PRIADEL Syrup 10.4% w/v %w/v
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
25-04-2024
Some documents for this product are not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain them.
Send request.
Send request.
Active ingredient:
LITHIUM CITRATE
Available from:
Sanofi-Aventis Ireland Limited
Dosage:
10.4% w/v %w/v
Pharmaceutical form:
Syrup
Authorization date:
2007-11-23
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)
PA0540/156/003
Case No: 2027972
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
Transferred from PA0077/151/001.
SANOFI-AVENTIS IRELAND LIMITED
CITYWEST BUSINESS CAMPUS, DUBLIN 24, IRELAND
an authorisation, subject to the provisions of the said Regulations, in respect of the product
PRIADEL SYRUP
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 23/11/2007 until 31/07/2009.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 27/11/2007_
_CRN 2027972_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Priadel Syrup
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Lithium citrate 520 mg equivalent to 200 mg lithium carbonate per 5 ml.
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Syrup
Clear, colourless pineapple flavoured sugar free syrup.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
1. In the management of acute manic or hypomanic episodes.
2. In the management of episodes of recurrent depressive disorders, where treatment with other antidepressants
has been unsuccessful.
3. In the prophylaxis against bipolar affective disorders.
4. Control of aggressive behaviour or intentional self harm.
Read the complete document
