BeneFIX

Nchi: Umoja wa Ulaya

Lugha: Kiingereza

Chanzo: EMA (European Medicines Agency)

Nunua Sasa

Taarifa za kipeperushi Taarifa za kipeperushi (PIL)
17-10-2022
Tabia za bidhaa Tabia za bidhaa (SPC)
17-10-2022
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma (PAR)
30-10-2015

Viambatanisho vya kazi:

Nonacog alfa

Inapatikana kutoka:

Pfizer Europe MA EEIG

ATC kanuni:

B02BD04

INN (Jina la Kimataifa):

nonacog alfa

Kundi la matibabu:

Antihemorrhagics

Eneo la matibabu:

Hemophilia B

Matibabu dalili:

Treatment and prophylaxis of bleeding in patients with haemophilia B (congenital factor-IX deficiency).,

Bidhaa muhtasari:

Revision: 42

Idhini hali ya:

Authorised

Idhini ya tarehe:

1997-08-27

Taarifa za kipeperushi

                                1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
BeneFIX 250 IU powder and solvent for solution for injection
BeneFIX 500 IU powder and solvent for solution for injection
BeneFIX 1000 IU powder and solvent for solution for injection
BeneFIX 1500 IU powder and solvent for solution for injection
BeneFIX 2000 IU powder and solvent for solution for injection
BeneFIX 3000 IU powder and solvent for solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
BeneFIX 250 IU powder and solvent for solution for injection
Each vial contains nominally 250 IU nonacog alfa (recombinant
coagulation factor IX). After
reconstitution with the accompanying 5 mL (0.234%) sodium chloride
solution for injection, each mL
of the solution contains approximately 50 IU nonacog alfa.
BeneFIX 500 IU powder and solvent for solution for injection
Each vial contains nominally 500 IU nonacog alfa (recombinant
coagulation factor IX). After
reconstitution with the accompanying 5 mL (0.234%) sodium chloride
solution for injection, each mL
of the solution contains approximately 100 IU nonacog alfa.
BeneFIX 1000 IU powder and solvent for solution for injection
Each vial contains nominally 1000 IU nonacog alfa (recombinant
coagulation factor IX). After
reconstitution with the accompanying 5 mL (0.234%) sodium chloride
solution for injection, each mL
of the solution contains approximately 200 IU nonacog alfa.
BeneFIX 1500 IU powder and solvent for solution for injection
Each vial contains nominally 1500 IU nonacog alfa (recombinant
coagulation factor IX). After
reconstitution with the accompanying 5 mL (0.234%) sodium chloride
solution for injection, each mL
of the solution contains approximately 300 IU nonacog alfa.
BeneFIX 2000 IU powder and solvent for solution for injection
Each vial contains nominally 2000 IU nonacog alfa (recombinant
coagulation factor IX). After
reconstitution with the accompanying 5 mL (0.234%) sodium chloride
solution for injection, each mL
of the solution contains approximately 400 IU non
                                
                                Soma hati kamili

Tabia za bidhaa

                                1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
BeneFIX 250 IU powder and solvent for solution for injection
BeneFIX 500 IU powder and solvent for solution for injection
BeneFIX 1000 IU powder and solvent for solution for injection
BeneFIX 1500 IU powder and solvent for solution for injection
BeneFIX 2000 IU powder and solvent for solution for injection
BeneFIX 3000 IU powder and solvent for solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
BeneFIX 250 IU powder and solvent for solution for injection
Each vial contains nominally 250 IU nonacog alfa (recombinant
coagulation factor IX). After
reconstitution with the accompanying 5 mL (0.234%) sodium chloride
solution for injection, each mL
of the solution contains approximately 50 IU nonacog alfa.
BeneFIX 500 IU powder and solvent for solution for injection
Each vial contains nominally 500 IU nonacog alfa (recombinant
coagulation factor IX). After
reconstitution with the accompanying 5 mL (0.234%) sodium chloride
solution for injection, each mL
of the solution contains approximately 100 IU nonacog alfa.
BeneFIX 1000 IU powder and solvent for solution for injection
Each vial contains nominally 1000 IU nonacog alfa (recombinant
coagulation factor IX). After
reconstitution with the accompanying 5 mL (0.234%) sodium chloride
solution for injection, each mL
of the solution contains approximately 200 IU nonacog alfa.
BeneFIX 1500 IU powder and solvent for solution for injection
Each vial contains nominally 1500 IU nonacog alfa (recombinant
coagulation factor IX). After
reconstitution with the accompanying 5 mL (0.234%) sodium chloride
solution for injection, each mL
of the solution contains approximately 300 IU nonacog alfa.
BeneFIX 2000 IU powder and solvent for solution for injection
Each vial contains nominally 2000 IU nonacog alfa (recombinant
coagulation factor IX). After
reconstitution with the accompanying 5 mL (0.234%) sodium chloride
solution for injection, each mL
of the solution contains approximately 400 IU non
                                
                                Soma hati kamili

Bidhaa zinazofanana

Viambatanisho vya kazi Nonacog alfa

Nonacog alfa

ATC kanuni B02BD04

B02BD04

Mzalishaji au wazalishaji wadogowadogo Pfizer Europe MA EEIG

Pfizer Europe MA EEIG

INN (Jina la Kimataifa) nonacog alfa

nonacog alfa

Nyaraka katika lugha zingine

Taarifa za kipeperushi Taarifa za kipeperushi Kibulgaria 17-10-2022
Tabia za bidhaa Tabia za bidhaa Kibulgaria 17-10-2022
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kibulgaria 30-10-2015
Taarifa za kipeperushi Taarifa za kipeperushi Kihispania 17-10-2022
Tabia za bidhaa Tabia za bidhaa Kihispania 17-10-2022
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kihispania 30-10-2015
Taarifa za kipeperushi Taarifa za kipeperushi Kicheki 17-10-2022
Tabia za bidhaa Tabia za bidhaa Kicheki 17-10-2022
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kicheki 30-10-2015
Taarifa za kipeperushi Taarifa za kipeperushi Kidenmaki 17-10-2022
Tabia za bidhaa Tabia za bidhaa Kidenmaki 17-10-2022
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kidenmaki 30-10-2015
Taarifa za kipeperushi Taarifa za kipeperushi Kijerumani 17-10-2022
Tabia za bidhaa Tabia za bidhaa Kijerumani 17-10-2022
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kijerumani 30-10-2015
Taarifa za kipeperushi Taarifa za kipeperushi Kiestonia 17-10-2022
Tabia za bidhaa Tabia za bidhaa Kiestonia 17-10-2022
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kiestonia 30-10-2015
Taarifa za kipeperushi Taarifa za kipeperushi Kigiriki 17-10-2022
Tabia za bidhaa Tabia za bidhaa Kigiriki 17-10-2022
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kigiriki 30-10-2015
Taarifa za kipeperushi Taarifa za kipeperushi Kifaransa 17-10-2022
Tabia za bidhaa Tabia za bidhaa Kifaransa 17-10-2022
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kifaransa 30-10-2015
Taarifa za kipeperushi Taarifa za kipeperushi Kiitaliano 17-10-2022
Tabia za bidhaa Tabia za bidhaa Kiitaliano 17-10-2022
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kiitaliano 30-10-2015
Taarifa za kipeperushi Taarifa za kipeperushi Kilatvia 17-10-2022
Tabia za bidhaa Tabia za bidhaa Kilatvia 17-10-2022
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kilatvia 30-10-2015
Taarifa za kipeperushi Taarifa za kipeperushi Kilithuania 17-10-2022
Tabia za bidhaa Tabia za bidhaa Kilithuania 17-10-2022
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kilithuania 30-10-2015
Taarifa za kipeperushi Taarifa za kipeperushi Kihungari 17-10-2022
Tabia za bidhaa Tabia za bidhaa Kihungari 17-10-2022
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kihungari 30-10-2015
Taarifa za kipeperushi Taarifa za kipeperushi Kimalta 17-10-2022
Tabia za bidhaa Tabia za bidhaa Kimalta 17-10-2022
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kimalta 30-10-2015
Taarifa za kipeperushi Taarifa za kipeperushi Kiholanzi 17-10-2022
Tabia za bidhaa Tabia za bidhaa Kiholanzi 17-10-2022
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kiholanzi 30-10-2015
Taarifa za kipeperushi Taarifa za kipeperushi Kipolandi 17-10-2022
Tabia za bidhaa Tabia za bidhaa Kipolandi 17-10-2022
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kipolandi 30-10-2015
Taarifa za kipeperushi Taarifa za kipeperushi Kireno 17-10-2022
Tabia za bidhaa Tabia za bidhaa Kireno 17-10-2022
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kireno 30-10-2015
Taarifa za kipeperushi Taarifa za kipeperushi Kiromania 17-10-2022
Tabia za bidhaa Tabia za bidhaa Kiromania 17-10-2022
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kiromania 30-10-2015
Taarifa za kipeperushi Taarifa za kipeperushi Kislovakia 17-10-2022
Tabia za bidhaa Tabia za bidhaa Kislovakia 17-10-2022
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kislovakia 30-10-2015
Taarifa za kipeperushi Taarifa za kipeperushi Kislovenia 17-10-2022
Tabia za bidhaa Tabia za bidhaa Kislovenia 17-10-2022
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kislovenia 30-10-2015
Taarifa za kipeperushi Taarifa za kipeperushi Kifinlandi 17-10-2022
Tabia za bidhaa Tabia za bidhaa Kifinlandi 17-10-2022
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kifinlandi 30-10-2015
Taarifa za kipeperushi Taarifa za kipeperushi Kiswidi 17-10-2022
Tabia za bidhaa Tabia za bidhaa Kiswidi 17-10-2022
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kiswidi 30-10-2015
Taarifa za kipeperushi Taarifa za kipeperushi Kinorwe 17-10-2022
Tabia za bidhaa Tabia za bidhaa Kinorwe 17-10-2022
Taarifa za kipeperushi Taarifa za kipeperushi Kiaisilandi 17-10-2022
Tabia za bidhaa Tabia za bidhaa Kiaisilandi 17-10-2022
Taarifa za kipeperushi Taarifa za kipeperushi Kroeshia 17-10-2022
Tabia za bidhaa Tabia za bidhaa Kroeshia 17-10-2022
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kroeshia 30-10-2015

Tafuta arifu zinazohusiana na bidhaa hii

Taadhari BeneFIX Nonacog alfa

BeneFIX Nonacog alfa

Tazama historia ya hati

Historia ya nyaraka Historia ya nyaraka

BeneFIX