(*= first listing)
amisulpride Date approved: 07.01.99
Solian, Amisulprid, Synthélabo: Germany; Solian, Synthélabo: Switzerland
tablet 50 mg, 200 mg
Switzerland: 200 mg only
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
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
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
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
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
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
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.
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.
Date approved: 07.12.98
Multihance, Bracco: Finland
solution for injection fluid 334 mg/mL
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
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
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
Indications: Moderately severe acne.
levamisole Date approved: 16.12.98
Ergamisol, Grünewald, Eurim-Pharma: Germany
coated tablet 50 mg
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
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
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
nebivolol Date approved: 10.04.99
Nebilet, Janssen: UK
tablet 5 mg
Indication: Essential hypertension.
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
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
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
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
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
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
tibolone Date approved: 28.12.98
Livial, Organon: Germany
tablet 2,5 mg
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
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
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;
trandolapril Date approved: 01.11.98
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
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
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
Australia and Finland: 2.5 mg
Norway: 5 mg
serotonin receptor agonist