[*first listing]

acamprosate calcium

Campral, Lipha: Spain

coated tablet 333 mg

psychotherapeutic agent

Indications: Alcohol withdrawal, in conjunction with psychotherapy.

adenosine

Adenocor, Adenoscan, Sanofi Winthrop: Iceland

solution for injection 3 mg/1 ml

antiarrhythmic agent

Indications: Tachycardia, arrhythmia.

alteplase

Actilyse, Boehringer Ingelheim: New Zealand

powder for injection 50 mg

recombinant human tissue plasminogen activator (TPA)

New indication: Accelerated administration (90 minutes) in patients treated within 6 hours of myocardial infarction symptoms, and a 3-hour dosage regimen in patient treated within 6 to 12 hours.

atorvastatin

Zarator; Sortis, Warner-Lambert: Denmark, Switzerland

capsules 10, 20, 40 mg

antihyperlipidaemic

Indications: As an adjunct to diet to reduce elevated total glyceride levels in patients with primary hypercholesterolaemia and mixed dyslipidaemia, and in patients with homozygous familial hypercholesterolaemia, when other drugs or dietary measures are ineffective.

*bromfenac

Duract, Wyeth-Ayerst: USA

tablet 25 mg

nonsteroidal anti-inflammatory agent (NSAID)

Indications: Short-term management of acute pain (less than 10 days), e.g. following major abdominal, gynaecological, oral and orthopaedic surgery. It is not indicated for the treatment of such conditions as osteoarthritis or rheumatoid arthritis.

cabergoline

Cabaseril; Cabergolin P&U, Pharmacia & Upjohn: Germany

scored tablets 1, 2, 4 mg

dopamine receptor agonist

New indications: Treatment of Parkinson's disease as an adjunct to levodopa/dopa-decarboxylase antagonists.

*candesartan cilexetil

Atacand, Astra; Blopress, Gruenenthal: Switzerland

tabelts 4, 8, 16 mg

antihypertensive

Indication: Essential hypertension.

*cerivastatin sodium

Zenas, Bayer-Vital; Lipobay; Vazqol, Bayer: Germany

coated tablets 0.1 mg, 0.2 mg, 0.3 mg

antihyperlipidaemic

Indications: Primary hypercholesterolaemia (type IIA and type IIB), with or without hypertriglyceridaemia in patients for whom dietary measures alone are insufficient.

ciclosporin

Sandimmun Neoral, Novartis: New Zealand

capsules 25, 100 mg

immunosuppressant

Extended indications: Nephrotic syndrome, uveitis, psoriasis, rheumatoid arthritis and atopic dermatitis.

dolasetron

Anemet, Hoechst Marion Roussel: Germany

solution for injection 12.5 mg, 100 mg; coated tablet 50 mg, 200 mg

antiemetic serotonin antagonist

Indications: Anemet 100 mg i.v. and Anemet 200 mg coated tablets: Nausea and vomiting induced by chemotherapy, especially high-dose cisplatin. Anemet 12.5 mg i.v and Anemet 50 mg coated tablets: Prevention of postoperative nausea and vomiting in patients at high risk, e.g. after intra-abdominal gynaecological operations or in patients with a known tendency for postoperative nausea and vomiting. Treatment of postoperative nausea and vomiting.

donepezil hydrochloride

Aricept, Pfizer: Germany

coated tablets 5 mg, 10 mg

cholinesterase inhibitor

Indications: Symptomatic treatment of mild to moderate Alzheimer's disease.

First approval: USA - see PN 3/4, 1997

fexofenadine hydrochloride

Telfast, Hoechst Marion Roussel: Switzerland

tablets 40, 120, 180 mg

histamine H1-antagonist (metabolite of terfenadine)

Indication: Symptomatic relief of seasonal allergic rhinitis in adults.

fluvoxamine

Luvox, Solvay: Australia

tablet 100 mg

selective serotonin receptor antagonist; antidepressant

Indications: Depressive diseases, obsessive compulsive disorder.

gadodiamide

Omniscan, Nycomed: Australia

solution for injection 287 mg/ml

contrast agent

Indications: For use in adults and children from 6 months of age for enhancement of magnetic resonance images of intracranial and spinal lesions where there is an abnormal blood-brain barrier or abnormal vascularity.

glimepiride

Amaryl, Hoechst Marion Roussel: Iceland

tablets 1 mg, 2 mg, 3 mg, 4 mg

antihyperglycaemic agent

Indications: Non insulin-dependent diabetes mellitus when dietary measures, exercise and weight reduction are ineffective.

*grepafloxacin

Raxar; Vaxar; Cerobin, Glaxo Wellcome: Germany, USA

coated tablet 200 mg, 400 mg, 600 mg

quinolone antibiotic

Indications: Treatment of infections induced by susceptible bacteria, including various types of pneumonia, acute bacterial exacerbations of chronic bronchitis, uncomplicated gonorrhoea (urethritis and cervixitis); urethritis and cervixitis induced by Chlamidiae.

ibandronic acid

Bondronat, Boehringer Ingelheim: Spain

infusion concentrate 1 mg/ml

biphosphonate

Indication: Treatment of hypercalcaemia caused by tumors with or without metastases.

iomeprol

Iomeron, Bracco: Switzerland

injection fluid 306.2 mg (150 mg I/ml), 408.2 mg (200 mg I/ml), 510.3 mg (250 mg I/ml)

contrast agent

Indications: Various radiographic diagnostic procedures.

*iosarcol

Melitrast, Franz K-hler Chemie: Germany

injection fluid 678.8 mg (300 mg I)/ml

contrast medium

Indications: Peripheral venous digital substraction angiography, phlebography, contrast enhancement in computer tomography, intravenous elimination urography, retrograde urethrocystography.

lamivudine

Epivir, Glaxo Wellcome: Iceland

coated tablet 150 mg; oral solution 10 mg/ml

antiviral agent

Indications: In combination with other antiretroviral agents for the treatment of HIV-infected adults and children over 12 years old with progressive immunodeficiency (CD4 count 500 or less cells per mm3).

letrozole

Femara, Novartis: Australia

tablet 2.5 mg

non-steroidal aromatase inhibitor of estrogen biosynthesis

Indications: Treatment of advanced breast cancer in women with natural or artificially induced postmenopausal status after relapse or disease progression, following anti-estrogen (e.g. tamoxifen) therapy. Efficacy has not been demonstrated in estrogen receptor-negative tumours.

lodoxamide trometamol

Lomide; Alomide, Alcon: Australia, Denmark

eye drops 1%

antiallergic

Indication: Treatment of seasonal allergic conjunctivitis.

meloxicam

Mobec; Hexaphlogin, Dr Karl Thomae: Germany

New formulation: suppository 7.5 mg

nonsteroidal anti-inflammatory agent (NSAID)

Indication: Short-term symptomatic treatment of active arthroses; long-term symptomatic treatment of rheumatoid arthritis (chronic polyarthritis).

mibefradil

Posicor, Hoffmann-La Roche: Australia, Germany

coated tablet 50 mg, 100 mg

calcium channel blocker

Indications: Treatment of essential hypertension; chronic stable angina pectoris.

mirtazapine

Remeron; Remergon; Zispin, Organon: Iceland, Norway, UK

tablets:

Iceland: 15, 30 mg

Norway: 15, 30, 45 mg

UK: 30 mg

tetracyclic antidepressant

Indications: Treatment of depression.

moxonidine

Physiotens [manufacturer not stated]: Denmark

[form/strength not stated]

central alpha2-adrenoreceptor agonist

Indications: Arterial hypertension.

nadroparin calcium

Fraxiparin; Okludex, Sanofi-Winthrop: Germany, Iceland Fraxiparine, Sanofi-Winthrop

solution for injection:

unit dose syringes 95-130 IU AXa/mg: 1,900 IU AXa in 0.2 ml; 2,850 IU AXa in 0.3 ml; 3,800 IU AXa in 0.4 ml; 5,700 IU AXa in 0.6 ml; 7,600 IU AXa in 0.8 ml; 9.500 IU AXa in 1.0 ml

platelet aggregation inhibitor

Indications: Perioperative prophylaxis against deep vein thrombosis in patients with low or moderate risk (e.g. general surgery); peri- or postoperative primary prophylaxis of deep vein thrombosis in patients at high risk of thromboembolism; prevention of clotting during haemodialysis.

*naratriptan

Naramig, Glaxo Wellcome: Germany

coated tablet 2.5 mg

serotonin receptor agonist

Indications: Acute treatment of headache due to migraine attacks with and without aura.

nimesulide

Antifloxil, Labs. Alter: Spain

tablets 50, 100 mg

sulfonanilide nonsteroidal anti-inflammatory agent (NSAID)

Indications: Short-term symptomatic treatment of mild to moderate pain, postoperative or post-traumatic inflammation; dysmenorrhoea; fever.

olanzapine

Zyprexa, Eli Lilly: Australia, Denmark, Spain, Switzerland

coated tablets 5, 7.5, 10 mg

antipsychotic

Indication: Treatment of schizophrenia.

pantoprazole

Pantoloc; Pantozol; Panto-Byk, Byk Gulden: Germany; Somac, Byk Gulden Iceland

enteric coated tablet 40 mg

cholinergic antisecretory agent; proton pump inhibitor

Indications: Elimination of Helicobacter pylori pathogens in combination with clarithromycin/amoxicillin or clarithromycin/metronidazole or amoxicillin/metronidazole in duodenal and gastric ulcer; treatment of duodenal and gastric ulcer; moderate and severe forms of reflux oesophagitis.

pramipexole

Sifrol, Boehringer Ingelheim: EC

[form/strength not stated]

dopamine receptor agonist

Indications: Treatment of the signs and symptoms of Parkinson's disease in combination with levodopa.

remifentanil hydrochloride

Ultiva, Glaxo: Australia

powder for reconstitution (intravenous injection) 1, 2, 5 mg/vial

analgesic/anaesthetic agent

Indication: Induction and maintenance of anaesthesia when endotracheal intubation and controlled ventilation are anticipated.

saquinavir

Invirase, Roche: Norway

capsule 200 mg

antiviral agent

Indications: Infections due to HIV in adults with severe immunodeficiency, in combination with other antiretroviral agents.

stavudine

Zerit, Bristol-Myers Squibb: UK

New formulation: powder for oral solution 1 mg/ml

antiviral agent

Indication: Treatment of HIV infection in adults and children with progressive or advanced immunodeficiency.

valaciclovir

Valtrex, Glaxo Wellcome: Iceland, Norway

tablet 500 mg, 1 g

antiviral agent

Indications: In immunocompetent patients, treatment of acute Herpes zoster (shingles); severe Herpes simplex infections; recurrent or primary genital herpes.

valsartan

Diovan, Novartis: Iceland

capsule 80 mg, 160 mg

antihypertensive (angiotensin II antagonist)

Indication: Treatment of essential hypertension.

*zolmitriptan

AscoTop, Zeneca: Germany

coated tablet 2.5 mg

serotonin receptor agonist

Indications: Acute treatment of headache due to migraine attacks with and without aura.