FDF

(FINISHED DOSAGE FORM)

PRODUCT NAME

STRENGTH

PHARMACEUTICAL

ANTIHISTAMINES

FOR SYSTEMIC USE

Ebastine

Ebastine

10 & 20 mg

10 & 20 mg

Film-coated tablet

Orodispersable tablet

PLATELET

AGGREGATION

INHIBITORS

Triflusal

300 mg

Hard capsule

ANTIINFLAMMATORY

AND ANTIRHEUMATIC

PRODUCTS, NON

STEROIDS

Aceclofenac

Chondroitin sulfate

Chondroitin sulfate

300 mg

400 mg

400 mg

Film-coated tablet

Granules for Oral solution

Dossier available

DERMATOLOGICALS

Ciclopirox olamina

Ketoconazole —

Ketoconazole

Mometasona —

15 mg/g

20 mg/g

20 mg/g

1 mg

Shampoo (100 ml)

Gel (100 ml)

Cream (30 g)

Skin solution (60 ml)

OPHTHALMOLOGICALS

Azelastine

Brimonidine/Timolol

Diclofenac

Olopatadine

Travoprost

0,5 mg/ml

2 mg/ml + 5 mg/ml

1 mg/l

1 mg/ml

40 micrograms/ml

Eye drops, solution (6 ml)

Eye drops, solution (5 ml)

Eye drops, solution (single dose units)

Eye drops, solution (5 ml)

Eye drops, solution (2,5 ml)

ANTIINFECTIVES

Fosfomycin

3 g

Granules for Oral solution

ANTIFUNGALS

Tioconazole —

Tioconazole

280 mg/ml

280 mg/ml

Medicated Nail lacquer (12 ml)

Skin solution

UROLOGICALS

Silodosin

4 mg & 8 mg

Hard capsules

ANALGESICS

Morphine chlorhydrate —

Morphine hydrochloride —

10 mg/ml

10 mg/ml

20 mg/ml

Solution for injection

Solution for injection

Solution for injection

HYPNOTICS

AND SEDATIVES

Midazolam hydrocloride

5 mg/ml

Solution for injection

GASTROINTESTINAL

DISORDERS

Atropine sulfate

1 mg/ml

Solution for injection

(1 or 100 ampoules, 1 ml)

ANESTHETICS

Procaine hydrochloride —

10 mg/ml

or 20 mg/ml

Solution for injection

(1 ampoule 5 ml & 10 ml / 100 ampoules 5 ml & 10 ml)

ANTIEMETICS

Ondansetron

Hydrochloride dihydrate —

4 mg/ 2 ml

8 mg/ 4ml

Solution for injection

(5 or 50 ampoules)

Solution for injection

(5 or 50 ampoules)

SOLVENTS

Water for injection (sterile) —

Solvent for injection

ISOTONIC

SOLUTIONS

Fisiological Isotonic

Solution (Sodium chloride) —

0,9 mg/ml

Solution for injection

ANTIBIOTICS

Amoxicillin-clavulanate

Amoxicillin-clavulanate

Amoxicillin-clavulanate

Amoxicillin

500/125 mg & 875/125 mg

500/125 mg & 875/125 mg

1,2 g & 2,2 g

500 mg

750 mg

1000 mg

500 mg

Granules for oral suspension

Film-coated capsules

Solution for injection

Hard capsules

EFG tablet

EFS tablet

Hard capsules

ANTIDEPRESSANTS

Escitalopram

10 mg

30 cpr

ANTICONVULSANT

Levetiracetam

500 mg

30 cpr

OTC

(OVER THE COUNTER)

Ibuprofen

Minoxidil

Methycellulose

CBD Patches

Oral rehydration salts

Red Korean Gingseng (Redton ©)

50 mg/g

20 mg/ml & mg/ml

500 mg

20 mg/ml

4 g/sachet

15 g

Gel (60 g)

Skin solution

Hard capsule

Patches

Granules for oral suspension

50 capsules

FDF

(UNDER

DEVELOPMENT)

PRODUCT NAME

STRENGTH

PHARMACEUTICAL

DOSSIER AVAILABILITY

Plerixafor

Ciclopirox chitosan

Ebastine solution

Paracetamol ODT

Amoxicillin

Amoxicillin

Amoxicillin

Pancrelipase

Obeticholic

Dexmedetomidine

Remidazolam

 

20 mg/ml

80 mg/g

1 mg/ml

325, 500, 1000 mg

500 mg

1000 mg

2000 mg

Solution for injection

Medicated Nail lacquer

Oral solution

Orodispersable tablet (ODT)

Solution for injection

Solution for injection

Solution for injection

Delayed-Release Capsules

Q4 2022

Q2 2022

Q4 2022

Q3 2022

Q2 2022

Q2 2022

Q2 2022

FDF

(FOR SYSTEMIC USE)

PRODUCT NAME

STRENGTH

PHARMACEUTICAL FORM

ANTIHISTAMINES

FOR SYSTEMIC USE

Ebastine

Ebastine

10 & 20 mg

10 & 20 mg

Film-coated tablet

Orodispersable tablet

PLATELET

AGGREGATION

INHIBITORS

Triflusal

300 mg

Hard capsule

ANTIINFLAMMATORY

AND ANTIRHEUMATIC

PRODUCTS, NON

STEROIDS

Aceclofenac

Chondroitin sulfate

Chondroitin sulfate

300 mg

400 mg

400 mg

Film-coated tablet

Granules for Oral solution

Dossier available

DERMATOLOGICALS

Ciclopirox olamina

Ketoconazole —

Ketoconazole

Mometasona —

15 mg/g

20 mg/g

20 mg/g

1 mg

Shampoo (100 ml)

Gel (100 ml)

Cream (30 g)

Skin solution (60 ml)

OPHTHALMOLOGICALS

Azelastine

Brimonidine/Timolol

Diclofenac

Olopatadine

Travoprost

0,5 mg/ml

2 mg/ml + 5 mg/ml

1 mg/l

1 mg/ml

40 micrograms/ml

Eye drops, solution (6 ml)

Eye drops, solution (5 ml)

Eye drops, solution (single dose units)

Eye drops, solution (5 ml)

Eye drops, solution (2,5 ml)

ANTIINFECTIVES

Fosfomycin

3 g

Granules for Oral solution

ANTIFUNGALS

Tioconazole —

Tioconazole

280 mg/ml

280 mg/ml

Medicated Nail lacquer (12 ml)

Skin solution

UROLOGICALS

Silodosin

4 mg & 8 mg

Hard capsule

ANALGESICS

Morphine chlorhydrate —

Morphine hydrochloride —

10 mg/ml

10 mg/ml

20 mg/ml

Solution for injection

Solution for injection

Solution for injection

HYPNOTICS

AND SEDATIVES

Midazolam hydrocloride

5 mg/ml

Solution for injection

GASTROINTESTINAL

DISORDERS

Atropine sulfate

1 mg/ml

Solution for injection
(1 or 100 ampoules, 1 ml)

ANESTHETICS

Procaine hydrochloride —

10 mg/ml

or 20 mg/ml

Solution for injection
(1 ampoule 5 ml & 10 ml / 100 ampoules 5 ml & 10 ml)

ANTIEMETICS

Ondansetron

Hydrochloride dihydrate —

4 mg/ 2 ml

8 mg/ 4ml

Solution for injection (5 or 50 ampoules)

Solution for injection (5 or 50 ampoules)

SOLVENTS

Water for injection (sterile) —

Solvent for injection

ISOTONIC

SOLUTIONS

Fisiological Isotonic

Solution (Sodium chloride) —

0,9 mg/ml

Solution for injection

ANTIBIOTICS

Amoxicillin-clavulanate

Amoxicillin-clavulanate

Amoxicillin-clavulanate

Amoxicillin

500/125 mg & 875/125 mg

500/125 mg & 875/125 mg

1,2 g & 2,2 g

500 mg

750 mg

1000 mg

500 mg

Granules for oral suspension

Film-coated capsules
Solution for injection
Hard capsules
EFG tablet

EFS tablet

Hard capsules

ANTIDEPRESSANTS

Escitalopram

10 mg

30 cpr

ANTICONVULSANT

Levetiracetam

500 mg

30 cpr

OTC

(OVER THE COUNTER)

Ibuprofen

Minoxidil

Methycellulose

CBD Patches

Oral rehydration salts

Red Korean Gingseng (Redton ©)

50 mg/g

20 mg/ml & mg/ml

500 mg

20 mg/ml

4g/sachet

15 g

Gel (60 g)

Skin solution

Hard capsule

Patches

Granules for oral suspension

50 capsules

FDF

(UNDER DEVELOPMENT)

PRODUCT NAME

STRENGTH

PHARMACEUTICAL FORM

DOSSIER AVAILABILITY

Plerixafor

Ciclopirox chitosan

Ebastine solution

Paracetamol ODT

Amoxicillin

Amoxicillin

Amoxicillin

Pancrelipase

Obeticholic

Dexmedetomidine

Remidazolam

20 mg/ml

80 mg/g

1 mg/ml

325, 500, 1000 mg

500 mg

1000 mg

2000 mg

Solution for injection

Medicated Nail lacquer

Oral solution

Orodispersable tablet (ODT)

Solution for injection

Solution for injection

Solution for injection

Delayed-Release Capsules

Q4 2022

Q2 2022

Q4 2022

Q3 2022

Q2 2022

Q2 2022

Q2 2022

FDF

(FOR SYSTEMIC USE)

PRODUCT NAME

STRENGTH

PHARMACEUTICAL FORM

ANTIHISTAMINES FOR SYSTEMIC USE

Ebastine

Ebastine

10 & 20 mg

10 & 20 mg

Film-coated tablet

Orodispersable tablet

PLATELET AGGREGATION INHIBITORS

Triflusal

300 mg

Hard capsule

ANTIINFLAMMATORY AND

ANTIRHEUMATIC PRODUCTS,

NON STEROIDS

Aceclofenac

Chondroitin sulfate

Chondroitin sulfate

300 mg

400 mg

400 mg

Film-coated tablet

Granules for Oral solution

Dossier available

DERMATOLOGICALS

Ciclopirox olamina

Ketoconazole —

Ketoconazale

Mometasona —

15 mg/g

20 mg/g

20 mg/g

1 mg

Shampoo (100 ml)

Gel (100 ml)

Cream (30 g)

Skin solution (60 ml)

OPHTHALMOLOGICALS

Azelastine

Brimonidine/Timolol

Diclofenac

Olopatadine

Travoprost

0,5 mg/ml

2 mg/ml + 5 mg/ml

1 mg/l

1 mg/ml

40 micrograms/ml

Eye drops, solution (6 ml)

Eye drops, solution (5 ml)

Eye drops, solution (single dose units)

Eye drops, solution (5 ml)

Eye drops, solution (2,5 ml)

ANTIINFECTIVES

Fosfomycin

3 g

Granules for Oral solution

ANTIFUNGALS

Tioconazole —

Tioconazole

280 mg/ml

280 mg/ml

Medicated Nail lacquer (12 ml)

Skin solution

UROLOGICALS

Silodosin

4 mg & 8 mg

Hard capsule

ANALGESICS

Morphine chlorhydrate —

Morphine hydrochloride —

10 mg/ml

10 mg/ml

20 mg/ml

Solution for injection

Solution for injection

Solution for injection

HYPNOTICS AND SEDATIVES

Midazolam hydrocloride

5 mg/ml

Solution for injection

GASTROINTESTINAL DISORDERS

Atropine sulfate

1 mg/ml

Solution for injection
(1 or 100 ampoules, 1 ml)

ANESTHETICS

Procaine hydrochloride —

10 mg/ml

or 20 mg/ml

Solution for injection
(1 ampoule 5 ml & 10 ml / 100 ampoules 5 ml & 10 ml)

ANTIEMETICS

Ondansetron

Hydrochloride dihydrate —

4 mg/ 2 ml

8 mg/ 4ml

Solution for injection (5 or 50 ampoules)

Solution for injection (5 or 50 ampoules)

SOLVENTS

Water for injection (sterile) —

Solvent for injection

ISOTONIC SOLUTIONS

Fisiological Isotonic Solution (Sodium chloride) —

0,9 mg/ml

Solution for injection

ANTIBIOTICS

Amoxicillin-clavulanate

Amoxicillin-clavulanate

Amoxicillin-clavulanate

Amoxicillin

500/125 mg & 875/125 mg

500/125 mg & 875/125 mg

1,2 g & 2,2 g

500 mg

750 mg

1000 mg

500 mg

Granules for oral suspension

Film-coated capsules

Solution for injection

Hard capsules

EFG tablet
EFS tablet
Hard capsules

ANTIDEPRESSANTS

Escilatopram

10 mg

30 cpr

ANTICONVULSANT

Levetiracetam

500 mg

30 cpr

OCT

(OVER THE COUNTER)

Ibuprofen

Minoxidil

Methycellulose

CBD Patches

Oral rehydration salts

Red Korean Gingseng (Redton ©)

50 mg/g

20 mg/ml & mg/ml

500 mg

20 mg/ml

4g/sachet

15 g

Gel (60 g)

Skin solution

Hard capsule

Patches

Granules for oral suspensión

50 capsules

FDF

(UNDER DEVELOPMENT)

PRODUCT NAME

STRENGTH

PHARMACEUTICAL FORM

DOSSIER AVAILABILITY

Plerixafor

Ciclopirox chitosan

Ebastine Sol
Paracetamol ODT
Amoxicillin
Amoxicillin
Amoxicillin
Pancrelipase
Obeticholic
Dexmedetomidine
Remidrazolam

20 mg/ml

80 mg/g

1 mg/ml
325,500,1000mg
500 mg
1000 mg
2000 mg

Solution for injection
Medicated Nail lacquer
Oral solution
(ODT) Solution for injection
Solution for injection
Solution for injection
Solution for injection
Delayed-Release Capsules

Q4 2022

Q2 2022

Q4 2022

Q3 2022

Q2 2022

Q2 2022

Q2 2022