FDF
(FINISHED DOSAGE FORM)
PRODUCT NAME
STRENGTH
PHARMACEUTICAL
ANTIHISTAMINES
FOR SYSTEMIC USE
10 & 20 mg
10 & 20 mg
Film-coated tablet
Orodispersable tablet
ANTIINFLAMMATORY
AND ANTIRHEUMATIC
PRODUCTS, NON
STEROIDS
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
(1 or 100 ampoules, 1 ml)
ANESTHETICS
Procaine hydrochloride —
10 mg/ml
or 20 mg/ml
(1 ampoule 5 ml & 10 ml / 100 ampoules 5 ml & 10 ml)
ANTIEMETICS
Ondansetron
Hydrochloride dihydrate —
4 mg/ 2 ml
8 mg/ 4ml
(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
ANTIDEPRESSANTS
Escitalopram
10 mg
30 cpr
ANTICONVULSANT
Levetiracetam
500 mg
30 cpr
OTC
(OVER THE COUNTER)
Ibuprofen
Minoxidil
Methycellulose
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
Paracetamol ODT
Pancrelipase
Obeticholic
Dexmedetomidine
Remidazolam
20 mg/ml
80 mg/g
1 mg/ml
325, 500, 1000 mg
Solution for injection
Medicated Nail lacquer
Oral solution
Orodispersable tablet (ODT)
Delayed-Release Capsules
Q4 2022
Q2 2022
Q4 2022
Q3 2022
FDF
(FOR SYSTEMIC USE)
PRODUCT NAME
STRENGTH
PHARMACEUTICAL FORM
ANTIHISTAMINES
FOR SYSTEMIC USE
10 & 20 mg
10 & 20 mg
Film-coated tablet
Orodispersable tablet
ANTIINFLAMMATORY
AND ANTIRHEUMATIC
PRODUCTS, NON
STEROIDS
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)
SOLVENTS
Water for injection (sterile) —
Solvent for injection
ISOTONIC
SOLUTIONS
Fisiological Isotonic
Solution (Sodium chloride) —
0,9 mg/ml
Solution for injection
ANTIDEPRESSANTS
Escitalopram
10 mg
30 cpr
ANTICONVULSANT
Levetiracetam
500 mg
30 cpr
OTC
(OVER THE COUNTER)
Minoxidil
Methycellulose
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
Paracetamol ODT
Pancrelipase
Obeticholic
Dexmedetomidine
Remidazolam
20 mg/ml
80 mg/g
1 mg/ml
325, 500, 1000 mg
Solution for injection
Medicated Nail lacquer
Oral solution
Orodispersable tablet (ODT)
Delayed-Release Capsules
Q4 2022
Q2 2022
Q4 2022
Q3 2022
FDF
(FOR SYSTEMIC USE)
PRODUCT NAME
STRENGTH
PHARMACEUTICAL FORM
ANTIHISTAMINES FOR SYSTEMIC USE
PLATELET AGGREGATION INHIBITORS
ANTIINFLAMMATORY AND
ANTIRHEUMATIC PRODUCTS,
NON STEROIDS
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
(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
ANTIDEPRESSANTS
Escilatopram
10 mg
30 cpr
ANTICONVULSANT
Levetiracetam
500 mg
30 cpr
OCT
(OVER THE COUNTER)
Minoxidil
Methycellulose
Oral rehydration salts
Red Korean Gingseng (Redton ©)
50 mg/g
20 mg/ml & mg/ml
500 mg
20 mg/ml
4g/sachet
15 g
Skin solution
Hard capsule
Patches
Granules for oral suspensión
50 capsules
MEDICAL DEVICE
FDF
(UNDER DEVELOPMENT)
PRODUCT NAME
STRENGTH
PHARMACEUTICAL FORM
DOSSIER AVAILABILITY
Plerixafor
Ciclopirox chitosan
Ebastine Sol
Paracetamol ODT
Pancrelipase
Obeticholic
Dexmedetomidine
Remidrazolam
20 mg/ml
80 mg/g
1 mg/ml
325,500,1000mg
Solution for injection
Medicated Nail lacquer
Oral solution
(ODT) Solution for injection
Delayed-Release Capsules
Q4 2022
Q2 2022
Q4 2022
Q3 2022