PUBLIC - Croatia, the War, and the Future
PUBLIC - Croatia, the War, and the Future
PUBLIC - Croatia, the War, and the Future
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INFANRIX-IPV+Hib,<br />
Combined Diph<strong>the</strong>ria,<br />
Tetanus, acellular<br />
Pertussis,inactivated Polio<br />
<strong>and</strong> Haemophilus<br />
influenzae type B<br />
conjugate Vaccine<br />
Influvac (inactivated<br />
influenza vaccine, surface<br />
antigen)<br />
Infusol (solution for<br />
infusion)<br />
powder <strong>and</strong> suspension<br />
for preparation of<br />
suspension for injection<br />
suspension for injection<br />
solution for intravenous<br />
infusion<br />
Inspra 25 mg tablets film coated tablets<br />
Inspra 50 mg tablets film coated tablets<br />
Instillagel 11 mL gel<br />
Instillagel 6 mL gel<br />
Insulatard HM 100<br />
Insulatard Penfill<br />
Integrilin solution for<br />
infusion 0.75 mg/mL<br />
Integrilin solution for<br />
injection 2 mg/mL<br />
solution for injection (for<br />
s.c. use)<br />
suspension for<br />
subcutaneous injection<br />
solution for infusion<br />
solution for injection<br />
Intralipid 10% emulsion for infusion<br />
Intralipid 10% emulsion for infusion<br />
GlaxoSmithKline<br />
Biologicals s.a., Rue<br />
de lInstitut 89,<br />
Rixensart, Belgium<br />
Solvay<br />
Pharmaceuticals B.V.,<br />
Veerweg 12, 8121 AA<br />
Olst, <strong>the</strong> Ne<strong>the</strong>rl<strong>and</strong>s<br />
Pliva <strong>Croatia</strong> Ltd., Ulica<br />
grada Vukovara 49,<br />
Zagreb, Republic of<br />
<strong>Croatia</strong><br />
Pharmacia Limited,<br />
Whalton Road,<br />
Morpeth,<br />
Northumberl<strong>and</strong><br />
NE613YA, Great<br />
Britain<br />
Pharmacia Limited,<br />
Whalton Road,<br />
Morpeth,<br />
Northumberl<strong>and</strong><br />
NE613YA, Great<br />
Britain<br />
Almed GmbH,<br />
Motzener Str. 41,<br />
Berlin, Germany<br />
Almed GmbH,<br />
Motzener Str. 41,<br />
Berlin, Germany<br />
Novo Nordisk A/S,<br />
Novo Allé, DK-2880<br />
Bagsvaerd, Denmark<br />
Novo Nordisk A/S,<br />
Novo Alle, Bagsvaerd,<br />
Denmark Novo Nordisk<br />
Production SAS, 45,<br />
Avenue d' Orleans,<br />
Chartres, France<br />
Schering-Plough Labo<br />
N.V., Heist-op-den-<br />
Berg, Belgium <strong>and</strong><br />
Glaxo Operations UK<br />
Ltd., Great Britain<br />
Schering-Plough Labo<br />
N.V., Heist-op-den-<br />
Berg, Belgium <strong>and</strong><br />
Glaxo Operations UK<br />
Ltd., Great Britain<br />
Fresenius Kabi Austria<br />
GmbH, Graz, Austria<br />
<strong>and</strong> Fresenius Kabi<br />
AB, Uppsala, Sweden<br />
Fresenius Kabi AB,<br />
Uppsala, Sweden<br />
in a box<br />
Box with 1 glass syringe<br />
containing 0.5 mL of<br />
suspension (component<br />
Infanrix IPV), 1 glass bottle<br />
with powder (component Hib)<br />
<strong>and</strong> 2 needles with protection<br />
Box with 1 pre-filled syringe<br />
(glass, type I) with 1 dose of<br />
vaccine (0.5 mL of<br />
suspension)<br />
10 glass vials with 500 mL of<br />
solution, supplied in a box<br />
30 (3x10) film coated tablets<br />
in a nontransparent PVC/Al<br />
blister, supplied in a carton<br />
box<br />
30 (3x10) film coated tablets<br />
in a nontransparent PVC/Al<br />
blister, supplied in a carton<br />
box<br />
10 syringes each containing<br />
11 mL of gel in a blister,<br />
supplied in a box<br />
10 syringes each containing<br />
6 mL of gel in a blister,<br />
supplied in a box<br />
10 mL of suspension in a<br />
glass bottle, supplied in a<br />
box<br />
5 glass cartridges with 3 mL<br />
of suspension in a blister,<br />
supplied in a box<br />
One glass vial with 10 mL of<br />
solution, supplied in a box<br />
One glass vial with 10 mL of<br />
solution, supplied in a box<br />
Glass infusion bottle<br />
containing 500 mL of<br />
emulsion, 10 bottles in a<br />
carton box<br />
Plastic bag ("Excel")<br />
containing 500 mL of<br />
emulsion for infusion with two<br />
attachments for drug<br />
administration <strong>and</strong> for<br />
infusion, one small bag<br />
containing oxygen absorber,<br />
<strong>and</strong> one bag with solution for<br />
packaging airtightness<br />
14509/11 WS/jj 301<br />
ANNEX II DGF 2A / DG K 2 EN<br />
YES<br />
YES<br />
YES YES<br />
YES YES YES YES<br />
YES YES YES YES<br />
YES YES<br />
YES YES<br />
YES YES<br />
YES YES<br />
YES YES YES YES<br />
YES YES YES YES<br />
YES YES<br />
YES YES