Lomexin 2% w/w Cream

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Fenticonazole nitrate

Available from:

Recordati Industria Chimica e Farmaceutica SpA

ATC code:

D01AC; D01AC12

INN (International Name):

Fenticonazole nitrate

Dosage:

2 percent weight/weight

Pharmaceutical form:

Cream

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Imidazole and triazole derivatives; fenticonazole

Authorization status:

Not marketed

Authorization date:

1988-07-25

Summary of Product characteristics

IRISH MEDICINES BOARD ACTS 1995 AND 2006
MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007
(S.I. NO.540 OF 2007)
PA0812/002/001
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 CREAM
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.
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PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lomexin 2% w/w Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Fenticonazole nitrate 2.0% w/w
Excipients: contains propylene glycol (E1520) 5.0% w/w, wool fat,
hydrogenated 1.0% w/w and cetyl alcohol 3.0%
w/w
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cream
An ivory-white, homogenous cream.
4 CLINICAL PARTICULARS
4.1 THE