*first listing
aceclofenac
Date approved: 03.11.97
Barcan, UCB Pharma; Airtal, Almirall Prodesfarma: Finland
tablet 100 mg
nonsteroidal anti-inflammatory agent (NSAID)
Indications: Treatment of pain and inflammation in osteoarthritis, rheumatoid arthritis and ankylosing spondylitis.
Adapalene
Date approved: 08.09.97
Differin, Galderma: Finland
gel 1 mg/g, cutaneous solution 1 mg/mL
retinoid
Indications: Mild or moderate acne vulgaris in face, chest and back where comedons, papules and pustules are dominant.
antilymphocyte-T immunoglobulin
Date approved: 12.01.98
Thymoglobuline, Pasteur Mérieux Serums & Vaccins: Finland
powder for intravenous infusion 25 mg
rabbit anti-T-lymphocyte immunoglobulin
Indications: Prevention of graft rejection following kidney transplant; treatment of transplant rejection.
bifonazole
Date approved: 00.08.98
Mycospor, Bayer: Malaysia
cream 1%, solution 1% w/v
antifungal agent
Indications: [Not stated].
bifonazole + urea (carbamide)
Date approved: 00.08.98
Mycospor Onychoset, Bayer: Malaysia
[formulation/strength not stated]
antifungal agent + keratolytic
Indications: Fungal infections of the nails.
cefdinir
Date approved: 01.12.97
Omnicef, Warner Lambert: Finland
capsule 300 mg; powder for oral liquid 25 mg/mL
cefalosporin antibiotic
Indications: Infections due to susceptible microorganisms: Upper respiratory tract infections: recurrent or chronic cases of pharyngitis/tonsillitis due to β-haemolytic streptococci (Streptococcus pyogenes); otitis media. Skin and soft tissue: infections suitable for treatment by the oral route (including impetigo, erysipelas, and wound infections).
cefprozil
Date approved: 21.09.98
Procef, Bristol-Myers Squibb: Finland
film-coated tablets 250 mg, 500 mg; powder for oral suspension 25 mg/mL, 50 mg/mL
cefalosporin antibiotic
Indications: Skin and skin structure infections; pharyngo-tonsillitis; acute sinusitis in adults: acute otitis media in children.
cerivastatin sodium
Date approved: 11.08.97
Lipobay, Bayer: Finland
tablet 100 micrograms
HMG-CoA reductase inhibitor; antihyperlipidaemic
Indications: Treatment of primary hypercholesterolaemia (types IIa and IIb) in patients who have not responded adequately to an appropriate diet.
cladribine
Date approved: 22.09.98
Leustatin, Janssen-Cilag: Switzerland
infusion concentrate 1 mg/mL
antineoplastic agent
Indications: Hairy cell leukaemia.
*crisantaspase
Date approved: 25.08.97
Erwinase, Ipsen: Finland
powder for injection (intramuscular, intravenous and subcutaneous) 10,000 units
asparaginase obtained from Erwinia chrysanthemi; antineoplastic agent
Indications: Treatment of acute lymphoblastic leukaemia in combination with other anti-neoplastic agents.
daclizumab
Date approved: 03.03.98
Zenapax, Roche: Switzerland
infusion concentrate 25 mg/5 ml
immunosuppressive agent
Indications: [Not stated].
[See also Pharmaceuticals Newsletter Nos. 1&2, January & February 1998]
danaparoid sodium Date approved: 21.09.98
Orgaran, Organon: Finland
solution for injection 1250 anti-Xa units/mL
low molecular weight heparinoid
Indications: Prevention of deep vein thrombosis in situations where heparin should not be used, including patients with heparin-induced thrombocytopenia (type II); treatment of thromboembolic disorders in patients who require urgent parenteral anticoagulation because they either develop or have a history of heparin-induced thrombocytopenia.
desflurane
Date approved: 00.08.99
Suprane, Zeneca: Malaysia
inhalation substance
volatile inhalational anaesthetic agent
Indications: Anaesthesia.
dexketoprofen trometamol
Date approved: 18.05.98
Enantyum, Labs. Menarini: Finland
film-coated tablets 12.5 mg, 25 mg
nonsteroidal anti-inflammatory agent (NSAID)
Indications: Symptomatic treatment of mild to moderate pain, such as musculoskeletal pain, dysmenorrhoea, dental pain.
diphtheria, tetanus and pertussis vaccine
Date approved: 19.05.97
Infanrix, SmithKline Beecham Biologicals: Finland
suspension for injection
triple antigen whole-cell vaccine
Indications: Active immunization against diphtheria, tetanus and pertussis (whooping cough) in children.
dolasetron
Date approved: 02.06.97
Anzemet, Hoechst Marion Roussel: Finland
tablet 50 mg, 200 mg
serotonin 5H3-receptor antagonist
Indications: Management of nausea and vomiting in patients receiving initial and repeat courses of cancer chemotherapy (including high dose cisplatin); prevention of postoperative nausea and vomiting. Caution: Not approved in children.
eprosartan
Date approved: 16.10.97
Teveten, SmithKline Beecham: Finland
tablet 200 mg, 300mg, 400 mg
angiotensin II receptor antagonist antihypertensive
Indication: Treatment of essential hypertension.
factor VIII inhibitor bypassing fraction
Date approved: 19.05.97
FEIBA, Immuno: Finland
powder for injection solution 500 units, 1000 units/vial
anti-inhibitor coagulant complex
Indications: Control of spontaneous bleeding episodes or to provide factor VIII during surgical interventions in haemophilia A and Factor VIII patients with inhibitors; treatment of non-haemophiliacs with acquired inhibitors to factor VIII in case of severe or life-threatening haemorrhages.
fosphenytoin
Date approved:
06.07.98
27.02.99
Pro-Epanutin: Warner Lambert: Finland, UK
concentrate for reconstitution for injection solution 75 mg/mL (50 mg phenytoin equivalent: PE)
anticonvulsant; antiepileptic
Indication: Control of status epilepticus of the tonic-clonic (grand mal) type and prevention and treatment of seizures occurring during or following neurosurgery and/or following head trauma. It can also be substituted for oral phenytoin.
glimepiride
Date approved: 07.07.97
Amaryl, Hoechst Marion Roussel: Finland
tablets 1 mg
antihyperglycaemic agent
Indications: As an adjunct to diet and exercise to lower blood glucose in patients with non insulin-dependent diabetes mellitus (Type II) when these measures are ineffective.
glucosamine sulfate
Date approved: 25.08.97
Arthryl, Rottapharm: Finland
single-dose oral powder 1.5 g
anti-inflammatory agent
Indications: Symtomatic treatment of osteoarthrosis.
grepafloxacin
Date approved:
17.11.97
15.05.98
Raxar: Glaxo Wellcome: Finland, Netherlands
tablet 400 mg, 600 mg
fluoroquinolone antibiotic
Indications: Treatment of infections induced by susceptible bacteria, including community- acquired pneumonia (except severe pneumonia requiring parenteral therapy), acute bacterial exacerbations of chronic bronchitis, uncomplicated gonorrhoea, and urethritis and cervicitis caused by Chlamydia trachomatis.
ibutilide
Date approved: 16.06.97
Corvert, Pharmacia & Upjohn: Finland
parenteral infusion (IV) 0.1 mg/mL
antiarrhythmic agent
Indications: For the rapid conversion of atrial fibrillation or atrial flutter to normal sinus rhythm.
imidapril
Date approved: 21.09.98
Tanatril, Algol: Finland
tablets 2.5 mg, 5 mg, 10 mg, 20 mg
angiotensin-converting enzyme (ACE) inhibitor
Indications: Treatment of essential hypertension.
imiquimod
Date approved: 18.09.98
Aldara, 3M Pharmaceuticals: Australia
topical cream 5% in single use sachets
immune response modifier
Indication: Topical treatment of external genital and perianal warts.
iobenguane
Date approved: 15.12.97
MIBG I-131, Mallinckrodt Medical: Finland
solution for injection/parenteral infusion
37 MBq/mL
contrast medium
Indications: [Not stated].
iomeprol
Date approved: 16.06.97
Iomeron, Bracco: Finland
injection fluid mg/mL (mg I/mL):
306 mg/mL (150 I), 408 mg/mL (200 I), 510/mL mg (250 I), 612/mL mg (300 I), 714 mg/mL (350 I), 816 mg/mL (400 I).
contrast medium
Indications: Various radiographic diagnostic procedures, including computer tomography and angiography.
isepamicin
Date approved: 00.08.99
Isepacin, Schering-Plough: Malaysia
injection fluid 100 mg/mL, 500 mg/2 mL
aminoglycoside antibiotic
Indications: Infections due to susceptible microorganisms.
*lanreotide
Date approved: 23.03.98
Somatuline PR, Ipsen: Finland
powder for intramuscular injection 30 mg
antineoplastic agent
Indications: Treatment of acromegaly when the circulating levels of growth hormone remain abnormal after surgery and/or radiotherapy or in patients who require treatment prior to such intervention. Relief of symptoms associated with neuro-endocrine (particularly carcinoid) tumours.
latanoprost
Date approved:
16.06.97
00.08.98
Xalatan, Pharmacia & Upjohn: Finland; Xalatan, Zuellig Pharma: Malaysia
eyedrops 50 micrograms/mL (125 micrograms per 2.5-mL vial)
antiglaucoma agent
Indications: Reduction of elevated intraocular pressure in patients with open angle glaucoma and ocular hypertension who are intolerant or insufficiently responsive to another intraocular pressure-lowering medication.
lercanidipine
Date approved: 09.02.98
Zanidip, Recordati: Finland
tablet 10 mg
calcium channel blocker
Indication: Treatment of mild to moderate essential hypertension.
levofloxacin
Date approved:
01.12.97
15.05.98
Tavanic, Hoechst Marion Roussel: Finland, Netherlands
tablet 250 mg, 500 mg; solution for parenteral infusion 5 mg/mL
fluoroquinolone antibiotic
Indications: Tablets: Mild to moderate infections in adults, e.g. acute sinusitis, acute exacerbation of chronic bronchitis; community-acquired pneumonia; complicated urinary tract infections including pyelonephritis; skin and soft tissue infections. Solution for infusion: Community- acquired pneumonia; complicated urinary tract infections including pyelonephritis; skin and soft tissue infections.
loperamide
Date approved: 19.05.97
Imodium Pro, Janssen-Cilag: Finland
tablet 1 mg
antidiarrhoeal agent
Indications: Symptomatic treatment of diarrhoea; reduction of the volume of stomal discharge in patients with an ileostomy; improving anorectal continence in chronic diarrhoea.
*macrogol 3350
Date approved: 15.12.97
Transipeg, Roche: Finland
powder for oral solution 2.95 g
laxative
Indications: Symptomatic treatment of constipation in adults.
milnacipran Date approved: 27.09.98
Ixel; Dalcipran, Pierre Fabre: Finland
hard capsules 25 mg, 50 mg
antidepressant
Indications: Treatment of major depressive episodes in adults.
mizolastine
Date approved: 19.05.97
Mizollen, Synthélabo: Finland
modified-release tablet 10 mg
histamine H1-receptor antagonist
Indications: Symptomatic treatment of seasonal and perennial allergic rhinitis, allergic rhinoconjunctivitis and urticaria.
modafinil
Date approved: 15.05.98
Modiodal, Lafon: Netherlands
tablets 100 mg
psychostimulant
Indications: Treatment of narcolepsy.
moexipril
Date approved: 01.06.98
Perdix, Alpharma: Finland
tablets 7.5, 15 mg
angiotensin-converting enzyme (ACE) inhibitor
Indications: Essential hypertension.
moxonidine
Date approved: 23.02.98
Physiotens, Solvay; Cynt, Eli Lilly: Finland
tablet 0.2 mg, 0.3 mg, 0.4 mg
central a2-adrenoreceptor agonist
Indications: Essential hypertension.
mycophenolic acid
Date approved: 00.08.98
CellCept, Roche: Malaysia
capsules 250 mg, 500 mg
immunosuppressive
Indications: [Not stated].
nefazodone
Date approved: 06.10.97
Nefadar, Bristol-Myers Squibb: Finland
tablets 50 mg, 100 mg, 200 mg, 300 mg
antidepressant
Indications: Depression.
nimesulide
Date approved: 11.08.97
Nimed, Rhone-Poulenc Rorer: Finland
tablet 100 mg
nonsteroidal anti-inflammatory agent (NSAID)
Indications: Treatment of pain due to osteoarthritis; temporary pain and fever; primary dysmenorrhoea.
orlistat
Date approved: 16.09.98
Xenical, Roche: Switzerland
capsule 120 mg
anti-obesity agent
Indications: Obesity.
*piracetam
Date approved: 02.06.97
Nootropil, UCB Pharma: Norway
tablet 1,200 mg; single dose granules 2,400 mg
inotropic agent; psychostimulant
Indications: Myoclonus of cortical origin.
*polycarbophil
Date approved: 06.07.99
Fibercon, Whitehall: Finland
coated tablet 625 mg
laxative
Indications: Treatment of constipation; prevention of straining at stool, where medically desirable (e.g. anal fissures, irritable bowel disease, diverticular diseases of the colon).
ranitidine bismuth citrate
Date approved: 21.09.98
Pylorid, Glaxo Wellcome: Finland
film-coated tablet 400 mg
histamine H2-receptor antagonist + bismuth salt
Indications: Eradication of Helicobacter pylori in combination with appropriate antibiotics.
reboxetine
Date approved: 17.11.97
Edronax, Pharmacia & Upjohn: Germany
scored tablet 2 mg, 4 mg
noradrenaline antagonist; antidepressant
Indications: Acute treatment of depressive illness/major depression and for maintaining clinical improvement in patients initially responding to treatment.
rizatriptan
Date approved: 10.08.98
Maxalt (Rapitab), Merck Sharp & Dohme: Finland
tablet 5 mg, 10 mg; oral lyophilisate 5 mg, 10 mg
serotonin receptor agonist
Indications: Acute treatment of the headache phase of migraine attacks with and without aura.
tazarotene
Date approved: 22.09.97
Zorac, Allergan: Finland
topical gel 0.05%, 0.1%
retinoid keratolytic agent
Indications: Topical treatment of mild to moderate plaque psoriasis involving up to 10% body surface area.
technetium (TC-99M) furifosmine
Date approved: 06.04.98
Technescan Q12, Mallinckrodt Medical: Finland
powder for intravenous injection
contrast medium
Indications: Diagnosis and localization of myocardial ischaemia and/or myocardial infarction.
temocapril
Date approved: 15.06.98
Acecor, Sankyo Pharma: Finland
coated tablets 5 mg, 10 mg, 20 mg
angiotensin-converting enzyme (ACE) inhibitor
Indications: Essential hypertension.
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