ประเทศ: ไอร์แลนด์
ภาษา: อังกฤษ
แหล่งที่มา: HPRA (Health Products Regulatory Authority)
TETRACYCLINE HYDROCHLORIDE
Amdipharm Limited
TETRACYCLINE HYDROCHLORIDE
0.22 % w/v %w/v
Unknown
Withdrawn
2008-10-29
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA1142/012/001 Case No: 2041147 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to Transferred from PA0488/018/001. AMDIPHARM LIMITED TEMPLE CHAMBERS, 3 BURLINGTON ROAD, DUBLIN 4, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product TOPICYCLINE 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 19/12/2007 until 29/10/2008. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 22/12/2007_ _CRN 2041147_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Topicycline® 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One bottle of powder containing 154 mg of Tetracycline Hydrochloride. One bottle containing 70 ml of solvent. Once reconstituted, Topicycline contains tetracycline hydrochloride 2.2mg per ml. For excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder and solvent for cutaneous solution. Topicycline is presented in two separate bottles as a yellow powder and as a solvent. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of acne vulgaris. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Once reconstituted, Topicycline is applied topi อ่านเอกสารฉบับเต็ม