Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Calendula officinalis
Weleda (UK) Limited
D03
Calendula officinalis
40 percent volume/volume
Concentrate for cutaneous solution
Product not subject to medical prescription
PREPARATIONS FOR TREATMENT OF WOUNDS AND ULCERS
Marketed
1991-10-11
IRISH MEDICINES BOARD ACT 1995 MEDICINAL PRODUCTS(LICENSING AND SALE)REGULATIONS, 1998 (S.I. NO.142 OF 1998) PA0407/025/001 Case No: 2021991 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to WELEDA (UK) LIMITED HEANOR ROAD , ILKESTON , DERBYSHIRE DE7 8DR , ENGLAND an authorisation, subject to the provisions of the said Regulations, in respect of the product CALENDULA LOTION, 40% V/V CONCENTRATE FOR CUTANEOUS SOLUTION 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 11/10/2006 . Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. 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_ _ _ _2_ _4_ _/_ _1_ _0_ _/_ _2_ _0_ _0_ _6_ _C_ _R_ _N_ _ _ _2_ _0_ _2_ _1_ _9_ _9_ _1_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Calendula Lotion 40% v/v Concentrate for Cutaneous Solution. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Ingredients per 100 ml: 40 ml of an ethanolic tincture of_ Calendula officinalis L Herba_ (1=2 in 43% w/w alcohol). Excipients: Ethanol content of the lotion 46% w/w For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FO Les hele dokumentet