ZIMOVANE 7.5 Milligram Film Coated Tablet
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
25-05-2024
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Active ingredient:
ZOPICLONE
Available from:
Profind Wholesale Ltd
INN (International Name):
ZOPICLONE
Dosage:
7.5 Milligram
Pharmaceutical form:
Film Coated Tablet
Prescription type:
Product subject to prescription which may not be renewed (A)
Authorization status:
Withdrawn
Authorization date:
2013-01-29
Summary of Product characteristics
IRISH MEDICINES BOARD ACT 1995, AS AMENDED
MEDICINAL PRODUCTS (CONTROL OF PLACING ON THE MARKET) REGULATIONS, 2007, AS AMENDED
PPA1500/006/001
Case No: 2083742
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
PROFIND WHOLESALE LTD.
UNIT 625, KILSHANE AVENUE, NORTHWEST BUSINESS PARK, DUBLIN 15, 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 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 28/07/2010.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 28/07/2010_
_CRN 2083742_
_page number: 1_
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 UK:_
White elliptical film-coated tablets with a score line on one side and plain on the reverse
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Short-term treatment of insomnia
Benzodiazepines and benzodiazepine-like agents are only indicated when the disorder is severe, disabling or subjecting
the individual to extreme distress.
4.2 POSOLOGY
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