ACYCLOVIR

800mg tablets

CTD Dossier available

Herpes Simplex

ACYCLOVIR

400mg/5ml syrup

CTDDossier available

“”

ACYCLOVIR

5 % cream

CTD Dossier available

“”

ACYCLOVIR

5 % 4.5 gr lipstick

CTD Dossier available, filed 2 EU countries

“”

ACYCLOVIR

5 % gel

CTD Dossier available

“”

ACYCLOVIR+

HYALURONIC ACID

5 % gel

CTD Dossier available, filed 2 EU countries

“”

ALENDRONATESOD.

5, 10 and70mg tablets

Under Dev. Ready after Patent expiry

Osteoporosis/Pagets

ALENDRONATE ACID

70mg tablets

CTD Dossier available

“”

ALFACALCIDOL

AMBROXOL

7.5mg/1ml unit dose

CTD Dossier available

Respiratory, Mucolytics

AMLODIPINE

5, 10mg tabs & capsules

CTD Dossier available

Angina, Hypertension

AMOXI-CLAVULAMIC

sterile inj. 0.5+0.1, 1+0.2, 2+0.2

CTD Dossier available

AMOXACILLIN

250, 500mg capsules

CTD Dossier availableTract Infections, Bronchitis, Gastro, Salmonella,Gonorrhea

AMTOLMETIN GUACYL

600mg tablets

CTD Dossier – registered Europe

Inflammatory

ANASTRAZOLE

1mg tablets

Under development

Breast Cancer

AZITHROMYCIN

250 – 500mg tablets

CTD Dossier available

Sexual, antimicrobial/

500mg vials

Chlamydia, gonnorhea

BETAMETHASONE,

DIPROPIONATE + GENYAMYCIN

0.1% - 0.5% cream

CTD Dossier available

BETAMETHASONE VALERATE

2250mg patches

Registered in EU

BICALUTAMIDE

50mg tablets

CTD Dossier available/not for Czech

ProstaticCancer

BICALUTAMIDE

150mg tablets

not known yet/not for Czech

BISOPROLOL + HCTZ

5mg/12.5 – 10mg/12.5 tabs

Heart/Cardio

CARBIDOPA + LEVODOPA

10/100mg – 25/100mg

under dev.

Parkinsons

CEFUROXIMEAXETIL

250 – 500mg tablets

CTD Dossier available

Anti-Bacterial

CEFUROXIME AXETL

125, 250, 500mg tablets

CITALOPRAM

20, 40mg tablets

CTD Dossier available

CITALOPRAM

10, 20, 40mg tablets

CLARITHROMYCIN

500mg vials

CTD Dossier available

Antibiotic

CLARITHROMYCIN

250, 500mg vials

CLOPIDOGREL

75mg tablets

under development-Patent Issue

Cardio

CYCLOSPORIN

25, 50, 100mg capsule

MA approved Portugal

DICLOFENAC

0.1% eye drops/unit dose

CTD Dossier available

Ophthalmic

1 % gel

Pain-osteo etc.

DICLOFENAC

1.5% cutaneous solution

under development

DICLOFENAC + HYALURONICACID

3% + 2.5% gel

under development

DEXAMETHASONE + TOBRAMYCIN

0.3% + 0.1% othologic. Drops

not known

DICLOFENACHYDROXY

ETHYLPIROLLIDINE

0.103% 100ml mouthwash

CTD dossier available

DIOSMIN

150, 300mg tablets

Registered in EU

DIOSMIN

450mg sachets

RegisteredinEU

DIOSMIN

5 % cream

Registered in EU

DIOSMIN+HESPERIDINE

450mg + 50g tablets

CTD Dossier available

Cardio

DOMPERIDONE

treatment

10mg tablets

CTD Dossier available

Gastro-nausea /cancer

DONEPEZIL

5 – 10mg tablets

CTD Dossier available

Dementia/Alzheimers

DORZOLAMIDE

5ml – 2% ophthalmic solution

CTD Dossier available

DORZOLAMIDE + TIMOLOL

5ml 2% + 0.5% ophthalm.solution

CTD Dossier available

EPIRUBICIN

2mg/ml inj. Solution 10,20,50

CTD Dossier available,submitted, validated EU

Cancer

FINASTERIDE

5gm tablets

CTD Dossier available

Prostrate/Baldness

FLUOXETINE

20mg dispersible tablets

CTD Dossier available

Anti-Depressant

FLUVASTATIN

20, 40 and 80mg tablets

underdev./Patent

Cardio

FOSFOMYCIN TROMETAMOL

Oral antibiotic sachet

CTD Dossier available

Antibiotic

GABAPENTINE

100, 300, 400mg capsules

CTD Dossier available

Epilepsy

GABAPENTINE

600 and 800mg tablets

under dev./Patent

Epilepsy

GABAPENTINE

100, 300 and 400mg capsules

CTD Dossier available

Epilepsy

GEMCITABIN

Inj. Lyoph. IV 200mg and 1gr vials

GINKBO BILOBA

NOT FOR CEE/POLAND

GLIMEPIRIDE

1, 2, 3 and 4mg tablets

under dev/Patent

Diabetes

HYALURONIC ACID

Inj. For Intra-Articular & Cosmetic Use

IBUPROFEN AMMONIUM

0.1% solution (gynaecological)

ISOBUTYL ALCOHOL

for internal use

CTD Dossier available, registered in EU

DITTO

1gr sachet (soluble powder)

For external use

Registered in EU

ICHTHOLE

10 % patch

Under Development

Dermo

IRINOTECAN

40mg/2ml and 100mg/5ml vials inj. SolutionSubmitting 1st ¼ 08

Cancer

IRON PROTEIN ACETYL

ASPARTILATE

800mg (= Fe+++40mg)

CTD Dossier available, reg. EU

Anaemia

IRON SACARATE

200mg/ml inj. Solution

CTD Dossier available

ITRACONAZOLE

100mg capsules

CTD Dossier available

Fungal

KETOTIFENE

0.025% / 0.4ml unit dose

CTD Format

Anti-histamine

LACTULOSE

600mg/ml syrup

CTD Format

Gastro

LATANOPROST

2.5ml 0.005% ophthalmic solution

Q1/2008

Gastro / Ulcers

LATANOPROST + TIMOLOL

50mcg+5mg/1ml

Q3/2008

Anti-neoplastic,

reg. Poland, submitting to Czech

Breast Cancer

LETROZOLE

2.5mg tablets

UD

LEVOCLOPERASTINE FENDIZOATE

708mg syrup

CTD Dossier available, Reg. EU

Cough suppressant

LISINOPRIL

10, 20, 30, 40mg tablets

CTD Dossier available

Cardio

ATADIN

reg. 4 countries, Marking Authorization

Anti-Histamine

LORAZEPAM

1, 2.5mg tablets

CTD Dossier available

Epilepsy/Anxiety

LORAZEPAM

2mg/ml drops

NTA Dossier available

LOSARTAN

12.5, 25, 50mg tablets

CTD Dossier ready

Cardio

MELOXICAM

7.5; 15mg tablets

CTD Dossier available

Rheumatoid Arthritis/Osteo

MEROPENEM

500; 1000mg powder inj.

CTD Dossier ready

Anti-bacterial

MESLAZINE DERIVATIVE

Under development

Inflam./bowel disease

METFORMIN

Reg. 4 countries, MA

Anti-diabetic

METFORMIN

500, 850, 1000mg tablets

CTD available with MA in Netherlands

MIRTAZAPINE

15; 30; 45mg tablets + OD tabs

CTD available

Anti depressant

MYCOPHENOLATE

500mg tablets

CTD available

Transplants/grafts

MYCOPHENOLA-TEMOFETHYL

500mg tablets

CTD Dossier available (not Hungary/Poland)

NAPROXEN

reg. 4 countries, MA

Anti-inflammatory/Osteo/Arthritis

OFLOXACIN

0.30%/0.5ml unit dose

CTD Dossier available

Eye drops

OMEGA-3-ACID ETHYL ESTERS

1000mg soft gel capsules

CTD Dossier available

Lipid reducer

OMEPRAZOLE

20mg capsules

CTD Dossier available

Gastro – intestinal

OMEPRAZOLE

40mg vials

CTD Dossier ready

ONDANSETRON

4.8mg FC tablets

CTD Dossier availableNausea/vomiting for Cancer treatment

PACLITAXEL

New dossier end 07 – check

Cancer

PAMIDRONIC ACID

CTD Dossier/EDMF – available for UK/Ireland registration

Bone diseases/cancers

PANTOPRAZOL

20; 40mg tablets

Under dev./ready for Patent expiry

Ulcers

PANTOPRAZOL

20; 40mg tablets

Q1/2008

PANTOPRAZOL

40mg vials

CTD ready

PARACETAMOL

500; 1000 mg dispersible tablets

CTD Dossier available

PAROXETINE

10; 20; 30; 40mg tablets

CTD Dossier available

Anti Depressant

PERINDOPRIL

2; 4; 8mg tablets

CTD Dossier available

Cardio

PERINDOPRIL + INDAPAMIDE

2mg/0.625; 4mg/1.25 tablets

check

PIPERACILLIN SODIUM+TAZOBACTAM

2g +0.25mg/4ml inj.

Should be ready

Anti bacterial

PIOGLITAZONE

15; 30; 45mg tablets

Under dev. Ready for Patent exp.

Diabetes

PRAMIPEXOLE

0.7mg; 0.18mg tablets

Ready June 2008

Parkinsons

PRAVASTATIN SODIUM

10; 20; 40mg tablets

CTD Dossier available

PRAVASTATIN

10; 20; 40; 80mg tablets

Under dev. Ready for Patent exp.

QUETIAPINE

Patent Reg. In Poland, submitted to Czech

Anti-psychotic

QUINAPRIL

5; 10; 20; 40mg tablets

CTD Dossier available

Cardio

RIBAVARIN

200mg tablets

CTD Dossier available

Anti viral

ready check

RISENDRONATESODIUM

35mg film coated tablets

Osteo

RISPERIDONE

1; 2; 3; 4; 6mg tablets

CTD Dossier available

Anti psychotic

RISPERIDONE

0.1; 1; 2; 3; 4; 6mg tablets

CTD Dossier available

RISPERIDONE

DITTO

Under dev./ ready for Patent expiry

ROPINIROLE HCl

0.25; 0.5; 1;2;5mg tablets

Ready for Patent expiry

Parkinsons

SALBUTAMOL

0.5mg/ml; 1mg/ml; 2.5mg/ml; 2.5ml unit dose

check

Broncho.

SERENOA REPENS

160; 320mg soft gel capsules

Dossier available

Sex Hormones

SIMVASTATIN

5; 10; 20; 40; 80mg tablets

CTD Dossier available

Cholestrol

SERTRALINE

50; 100mg tablets & 25;50;100mg caps

CTD Dossier available
ObsessiveCompulsive Disorder / anti-depressant

SULODEXIDE

250 ULS soft gel capsules

Registered in EU

Thrombosis/Cardio

SUMATRIPTAN

50; 100mg tablets

CTD Dossier available

Migraine

TERBINAFINE

250mg tablets

CTD Dossier available

Anti-fungal

TERAZOSIN

1; 2; 5; 10mg tablets

Under dev. Ready for Patent exp

Cardio/hypertension

TOPIRAMATE

25; 50; 100;200mg tablets

Under dev. Ready for Patent exp.

Anti-epileptic

TRAMADOL

100; 150; 200mg prolonged release tabs

Registered in EU(Not for Italy)

Analgesic

VALACYCLOVIR

500; 100mg tablets(only for Italy/France due to Patent)-check

anti-viral/Herpes

VINORELBINE

10; 50mg vials inj. Solution Cancer

CTD Dossier ready/submitted & validated EUBreast/Lung