HYALGAN VIAL 20mg/2ml Mg/Ml Solution for Injection
Država: Irska
Jezik: engleski
Izvor: HPRA (Health Products Regulatory Authority)
Svojstava lijeka
(SPC)
16-05-2024
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Aktivni sastojci:
HYALURONATE SODIUM
Dostupno od:
Fidia Farmaceutici S.p.A.
INN (International ime):
HYALURONATE SODIUM
Doziranje:
20mg/2ml Mg/Ml
Farmaceutski oblik:
Solution for Injection
Tip recepta:
Product subject to prescription which may not be renewed (A)
Status autorizacije:
Withdrawn
Datum autorizacije:
0000-00-00
Svojstava lijeka
IRISH MEDICINES BOARD ACTS 1995 AND 2006
MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007
(S.I. NO.540 OF 2007)
PA0814/001/002
Case No: 2057235
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
FIDIA FARMACEUTICI S.P.A.
VIA PONTE DELLA FABBRICA 3/A, ABANO TERME (PADOVA) 35031, ITALY
an authorisation, subject to the provisions of the said Regulations, in respect of the product
HYALGAN SOLUTION FOR INTRA-ARTICULAR INJECTION, 20 MG/2 ML, VIAL.
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 01/04/2009.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 23/06/2009_
_CRN 2057235_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Hyalgan solution for intra-articular injection, 20 mg/2 ml, vial.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 20 mg/2 ml of Sodium hyaluronate.
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Solution for intra-articular injection.
Clear, viscous solution
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the sustained relief of pain in osteoarthritis of the knee.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
ADULTS (INCLUDING THE ELDERLY)
The contents of one vial (20 mg/2mL) to be injected into the affected joint once a week to a
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