What HBVAXPRO 10 micrograms/ml contains
The active substance is, for one dose of 1 ml:
Hepatitis B virus surface antigen, recombinant (HBsAg) *...................10.00 micrograms Adsorbed on amorphous aluminium hydroxyphosphate sulfate (0.50 milligram Al +)
* produced from recombinant strain of the yeast Saccharomyces cerevisiae (strain 2150-2-3)
The other ingredients are sodium chloride, borax and water for injections.
What HBVAXPRO 10 micrograms/ml looks like and contents of the pack
Each dose contains 1 ml of suspension for injection in a vial.
Pack sizes of 1 and 10 vials.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: Sanofi Pasteur MSD SNC, 8 rue Jonas Salk, F-69007 Lyon, France
Manufacturer Responsible for Batch Release: Merck Sharp and Dohme, B.V., Waarderweg, 39, 2031 BN Haarlem, The Netherlands
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
België/Belgique/Belgien: Sanofi Pasteur MSD, Tél/Tel: +32.2.726.95.84
--------: ---- ---- - ---- -------- ----, ---. + 359 2 8193740
-eská republika: Merck Sharp & Dohme, IDEA, Inc., org. sl., Tel.: +420.233.010.111 Danmark: Sanofi Pasteur MSD, Tlf: +45 23 32 69 29
Deutschland: Sanofi Pasteur MSD GmbH, Tel: +49.6224.5940
Eesti: Merck Sharp & Dohme OÜ, Tel: +372.613.9750
???-??: ?????? ?.?., ???: +30.210.8009111
España: Sanofi Pasteur MSD S.A., Tel: +34.91.371.78.00
France: Sanofi Pasteur MSD SNC, Tél: +33.4.37.28.40.00
Ireland: Sanofi Pasteur MSD Ltd, Tel: +3531.468.5600
Ísland: Sanofi Pasteur MSD, Tel: +32.2.726.95.84
Italia: Sanofi Pasteur MSD Spa, Tel: +39.06.664.092.11
K-????: Merck Sharp & Dohme (Middle East) Limited., ???: +357 22866700
Latvija: SIA Merck Sharp & Dohme Latvija, Tel: +371.67364.224
Lietuva: UAB Merck Sharp & Dohme, Tel.: +370.5.2780.247
Luxembourg/Luxemburg: Sanofi Pasteur MSD, Tél: +32.2.726.95.84
Magyarország: MSD Magyarország Kft, Tel.: + 36.1.888.5300
Malta: Merck Sharp & Dohme (Middle East) Limited, Tel: +357 22866700
Nederland: Sanofi Pasteur MSD, Tel: +31.23.567.96.00
Norge: Sanofi Pasteur MSD, Tlf: +47.67.50.50.20
Österreich: Sanofi Pasteur MSD GmbH, Tel: +43.1.866.70.22.202
Polska: MSD Polska Sp. z o.o., Tel.: +48.22.549.51.00
Portugal: Sanofi Pasteur MSD, SA, Tel: +351 21 470 45 50
România: Merck Sharp & Dohme Romania S.R.L., Tel: + 4021 529 29 00
Slovenija: Merck Sharp & Dohme, inovativna zdravila d.o.o., Tel: +386.1.520.4201
Slovenská republika: Merck Sharp & Dohme IDEA, Inc., Tel: +421.2.58282010
Suomi/Finland: Sanofi Pasteur MSD, Puh/Tel: +358.9.565.88.30
Sverige: Sanofi Pasteur MSD, Tel: +46.8.564.888.60
United Kingdom: Sanofi Pasteur MSD Ltd, Tel: +44 1 628 785 291
This leaflet was last approved in ????.