国: アイルランド
言語: 英語
ソース: HPRA (Health Products Regulatory Authority)
Sulfadimidine
Chanelle Pharmaceuticals Manufacturing Limited
QJ01EQ
Sulfadimidine
99.01 percent weight/weight
Powder for oral solution
POM: Prescription Only Medicine as defined in relevant national legislation
Cattle
Sulfonamides (ATC human differently classified, see guidelines)
Antibacterial
Authorised
1988-10-01
IRISH MEDICINES BOARD ACT 1995 EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007 (S.I. NO. 786 OF 2007) VPA: 10987/018/001 Case No: 7006763 The Irish Medicines Board in exercise of the powers conferred on it by Animal Remedies (No. 2) Regulations (S.I. No. 786 of 2007) hereby grants to: CHANELLE PHARMACEUTICALS MANUFACTURING LIMITED LOUGHREA , CO. GALWAY , IRELAND an authorisation, subject to the provisions of the said Regulations and the general conditions of the attached authorisation, in respect of the Veterinary Medicinal Product: SULPHA NO.2 POWDER FOR ORAL SOLUTION The particulars of which are set out in Part 1 and Part 2 of the said Schedule. The authorisation is also subject to any special conditions as may be specified in the said Schedule. The authorisation,unless revoked, shall continue in force from 02/11/2009 . Signed on behalf of the Irish Medicines Board ________________ A person authorised in that behalf by the said Board. (NOTE: This authorisation replaces any previous authorisation in respect of this product which is now null and void.) I R I S H M E D I C I N E S B O A R D ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _0_ _5_ _/_ _1_ _1_ _/_ _2_ _0_ _0_ _9_ _C_ _R_ _N_ _ _ _7_ _0_ _0_ _6_ _7_ _6_ _3_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Sulpha No.2 Powder for Oral Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each g contains : ACTIVE SUBSTANCE Sulfadimidine 99.01% w/w For a full list of excipients see s 完全なドキュメントを読む