What Daronrix contains
- The active substances are:Whole virion influenza vaccine of pandemic strain, inactivated, containing antigen * equivalent to:
AVietnam11942004 H5N115 micrograms
per 0.5 ml dose
propagated in eggs haemagglutinin adjuvanted by aluminium phosphate and aluminium hydroxide, hydrated 0.45 milligrams Al30.05 milligrams Al3
- The other ingredients are: sodium chloride, disodium phosphate dodecahydrate, potassium dihydrogen phosphate, potassium chloride, magnesium chloride hexahydrate, thiomersal, water for injections
What Daronrix looks like and contents of the pack
Daronrix is a white, slightly milky liquid and is presented as follows in an ampoule (0.5 ml) for 1 dose in a pack of 100
Marketing Authorisation Holder
GlaxoSmithKline Biologicals s.a.Rue de l?Institut 89
B-1330 Rixensart
Belgium
Manufacturer
Sächsisches Serumwerk Dresden (SSW)
Zirkusstraße 40
D-01069 Dresden
Germany
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
BelgiëBelgiqueBelgien GlaxoSmithKline s.a.n.v. TélTel 32 2 656 21 11 LuxembourgLuxemburg GlaxoSmithKline s.a.n.v. TélTel 32 2 656 21 11
. 359 2 953 10 34 Magyarország GlaxoSmithKline Kft. Tel. 36-1-2255300
Malta GlaxoSmithKline Malta Tel 356 21 238131 eská republika GlaxoSmithKline s.r.o. Tel 420 2 22 00 11 11 gsk.czmailgsk.com
Danmark GlaxoSmithKline Pharma AS Tlf 45 36 35 91 00 infoglaxosmithkline.dk Nederland GlaxoSmithKline BV Tel 31 030 69 38 100 nlinfogsk.com
Deutschland GlaxoSmithKline GmbH Co. KG Tel 49 089 360448701 produkt.infogsk.com Norge GlaxoSmithKline AS Tlf 47 22 70 20 00 firmapostgsk.no
Eesti GlaxoSmithKline Eesti OÜ Tel 372 667 6900 estoniagsk.com Österreich GlaxoSmithKline Pharma GmbH. Tel 43 1 970 75-0 at.infogsk.com
GlaxoSmithKline A.E.B.E T 30 210 68 82 100 Polska GSK Commercial Sp. z o.o. Tel. 48 22 576 9000
España GlaxoSmithKline, S.A. Tel 34 902 202 700 es-cigsk.com Portugal Smith Kline French Portuguesa, Produtos Farmacêuticos, Lda. Tel 351 21 412 95 00 FI.PTgsk.co
France Laboratoire GlaxoSmithKline Tél 33 0 1 39 17 84 44 diamgsk.com România GlaxoSmithKline GSK SRL Tel 40 021 3028 208 www.gsk.r
Ireland GlaxoSmithKline Ireland Ltd Tel 353 01 4955000 Slovenija GlaxoSmithKline d.o.o. Tel 386 0 1 280 25 00 medical.x.sigsk.com
Ísland GlaxoSmithKline ehf. Sími 354-530 3700 Slovenská republika GlaxoSmithKline Slovakia s.r.o. Tel 421 02 49 10 33 11 recepcia.skgsk.com
Italia GlaxoSmithKline S.p.A. Tel 39 04 59 21 81 11 SuomiFinland GlaxoSmithKline Oy PuhTel 358 10 30 30 30 Finland.tuoteinfogsk.com
GlaxoSmithKline Cyprus Ltd 357 22 89 95 01 Sverige GlaxoSmithKline AB Tel 46 08 638 93 00 info.produktgsk.co
Latvija GlaxoSmithKline Latvia SIA Tel 371 7312687 lv-epastsgsk.com United Kingdom GlaxoSmithKline UK Tel 44 0808 100 9997 customercontactukgsk.com
Lietuva
GlaxoSmithKline Lietuva UAB
Tel. +370 5 264 90 00
info.lt@gsk.com
This leaflet was last approved in {MM/YYYY}.
Daronrix has been authorised under ?Exceptional Circumstances?.
This means that for scientific reasons, it has not been possible to obtain complete information on this medicinal product.
The European Medicines Agency (EMEA) will review any new information on the medicine every year and this leaflet will be updated as necessary.