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Export table
FILTERS
Therapeutic Area
Select some options
Pharmaceutical Form
Select some options
Zone IV Stability
Select some options
CPP Feasibility
Select some options
PRODUCT NAME
THERAPEUTIC AREA
PHARMACEUTICAL
FORM
VISUAL
FORM
STRENGTH
REFERENCE
PRODUCT
lactose
Stability Zone
CPP
FEASIBILITY

Blood & Blood forming organs
Film-coated tablets

2.5 mg
5 mg
Eliquis / Bristol-Myers Squibb
II: on-going
IVa: ext. From b
IVb: on-going
No
Blood & Blood forming organs
Film-coated tablets

2.5 mg
10 mg
15 mg
20 mg
Xarelto / Bayer
II: on-going
IVa: ext. From b
IVb: on-going
No
Blood & Blood forming organs
Film-coated tablets

60 mg
90 mg
Brilique / AstraZeneca

II: available
IVa: ext. From b
IVb: available
No
* Polpharma Group API
CA Dossier suitable for Canadian Market
(1) No CPP feasibility for Hydrochlorothiazide 50 mg
(2) Dossier availability subject to some restriction
(3) Delayed release capsules, as per CA standard Terms
(4) BEQ study against Canadian reference product available
(5) Pending dossier update (new API Valsartan source required)
(6) Only for higher Strength: 1 mg/ml + 50 mg/ml (10 ml)

Dossier ready to file

No contains lactose
DISCLAIMER
The above list is presented solely for informational purposes and does not constitute an offer in any sense. Products under patent (SPC) protection in Poland and/or other countries are not offered until expiration of the corresponding IP right.
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* Polpharma Group API
CA Dossier suitable for Canadian Market
(1) No CPP feasibility for Hydrochlorothiazide 50 mg
(2) Dossier availability subject to some restriction
(3) Delayed release capsules, as per CA standard Terms
(4) BEQ study against Canadian reference product available
(5) Pending dossier update (new API Valsartan source required)
(6) Only for higher Strength: 1 mg/ml + 50 mg/ml (10 ml)

