EU PRODUCT LIST – READY DOSSIERS

MoleculeStrengthDosage FormTherapeutic AreaDossierMA Status
Acebutolol200mg, 400mgTabletAntihypertensiveAvailable*Approved (FR)
Aciclovir200mgTabletAntiretroviralAvailable*Approved (FR & ES)
Alfuzosin10mgTabletBenign Prostatic HyperplasiaAvailable*Approved (FR & ES)
Almotriptan12.5mgTabletAntimigraine AgentAvailableApproved (FR & ES)
Amlodipine5mg, 10mgCapsuleCalcium AntagonistAvailable*Approved (FR & ES)
Anastrozole1mgTabletCystostatic Hormone AntagonistAvailableApproved (FR & ES)
Apixaban2.5mg, 5mgTabletPrevention of Blood ClotsAvailableApproved (FR, ES & DE)
Aripiprazole5mg, 10mg, 15mgTabletAntipsychotic AgentAvailable*Approved (FR & ES)
Atenolol50mg, 100mgTabletAntihypertensiveAvailable*Approved (FR & ES)
Atorvastatin10mg, 20mg, 40mg, 80mgTabletCholesterol & Triglyceride RegulatorAvailable*Approved (FR & ES)
Azithromycin250mgTabletAntiinfectiveAvailable*Approved (FR)
Baclofen10mgTabletMuscle RelaxantAvailableUnder Approval (FR & ES)
Betahistine8mg, 24mgTabletAntivertigo AgentAvailable*Approved (FR & ES)
Bicalutamide50mgTabletCystostatic Hormone TherapyAvailable*Approved (FR & ES)
Bisoprolol1.25mg, 2.5mg, 5mgTabletAntihypertensiveAvailableUnder Approval (FR & ES)
Bortezomib3.5mg/vialInjectionAnticancerAvailableApproved (FR, ES & DE)
Bromazepam6mgTabletAntianxietyAvailableApproved (FR)
Celecoxib100mg, 200mgCapsuleAntirheumatic AgentAvailable*Approved (FR & ES)
Celiprolol200mgTabletAntihypertensiveAvailable*Approved (FR)
Ciprofloxacin250mg, 500mgTabletAntibioticAvailable*Approved (FR & ES)
Citalopram20mgTabletAntidepressant & Mood StabilizerAvailable*Approved (FR & ES)
Clarithromycin250mg, 500mgTabletAntibioticAvailable*Approved (FR & ES)
Clopidogrel75mgTabletAntithrombotic AgentAvailable*Approved (FR & ES)
Desloratadine5mgTabletAntihistamine Systemic AgentAvailableApproved (FR & ES)
Diosmin600mgTabletHemorrhoidsAvailableApproved (FR)
Donepezil5mg, 10mgTabletAnti-Alzheimer AgentAvailable*Approved (FR & ES)
Donepezil5mg, 10mgODTAnti-Alzheimer AgentAvailableApproved (FR & ES)
Domperidone10mgTabletAntiemeticAvailable*Approved (FR)
Duloxetine30mg, 60mgGastro-resistant CapsuleAntidepressant & Mood StabilizerAvailableApproved (FR & ES)
Eletriptan20mg, 40mgTabletAntimigraine AgentAvailableApproved (FR & ES)
Escitalopram5mg, 10mg, 15mg, 20mgTabletAntidepressant & Mood StabilizerAvailableApproved (FR & ES)
Esomeprazole20mg, 40mgTabletAntiulcerantAvailableApproved (FR & ES)
Etoricoxib30mg, 60mg, 90mg, 120mgTabletPain & InflammationAvailableApproved (FR, ES & DE)
Ezetimibe10mgTabletLipid RegulatorAvailableApproved (FR & ES)
Ezetimibe + Simvastatin10+20mg, 10+40mgTabletLipid RegulatorAvailableApproved (FR & ES)
Fenofibrate160mgTabletAnti-hypertriglyceridaemiaAvailable*Approved (FR)
Fenofibrate300mgCapsuleAnti-hypertriglyceridaemiaAvailable*Approved (FR)
Finasteride1mg, 5mgTabletDermatological / BPHAvailable*Approved (FR & ES)
Fluconazole50mg, 100mg, 150mg, 200mgCapsuleAntifungalAvailable*Approved (FR & ES)
Fluoxetine20mgODTAntidepressant & Mood StabilizerAvailable*Approved (FR & ES)
Fluoxetine20mgCapsuleAntidepressant & Mood StabilizerAvailableApproved (FR & ES)
Furosemide20mg, 40mgTabletDiuretic AgentAvailableApproved (FR & ES)
Gabapentin100mg, 300mg, 400mgCapsuleAnti-epileptic AgentAvailableApproved (FR & ES)
Gabapentin600mg, 800mgTabletAnti-epileptic AgentAvailableApproved (FR, ES & DE)

UPCOMING DOSSIERS

MoleculeStrengthDosage FormTherapeutic AreaTimelineMA Status
Enalapril2.5mg, 5mg, 10mg, 20mgTabletCardiovascular AgentQ2-25NA
Eltrombopag25mg, 50mg, 75mgTabletThrombopoietin Receptor AgonistQ4-24NA
Brivaracetam25mg, 50mg, 75mg, 100mgTabletAnticonvulsantQ4-24NA
Vortioxetine5mg, 10mgTabletAntidepressantQ2-25NA
Escitalopram ODT10mg, 15mg, 20mgTabletAntidepressantQ4-24NA
Trazodone100mgTabletAntidepressantQ4-24NA
Lisdexamfetamine30mg, 50mg, 70mgCapsuleStimulantQ2-25NA
Safinamide50mg, 100mgTabletParkinson’s DiseaseQ3-25NA
Alverine + Simethicone60mg + 300mgSoftgel CapsuleIrritable Bowel SyndromeQ4-25NA
Teriflunomide14mgTabletMultiple SclerosisQ1-25NA
Dapagliflozin + Metformin5+850mg, 5+1000mgTabletAntidiabeticQ3-25NA
Dutasteride + Tamsulosin0.5mg + 0.4mgCapsuleBenign Prostatic HyperplasiaQ3-24NA
Ivermectin3mgTabletAntiparasiticQ2-25NA
Apremilast30mgTabletPsoriatic ArthritisQ3-25NA
Dutasteride0.5mgSoftgel CapsuleBenign Prostatic HyperplasiaQ4-25NA
Tofacitinib5mg, 10mgTabletRheumatoid ArthritisQ1-26NA
Prednisolone ODT20mgTabletAnti-allergicQ1-26NA

Available: Bioequivalence study to be updated.