Calendula Lotion 40% v/v Concentrate for Cutaneous Solution

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

Calendula officinalis

Διαθέσιμο από:

Weleda (UK) Limited

Φαρμακολογική κατηγορία (ATC):

D03

INN (Διεθνής Όνομα):

Calendula officinalis

Δοσολογία:

40 percent volume/volume

Φαρμακοτεχνική μορφή:

Concentrate for cutaneous solution

Τρόπος διάθεσης:

Product not subject to medical prescription

Θεραπευτική περιοχή:

PREPARATIONS FOR TREATMENT OF WOUNDS AND ULCERS

Καθεστώς αδειοδότησης:

Marketed

Ημερομηνία της άδειας:

1991-10-11

Αρχείο Π.Χ.Π.

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