What Baraclude contains
--The active substance is entecavir. Each ml of oral solution contains 0.05 mg entecavir. --The other ingredients are: citric acid anhydrous, maltitol (E965), methylhydroxybenzoate (E218), propylhydroxybenzoate (E216), orange flavour (acacia and natural flavours), sodium citrate, sodium hydroxide, hydrochloric acid and purified water.
What Baraclude looks like and contents of the pack
The oral solution is a clear, colorless to pale yellow solution. Baraclude 0.05 mg/ml oral solution is supplied in a bottle containing 210 ml oral solution.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
BRISTOL-MYERS SQUIBB PHARMA EEIG
Uxbridge Business Park
Sanderson Road
Uxbridge UB8 1DH
United Kingdom
Manufacturer:
Bristol-Myers Squibb S.r.l.
Contrada Fontana del Ceraso
03012 Anagni (FR)
Italy
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
BelgiqueBelgiëBelgien BRISTOL-MYERS SQUIBB BELGIUM S.A.N.V. TélTel 32 2 352 76 11 LuxembourgLuxemburg BRISTOL-MYERS SQUIBB BELGIUM S.A.N.V. TélTel 32 2 352 76 11
BRISTOL-MYERS SQUIBB GYÓGYSZERKERESKEDELMI KFT. Te. 359 800 12 400 Magyarország BRISTOL-MYERS SQUIBB GYÓGYSZERKERESKEDELMI KFT. Tel. 36 1 301 9700
eská republika BRISTOL-MYERS SQUIBB SPOL. S R.O. Tel 420 221 016 111 Malta BRISTOL-MYERS SQUIBB S.R.L. Tel 39 06 50 39 61
Danmark BRISTOL-MYERS SQUIBB Tlf 45 45 93 05 06 Nederland BRISTOL-MYERS SQUIBB BV Tel 31 34 857 42 22
Deutschland BRISTOL-MYERS SQUIBB GMBH CO. KGAA Tel 49 89 121 42-0 Norge BRISTOL-MYERS SQUIBB NORWAY LTD Tlf 47 67 55 53 50
Österreich BRISTOL-MYERS SQUIBB GESMBH Tel 43 1 60 14 30 Eesti BRISTOL-MYERS SQUIBB GYÓGYSZERKERESKEDELMI KFT. Tel 372 682 7400
BRISTOL-MYERS SQUIBB A.E. 30 210 6074300 Polska BRISTOL-MYERS SQUIBB POLSKA SP. Z O.O. Tel. 48 22 5796666
España BRISTOL-MYERS SQUIBB, S.A. Tel 34 91 456 53 00 Portugal BRISTOL-MYERS SQUIBB FARMACÊUTICA PORTUGUESA, S.A. Tel 351 21 440 70 00
France BRISTOL-MYERS SQUIBB SARL Tél 33 0810 410 500 România BRISTOL-MYERS SQUIBB GYÓGYSZERKERESKEDELMI KFT. Tel 40 021 272 16 00
IrelandSlovenija
BRISTOL-MYERS SQUIBB PHARMACEUTICALS LTDBRISTOL-MYERS SQUIBB SPOL. S R.O. Tel: + 353 (1 800) 749 749 Tel: + 386 1 236 47 00
Ísland VISTOR HF Sími 354 535 7000 Slovenská republika BRISTOL-MYERS SQUIBB SPOL. S R.O. Tel 421 2 59298411
Italia BRISTOL-MYERS SQUIBB S.R.L. Tel 39 06 50 39 61 SuomiFinland OY BRISTOL-MYERS SQUIBB FINLAND AB PuhTel 358 9 251 21 230
BRISTOL-MYERS SQUIBB A.E 357 800 92666 Sverige BRISTOL-MYERS SQUIBB AB Tel 46 8 704 71 00
United Kingdom BRISTOL-MYERS SQUIBB PHARMACEUTICALS LTDTel 44 0800 731 1736 Latvija BRISTOL-MYERS SQUIBB GYÓGYSZERKERESKEDELMI KFT. Tel 371 67 50 21 85
Lietuva
BRISTOL-MYERS SQUIBB
GYÓGYSZERKERESKEDELMI KFT.
Tel: + 370 5 2790 762
The measuring spoon is manufactured by: Comar Plastics Division, One Comar Place, Buena, NJ 08310, USA.
Authorised Representative in the EEA for Comar Plastics: MDSS, Burckhardstrasse 1, 30163 Hannover, Germany
This leaflet was last approved on