Ibutop

Medicinal product

(Invented) name

Ibutop

Active substance (s)

Ibuprofenas

Strength

50 mg/g

Pharmaceutical form

kremas

Route (s) of administration

vartoti ant odos

Legal status for supply

Nereceptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

M02AA13, Ibuprofen

Marketing authorisation holder

Dolorgiet GmbH & Co. KG, Vokietija

Date of authorisation

2023-12-18

Date of renewal

Documents

5297 Ibutop RPP 2024 09 27.docx

5297 Pakuotės lapelis 2024 09 27.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

DE/H/7418/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 g kremo yra:	1 g
Ibuprofenas	50 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
112296	98411	1098411	tūbelė	20 g N1		Nereceptinis	LT/1/23/5297/001	Netiekiama	-	-	No	-	-
112297	98412	1098412	tūbelė	40 g N1		Nereceptinis	LT/1/23/5297/002	Netiekiama	-	-	No	-	-
112298	98413	1098413	tūbelė	50 g N1		Nereceptinis	LT/1/23/5297/003	Netiekiama	-	-	No	-	-
112299	98414	1098414	tūbelė	60 g N1		Nereceptinis	LT/1/23/5297/004	Netiekiama	-	-	No	-	-
112300	98415	1098415	tūbelė	100 g N1		Nereceptinis	LT/1/23/5297/005	Netiekiama	-	-	No	-	-
112301	98416	1098416	tūbelė	120 g N1		Nereceptinis	LT/1/23/5297/006	Netiekiama	-	-	No	-	-
112302	98417	1098417	tūbelė	150 g N1		Nereceptinis	LT/1/23/5297/007	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-12-18	Registruotas