CALENDOLON 20 %v/w Ointment
Nchi: Ayalandi
Lugha: Kiingereza
Chanzo: HPRA (Health Products Regulatory Authority)
Tabia za bidhaa
(SPC)
11-05-2024
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Viambatanisho vya kazi:
CALENDULA OFFICINALIS
Inapatikana kutoka:
Weleda (UK) Limited
ATC kanuni:
D03
INN (Jina la Kimataifa):
CALENDULA OFFICINALIS
Kipimo:
20 %v/w
Dawa fomu:
Ointment
Dawa ya aina:
Product not subject to medical prescription
Eneo la matibabu:
PREPARATIONS FOR TREATMENT OF WOUNDS & ULCERS
Idhini hali ya:
Authorised
Idhini ya tarehe:
1991-10-11
Tabia za bidhaa
IRISH MEDICINES BOARD ACT 1995
MEDICINAL PRODUCTS(LICENSING AND SALE)REGULATIONS, 1998
(S.I. NO.142 OF 1998)
PA0407/005/001
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
CALENDOLON OINTMENT 20%V/V CALENDULA OFFICINALIS OINTMENT
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.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 24/10/2006_
_CRN 2021991_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Calendolon Ointment 20% v/w Calendula Officinalis Ointment
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
20 ml tincture of _Calendula officinalis L _fresh plant (1=2) in 43% w/w ethanol per 100g ointment.
Excipient: Contains 32% w/w wool fat
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Ointment.
A smooth, homogeneous, pale yellow cutaneous ointment, with a faint odour characteristic of wool fat.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the treatment of cuts, minor wounds and abrasions.
For topical application only.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Cleanse the affected area and ap
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