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PUBLIC - Croatia, the War, and the Future

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NAME OF THE<br />

MEDICINAL PRODUCT<br />

1M potassium-chloride<br />

(7.45%) concentrate 50<br />

mL<br />

1M sodium<br />

hydrogencarbonate (8.4%)<br />

solution for intravenous<br />

infusion, 100 mL<br />

PHARMACEUTICAL FORM MANUFACTURER<br />

concentrate for<br />

intravenous after<br />

reconstitution<br />

solution for intravenous<br />

infusion<br />

A.T. 10 solution oral solution<br />

Abaktal 400 mg film<br />

coated tablets<br />

Abaktal 400 mg/5 mL<br />

solution for injection<br />

film coated tablets<br />

solution for injection<br />

Accupro 10 mg tablets film coated tablets<br />

Accupro 20 mg tablets film coated tablets<br />

Accupro 5 mg tablets film coated tablets<br />

Aclasta 5 mg solution for<br />

infusion<br />

Act HIB, vaccine against<br />

Haemophilus influenzae<br />

type B<br />

Actilyse lyophilisate for<br />

injection 50 mg<br />

solution for infusion<br />

lyophilisate <strong>and</strong> diluent<br />

for preparation of<br />

injection solution<br />

lyophilisate <strong>and</strong> diluent<br />

for preparation of solution<br />

for injection<br />

Activelle film coated tablets<br />

Actonel 30 mg tablets film coated tablets<br />

Actonel 35 mg tablets film coated tablets<br />

Actonel 5 mg tablets film coated tablets<br />

Actrapid HM 100<br />

Actrapid Penfill<br />

solution for injection (for<br />

s.c., i.m. <strong>and</strong> i.v. use)<br />

solution for subcutaneous<br />

injection<br />

Hrvatski zavod za<br />

transfuzijsku medicinu,<br />

Petrova 3, Zagreb,<br />

Hrvatski zavod za<br />

transfuzijsku medicinu,<br />

Petrova 3, Zagreb,<br />

Republic of <strong>Croatia</strong><br />

Merck KGaA,<br />

Frankfurter Straße 250,<br />

Lek Darmstadt, farmacevtska Germany<br />

družba d.d.,<br />

Lek Verovškova farmacevtska 57,<br />

družba d.d.,<br />

Verovškova Gödecke GmbH, 57, dio<br />

Pfizer grupe,<br />

Karlsruhe, Gödecke GmbH, Germany dio<br />

Pfizer grupe,<br />

Karlsruhe, Gödecke GmbH, Germany dio<br />

Pfizer grupe,<br />

Novartis Karlsruhe, Pharma Germany Stein<br />

AG,<br />

Sanofi Schaffhauserstrasse,<br />

Pasteur S.A., 2<br />

avenue Pont Pasteur,<br />

Lyon, France<br />

Boehringer Ingelheim<br />

Pharma GmbH & Co.<br />

KG, Birkendorfer<br />

Strasse 65, Biberach<br />

an der Riss, Germany<br />

Novo Nordisk A/S,<br />

Novo Allé, DK-2880<br />

Bagsvaerd, Denmark<br />

Procter & Gamble<br />

Pharmaceuticals<br />

Germany GmbH,<br />

Weiterstadt, Germany<br />

Procter & Gamble<br />

Pharmaceuticals<br />

Germany GmbH,<br />

Weiterstadt, Germany<br />

Procter & Gamble<br />

Pharmaceuticals<br />

Germany GmbH,<br />

Weiterstadt, 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 />

NATURE AND CONTENTS<br />

OF CONTAINER<br />

50 mL of solution in a glass<br />

injection bottle with a<br />

chlorobutyl stopper protected<br />

100 mL of solution in a glass<br />

infusion bottle with rubber<br />

stopper protected by Al cap,<br />

20 bottles with plastic holders<br />

15 mL of solution in an<br />

amber glass bottle with<br />

plastic<br />

10 (1x10)<br />

dropper<br />

tablets<br />

attachment,<br />

in a blister,<br />

supplied in a box<br />

10 ampoules each containing<br />

5 mL of solution, supplied in<br />

a<br />

30<br />

box<br />

(3x10) tablets in a blister,<br />

supplied in a box<br />

31 (3x10) tablets in a blister,<br />

supplied in a box<br />

32 (3x10) tablets in a blister,<br />

supplied in a box<br />

100 mL solution in a plastic<br />

bottle with rubber stopper,<br />

aluminum Bottle with ring 1 dose <strong>and</strong> of plastic<br />

lyophilised vaccine <strong>and</strong> 1<br />

glass syringe with solvent for<br />

50 mg of lyophilisate in a<br />

bottle, 50 mL of solvent<br />

(water for injection) in a<br />

bottle <strong>and</strong> a transfer needle,<br />

supplied in a box<br />

28 tablets in a plastic<br />

calendar dial pack (dispenser<br />

with marked days of <strong>the</strong><br />

week), supplied in a box<br />

28 (2x14) tablets in a blister,<br />

supplied in a box<br />

4 (1x4) tablets in a blister,<br />

supplied in a box<br />

28 (2x14) tablets in a blister,<br />

supplied in a box<br />

10 mL of solution in a glass<br />

bottle, supplied in a box<br />

5 glass cartridges with 3 mL<br />

of solution in a blister,<br />

supplied in a box<br />

Domestic Imported Proprietary Generic<br />

14509/11 WS/jj 221<br />

ANNEX II DGF 2A / DG K 2 EN<br />

UDMP<br />

YES YES<br />

YES YES<br />

YES YES<br />

YES YES<br />

YES YES<br />

YES YES<br />

YES YES<br />

YES YES<br />

nCADREAC CP MRP OTC H<br />

YES YES YES<br />

YES<br />

YES YES<br />

YES YES<br />

YES YES<br />

YES YES<br />

YES YES<br />

YES YES<br />

YES YES

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