Zimovane 7.5 mg Film-coated Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Zopiclone

Available from:

IMED Healthcare Ltd.

ATC code:

N05CF; N05CF01

INN (International Name):

Zopiclone

Dosage:

7.5 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Benzodiazepine related drugs; zopiclone

Authorization status:

Authorised

Authorization date:

2009-01-23

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)
PPA1463/011/001
Case No: 2073373
The Irish Medicines Board in exercise of the powers conferred on it by
the above mentioned Regulations hereby grants to
IMED HEALTHCARE LTD.
NEW ROAD
,
BUNCRANA
,
CO. DONEGAL
,
IRELAND
an authorisation, subject to the provisions of the said Regulations,
in respect of the product
ZIMOVANE 7.5MG FILM-COATED TABLETS
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
29/01/2010
.
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
Zimovane 7.5mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 7.5mg zopiclone
Excipients : also contains lactose and wheat starch
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
_Product imported from the UK_
White elliptical film-coated tablet with a score