ARNICA

Страна: Ирландия

Язык: английский

Источник: HPRA (Health Products Regulatory Authority)

Активный ингредиент:

ARNICA MONTANA

Доступна с:

Weleda (UK) Limited

код АТС:

M02AX10

ИНН (Международная Имя):

ARNICA MONTANA

дозировка:

%v/w

Фармацевтическая форма:

Ointment

Тип рецепта:

Product not subject to medical prescription

Терапевтические области:

various

Статус Авторизация:

Marketed

Дата Авторизация:

1992-11-04

Характеристики продукта

IRISH MEDICINES BOARD ACTS 1995 AND 2006
MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007
(S.I. NO.540 OF 2007)
PA0407/001/001
Case No: 2038411
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
ARNICA 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
04/11/2007
.
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
Arnica Ointment.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
100g of ointment contains 10mL of tincture from_ Arnica montana_ L.,
planta tota (Arnica, whole plant) (1:2)
Extraction solvent: Ethanol 30% w/w
Contains Wool Fat.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Ointment.
Pale yellow cutaneous ointment.
4 CLINICAL PARTICULARS