WHO Pharmaceuticals Newsletter 1998, No. 11&12
(1998; 10 pages)
Table of Contents
Open this folder and view contentsRegulatory actions
Open this folder and view contentsDrug surveillance
Close this folderNew developments
View the documentCarvedilol: approved for use in chronic heart failure: UK
View the documentEfavirenz: approved for use in HIV infection and AIDS: USA
View the documentEssential fatty acids and coal tar (Exorex): approved for treatment of psoriasis: UK
View the documentEtanercept: first biotechnology product approved for arthritis: USA
View the documentFentanyl citrate lozenges: approved for breakthrough cancer pain: USA
View the documentRizatriptan: approved for treatment of migraine: UK
View the documentTamoxifen: approved for reduction of breast cancer incidence: USA
View the documentTrastuzumab: new monoclonal antibody approved for advanced breast cancer: USA
View the documentNew indications
View the documentNewly approved products
Open this folder and view contentsMedical devices
Open this folder and view contentsGeneral information
Open this folder and view contentsMedication errors
Open this folder and view contentsVeterinary medicine
 

Newly approved products

alprostadil

Viridal, Schwarz Pharma: Germany

injection substance 5 micrograms, 10 micrograms, 20 micrograms

prostaglandin-E1

Indications: Diagnosis and treatment of erectile dysfunction.

*cidofovir

Vistide, Pharmacia & Upjohn: France

solution for intravenous perfusion 375 mg/5 ml

antiviral agent

Indication: Cytomegalovirus retinitis in AIDS patients when other treatments are not considered appropriate.

*ebrotidine

Ulsan, Ferrer: Spain

scored tablet 400 mg

histamine H1-receptor antagonist

Indication: Allergic rhinitis.

eprosartan

Teveten, SmithKline Beecham: Iceland

coated tablet 200, 300, 400 mg

antihypertensive (angiotensin II antagonist)

Indication: Essential hypertension.

icosapent

Omegaven, Fresenius: Germany

gelatin capsule 180 + 120 mg

fish lipid concentrate; antihyperlipidaemic

Indication: To provide intake of omega-3 fatty acids during parenteral nutrition.

ifosfamide

Holoxan, Asta Medica: Iceland

powder for injection 500 mg, 1000 mg, 2000 mg/ampoule

antineoplastic agent

Indications: Various malignancies.

irbesartan

Aprovel, Sanofi Winthrop: Spain

tablet 75 mg, 150 mg, 300 mg

antihypertensive (angiotensin II antagonist)

Indication: Essential hypertension.

loratadine + pseudoephedrine

Clarinex, Schering-Plough: Iceland

coated tablet 10 mg + 240 mg

histamine H1-antagonist + vasoconstrictor

Indication: Allergic rhinitis.

mizolastine

Mizollen, Synthélabo: Spain; Mizollen, Lorex Synthélabo: UK

scored coated tablet 10 mg

histamine H1-receptor antagonist

Indications: Symptomatic relief of seasonal allergic rhino-conjunctivitis, perennial allergic rhino- conjunctivitis and urticaria.

montelukast

Montelukast; Singulair, Merck, Sharp & Dohme: Germany, Spain, Switzerland

chewable tablet 5 mg; coated tablet 10 mg

antiallergy agent

Indication: Mild to moderate asthma for patients in whom other therapies are ineffective or inappropriate.

paclitaxel

Taxol, Bristol-Myers Squibb: Japan

concentrate for intravenous infusion 30 mg/vial

antineoplastic agent

Indication: Ovarian cancer.

perindopril erbumine

Coversyl, Servier: Japan

tablet 2 mg, 4 mg

angiotensin-converting enzyme (ACE) inhibitor

Indication: Hypertension.

*rabeprazole

Pariet, Eisai: Japan

enteric coated capsule 10 mg, 20 mg

antisecretory agent

Indications: Gastric ulcer, duodenal ulcer, stomal ulcer, reflux oesophagitis, Zollinger-Ellison syndrome.

Contraindications, precautions & warnings: As for other drugs of this class.

raltitrexed

Tomudex, Zeneca: Switzerland

powder for infusion 2 mg/vial

antineoplastic agent

Indications: [Not stated].

*ramipril + felodipine

Unimax, Astra: Norway

tablet 2.5 mg + 2.5 mg, 5 mg + 5 mg

angiotensin-converting enzyme (ACE) inhibitor + calcium channel blocker

Indication: Hypertension when monotherapy was ineffective.

salbutamol

Airomir, 3M Health Care: Iceland

aerosol inhaler 0.1 mg/dose

beta-adrenoreceptor agonist

Indication: Bronchial asthma.

saquinavir

Invirase, Nippon Roche: Japan

capsule 200 mg

antiretroviral agent

Indications: AIDS and symptomatic and asymptomatic HIV infections with CD4 cell counts of 500/mm3 or less, in combination with other antiretroviral agents.

sodium nitroprusside

Nitopro, Maruishi: Japan

solution for intravenous infusion 6 mg/2 ml ampoule; 30 mg/10 ml ampoule (0.3%)

antihypertensive

Indications: Intraoperative maintenance of hypotension; emergent intervention of abnormal intraoperative hypertension.

tazarotene

Zorac, Allergan: Switzerland

topical gel 0.5 mg/g, 1 mg/g

keratolytic agent

Indication: Psoriasis.

*tilactase

Lacdiges, Grogg: Switzerland

coated tablet 60 mg

enzyme

Indication: Enzyme substitution in lactose intolerance.

*tirofiban

Aggrastat, Merck Sharp Dohme & Chibret: Switzerland

infusion concentrate 0.25 mg/ml

thrombocyte aggregation antagonist

Indication: [Not stated].

topotecan

Hycamtin, SmithKline Beecham: Iceland

lyophilised powder for reconstitution 4 mg/vial

antineoplastic agent

Indication: Ovarian cancer.

 

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Last updated: May 3, 2013