FALCÃO TELES LDA. Dossier List

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FALCÃO TELES LDA. Dossier List
FALCÃO TELES LDA.
Dossier List
AVA
AILABLE DOSSIERS
Prroduct Name
Pharm
maceutical Form
m
Strength
S
Refereence
Therapeutic cla
ass
1
ylsalicylic acid+
+
Acety
Phenyle
ephrine bitartratte+
Chlorphenamine malea
ate *
er for oral solutio n
Powde
500mg+
+15,58mg +2mg
-
Cough and Co
old
2
Acety
ylsalicylic acid+
+
Phenyle
ephrine bitartratte *
Orodis
spersible powderr
(cola taste)
500m
mg+15,58mg
-
Cough and Co
old
3
ylsalicylic acid +
Acety
Ascorbic acid + Caffein
ne *
Powde
er for oral solutio n
500mg+
+50mg +300mg
-
Cough and Co
old
4
Aciclovir 1
Tablets
200mg – 400mg – 800mg
g
Zovirax / Glaxo
Antiviral
5
Amoldip
pine + Atorvasta
atin
Film
m-coated tablets
5m
mg+10mg
10mg+10mg
Caduet / Pfizer
Calcium
C
antagon
nist +
Lipid
L
modifying agent
a
6
Alendronic acid 1
Tablets
70mg
Fosamax / Merck
Bo
one calcium regu
ulators
7
Aripiprazole 1
Tablets
5mg – 10mg
1
– 15mg –
30mg
Abilify / Brisstol-Myers
Squibbb
Antipsychoticcs
8
Betaxo
olol hydrochlorid
de
Eye drops, solution
5 mg/ml
Betoptic//Alcon
Anttiglaucoma prepa
arations
and miotics
9
B
Bicalutamide
Film
m-coated tablets
50m
mg - 150 mg
Casodex / AstraZ.
Anti-neoplastic
A
ag
gents
Antiglaucoma preparation
and miotics
(o
orange taste)
(llemon taste)
10
B
Bimatoprost
Eye drops
0,3 mg/ml
Lumigan /A
Allergan
Pharmaceeuticals
11
aine hydrochlorride
Bupivaca
Soluttion for injection
5 mg/ml
Marcain / AsttraZeneca
Anesthetics, local
12
C
Candesartan
Tablets
4mg - 8mg - 16mg - 32mg
g
Atacand / AstraZ.
Angiotensin II antag
gonists
13
Ciprofloxacin
Tablets
250m
mg – 500mg
Ciproxin / Bayer
Che
emotherapeutic antibiotic
a
14
C
Citalopram
Film
m-coated tablets
Seropram / LLundbeck
Antidepressan
nts
15
C
Citalopram
Oral
O solution
40mg/ml
4
Seropram / LLundbeck
Antidepressan
nts
16
C
Citalopram
Concenttrate for solution for
infusion
20mg/0,5ml - 40mg/1ml
Seropram / LLundbeck
Antidepressan
nts
17
Cla
arithromycin
Powde
er for solution forr
infusion
500mg
Klacid IV / Abbot
Macrolide
M
Antibaccterial
18
De
esloratadine
Film
m-coated tablets
5mg
Neoclarityn / Schering
Anti-histamines for systemic
s
use
19
esloratadine
De
Oral
O solution
0,5mg/ml
0
Neoclarityn / Schering
Anti-histamines for systemic
s
use
20
D
Dorzolamide
Eye drops, solution
20
2 mg/ml
Trusopt / Merck
Anttiglaucoma prepa
arations
and miotics
21
D
Doxylamine
Tablets
15m
mg - 25mg
Hoggar nighht / Stada
Antihistamines for systemic
use
22
Enalapril
Tablets
5mg – 10mg – 20mg
Renitec / MSD
ACE inhibitor
23
Enalapril
Table
ets with breaklinee
5mg – 10mg – 20mg
Xanef / MSD
ACE inhibitorrs
Tablets
20m
mg+12,5mg
CoRenitec
ec/MSD
AC
CE inhibitors + diuretics
25m
mg - 50mg
Inspra / P
Pfizer
Pota
assium-sparing diuretics
d
Cipralex / LLundbeck
Antidepressan
nts
24
Ena
alapril +HCTZ
1
10m
mg - 20mg –
30mg
g - 40 mg
25
E
Eplerenone
Film
m-coated tablets
26
Escitalopram
Film
m-coated tablets
27
someprazole
Es
Powde
er for solution forr
injec
ction / perfusion
40mg
Nexium / A
AstraZ.
Acid
A
Related diso
orders
28
Fenspiride
Syrup
2mg/ml
Pneumorel / Servier
Obs
structive airway diseases
d
29
Fenspiride
Tablets
80mg
Pneumorel / Servier
Obs
structive airway diseases
d
30
G
Gabapentin
Hard capsules
100mg - 300mg - 400mg
Neurontin / Pfizer
Antiepilepticc
31
H
Haloperidol
Soluttion for injection
5 mg/ml
Haldol / Jaanssen
Antipsychoticcs
32
Hy
yaluronic acid
Eye drops
-
Artificial tearss
5mg
g - 10mg –
15m
mg - 20mg
0,1%
% 0,5 ml x 12
0,1% bottle
b
2 x 5ml
1/4
FALCÃO TELES LDA.
Dossier List
AVA
AILABLE DOSSIERS
Prroduct Name
Pharm
maceutical Form
m
Strength
S
Refereence
Therapeutic cla
ass
33
Ibuprofen
Ora
al - suspension
10
00mg/ 5ml
20
00mg/5 ml
Nurofen / Reckitt
Benckkiser
Antiinflammatory
A
y and
antiheumaticss
34
Ind
dapamide SR
Prolong
ged-release tableets
1,5mg
Natrilix / S
Servier
Diuretics
35
Irbesartan
Film
m-coated tablets
75mg – 150mg
1
– 300mg
Aprovel / Sanofi
Angiotensin II antag
gonists
36
Irbes
sartan+HCTZ 1
Film
m-coated tablets
Co-Aprovell / Sanofi
Angiotensin II antag
gonists
+ diuretics
Keppra / UCB
B Pharma
Antiepilepticc
150m
mg+12,5mg
300mg+12,5mg
300
0mg+25mg
250m
mg - 500mg
37
Le
evetiracetam
Film
m-coated tablets
38
Le
evetiracetam
Concenttrate for solution for
infusion
100mg/ml
Keppra / UCB
B Pharma
Antiepilepticc
39
evetiracetam
Le
Oral
O solution
100mg/ml
Keppra / UCB
B Pharma
Antiepilepticc
40
L
Levofloxacin
Solution for infusion
250mg/50m
ml – 500mg/100m
ml
Tavanic / A
Aventis
Quinolone
Q
Antibaccterial
41
L
Levofloxacin
Film
m-coated tablets
250m
mg – 500mg
Tavanic / A
Aventis
Quinolone
Q
Antibaccterial
42
Linezolid
Solution for infusion
2mg/ml
Zyvox / P
Pfizer
Antib
bacterial for syste
emic use
43
Losartan
Film
m-coated tablets
Cozaar / MSD
Angiotensin II antag
gonists
44
Los
sartan +HCTZ
Film
m-coated tablets
50m
mg+12,5mg
100
0mg+25mg
Cozaar Pluus / MSD
Angiotensin II antag
gonists
+ diuretics
45
M
Meloxicam
Soluttion for injection
15
5mg/1,5ml
Movalis / BooehringerIngelheeim
Anti-inflammato
ory,
antirheumaticc
46
M
Memantine
Film
m-coated tablets
10m
mg – 20 mg
Ebixa / Luundbeck
Anti-dementia drrugs
47
M
Memantine
Oral drops
10mg/g
Ebixa / Luundbeck
Anti-dementia drrugs
48
Metopro
olol Succinate SR
S
Prolong
ged release tableets
23,75
5mg - 47,5mg
- 95m
mg - 190mg
Beloc-Zoc / AstraZ.
Beta
B
blocking ag
gents
49
Montelukast 1
M
Film
m-coated tablets
10mg
Singulair / Merck
Obs
structive airway diseases
d
50
M
Montelukast ¹
Che
ewable tablets
4m
mg - 5mg
Singulair / Merck
Obs
structive airway diseases
d
51
M
Montelukast ¹
Sachets
4mg
Singulair / MSD
Obs
structive airway diseases
d
52
No
oradrenaline
Soluttion for injection
1 mg/ml
Noradrenalinee / Hospira
Adre
energic and dopa
aminergic
agents
53
O
Olanzapine
Tablets
5mg - 10m
mg - 15mg - 20mg
g
Zyprexa / Lilly
Antipsychoticcs
54
Ola
anzapine ODT
Orodispersible tabletss
5mg - 10m
mg - 15mg - 20mg
g
Zyprexa / Lilly
Antipsychoticcs
55
O
Olmesartan
Film
m-coated tablets
10mg – 20mg – 40mg
Benicar / Daiicchi Sankyo
Angiotensin II antag
gonists
56
O
Olopatadine
Eye drops
0,1%
Pataday / Alcon
Eyes allergies
57
O
Omeprazole
Powde
er for solution forr
infusion
40mg
Losec / A
Astra Z.
Acid
A
related disorders
58
O
Ondansetron
Soluttion for injection
4mg/2
2ml - 8mg/4ml
Zofran / GSK
Antiemetics an
nd
antinauseants
59
Ond
dansetron ODT
Orodispersible tabletss
4m
mg - 8mg
Zofran / GSK
Antiemetics an
nd
antinauseants
60
O
Opipramol 1
Film
m-coated tablets
50mg
Insidon / N
Novartis
Antidepressant, An
nxiolytic
61
Orlistat
Capsules
60m
mg - 120mg
Xenical / Roche
An
ntiobesity preparrations
- 750m
mg - 1000mg
12,5
5mg - 25mg
- 50m
mg - 100mg
62
Oxymetazzoline hydrochlo
oride
Nasa
al spray, solution
0.025 mg
g/ml, 0.05 mg/ml
Nasivin / Merck
De
econgestants and
d other
nasal preparatio
ons
for topical use
e
63
Pantoprazole
Lyophilis
sate for solution for
infu
usion/injection
40mg
Pantozol / Altana
Acid
A
related disorders
64
P
Perindopril
Tablets
4m
mg - 8mg
Coversyl / Servier
ACE inhibitorrs
2/4
FALCÃO TELES LDA.
Dossier List
AVA
AILABLE DOSSIERS
Prroduct Name
Pharm
maceutical Form
m
Strength
S
Refereence
Therapeutic cla
ass
P
Piracetam1
Film
m-coated tablets
800m
mg – 1200mg
Nootropil / UCB
Nootropic
66
Propofol
Emulsiion for injection oor
infusion
10 mg/ml
Diprivan / Ast
straZeneca
Anesthetics, gen
neral
67
Q
Quetiapine
Film
m-coated tablets
25mg – 10
00mg – 150mg –
200m
mg – 300mg
Seroquel / AstraZ.
Antipsychoticcs
68
Ro
osuvastatin 2
Film
m-coated tablets
5mg – 10m
mg – 20mg – 40m
mg
Crestor / A
AstraZ.
Lipid
L
modifying ag
gents
69
Salicylam
mide + Ascorbic acid
+ Ru
utoside + Zinc
Coated
C
tablet
300 mg
m + 200 mg
+50
0 mg + 5mg
-
Cold preparatio
ons
70
Sild
denafil citrate ¹
Tablets
25mg – 50
5 mg – 100mg
Viagra / Pfizer
Erec
ctile dysfunction products
71
S
Simeticone
Oral drops
66
6,66mg/ml
-
Alimentary
A
Tractt and
Metabolism
72
S
Simvastatin
Film
m-coated tablets
10mg – 20mg
2
– 40mg –
80mg
Zocor / MSD
Lipid
L
modifying ag
gents
73
S
Sumatriptan
Film
m-coated tablets
50m
mg - 100mg
Imitrex / GSK
Antimigraine dru
ugs
74
T
Tianeptine
Film
m-coated tablets
12,5mg
Coaxil / S
Servier
Antidepressan
nts
75
T
Tobramycin
Eye drops, solution
3 mg/ml
Tobrex / Alcon
Antiinfectivess
76
T
Topiramate 2
Tablets
Topamax / Orrtho-McNeil
Antiepilepticc
77
dol+ Paracetam
mol
Tramad
Film
m-coated tablets
37,5
5mg/ 325mg
Zaldiar/Grüünenthal
Analgesics
78
T
Travoprost
Eye drops
0,,04mg/ml
Travata
tan /
Alcon Laboraatories Ltd
Antiglaucoma preparation
and miotics
79
Valsartan
Film
m-coated tablets
80m
mg – 160mg
Diovan / N
Novartis
Angiotensin II antag
gonists
80
Vals
sartan +HCTZ1
Film
m-coated tablets
160
0+12,5mg
Co-Diovan / Novartis
Angiotensin II antag
gonists
+ diuretics
65
25m
mg – 50mg
– 100
0mg – 200mg
80
0+12,5mg
16
60+25mg
81
V
Venlafaxine
Tablets
25m
mg - 37,5mg
- 50
0mg –75mg
Effexor / W
Wyeth
Antidepressan
nts
82
Ve
enlafaxine SR
Prolonge
ed release capsuules
37,5mg - 75mg - 150mg
Effexor XR
R / Wyeth
Antidepressan
nts
83
V
Voriconazole
Film
m-coated tablets
50m
mg– 200mg
Vfend /P
Pfizer
Anti-fungal age
ents
84
Xy
ylometazoline
Nasal sprray, solution soluution
1 mg/m
ml, 0.5 mg/ml
Otrivin / N
Novartis
De
econgestants and
d other
nasa
al preparations fo
or topical
use
85
Zole
edronic Acid ¹
Concenttrate for solution for
infusion
4mg/5ml
4
Zometa / N
Novartis
Drugs affecting bo
ones &
mineralisation
n
86
Zole
edronic Acid ¹
Powder for concentrate ffor
infusion
4mg/5ml
4
Zometa / N
Novartis
Drugs affecting bo
ones &
mineralisation
n
1
based on APII from Business Unit
U Fine Chemic
cals, Polpharma (BUFC)
dossier based
d on API from firsst supplier, API from
f
BUFC will bbe registered as a second supplie
er later
* limited offer te
erritory (excluding
g Spain, Portuga
al, Greece)
2
DOS
SSIERS UN
NDER DEV
VELOPMENT
T in 2013
P
Product Name
Pharmaceutical
Form
Strength
Reference
Therapeutic class
c
Expe
ected
1
Amoldipine + Atorvasttatin
ated tablets
Film-coa
5mg+20mg
10mg+20mg
Caduett / Pfizer
Calcium antago
onist +
Lipid modifying agent
3Q 2013
2
Diosmin
Gel
G
50g
-
Chronic veno
ous
insufficiency (cosmetic)
2Q 2013
3
Diosm
min + Vitis vinife
era
+ Ruttine + Tocopherrol
Ca
apsule
300mg
+25mg+50mg
-
Chronic veno
ous
insufficienc
cy
(food supplem
ment)
1Q 2013
4
Linezolid
Film-coa
ated tablets
600mg
Zyvox
x /Pfizer
Antibacterials
s for
systemic us
se
4Q 2013
3/4
FALCÃO TELES LDA.
Dossier List
DOS
SSIERS UN
NDER DEV
VELOPMENT
T in 2013
1
P
Product Name
Pharmace
eutical Form
Strength
Refe
erence
Therapeutic class
c
Expe
ected
5
Mettamizole sodium
m
Gel capsules
c
500mg
-
Analgesics
s
2Q 2013
2
6
M
Moxifloxacin
Eye
e drops
15mg/3ml
Vigamo
ox / Alcon
Q
Quinolone Antiba
acterials
1Q 2013
2
Benicar HCT
H
/ Daiichi
Sankyo
Angiotensin
n II
antagonists + diuretic
1Q 2013
2
7
Olm
mesartan+HCTZ
Z
Film-coa
ated tablets
20mg+12,5mg
20mg+25mg
40mg+12,5mg
40mg+25mg
8
etamol + Ibupro
ofen
Parace
Ta
ablets
325mg+200mg
g
-
Analgesics
s
2Q 2013
2
9
P
Posaconazole
Oral su
uspension
440mg/ml (105ml)
Noxafil / Merck
M
& Co
Antifungal
4Q 2013
2
10
Pregabaline
Capsules
255mg -75mg -100m
mg
- 150mg - 200mg
g225mg - 300mg
g
Lyrica
a /Pfizer
Antiepileptics
2
3Q 2013
11
Salicy
ylamide + Ascorrbic
acid + Rutoside + Zin
nc
Powder for oral solution
-
Cold preparattions
3Q 2013
2
12
S
Simethicone
Capsule twist-off
20mg
-
Alimentary Trac
ct and
Metabolism
m
(medical dev
vice)
1Q 2013
2
13
S
Simethicone
Ora
al drops
135mg/ml
-
Alimentary Trac
ct and
Metabolism
m
(medical dev
vice)
1Q 2013
2
14
Vardenafil 1
Coate
ed tablets
5m
mg – 10mg – 20m
mg
Levitra
a / Bayer
Erectile dysfun
nction
products
1Q 2013
2
15
V
Voriconazole
Inffusion
200mg
Vfend
d /Pfizer
Anti-fungal ag
gents
2Q 2013
2
3300 mg + 300 mg
g
+ 50 mg + 5mg
based on API from Business Unit
U Fine Chemic
cals, Polpharma ((BUFC)
D
DCP SLOT in
i 2013
Produ
uct Name
Ph
harmaceutical Form
F
DCP Slot
1
Ibu
uprofen
Oral suspensio
on
March 2013
2
Olmesa
artan+HCTZ
Film-coated tablets
January 2013
3
Voric
conazole
Infusion
November
N
2013
For more inform
mation and up-da
ates regarding av
vailable dossiers and dossiers in development, ple
ease contact youur assigned Sales Manager or ou
ur
Commercial De
epartment.
Note: Products protected by vallid patents are no
ot offered for salee in countries wh
here the sale of such
s
products coonstitutes patent infringement.
Availability mayy be restricted to certain markets or countries.
4/4

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