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IRISH MEDICINES BOARD ACT 1995
MEDICINAL PRODUCTS(LICENSING AND SALE)REGULATIONS, 1998
(S.I. NO.142 OF 1998)
PA0019/015/004
Case No: 2014474
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
PFIZER LIMITED
RAMSGATE ROAD, SANDWICH, KENT CT13 9NJ, ENGLAND
an authorisation, subject to the provisions of the said Regulations, in respect of the product
SINEQUAN CAPSULES 50MG
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 24/01/2006 until 31/03/2008 .
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 27/01/2006_
_CRN 2014474_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
SINEQUAN™ Capsules 50mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains doxepin hydrochloride equivalent to 50mg
doxepin.
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard
Sinequan 50mg capsule: Size no. 2, opaque, dark, blue, hard gelatin capsules, having the monogram ‘Pfizer’ and the
identifying code ‘SQN 50’ imprinted on
the capsule shells and containing a white powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In the management of anxiety and for depression including reactive psychosomatic and endogenous types, or in
anxiety/tension states associated with diagnostic procedure
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