Nereceptinis	LT/1/06/0539/040	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-02-10	Perregistruotas
2017-04-27	Registruotas