Calendula Lotion 40% v/v Concentrate for Cutaneous Solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Calendula officinalis

Available from:

Weleda (UK) Limited

ATC code:

D03

INN (International Name):

Calendula officinalis

Dosage:

40 percent volume/volume

Pharmaceutical form:

Concentrate for cutaneous solution

Prescription type:

Product not subject to medical prescription

Therapeutic area:

PREPARATIONS FOR TREATMENT OF WOUNDS AND ULCERS

Authorization status:

Marketed

Authorization date:

1991-10-11

Summary of Product characteristics

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.
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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