Thursday, October 27, 2016

Calcio 600 MK




Calcio 600 MK may be available in the countries listed below.


Ingredient matches for Calcio 600 MK



Calcium Carbonate

Calcium Carbonate is reported as an ingredient of Calcio 600 MK in the following countries:


  • Colombia

International Drug Name Search


Flucillin




Flucillin may be available in the countries listed below.


Ingredient matches for Flucillin



Flucloxacillin

Flucloxacillin sodium salt (a derivative of Flucloxacillin) is reported as an ingredient of Flucillin in the following countries:


  • Ireland

International Drug Name Search


Apo-Citopram




Apo-Citopram may be available in the countries listed below.


Ingredient matches for Apo-Citopram



Citalopram

Citalopram is reported as an ingredient of Apo-Citopram in the following countries:


  • Poland

International Drug Name Search


Glipicontin




Glipicontin may be available in the countries listed below.


Ingredient matches for Glipicontin



Glipizide

Glipizide is reported as an ingredient of Glipicontin in the following countries:


  • India

International Drug Name Search


Rebone




Rebone may be available in the countries listed below.


Ingredient matches for Rebone



Ipriflavone

Ipriflavone is reported as an ingredient of Rebone in the following countries:


  • Brazil

International Drug Name Search


Wednesday, October 26, 2016

Citalopram Tiefenbacher




Citalopram Tiefenbacher may be available in the countries listed below.


Ingredient matches for Citalopram Tiefenbacher



Citalopram

Citalopram hydrobromide (a derivative of Citalopram) is reported as an ingredient of Citalopram Tiefenbacher in the following countries:


  • Netherlands

International Drug Name Search


Lamivudina Delta




Lamivudina Delta may be available in the countries listed below.


Ingredient matches for Lamivudina Delta



Lamivudine

Lamivudine is reported as an ingredient of Lamivudina Delta in the following countries:


  • Argentina

International Drug Name Search


Arendal




Arendal may be available in the countries listed below.


Ingredient matches for Arendal



Alendronic Acid

Alendronic Acid is reported as an ingredient of Arendal in the following countries:


  • Chile

  • Peru

Alendronic Acid sodium trihydrate (a derivative of Alendronic Acid) is reported as an ingredient of Arendal in the following countries:


  • Argentina

International Drug Name Search


Promiten




Promiten may be available in the countries listed below.


Ingredient matches for Promiten



Dextran

Dextran average molecular weight about 1000 (a derivative of Dextran) is reported as an ingredient of Promiten in the following countries:


  • Denmark

  • Iceland

  • Luxembourg

  • Norway

  • Sweden

International Drug Name Search


Regaine for Men Gel





1. Name Of The Medicinal Product



Regaine for Men Gel


2. Qualitative And Quantitative Composition



Minoxidil 20 mg/g (2% w/w).



For excipients see section 6.1.



3. Pharmaceutical Form



Cutaneous Gel (to be applied to the scalp).



4. Clinical Particulars



4.1 Therapeutic Indications



Regaine for Men Gel is indicated for the treatment of alopecia androgenetica in men aged between 18 and 65.



Onset and degree of hair regrowth may be variable among users. Although trends in the data suggest that those users who are younger, who have been balding for a shorter period of time or who have a smaller area of baldness on the vertex are more likely to respond to Regaine for Men Gel, individual responses cannot be predicted.



4.2 Posology And Method Of Administration



Hair and scalp should be thoroughly dry prior to topical application of Regaine for Men Gel. A dose of 1 ml Regaine for Men Gel should be applied to the total affected areas of the scalp twice daily. The total daily dosage should not exceed 2 ml. If fingertips are used to facilitate drug application, hands should be washed afterwards.



It may take twice daily applications for four months or more before evidence of hair growth can be expected.



If hair regrowth occurs, twice daily applications of Regaine for Men Gel are necessary for continued hair growth. Anecdotal reports indicate that regrown hair may disappear three to four months after stopping Regaine for Men Gel application and the balding process will continue.



Users should discontinue treatment if there is no improvement after one year.



Children and the elderly



Not recommended. The safety and effectiveness of Regaine for Men Gel in users under 18 or over 65 years of age has not been established.



4.3 Contraindications



Regaine for Men Gel is contraindicated:



− in users with a history of sensitivity to minoxidil, ethanol, propylene glycol, carbomer and diisopropanolamine



− in users with treated or untreated hypertension



− in users with any scalp abnormality (including psoriasis and sunburn)



− in users with a shaved scalp



− if occlusive dressings or other topical medical preparations are being used.



4.4 Special Warnings And Precautions For Use



Before using Regaine for Men Gel, the user should determine that the scalp is normal and healthy.



The user should stop using Regaine for Men Gel and see a doctor if hypotension is detected or if the patient is experiencing chest pain, rapid heart beat, faintness or dizziness, sudden unexplained weight gain, swollen hands or feet or persistent redness.



Users with known cardiovascular disease or cardiac arrhythmia should contact a physician before using Regaine for Men Gel.



Regaine for Men Gel is for external use only. Do not apply to areas of the body other than the scalp.



Hands should be washed thoroughly after applying the gel.



Regaine for Men Gel contains an alcohol base which will cause burning and irritation of the eye. In the event of accidental contact with sensitive surfaces (eye, abraded skin and mucous membranes) the area should be bathed with large amounts of cool tap water.



Regaine for Men Gel contains propylene glycol, which may cause skin irritation.



Some users have experienced changes in hair colour and/or texture with use of Regaine for Men Gel.



Users should be advised to consult their doctor or pharmacist if they are concerned at any time during treatment with Regaine for Men Gel.



Users should be aware that, whilst extensive use of Regaine for Men Gel has not revealed evidence that sufficient minoxidil is absorbed to have systemic effects, greater absorption because of misuse, individual variability, unusual sensitivity or decreased integrity of the epidermal barrier caused by inflammation or disease processes in the skin (e.g. excoriations of the scalp, or scalp psoriasis) could lead, at least theoretically, to systemic effects.



4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction



Topical drugs, such as corticosteroids, tretinoin, dithranol or petrolatum which alter the stratum corneum barrier, could result in increased absorption of minoxidil if applied concurrently. Although it has not been clinically demonstrated, there exists the theoretical possibility of absorbed minoxidil potentiating orthostatic hypotension in patients concurrently taking peripheral vasodilators.



4.6 Pregnancy And Lactation



There is no evidence as to drug safety in human pregnancy nor is there evidence from animal work that it is free from hazard. Regaine for Men Gel should not be used during pregnancy or lactation.



4.7 Effects On Ability To Drive And Use Machines



Based on the pharmacodynamic and overall safety profile of minoxidil, it is not expected that Regaine for Men Gel would interfere with the ability to drive or operate machinery.



4.8 Undesirable Effects



In placebo controlled trials of Regaine, the overall frequency of medical events in females in all body system categories was approximately five times that of males.



Several thousand patients have used topical minoxidil in clinical trials where a comparison with an inactive solution was made. Dermatological reactions (e.g. irritation, itching) occurred in patients using both solutions. This has been explained by the presence of propylene glycol in both the active and inactive solution. Regaine for Men Gel also contains propylene glycol.



Reactions reported in commercial marketing experience include: hypertrichosis (unwanted non-scalp hair including facial hair growth in women), local erythema, itching, dry skin/scalp flaking, and exacerbation of hair loss. Users should stop using Regaine for Men Gel if they experience persistent redness or irritation of the scalp.



Some consumers reported increased hair shedding upon initiation of therapy with Regaine for Men Gel. This is most likely due to minoxidil's action of shifting hairs from the resting telogen phase to the growing anagen phase (old hairs fall out as new hairs grow in their place). This temporary increase in hair shedding generally occurs two to six weeks after beginning treatment and subsides within a couple of weeks. If shedding persists (>2 weeks), users should stop using Regaine for Men Gel and consult their doctor.



Particular attention has been paid to body systems, such as cardiovascular and metabolic, which might have some relevance based on the pharmacology of minoxidil. There was no increased risk to users due to drug related medical reactions in these, or other, body system categories.



Users should stop using Regaine for Men Gel if they experience chest-pain, tachycardia, faintness, dizziness, sudden unexplained weight gain, or swollen hands or feet. Rare cases of hypotension have been reported.



4.9 Overdose



Increased systemic absorption of minoxidil may potentially occur if higher-than-recommended doses of Regaine for Men Gel are applied to larger surface areas of the body or areas other than the scalp. There are no known cases of minoxidil overdosage resulting from topical administration of Regaine for Men Gel.



Because of the concentration of minoxidil in Regaine for Men Gel, accidental ingestion has the potential of producing systemic effects related to the pharmacological action of the drug (5 ml of Regaine for Men Gel contains 100 mg minoxidil, the maximum recommended adult dose for oral minoxidil administration in the treatment of hypertension). Signs and symptoms of minoxidil overdosage would most likely be cardiovascular effects associated with sodium and water retention and tachycardia. Fluid retention can be managed with appropriate diuretic therapy. Clinically significant tachycardia can be controlled by administration of a beta-adrenergic blocking agent.



5. Pharmacological Properties



5.1 Pharmacodynamic Properties



Minoxidil is a powerful vasodilator. It was noticed that in patients with severe hypertension, about 80% developed hypertrichosis as a side-effect.



Individual responses to Regaine are variable and unpredictable.



The effect of Regaine 2% solution has been assessed in phase III clinical trials in men conducted over a 48 week treatment period. In these studies Regaine 2% solution was compared to the product vehicle without the minoxidil active ingredient. The primary efficacy criterion was non-vellus hair count in a 1.0cm2 reference area of affected scalp. The mean changes observed in this parameter in these studies were significantly in favour of Regaine 2% solution and were as follows:



Mean change in non-vellus hair count in reference 1cm2 area of scalp compared with baseline




























 




Minoxidil 2% solution




Vehicle




Pairwise comparison




Baseline




143.6




152.4




 




 




Mean change from baseline




Mean change from baseline




 



 




16 weeks




+29.8




+15.3




2%>vehicle




32 weeks




+22.2




+7.7




2%>vehicle




48 weeks




+12.7




+3.9




2%>vehicle



In addition, efficacy was further assessed by comparing photographs taken at various timepoints with baseline. Assessment was undertaken by patients using a 100 mm visual analogue scale where point 0 represented much less scalp coverage, 50 mm no difference and 100 mm much more scalp coverage. The results were as follows:



Patient evaluation of change in scalp coverage
























 




Minoxidil 2% solution




Vehicle




Pairwise comparison




 




mm




mm




 




16 weeks




58.2




51.4




2%>vehicle




32 weeks




58.0




52.0




2%>vehicle




48 weeks




56.9




51.0




2%>vehicle



Assessment was also undertaken by two blinded reviewers who compared photographs taken at baseline and after 48 weeks. Differences were assessed using a 7 point categorical scale viz:



Dense growth



Moderate growth



Minimal Growth



No change



Minimal loss



Moderate loss



Dense loss



The results were as follows:



Photographic Evaluation of Clinical Response (Reviewer 1)

























 




Dense Growth



%




Moderate Growth



%




Minimal Growth



%




No change



%




Hair Loss



%




Unable to rate




Minoxidil 2% solution




2.8




19.7




21.1




50.0




2.8




3.5




Placebo




0




7.0




22.5




60.6




9.9




0



Photographic Evaluation of Clinical Response (Reviewer 2)

























 




Dense Growth



%




Moderate Growth



%




Minimal Growth



%




No change



%




Hair Loss



%




Unable to rate




Minoxidil 2% solution




3.5




12.0




22.5




47.2




1.4




13.4




Placebo




0




7.0




9.9




60.6




14.1




8.5



Based upon the photographic data around 40% of the patients experienced an increased scalp coverage after 48 weeks treatment with Regaine 2% solution as defined by regrowth of hair compared with 23% at an average for those who received vehicle alone. Around 19% treated with Regaine 2% solution experienced dense or moderate regrowth compared with around 7% who received vehicle alone. In addition 49% of patients who received Regaine 2% solution were adjudged to have no change between the photographic assessments of hair growth compared with 60% who received vehicle alone. Stabilisation of hair loss (i.e. regrowth or no loss) can therefore be expected in about 4 out of 5 patients using Regaine 2% solution compared with 3 out of 4 patients using vehicle alone.



The mechanism by which minoxidil stimulates hair growth is not fully understood, but minoxidil can reverse the hair loss process of androgenetic alopecia by the following means:



- increasing the diameter of the hair shaft



- stimulating anagen growth



- prolonging the anagen phase



- stimulating anagen recovery from the telogen phase



As a peripheral vasodilator minoxidil enhances microcirculation to hair follicles. The Vascular Endothelial Growth Factor (VEGF) is stimulated by minoxidil and VEGF is presumably responsible for the increased capillary fenestration, indicative of a high metabolic activity, observed during the anagen phase.



5.2 Pharmacokinetic Properties



The failure to detect evidence of systemic effects during treatment with Regaine 2% solution reflects the poor absorption of topical minoxidil, which averages about 1.4% (range 0.3-4.5%) of the total applied dose from normal intact skin. Absorption is about 2% when applied topically to shaved scalps of hypertensive users.



Results of extensive pharmacokinetic studies indicate that the three major factors by which topical minoxidil absorption is increased are: increasing the dose applied, increasing the frequency of dosing and decreasing the barrier function of the stratum corneum.



Serum minoxidil levels and systemic effects resulting from administration of Regaine are governed by the drug's absorption rate through the skin. Following cessation of topical dosing, approximately 95% of the systemically absorbed drug is eliminated within 4 days. Minoxidil and its metabolites are excreted principally in the urine.



5.3 Preclinical Safety Data



Preclinical data reveal no special hazards for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity or carcinogenic potential.



Cardiac effects of minoxidil in dogs are species-specific in terms of the low doses that cause profound haemodynamic effects and associated changes in the heart. Available data indicate that similar cardiac effects do not occur in humans treated topically or orally with minoxidil.



In rat fertility studies, minoxidil at dose levels between 3 and 80 mg/kg exhibited adverse effects on fertility. Animal reproduction toxicity studies have shown a risk to the foetus at exposure levels that in comparison to levels obtained in humans are very high (doses that ranged from 569- to 1139-fold anticipated human exposures) and showed signs of maternal toxicity.



6. Pharmaceutical Particulars



6.1 List Of Excipients



Propylene glycol



Ethanol



Carbomer



Diisopropanolamine



Water



6.2 Incompatibilities



None known.



6.3 Shelf Life



24 months



6.4 Special Precautions For Storage



Do not store above 25˚C. Regaine for Men Gel is flammable.



6.5 Nature And Contents Of Container



Polyethylene bottle containing 60 ml of gel. An integral metered pump is included.



6.6 Special Precautions For Disposal And Other Handling



One press of the integral pump supplies 0.5 ml of gel. Regaine for Men Gel is flammable. Do not use while smoking, or near any naked flame or strong heat source. Avoid exposure of the container and contents to naked flames during use, storage and disposal.



Administrative Data


7. Marketing Authorisation Holder



McNeil Products Limited



Foundation Park



Roxborough Way



Maidenhead



Berkshire SL6 3UG



United Kingdom



8. Marketing Authorisation Number(S)



PL 15513/0129



9. Date Of First Authorisation/Renewal Of The Authorisation



9 June 2005



10. Date Of Revision Of The Text



11th April 2008





Rompirin




Rompirin may be available in the countries listed below.


Ingredient matches for Rompirin



Aspirin

Acetylsalicylic Acid is reported as an ingredient of Rompirin in the following countries:


  • Romania

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Atren




Atren may be available in the countries listed below.


Ingredient matches for Atren



Naproxen

Naproxen sodium salt (a derivative of Naproxen) is reported as an ingredient of Atren in the following countries:


  • Turkey

International Drug Name Search


Isometeptene




Isometeptene may be available in the countries listed below.


Ingredient matches for Isometeptene



Isometheptene Mucate

Isometeptene (DCIT) is known as Isometheptene Mucate in the US.

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Glossary

DCITDenominazione Comune Italiana

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Claritromycine Apotex




Claritromycine Apotex may be available in the countries listed below.


Ingredient matches for Claritromycine Apotex



Clarithromycin

Clarithromycin is reported as an ingredient of Claritromycine Apotex in the following countries:


  • Netherlands

International Drug Name Search


Flucloxacilline A




Flucloxacilline A may be available in the countries listed below.


Ingredient matches for Flucloxacilline A



Flucloxacillin

Flucloxacillin sodium salt (a derivative of Flucloxacillin) is reported as an ingredient of Flucloxacilline A in the following countries:


  • Netherlands

International Drug Name Search


Cefonax




Cefonax may be available in the countries listed below.


Ingredient matches for Cefonax



Cefadroxil

Cefadroxil monohydrate (a derivative of Cefadroxil) is reported as an ingredient of Cefonax in the following countries:


  • Venezuela

International Drug Name Search


Tuesday, October 25, 2016

Monozide




Monozide may be available in the countries listed below.


Ingredient matches for Monozide



Fosinopril

Fosinopril sodium salt (a derivative of Fosinopril) is reported as an ingredient of Monozide in the following countries:


  • Slovakia

  • South Africa

Hydrochlorothiazide

Hydrochlorothiazide is reported as an ingredient of Monozide in the following countries:


  • Slovakia

  • South Africa

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Prednisolone Beacons




Prednisolone Beacons may be available in the countries listed below.


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Prednisolone

Prednisolone is reported as an ingredient of Prednisolone Beacons in the following countries:


  • Singapore

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Ambiz




Ambiz may be available in the countries listed below.


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Zolpidem

Zolpidem is reported as an ingredient of Ambiz in the following countries:


  • India

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Lipista




Lipista may be available in the countries listed below.


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Pravastatin

Pravastatin sodium salt (a derivative of Pravastatin) is reported as an ingredient of Lipista in the following countries:


  • Vietnam

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Terazosina Merck




Terazosina Merck may be available in the countries listed below.


Ingredient matches for Terazosina Merck



Terazosin

Terazosin hydrochloride (a derivative of Terazosin) is reported as an ingredient of Terazosina Merck in the following countries:


  • Italy

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Tenomet




Tenomet may be available in the countries listed below.


Ingredient matches for Tenomet



Cimetidine

Cimetidine is reported as an ingredient of Tenomet in the following countries:


  • Cyprus

  • Ethiopia

  • Oman

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Lamotrigin real




Lamotrigin real may be available in the countries listed below.


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Lamotrigine

Lamotrigine is reported as an ingredient of Lamotrigin real in the following countries:


  • Germany

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Monday, October 24, 2016

Arsumax




Arsumax may be available in the countries listed below.


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Artesunate

Artesunate is reported as an ingredient of Arsumax in the following countries:


  • Ghana

  • Kenya

  • Nigeria

  • Tanzania

  • Uganda

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Methylthioninium Chloride




In some countries, this medicine may only be approved for veterinary use.

Scheme

Rec.INN

ATC (Anatomical Therapeutic Chemical Classification)

V03AB17,V04CG05

CAS registry number (Chemical Abstracts Service)

0000061-73-4

Chemical Formula

C16-H18-Cl-N3-S

Molecular Weight

319

Therapeutic Categories

Diagnostic agent

Urinary tract antiseptic

Antidote in methemoglobinemia

Chemical Name

Phenothiazin-5-ium, 3,7-bis(dimethylamino)-, chloride

Foreign Names

  • Methylthioninii Chloridum (Latin)
  • Methylthioninium chlorid (German)
  • Chlorure de Méthylthioninium (French)
  • Cloruro de metiltioninio (Spanish)

Generic Names

  • Bleu de méthylène (OS: DCF)
  • Methylene Blue (OS: BAN)
  • Methylthioninium Chloride (OS: BAN)
  • Metiltioninio clorure (OS: DCIT)
  • Methylenblau (IS)
  • Methylenum coeruleum (IS)
  • Tetramethylthioninium chloratum (IS)
  • Methylene Blue (PH: USP 32)
  • Methylthionini chloridum (PH: Ph. Int. 2)
  • Methylthioninii chloridum (PH: Ph. Int. 4, Ph. Eur. 6)
  • Methylthioninium Chloride (PH: Ph. Eur. 6, BP 2010)
  • Methylthioniniumchlorid (PH: Ph. Eur. 6)

Brand Names

  • Azul de Metileno
    Valma, Chile; Volta, Chile


  • Centilux (Methylthioninium Chloride and Naphazoline)
    Alcon, Spain


  • Collyre Bleu Laiter (Methylthioninium Chloride and Naphazoline)
    Leurquin, France; Uhlmann-Eyraud Pharma, Switzerland


  • Methylene Blue for Injection DBL
    AFT, New Zealand


  • Methylene Blue Injection USP
    Phebra, Australia


  • Methylene Blue
    IFET, Greece; MaCarthys, Malta


  • Methylthioninum Chloride (veterinary use)
    Martindale Animalhealth, United Kingdom


  • Metiltioninio Cloruro Afom
    AFOM, Italy


  • Metiltioninio Cloruro Bioindustria Lim
    Bioindustria Lim, Italy


  • Metiltioninio Cloruro Marco Viti
    Marco Viti, Italy


  • Metiltioninio Cloruro Monico
    Monico, Italy


  • Metiltioninio Cloruro Novo Arcentia
    Nova Argentia, Italy


  • Metiltioninio Cloruro Salf
    Salf, Italy


  • Metiltioninio Cloruro Zeta
    Zeta, Italy


  • Sepurin
    Gross, Brazil


  • Urolene Blue
    Star, United States

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Glossary

BANBritish Approved Name
DCFDénomination Commune Française
DCITDenominazione Comune Italiana
ISInofficial Synonym
OSOfficial Synonym
PHPharmacopoeia Name
Rec.INNRecommended International Nonproprietary Name (World Health Organization)

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Apo-ISMN




Apo-ISMN may be available in the countries listed below.


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Isosorbide Mononitrate

Isosorbide Mononitrate is reported as an ingredient of Apo-ISMN in the following countries:


  • Canada

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Mefenan




Mefenan may be available in the countries listed below.


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Mefenamic Acid

Mefenamic Acid is reported as an ingredient of Mefenan in the following countries:


  • Myanmar

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Rydene




Rydene may be available in the countries listed below.


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Nicardipine

Nicardipine hydrochloride (a derivative of Nicardipine) is reported as an ingredient of Rydene in the following countries:


  • Belgium

  • Luxembourg

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Sunday, October 23, 2016

Insulin Glinux-N




Insulin Glinux-N may be available in the countries listed below.


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Insulin, Isophane

Insulin, Isophane human (a derivative of Insulin, Isophane) is reported as an ingredient of Insulin Glinux-N in the following countries:


  • Mexico

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Saturday, October 22, 2016

Cilpier




Cilpier may be available in the countries listed below.


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Piperacillin

Piperacillin sodium salt (a derivative of Piperacillin) is reported as an ingredient of Cilpier in the following countries:


  • Italy

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Acido Tranexamico




Acido Tranexamico may be available in the countries listed below.


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Tranexamic Acid

Acido Tranexamico (DCIT) is known as Tranexamic Acid in the US.

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Glossary

DCITDenominazione Comune Italiana

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Acy




Acy may be available in the countries listed below.


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Acyclovir

Aciclovir is reported as an ingredient of Acy in the following countries:


  • Italy

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Friday, October 21, 2016

Risperdal Flas




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Risperidone

Risperidone is reported as an ingredient of Risperdal Flas in the following countries:


  • Spain

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Melovis




Melovis may be available in the countries listed below.


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Meloxicam

Meloxicam is reported as an ingredient of Melovis in the following countries:


  • Czech Republic

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Anapenil




Anapenil may be available in the countries listed below.


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Phenoxymethylpenicillin

Phenoxymethylpenicillin potassium (a derivative of Phenoxymethylpenicillin) is reported as an ingredient of Anapenil in the following countries:


  • Mexico

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Benzylhydrochlorothiazide




Scheme

JAN

CAS registry number (Chemical Abstracts Service)

0001824-50-6

Chemical Formula

C14-H14-Cl-N3-O4-S2

Molecular Weight

387

Therapeutic Categories

Diuretic agent

Antihypertensive agent

Chemical Name

2H-1,2,4-Benzothiadiazine-7-sulfonamide, 6-chloro-3,4-dihydro-3-(phenylmethyl)-, 1,1-dioxide

Foreign Name

  • Benzylhydrochlorothiazid (German)

Generic Name

  • Benzylhydrochlorothiazide (OS: JAN)

Brand Names

  • Behyd RA (Benzylhydrochlorothiazide and Reserpine)
    Kyorin, Japan


  • Behyd
    Kyorin, Japan; Shinlin Sinseng, Taiwan


  • Tenazide (Benzylhydrochlorothiazide and Enalapril)
    Combiphar, Indonesia

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Glossary

JANJapanese Accepted Name
OSOfficial Synonym

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Geneprami




Geneprami may be available in the countries listed below.


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Metoclopramide

Metoclopramide hydrochloride (a derivative of Metoclopramide) is reported as an ingredient of Geneprami in the following countries:


  • Greece

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Thursday, October 20, 2016

Albalon




In the US, Albalon (naphazoline ophthalmic) is a member of the drug class ophthalmic antihistamines and decongestants and is used to treat Eye Dryness/Redness and Eye Redness/Itching.

US matches:

  • Albalon

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Naphazoline

Naphazoline hydrochloride (a derivative of Naphazoline) is reported as an ingredient of Albalon in the following countries:


  • Australia

  • Bahrain

  • Hong Kong

  • Luxembourg

  • Netherlands

  • New Zealand

  • Oman

  • Thailand

  • United States

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Algiderma




Algiderma may be available in the countries listed below.


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Diethylamine Salicylate

Diethylamine Salicylate is reported as an ingredient of Algiderma in the following countries:


  • Portugal

International Drug Name Search


Trigoa




Trigoa may be available in the countries listed below.


Ingredient matches for Trigoa



Ethinylestradiol

Ethinylestradiol is reported as an ingredient of Trigoa in the following countries:


  • Germany

Levonorgestrel

Levonorgestrel is reported as an ingredient of Trigoa in the following countries:


  • Germany

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Exolit




Exolit may be available in the countries listed below.


Ingredient matches for Exolit



Bromhexine

Bromhexine hydrochloride (a derivative of Bromhexine) is reported as an ingredient of Exolit in the following countries:


  • Bahrain

  • Cyprus

  • Iraq

  • Jordan

  • Sudan

  • Tanzania

  • Yemen

International Drug Name Search


Wednesday, October 19, 2016

C. M.P.200




C.M.P.200 may be available in the countries listed below.


Ingredient matches for C.M.P.200



Carbamazepine

Carbamazepine is reported as an ingredient of C.M.P.200 in the following countries:


  • Argentina

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Metildigossina




Metildigossina may be available in the countries listed below.


Ingredient matches for Metildigossina



Metildigoxin

Metildigossina (DCIT) is also known as Metildigoxin (Rec.INN)

International Drug Name Search

Glossary

DCITDenominazione Comune Italiana
Rec.INNRecommended International Nonproprietary Name (World Health Organization)

Click for further information on drug naming conventions and International Nonproprietary Names.

Hépadial




Hépadial may be available in the countries listed below.


Ingredient matches for Hépadial



Dimecrotic Acid

Dimecrotic Acid magnesium salt (a derivative of Dimecrotic Acid) is reported as an ingredient of Hépadial in the following countries:


  • France

International Drug Name Search


Hydrapres




Hydrapres may be available in the countries listed below.


Ingredient matches for Hydrapres



Hydralazine

Hydralazine hydrochloride (a derivative of Hydralazine) is reported as an ingredient of Hydrapres in the following countries:


  • Argentina

  • Spain

International Drug Name Search


Tuesday, October 18, 2016

Ratinal




Ratinal may be available in the countries listed below.


Ingredient matches for Ratinal



Ranitidine

Ranitidine hydrochloride (a derivative of Ranitidine) is reported as an ingredient of Ratinal in the following countries:


  • Indonesia

International Drug Name Search


Rephoren




Rephoren may be available in the countries listed below.


Ingredient matches for Rephoren



Calcium Acetate

Calcium Acetate is reported as an ingredient of Rephoren in the following countries:


  • United Kingdom

Magnesium Carbonate

Magnesium Carbonate heavy (a derivative of Magnesium Carbonate) is reported as an ingredient of Rephoren in the following countries:


  • United Kingdom

International Drug Name Search


Clopidogrel AAA




Clopidogrel AAA may be available in the countries listed below.


Ingredient matches for Clopidogrel AAA



Clopidogrel

Clopidogrel is reported as an ingredient of Clopidogrel AAA in the following countries:


  • Germany

International Drug Name Search


Folsäure-Hevert




Folsäure-Hevert may be available in the countries listed below.


Ingredient matches for Folsäure-Hevert



Folic Acid

Folic Acid is reported as an ingredient of Folsäure-Hevert in the following countries:


  • Germany

International Drug Name Search


Monday, October 17, 2016

Povidine




In the US, Povidine is a member of the following drug classes: antiseptic and germicides, vaginal anti-infectives.

Ingredient matches for Povidine



Povidone Iodine

Povidone-Iodine is reported as an ingredient of Povidine in the following countries:


  • Bangladesh

  • India

  • Venezuela

International Drug Name Search


Sunday, October 16, 2016

Ferro Gyn




Ferro Gyn may be available in the countries listed below.


Ingredient matches for Ferro Gyn



Ferrous Glycine Sulfate

Ferrous Glycine Sulfate is reported as an ingredient of Ferro Gyn in the following countries:


  • Peru

Folic Acid

Folic Acid is reported as an ingredient of Ferro Gyn in the following countries:


  • Peru

International Drug Name Search


Cefazolina Germed




Cefazolina Germed may be available in the countries listed below.


Ingredient matches for Cefazolina Germed



Cefazolin

Cefazolin sodium salt (a derivative of Cefazolin) is reported as an ingredient of Cefazolina Germed in the following countries:


  • Italy

International Drug Name Search


Tyklid




Tyklid may be available in the countries listed below.


Ingredient matches for Tyklid



Ticlopidine

Ticlopidine hydrochloride (a derivative of Ticlopidine) is reported as an ingredient of Tyklid in the following countries:


  • India

International Drug Name Search


Saturday, October 15, 2016

KLEAN PREP 69g, sachet powder for oral solution





1. Name Of The Medicinal Product



KLEAN-PREP 69g, sachet powders for oral solution.


2. Qualitative And Quantitative Composition



Each sachet of KLEAN-PREP contains the following active ingredients:














Macrogol 3350




59.000 g




Anhydrous Sodium Sulphate




5.685 g




Sodium Bicarbonate




1.685 g




Sodium Chloride




1.465 g




Potassium Chloride




0.7425 g



The content of electrolyte ions per sachet when made up to one litre of water is as follows:














Sodium




125 mM




Sulphate




40 mM




Chloride




35 mM




Bicarbonate




20 mM




Potassium




10 mM



For excipients, see 6.1.



3. Pharmaceutical Form



A whitish powder which, when dissolved in water, gives a clear, colourless solution for oral administration.



4. Clinical Particulars



4.1 Therapeutic Indications



For colonic lavage prior to diagnostic examination or surgical procedures requiring a clean colon, e.g. colonoscopy, barium enema or colonic resection.



4.2 Posology And Method Of Administration



Adults: Each sachet should be dissolved in 1 litre of water. The usual dose is up to 4 sachets taken at a rate of 250 ml every 10 to 15 minutes until the total volume is consumed or rectal effluent is clear, or as directed by the physician.



The solutions from all 4 sachets should be drunk within 4 to 6 hours. Alternatively, administration may be divided, for example, taking 2 sachets during the evening before the examination, and the remaining 2 sachets on the morning of the examination.



If administration is by nasogastric tube, the usual rate should be 20 to 30 ml/minute.



Children: There is no recommended dosage.



Renal patients: No dosage adjustment need be made.



4.3 Contraindications



Use in patients with known or suspected gastrointestinal obstruction or perforation, ileus, gastric retention, toxic colitis and toxic megacolon.



Congestive cardiac failure (NYHA class III and IV)



Hypersensitivity to any of the ingredients.



4.4 Special Warnings And Precautions For Use



No solid food should be eaten for at least 2 hours before taking KLEAN-PREP. The product should only be administered with caution to patients with impaired gag reflex, reflux oesophagitis, or those with diminished levels of consciousness and patients with ulcerative colitis.



Unconscious, semi-conscious patients or patients prone to aspiration or regurgitation should be observed during administration especially if this is via the nasogastric route. There have been reports of pulmonary oedema resulting from aspiration of macrogol lavage solutions requiring immediate treatment.



Although not expected due to the isotonic composition of the product, cases of electrolyte disturbances have been rarely reported in at-risk patients. Therefore, KLEAN-PREP should be used with care in patients at risk of electrolyte disturbance, such as patients with renal failure, mild (NYHA class I and II) congestive cardiac impairment (see also section 4.3), or those simultaneously treated with diuretics.



Should abdominal distension or pain arise, the rate of administration should be slowed down or temporarily stopped until symptoms subside.



KLEAN-PREP contains aspartame, which is metabolised to phenylalanine. This may be harmful for patients with phenylketonuria.



Caution should be used in the administration of KLEAN-PREP to elderly, fragile or debilitated patients.



4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction



Oral medication taken within one hour of administration of KLEAN-PREP may be flushed from the gastro-intestinal tract and not absorbed.



4.6 Pregnancy And Lactation



The preparation should only be used during pregnancy and lactation if considered essential by the physician. There is no experience of use during pregnancy. The purpose and mechanisms of use should be borne in mind if the physician is considering administration.



4.7 Effects On Ability To Drive And Use Machines



There is no known effect on the ability to drive and use machines.



4.8 Undesirable Effects



The most commonly experienced undesirable effects are gastrointestinal in nature. The following Adverse Events have been observed in post-marketing experience and therefore the frequencies are not known:


















Body System




Adverse Drug reaction




Immune system disorders




Allergic reactions including anaphylactic reaction, dyspnoea, skin reactions (see below)




Metabolism and nutrition disorders




Electrolyte disturbances, specifically hypokalaemia and hyponatraemia These occur more commonly in patients taking concomitant medication affecting the kidneys such as ACE inhibitors and diuretics.




Nervous System Disorders




Convulsions associated with severe hyponatraemia, headaches




Gastrointestinal disorders




Vomiting, nausea, abdominal pain, anorectal discomfort, abdominal distension, flatulence.



Should nausea, vomiting, abdominal pain or distension arise, the rate of administration should be slowed down or stopped until symptoms subside.




Skin and subcutaneous tissue disorders




Allergic skin reactions including angioedema, urticaria, pruritus, rash, erythema.




General disorders and administration site conditions




Rigors



Transient increases in blood pressure have been observed in association with bowel preparations.



4.9 Overdose



In case of gross accidental overdosage, where diarrhoea is severe, conservative measures are usually sufficient; generous amounts of fluid, especially fruit juices, should be given.



5. Pharmacological Properties



5.1 Pharmacodynamic Properties



ATC Code: A06A D



Macrogol 3350 exerts its effects by virtue of its osmotic effect in the gut, which induces a laxative effect. Electrolytes are present in the formulation and are exchanged across the intestinal barrier (mucosa) with serum electrolytes and water to prevent the occurrence of potential clinically significant variations of net electrolyte or net water balance.



Macrogol 3350 increases the stool volume, which triggers colon motility via neuromuscular pathways. The physiological consequence is an improved propulsive colonic transportation of the softened stools and a facilitation of the defecation.



5.2 Pharmacokinetic Properties



Macrogol 3350 is unchanged along the gut. It is virtually unabsorbed from the gastro-intestinal tract. Any macrogol 3350 that is absorbed is excreted via the urine.



5.3 Preclinical Safety Data



Preclinical studies provide evidence that macrogol 3350 has no significant systemic toxicity potential.



6. Pharmaceutical Particulars



6.1 List Of Excipients



Vanilla flavour



Aspartame.



6.2 Incompatibilities



None are known.



6.3 Shelf Life








Sachets:




3 years




Solution after reconstitution:




24 hours



6.4 Special Precautions For Storage



Sachets: Store in a dry place. Do not store above 25°C.



Reconstituted solution: Store in a refrigerator (2 – 8°C)



6.5 Nature And Contents Of Container



Sachets containing 69gm white powder, in a box of 4 sachets.



6.6 Special Precautions For Disposal And Other Handling



The solution should be used within 24 hours.



ADMINISTRATIVE DATA


7. Marketing Authorisation Holder



Norgine Limited



Norgine House



Widewater Place



Moorhall Road



Harefield



UXBRIDGE



Middlesex UB9 6NS



United Kingdom.



8. Marketing Authorisation Number(S)



PL: 00322/0068.



9. Date Of First Authorisation/Renewal Of The Authorisation



August 1991/March 1997.



10. Date Of Revision Of The Text



Feb 2011





Bupivacaina Angelini




Bupivacaina Angelini may be available in the countries listed below.


Ingredient matches for Bupivacaina Angelini



Bupivacaine

Bupivacaine hydrochloride (a derivative of Bupivacaine) is reported as an ingredient of Bupivacaina Angelini in the following countries:


  • Italy

International Drug Name Search


Maveral




Maveral may be available in the countries listed below.


Ingredient matches for Maveral



Fluvoxamine

Fluvoxamine maleate (a derivative of Fluvoxamine) is reported as an ingredient of Maveral in the following countries:


  • Italy

International Drug Name Search


Lansoprazol KRKA




Lansoprazol KRKA may be available in the countries listed below.


Ingredient matches for Lansoprazol KRKA



Lansoprazole

Lansoprazole is reported as an ingredient of Lansoprazol KRKA in the following countries:


  • Denmark

  • Finland

  • Norway

  • Sweden

International Drug Name Search


Pantosec-D




Pantosec-D may be available in the countries listed below.


Ingredient matches for Pantosec-D



Domperidone

Domperidone is reported as an ingredient of Pantosec-D in the following countries:


  • India

Pantoprazole

Pantoprazole is reported as an ingredient of Pantosec-D in the following countries:


  • India

International Drug Name Search


Friday, October 14, 2016

Colistin Link




Colistin Link may be available in the countries listed below.


Ingredient matches for Colistin Link



Colistin Sulfate

Colistin sulphomethate sodium (a derivative of Colistin) is reported as an ingredient of Colistin Link in the following countries:


  • Australia

  • New Zealand

International Drug Name Search


Ximocef




Ximocef may be available in the countries listed below.


Ingredient matches for Ximocef



Cefpodoxime

Cefpodoxime is reported as an ingredient of Ximocef in the following countries:


  • Bangladesh

International Drug Name Search


Cardigard




Cardigard may be available in the countries listed below.


Ingredient matches for Cardigard



Carvedilol

Carvedilol is reported as an ingredient of Cardigard in the following countries:


  • Bangladesh

International Drug Name Search


Thursday, October 13, 2016

Lecimar




Lecimar may be available in the countries listed below.


Ingredient matches for Lecimar



Fluoxetine

Fluoxetine hydrochloride (a derivative of Fluoxetine) is reported as an ingredient of Lecimar in the following countries:


  • Spain

International Drug Name Search


Paclitaxel-Teva




Paclitaxel-Teva may be available in the countries listed below.


Ingredient matches for Paclitaxel-Teva



Paclitaxel

Paclitaxel is reported as an ingredient of Paclitaxel-Teva in the following countries:


  • Czech Republic

  • Estonia

  • France

  • Hungary

  • Italy

  • Latvia

  • Lithuania

  • Slovakia

  • Spain

  • Sweden

  • Switzerland

International Drug Name Search


Feedmix TS




Feedmix TS may be available in the countries listed below.


In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Feedmix TS



Sulfamethoxazole

Sulfamethoxazole is reported as an ingredient of Feedmix TS in the following countries:


  • Netherlands

Trimethoprim

Trimethoprim is reported as an ingredient of Feedmix TS in the following countries:


  • Netherlands

International Drug Name Search


Gizende




Gizende may be available in the countries listed below.


Ingredient matches for Gizende



Heparin

Heparin sodium salt (a derivative of Heparin) is reported as an ingredient of Gizende in the following countries:


  • Georgia

International Drug Name Search


Wednesday, October 12, 2016

Ketoprofen SR




Ketoprofen SR may be available in the countries listed below.


Ingredient matches for Ketoprofen SR



Ketoprofen

Ketoprofen is reported as an ingredient of Ketoprofen SR in the following countries:


  • Romania

International Drug Name Search


Bassamin




Bassamin may be available in the countries listed below.


Ingredient matches for Bassamin



Aspirin

Acetylsalicylic Acid is reported as an ingredient of Bassamin in the following countries:


  • Japan

International Drug Name Search


Clinax




Clinax may be available in the countries listed below.


Ingredient matches for Clinax



Minocycline

Minocycline is reported as an ingredient of Clinax in the following countries:


  • Argentina

Sulindac

Sulindac is reported as an ingredient of Clinax in the following countries:


  • Japan

International Drug Name Search


Flagyl Vaginal




Flagyl Vaginal may be available in the countries listed below.


Ingredient matches for Flagyl Vaginal



Metronidazole

Metronidazole is reported as an ingredient of Flagyl Vaginal in the following countries:


  • Spain

International Drug Name Search


Tuesday, October 11, 2016

Halfdopa




Halfdopa may be available in the countries listed below.


Ingredient matches for Halfdopa



Methyldopa

Methyldopa is reported as an ingredient of Halfdopa in the following countries:


  • Japan

International Drug Name Search


Balsoclase




Balsoclase may be available in the countries listed below.


Ingredient matches for Balsoclase



Carbocisteine

Carbocisteine is reported as an ingredient of Balsoclase in the following countries:


  • Belgium

Pentoxyverine

Pentoxyverine citrate (a derivative of Pentoxyverine) is reported as an ingredient of Balsoclase in the following countries:


  • Belgium

  • Luxembourg

  • Netherlands

International Drug Name Search


Letrozole




In the US, Letrozole (letrozole systemic) is a member of the following drug classes: aromatase inhibitors, hormones/antineoplastics and is used to treat Breast Cancer, Breast Cancer - Adjuvant, Breast Cancer - Metastatic and Female Infertility.

US matches:

  • Letrozole

Scheme

Rec.INN

ATC (Anatomical Therapeutic Chemical Classification)

L02BG04

CAS registry number (Chemical Abstracts Service)

0112809-51-5

Chemical Formula

C17-H11-N5

Molecular Weight

285

Therapeutic Categories

Antineoplastic agent

Enzyme inhibitor, aromatase

Chemical Name

Benzonitrile, 4,4'-(1H-1,2,4-triazol-1-ylmethylene)bis-

Foreign Names

  • Letrozolum (Latin)
  • Letrozol (German)
  • Letrozole (French)
  • Letrozol (Spanish)

Generic Names

  • Letrozole (OS: USAN, BAN)
  • CGS 20267 (IS: Ciba-Geigy)
  • Letrozole (PH: USP 32, Ph. Eur. 5, BP 2010)
  • Letrozolum (PH: Ph. Eur. 6)

Brand Names

  • Aromek
    Celon, Poland


  • Cendalon
    Teva, Argentina


  • Etruzil
    Egis, Slovakia


  • Fecinole
    Dosa, Argentina; Medigroup, Peru


  • Femaplex
    Genepharm, Greece


  • Femar
    Novartis, Denmark; Novartis, Finland; Novartis, Iceland; Novartis, Norway; Novartis, Sweden


  • Femara
    Delphi, Netherlands; Euro, Netherlands; Novartis, United Arab Emirates; Novartis, Argentina; Novartis, Austria; Novartis, Australia; Novartis, Bosnia & Herzegowina; Novartis, Bangladesh; Novartis, Belgium; Novartis, Bulgaria; Novartis, Bahrain; Novartis, Brazil; Novartis, Canada; Novartis, Switzerland; Novartis, Chile; Novartis, China; Novartis, Colombia; Novartis, Czech Republic; Novartis, Germany; Novartis, Ecuador; Novartis, Estonia; Novartis, Egypt; Novartis, Spain; Novartis, United Kingdom; Novartis, Greece; Novartis, Hong Kong; Novartis, Croatia (Hrvatska); Novartis, Hungary; Novartis, Indonesia; Novartis, Ireland; Novartis, Israel; Novartis, Iraq; Novartis, Iran; Novartis, Italy; Novartis, Jordan; Novartis, Japan; Novartis, Kuwait; Novartis, Lebanon; Novartis, Sri Lanka; Novartis, Lithuania; Novartis, Luxembourg; Novartis, Latvia; Novartis, Malta; Novartis, Mexico; Novartis, Malaysia; Novartis, Netherlands; Novartis, New Zealand; Novartis, Oman; Novartis, Philippines; Novartis, Poland; Novartis, Portugal; Novartis, Qatar; Novartis, Romania; Novartis, Serbia; Novartis, Russian Federation; Novartis, Saudi Arabia; Novartis, Singapore; Novartis, Slovenia; Novartis, Slovakia; Novartis, Syria; Novartis, Thailand; Novartis, Turkey; Novartis, Taiwan; Novartis, United States; Novartis, Venezuela; Novartis, Vietnam; Novartis, Yemen; Novartis, South Africa; Novartis Pharmaceuticals, Peru


  • Fémara
    Novartis, France; Novartis, France; Novartis, Tunisia; Novartis, Tunisia


  • Femtozone
    Helm, Slovakia


  • Kebirzol
    Aspen, Argentina


  • Lametta
    Vipharm, Poland


  • Leoncol
    Pharmanel, Greece


  • Letrol
    Renata, Bangladesh


  • Letropen
    Elpen, Greece


  • Letroz
    Sun, Myanmar


  • Letrozin
    Meditrina, Greece


  • Letrozol Microsules
    Microsules, Argentina


  • Letrozol Nucleus
    Rottendorf, Bulgaria; Synthon, Bulgaria; Synthon, Bulgaria


  • Letrozol Sandoz
    Lek, Bulgaria; Rottendorf, Bulgaria; Sandoz, Slovakia; Synthon, Bulgaria


  • Letrozol Streuli
    Streuli Pharma, Switzerland


  • Letrozol Teva
    Teva, Slovakia


  • Letrozole Helm
    Medihelm, Greece


  • Letrozole Medico Uno
    Medico Uno, Slovakia


  • Letrozol-Mepha
    Mepha Pharma, Switzerland


  • Letrozolum Genthon
    Genthon, Slovakia


  • Letrozolum Polpharma
    Polpharma, Slovakia


  • Letrozolum Synthon
    Synthon, Slovakia


  • Levinox
    Santa, Greece


  • Linol
    Vianex / BIANEΞ, Greece


  • Loosyn
    Synthon, Slovakia


  • Losiral
    Farmindustria, Peru; Neoraxis, Chile; Recalcine, Ecuador


  • Loxifan
    Padro, Spain


  • Mimor
    png Gerolymatos, Greece


  • Picozone
    Helm, Slovakia


  • Trozet
    Dabur, India

International Drug Name Search

Glossary

BANBritish Approved Name
ISInofficial Synonym
OSOfficial Synonym
PHPharmacopoeia Name
Rec.INNRecommended International Nonproprietary Name (World Health Organization)
USANUnited States Adopted Name

Click for further information on drug naming conventions and International Nonproprietary Names.