(*= first listing)

amisulpride Date approved: 07.01.99

30.09.98

Solian, Amisulprid, Synthélabo: Germany; Solian, Synthélabo: Switzerland

tablet 50 mg, 200 mg

Switzerland: 200 mg only

neuroleptic

Indications: Treatment of acute and chronic schizophrenic disorders in which positive symptoms and/or negative symptoms are prominent.

*artemether + lumefantrine

Date approved: 22.01.99

Riamet, Novartis: Switzerland

tablet 20 mg + 120 mg

antimalarial agent

Indications: Treatment of malaria.

basiliximab Date approved: 05.12.98

Simulect, Novartis: UK

powder 20 mg/vial and 5-ml ampoule of water for injection

platelet aggregation inhibitor

Indications: Prophylaxis of acute organ rejection in de novo allogenic renal transplantation.

To be used concomitantly with ciclosporin for microemulsion and corticosteroid-based immunosuppression.

brimonidine tartrate Date approved: 15.12.98, 15.05.98, 00.10.99

Alphagan, Allergan: Finland, Netherlands, Spain

eyedrops 2 mg/ml

a2-adrenoreceptor agonist

Indications: Lowering of intraocular pressure in patients with wide-angle glaucoma or ocular hypertension who do not respond or are intolerant to topical therapy with a beta-adrenoreceptor antagonist, or in whom therapy with a beta-adrenoreceptor antagonist is contraindicated; adjunctive therapy when intraocular pressure is not adequately controlled by a topical beta-adrenoreceptor antagonist.

calcium levofolinate Date approved: 19.05.99

Isovorin, Wyeth Lederle Nordisk: Finland

intravenous injection 10 mg/mL

levo isomer of folinic acid; antidote

Indications: To counteract toxic effects of methotrexate. Treatment of advanced colorectal cancer in combination with 5-fluorouracil.

candesartan cilexetil Date approved: 00.02.99, 20.10.97

Atacand, Astra: Australia, Finland

tablet 4 mg, 8mg, 16 mg

Finland: also 2 mg

angiotensin II receptor antagonist; antihypertensive

Indication: Essential hypertension.

*candesartan cilexetil + hydrochlorothiazide

Date approved: 01.02.99

Atacand plus, Promed Arzneimittel; Blopress Plus, Takeda: Germany

tablets 8 mg + 12.5 mg

antihypertensive + thiazide diuretic

Indication: Essential hypertension unresponsive to monotherapy.

celecoxib Date approved: 21.01.99, 15.03.99

Celebra, GD Searle and Pfizer: Brazil, Switzerland

capsules 100 mg, 200 mg

nonsteroidal anti-inflammatory agent (NSAID); selective COX-2 inhibitor

Indication: Treatment of arthritis.

*cetrorelix acetate Date approved: 13.04.99

Cetrotide, ASTA Medica: EU

powder and solvent for solution for subcutaneous injection 3 mg, 0.25 mg

LHRH-antagonist

Indication: Prevention of premature ovulation in patients undergoing a controlled ovarian stimulation, followed by oocyte pick-up and assisted reproductive techniques.

Adverse reactions: Injection site reactions (ovarian hyperstimulation). Occasionally nausea, pruritus, headache.

donepezil Date approved: 00.02.99, 28.07.97

Aricept, Pfizer: Australia, Finland

tablets 5 mg, 10 mg

cholinesterase inhibitor

Indications: Alzheimer’s disease.

entacapone Date approved: 16.02.99

Comtan, Novartis: Switzerland

coated tablets 200 mg

catechol-O-methyltransferase inhibitor; antiparkinsonism agent

Indication: Parkinson’s disease.

erdosteine Date approved: 23.03.99

Tussol, Merckle: Germany

capsule 300 mg

mucolytic agent

Indication: Mucolytic therapy in acute and chronic bronchopulmonary diseases caused by a disturbance in the development and transport of mucous.

estradiol and dydrogesterone

Date approved: 28.01.99

Femphascyl, Solvay: Germany

2 mg + 10 mg and 2 mg + 20 mg

First 14 days of cycle:

1 orange tablet containing estradiol 2 mg

Second 14 days of cycle:

1 yellow tablet containing estradiol 2 mg and dydrogesterone 10 mg or 20 mg

estrogen and progestogen

Indications: In women with intact uterus, replacement therapy for estrogen deficiency; relief of postmenopausal symptoms following natural or artificial menopause; prevention of osteoporosis due to estrogen deficiency.

etonogestrel Date approved: 29.03.99, 15.02.99

Implanon, Organon: Finland, Germany

slow release implant 68 mg

progestogen

Indications: Long-term contraception.

Note: See also Pharmaceuticals Newsletter Nos. 3&4, March & April 1999.

*fenoldopam Date approved: 15.02.99

Corlopam, Ipsen: Finland

concentrate for solution for infusion 10 mg/mL

dopamine agonist; antihypertensive

Indications: Short-term use in the treatment of severe hypertension when oral medication is either inappropriate or not possible.

*fludeoxyglucose (18F)

Date approved: 04.02.99

Efdege, Forschungszentrum Jülich: Germany

injection solution 185-1110 MBq/mL

radioactive contrast agent

Indications: Diagnostic radioactive contrast agent for imaging of the myocardial tissue in patients with coronary heart disease, and global or restricted regions of left ventricular function; localization of epileptic zones for surgical treatment of epilepsy; recurrent high-malignancy glioma (grades III and IV); assessment of the status of peripheral bronchial passages in patients at high operational risk in whom invasive methods are not possible (e.g. thoracic puncture); assessment of adenocarcinoma of the pancreas.

*gadobenate dimeglumine

Date approved: 07.12.98

Multihance, Bracco: Finland

solution for injection fluid 334 mg/mL

contrast agent

Indications: A paramagnetic contrast agent for use in diagnostic magnetic resonance imaging (MRI) of the liver, for the detection of focal liver lesions in patients with known or suspected primary liver cancer (e.g. hepatocellular carcinoma) or metastatic disease.

imiglucerase Date approved: 06.05.98, 01.03.99

Cerezyme, Genzyme: Netherlands, Switzerland

powder for infusion solution 200 units/vial

beta-glucocerebrosidase enzyme replenisher

Indications: Long-term enzyme substitution therapy in patients with Type I Gaucher’s disease.

insulin, human (recombinant)

Date approved: 11.11.98

31.03.99

Insuman Rapid, Insuman Infusat, Insuman Basal, Insuman Comb, Hoechst Marion Roussel: EU, Switzerland

solution for injection 40 U/ml, 100 U/ml, 100 U/10 ml vials and cartridges: fast-acting (Insuman Rapid and Insuman Infusat),

intermediate acting (Insuman Basal), fast-acting combined with intermediate acting (Insuman Comb)

recombinant human insulin

Indications: Treatment of diabetes mellitus where treatment with insulin is required for the maintenance of normal glucose haemostasis.

*interferon alfacon-1 Date approved: 01.02.99

Infergen, Yamanouchi: EU

solution for injection 9 micrograms

recombinant interferon; immunomodulator and immunoregulator with antiviral and antiproliferative effects

Indications: Treatment of adult patients with histologically proven chronic hepatitis with serum markers for hepatitis C virus (HCV) infection, e.g. those who have elevated serum transaminase without decompensated liver disease.

*isosorbide mononitrate + acetylsalicylic acid Date approved: 20.02.99

Imazin XL, Imazin XL Forte, Napp: UK

tablets 60 mg + 75 mg, 60 mg + 150 mg

anti-anginal vasodilator

Indications: Prophylaxis of angina and the prevention of secondary myocardial infarction.

*isotretinoin + erythromycin

Date approved: 27.01.99

Isotrexin, Stiefel: Germany

gel 0.5 mg + 20 mg/g

retinoid

Indications: Moderately severe acne.

levamisole Date approved: 16.12.98

Ergamisol, Grünewald, Eurim-Pharma: Germany

coated tablet 50 mg

immunostimulant

Indications: In combination with 5-fluorouracil for adjuvant therapy in patients with cancer of the colon (Dukes C stage) after colon surgery.

levofloxacin Date approved: 00.08.98

Cravit, Kyowa Hakko: Malaysia

tablet 100 mg

broad-spectrum fluoroquinolone antimicrobial agent

Indications: [Not stated].

lornoxicam Date approved: 10.12.98

Xefo, Nycomed; Telos, Merckle: Finland, Germany

tablets 4 mg, 8 mg

nonsteroidal anti-inflammatory agent (NSAID)

Indications: Finland: Short-term treatment of moderate postoperative pain, such as pain after dental surgery; treatment of pain associated with acute lumbo-sciatica; symptomatic treatment of pain and inflammation in osteoarthritis and rheumatoid arthritis.

Germany: Short-term symptomatic treatment of pain and inflammation due to active arthrosis (osteoarthritis): symptomatic treatment of pain and inflammation due to rheumatoid arthritis (chronic polyarthritis).

miltefosine Date approved: 02.11.98

Miltex, ASTA Medica: Finland

cutaneous solution 60 mg/mL

antineoplastic

Indications: Treatment of malignant skin lesions in breast cancer (superficial and/or nodular infiltrations) in which surgery, radiotherapy, hormonal therapy or chemotherapy are ineffective or unlikely to be effective (ongoing hormonal or chemotherapy needs not necessarily to be stopped); or in cases where the aforementioned treatment modalities are contraindicated.

montelukast Date approved: 00.02.99, 25.08.97, 01.11.98

Singulair, Merck, Sharp & Dohme: Australia, Finland, Norway

chewable tablet 5 mg; film-coated tablet 10 mg

antiallergy agent

Indication: Bronchial asthma.

moxisylyte Date approved: 01.02.99

Erecnos, Labs. Debat: Finland

powder and solvent for solution for injection 10 mg/mL, 20 mg/mL

alfa-adrenoreceptor blocking agent

Indications: Treatment of erectile dysfunction.

naratriptan Date approved: 00.02.99, 11.08.97

Naramig, Glaxo Wellcome: Australia, Finland

film-coated tablet 2.5 mg

serotonin receptor agonist

Indications: Migraine.

nebivolol Date approved: 10.04.99

Nebilet, Janssen: UK

tablet 5 mg

beta-adrenoreceptor antagonist

Indication: Essential hypertension.

omeprazole magnesium

Date approved: 01.11.98

Losec MUPS, Astra: Norway

enteric-coated capsule 10 mg, 20 mg, 40 mg (omeprazole)

anticholinergic antisecretory agent

Indications: Treatment and prophylaxis of recurrent reflux oesophagitis and gastroduodenal ulcers; eradication of Helicobacter pylori in combination with antimicrobial treatment in adults with ulcers; Zollinger-Ellison syndrome; treatment of gastric and duodenal ulcers and/or erosions associated with nonsteroidal anti-inflammatory drugs.

porfimer sodium Date approved: 15.02.99

Photofrin, Ipsen: Finland

powder for injection 15, 75 mg/vial

antineoplastic agent

Indications: Palliative photodynamic therapy of obstructive intrabronchial non-small cell lung cancer and obstructive oesophageal cancer, when standard therapy is either ineffective, not tolerated or inappropriate.

pramipexole Date approved: 23.02.98, 15.05.98, 03.04.99

Mirapexin, Pharmacia & Upjohn: EU, UK; Daquiran, Thomae: Netherlands

EU and Netherlands: tablets 0.088 mg, 0.18 mg, 0.7 mg, 0.88 mg, 1.1 mg

UK: tablets 0.088 mg, 0.18 mg, 0.7 mg

dopamine receptor agonist

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

pranoprofen Date approved: 21.12.98

Pranofen SE, Alcon: Germany

eye drops 1 mg/ml

nonsteroidal anti-inflammatory agent (NSAID)

Indications: Noninfectious inflammatory diseases of the external and anterior segments of the eye including blepharitis, noninfectious conjunctivitis, keratitis, scleritis, anterior uveitis and postoperative inflammation.

propacetamol Date approved: 21.12.98

Pro-Dafalgan, Bristol-Myers Squibb: Finland

powder and solvent for injection/infusion

0.5 g/ampoule

a prodrug metabolized to paracetamol

Indications: Fever in children unable to take oral or rectal formulations.

rabeprazole sodium Date approved: 01.02.99

Pariet: Janssen-Cilag: Finland

gastro-resistant capsule 10 mg, 20 mg

antisecretory agent

Indications: Treatment of active duodenal ulcer; active benign gastric ulcer; symptomatic erosive or ulcerative gastro-oesophageal reflux disease (GORD).

rituximab Date approved: 00.02.99

Mabthera, Roche Products: Australia

solution for injection 10 mg/mL (in 10-mL and 50-mL vials)

human monoclonal antibody

Indications: Lymphoma.

salmeterol xinafoate + fluticasone

Date approved: 24.02.99

Viani Diskus, Seretide Diskus, Glaxo Wellcome: Germany

single dose powder for inhalation

50 micrograms + 100 micrograms

50 micrograms + 250 micrograms

50 micrograms + 500 micrograms

long-acting beta₂-adrenoreceptor agonist + corticosteroid

Indications: Long-term treatment of bronchial asthma in patients in whom use of a bronchodilator and inhaled corticosteroid in combination is not indicated.

sibutramine chloride monohydrate

Date approved: 14.01.99

Reductil, Zelium, Knoll: Germany, Switzerland

capsule 10 mg, 15 mg

anti-obesity agent

Indications: As adjunctive therapy in weight management in patients with a body mass index (BMI) of 30 kg/m2 or higher; or overweight patients with associated risk factors such diabetes mellitus or dyslipidaemia.

sildenafil Date approved: 00.02.99

Viagra, Pfizer: Australia

tablets 25 mg, 50 mg, 100 mg

cGMP-specific type 5 phosphodiesterase inhibitor

Indications: Erectile dysfunction.

*telmisartan Date approved: 11.12.98

Pritor, Glaxo Group; Telmisartan: Boehringer Ingelheim; Pritor, Glaxo Wellcome: EU

tablet 40 mg, 80 mg

angiotensin II receptor antagonist

Indication: Hypertension.

tibolone Date approved: 28.12.98

Livial, Organon: Germany

tablet 2,5 mg

progestogen

Indications: Menopausal symptoms in women with natural or therapeutically-induced menopause.

*tolonium chloride Date approved: 21.12.98

OraScreen, Zila: Finland

oromucosal solution 10 mg/mL

diagnostic aid

Indications: Diagnostic kit for use as an adjunctive method to clinical examination and biopsy in the initial diagnosis and treatment of malignant lesions and conditions of the oral mucosa; monitoring of the oral mucosa of patients with previously treated oral squamous carcinoma.

tolterodine Date approved: 12.01.98

12.02.99

Detrusitol, Pharmacia & Upjohn: Finland, Switzerland

coated tablets 1 mg, 2 mg

muscarine receptor antagonist

Indications: Treatment of overactive bladder with symptoms such as urinary frequency, urgency or urge incontinence.

tramadol Date approved: 00.02.99

Tramal, Covance: Australia

injection fluid 50 mg/mL (2-mL ampoules); capsules 50 mg;

opioid analgesic

Indications: Analgesia.

trandolapril Date approved: 01.11.98

11.01.99

Gopten, Knoll: Germany; Udrik, Albert Roussel: Norway

capsule 0.5, 2 mg

Germany: also 1 mg

angiotensin-converting enzyme (ACE) inhibitor

Indications: Hypertension; reduced left ventricular function (ejection fraction 35% or less) after myocardial infarction.

ursodeoxycholic acid Date approved: 13.03.99

Ursofalk, Cortecs Healthcare: UK

suspension 250 mg/5 mL

inhibitor of hepatic cholesterol synthesis

Indications: Treatment of primary biliary cirrhosis and for the dissolution of radiolucent gallstones in patients with a functioning gall bladder.

vinorelbine Date approved: 01.11.98

Navelbine, Pierre Fabre: Norway

injection concentrate 10 mg/mL

antineoplastic agent

Indications: Metastatic breast cancer in patients in whom anthracycline treatment was ineffective or not tolerated; advanced non-small cell lung cancer.

*zaleplon Date approved: 12.03.99

Sonata, Wyeth: EU, Switzerland

hard capsules 5 mg, 10 mg

hypnotic sedative

Indications: Treatment of patients with insomnia who have difficulty in falling to sleep.

Adverse reactions: Headache, asthenia (weakness), somnolence, dizziness.

zolmitriptan Date approved: 00.02.99, 28.07.97, 01.11.98

Zomig, Zeneca: Australia, Finland, Norway

coated tablet

Australia and Finland: 2.5 mg

Norway: 5 mg

serotonin receptor agonist

Indications: Migraine.