Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
DOXEPIN HYDROCHLORIDE
Pfizer Limited
50 mg Milligram
Capsule
1978-04-01
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 Read the complete document