Lomexin 2% w/w Cutaneous Powder

País: Irlanda

Idioma: inglés

Fuente: HPRA (Health Products Regulatory Authority)

Ingredientes activos:

Fenticonazole nitrate

Disponible desde:

Recordati Industria Chimica e Farmaceutica SpA

Código ATC:

D01AC; D01AC12

Designación común internacional (DCI):

Fenticonazole nitrate

Dosis:

2 percent weight/weight

formulario farmacéutico:

Cutaneous powder

tipo de receta:

Product subject to prescription which may be renewed (B)

Área terapéutica:

Imidazole and triazole derivatives; fenticonazole

Estado de Autorización:

Not marketed

Fecha de autorización:

1988-07-25

Ficha técnica

IRISH MEDICINES BOARD ACTS 1995 AND 2006
MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007
(S.I. NO.540 OF 2007)
PA0812/002/004
Case No: 2072367
The Irish Medicines Board in exercise of the powers conferred on it by
the above mentioned Regulations hereby grants to
RECORDATI PHARMACEUTICALS LIMITED
VIA MATTEO CIVITALI
,
20148
,
MILAN
,
ITALY
an authorisation, subject to the provisions of the said Regulations,
in respect of the product
LOMEXIN 2% W/W CUTANEOUS POWDER
The particulars of which are set out in Part I and Part II of the
attached Schedule. The authorisation is also subject to the general
conditions as
may be specified in the said Regulations as listed on the reverse of
this document.
This authorisation, unless previously revoked, shall continue in force
from
28/01/2010
.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
I
R
I
S
H
M
E
D
I
C
I
N
E
S
B
O
A
R
D
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
_D_
_a_
_t_
_e_
_ _
_P_
_r_
_i_
_n_
_t_
_e_
_d_
_ _
_3_
_0_
_/_
_0_
_1_
_/_
_2_
_0_
_1_
_0_
_C_
_R_
_N_
_ _
_2_
_0_
_7_
_2_
_3_
_6_
_7_
_p_
_a_
_g_
_e_
_ _
_n_
_u_
_m_
_b_
_e_
_r_
_:_
_ _
_1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lomexin 2% w/w Cutaneous Powder
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Fenticonazole nitrate 2.0% w/w
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cutaneous powder.
An ivory-white homogeneous powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the topical treatment of infections due to_ C. albicans