Օկտանին

Հիմնական տեղեկություններ

  • Ֆիրմային անվանումը:
  • Օկտանին Ֆ 1000ՄՄ
  • Դոզան:
  • 1000ՄՄ
  • Դեղագործական ձեւ:
  • դեղափոշի ն/ե ներարկման լուծույթի
  • Միավորները փաթեթում:
  • ապակե սրվակ, 10մլ լուծիչ ապակե սրվակում, միանվագ ներարկիչ, փոխանցման հավաքածու (երկծայր ասեղ, ֆիլտր ասեղ), կաթիլաներարկման հավաք
  • Ռեկվիզորի տեսակը:
  • Դեղատոմսով
  • Բժշկության տիրույթում:
  • Մարդիկ
  • Բժշկության տեսակ:
  • Ալլոպատիկ դեղամիջոց
  • Պատրաստված է:
  • Օկտաֆարմա Ֆարմազյուտիկա Պրոդուկտիոնսգես.մ.բ.Հ.

Փաստաթղթեր

  • Հանրության համար:
  • Այս ապրանքի տեղեկատվական թերթիկը ներկայումս մատչելի չէ, դուք կարող եք խնդրանքը ուղարկել մեր հաճախորդների սպասարկմանը եւ մենք կտեղեկացնենք այն ժամանակ, երբ մենք կարող ենք ձեռք բերել այն:


    Տեղեկատվության թերթիկից պահանջել հանրությանը:

Տեղայնացումը

  • Հասանելի է:
  • Օկտանին Ֆ 1000ՄՄ
    አርሜኒያ
  • Լեզու:
  • አማርኛ

Այլ տեղեկություններ

Կարգավիճակը

  • Աղբյուրը:
  • Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում - Armenia
  • Վերջին թարմացումը:
  • 09-08-2016
  • Այս ապրանքի տեղեկատվական թերթիկը ներկայումս մատչելի չէ, դուք կարող եք խնդրանքը ուղարկել մեր հաճախորդների սպասարկմանը եւ մենք կտեղեկացնենք այն ժամանակ, երբ մենք կարող ենք ձեռք բերել այն:

    Տեղեկատվության թերթիկից պահանջել հանրությանը:



  • Այլ լեզուներով փաստաթղթերը հասանելի են Այստեղ
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28-3-2018

Orphan designation:  Recombinant fusion protein linking coagulation factor VIIa with albumin,  for the: Treatment of congenital factor VII deficiency

Orphan designation: Recombinant fusion protein linking coagulation factor VIIa with albumin, for the: Treatment of congenital factor VII deficiency

On 7 October 2013, orphan designation (EU/3/13/1188) was granted by the European Commission to CSL Behring GmbH, Germany, for recombinant fusion protein linking coagulation factor VIIa with albumin for the treatment of congenital factor VII deficiency.

Europe - EMA - European Medicines Agency

28-3-2018

Orphan designation:  Recombinant fusion protein linking human coagulation factor VIIa with human albumin,  for the: Treatment of haemophilia B

Orphan designation: Recombinant fusion protein linking human coagulation factor VIIa with human albumin, for the: Treatment of haemophilia B

On 13 May 2011, orphan designation (EU/3/11/863) was granted by the European Commission to CSL Behring GmbH, Germany, for recombinant fusion protein linking human coagulation factor VIIa with human albumin for the treatment of haemophilia B.

Europe - EMA - European Medicines Agency

2-2-2018

ORTHO T. cruzi ELISA Test System

ORTHO T. cruzi ELISA Test System

Donor screening test to detect antibodies to T. cruzi in plasma and serum samples from individual human donors, including donors of whole blood, blood components or source plasma, and other living donors. It is also intended for use to screen organ and tissue donors when specimens are obtained while the donor's heart is still beating

FDA - U.S. Food and Drug Administration

11-12-2017

FDA Drug Safety Communication: Updated information on drug interactions between Victrelis (boceprevir) and certain boosted HIV protease inhibitor drugs

FDA Drug Safety Communication: Updated information on drug interactions between Victrelis (boceprevir) and certain boosted HIV protease inhibitor drugs

The U.S. Food and Drug Administration (FDA) is notifying the public that co-administration of Victrelis (boceprevir), a hepatitis C virus (HCV) protease inhibitor, along with certain ritonavir-boosted human immunodeficiency virus (HIV) protease inhibitors, is not recommended at this time because of the possibility of reducing the effectiveness of the medicines, permitting the amount of HCV or HIV virus in the blood (viral load) to increase.

FDA - U.S. Food and Drug Administration

12-10-2017

Scientific guideline:  Guideline on good pharmacovigilance practices (GVP): Module IX – Signal management (Rev. 1), adopted

Scientific guideline: Guideline on good pharmacovigilance practices (GVP): Module IX – Signal management (Rev. 1), adopted

Revision 1 is a major revision with modifications throughout and contains the following: - Revised definition and process for emerging safety issues, previously addressed in GVP Module VI (IX.A.1.1. and IX.C.2.); - Streamlined information on scientific aspects of signal management (IX.B.2. to IX.B.4.), statistical aspects now addressed in Addendum I;

Europe - EFSA - European Food Safety Authority EFSA Journal

28-9-2017

FDA approves new treatment for certain advanced or metastatic breast cancers

FDA approves new treatment for certain advanced or metastatic breast cancers

The U.S. Food and Drug Administration today approved Verzenio (abemaciclib) to treat adult patients who have hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer that has progressed after taking therapy that alters a patient’s hormones (endocrine therapy).

FDA - U.S. Food and Drug Administration

6-4-2018

EU/3/12/1072 (Le4D Limited)

EU/3/12/1072 (Le4D Limited)

EU/3/12/1072 (Active substance: Encapsulated human retinal pigment epithelial cell line transfected with plasmid vector expressing human ciliary neurotrophic factor) - Transfer of orphan designation - Commission Decision (2018)2008 of Fri, 06 Apr 2018 European Medicines Agency (EMA) procedure number: EMA/OD/160/11/T/01

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/1999 (uniQure Biopharma B.V.)

EU/3/18/1999 (uniQure Biopharma B.V.)

EU/3/18/1999 (Active substance: Recombinant adeno-associated viral vector containing a codon-optimized Padua derivative of human coagulation factor IX cDNA) - Orphan designation - Commission Decision (2018)1888 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/232/17

Europe -DG Health and Food Safety

23-3-2018

COAGADEX (Coagulation Factor X Human) Kit [Bio Products Laboratory Limited]

COAGADEX (Coagulation Factor X Human) Kit [Bio Products Laboratory Limited]

Updated Date: Mar 23, 2018 EST

US - DailyMed

21-3-2018

EU/3/15/1595 (Quintiles Ireland Limited)

EU/3/15/1595 (Quintiles Ireland Limited)

EU/3/15/1595 (Active substance: Live attenuated Listeria monocytogenes bioengineered with a chimeric human epidermal growth factor receptor 2 fused to a truncated form of the Lm protein listeriolysin O) - Transfer of orphan designation - Commission Decision (2018)1819 of Wed, 21 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/162/15/5T/01

Europe -DG Health and Food Safety

26-2-2018

EU/3/18/1979 (Bayer AG)

EU/3/18/1979 (Bayer AG)

EU/3/18/1979 (Active substance: Human monoclonal IgG2 antibody against tissue factor pathway inhibitor) - Orphan designation - Commission Decision (2018)1246 of Mon, 26 Feb 2018 European Medicines Agency (EMA) procedure number: EMA/OD/189/17

Europe -DG Health and Food Safety

24-1-2018

ADVATE (Antihemophilic Factor, Human Recombinant) Kit [Baxalta US Inc.]

ADVATE (Antihemophilic Factor, Human Recombinant) Kit [Baxalta US Inc.]

Updated Date: Jan 24, 2018 EST

US - DailyMed

19-1-2018

BDNF (Brain-Derived Neurotrophic Factor Human) Spray [VIATREXX BIO INCORPORATED]

BDNF (Brain-Derived Neurotrophic Factor Human) Spray [VIATREXX BIO INCORPORATED]

Updated Date: Jan 19, 2018 EST

US - DailyMed

2-1-2018

PROFILNINE (Factor Ix Complex) Kit [GRIFOLS USA, LLC]

PROFILNINE (Factor Ix Complex) Kit [GRIFOLS USA, LLC]

Updated Date: Jan 2, 2018 EST

US - DailyMed

29-12-2017

ALPHANINE SD (Coagulation Factor Ix (Human)) Kit [GRIFOLS USA, LLC]

ALPHANINE SD (Coagulation Factor Ix (Human)) Kit [GRIFOLS USA, LLC]

Updated Date: Dec 29, 2017 EST

US - DailyMed

1-12-2017

REBINYN ((Coagulation Factor Ix (Recombinant), Glycopegylated)) Kit [Novo Nordisk]

REBINYN ((Coagulation Factor Ix (Recombinant), Glycopegylated)) Kit [Novo Nordisk]

Updated Date: Dec 1, 2017 EST

US - DailyMed

29-11-2017

RIXUBIS (Coagulation Factor Ix (Recombinant)) Kit [BAXALTA US INC.]

RIXUBIS (Coagulation Factor Ix (Recombinant)) Kit [BAXALTA US INC.]

Updated Date: Nov 29, 2017 EST

US - DailyMed

20-11-2017

KOGENATE Bayer (Bayer AG)

KOGENATE Bayer (Bayer AG)

KOGENATE Bayer (Active substance: Recombinant coagulation factor VIII (octocog alfa)) - Referral - Commission Decision (2017)7811 of Mon, 20 Nov 2017 European Medicines Agency (EMA) procedure number: EMEA/H/C/275/A31/185

Europe -DG Health and Food Safety

20-11-2017

Helixate NexGen (Bayer AG)

Helixate NexGen (Bayer AG)

Helixate NexGen (Active substance: Recombinant coagulation factor VIII (octocog alfa)) - Referral - Commission Decision (2017)7812 of Mon, 20 Nov 2017 European Medicines Agency (EMA) procedure number: EMEA/H/C/276/A31/178

Europe -DG Health and Food Safety

16-11-2017

BEBULIN (Coagulation Factor Ix Human) Kit [Baxalta Incorporated]

BEBULIN (Coagulation Factor Ix Human) Kit [Baxalta Incorporated]

Updated Date: Nov 16, 2017 EST

US - DailyMed

13-11-2017

Human coagulation factor VIII

Human coagulation factor VIII

Human coagulation factor VIII (Active substance: Human coagulation factor VIII) - Community Referrals - Art 31 - Commission Decision (2017)7630 of Mon, 13 Nov 2017 European Medicines Agency (EMA) procedure number: EMEA/H/A-31/1448

Europe -DG Health and Food Safety

30-10-2017

Scientific guideline:  Draft guideline on clinical investigation of recombinant and 4 human plasma-derived factor VIII products, draft: consultation open

Scientific guideline: Draft guideline on clinical investigation of recombinant and 4 human plasma-derived factor VIII products, draft: consultation open

This guideline describes the information to be documented when an application for a marketing authorisation for recombinant or human plasma-derived factor VIII products is made for use in treatment and prevention of bleeding in patients with haemophilia A. The guidance covers clinical investigations to be conducted pre- and post-marketing authorisation. Guidance is also provided for authorised products where a significant change in the manufacturing process has been made.

Europe - EMA - European Medicines Agency

30-10-2017

Scientific guideline:  Draft guideline on core SmPC for human plasma derived and recombinant coagulation factor VIII products, draft: consultation open

Scientific guideline: Draft guideline on core SmPC for human plasma derived and recombinant coagulation factor VIII products, draft: consultation open

This guideline describes the information to be included in the Summary of Product Characteristics (SmPC) for human plasma derived and recombinant coagulation factor VIII products, which are indicated for use in the treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency). In case of an indication claim in von Willebrand’s disease, see also core SmPC for von Willebrand factor products (CPMP/BPWG/278/02).

Europe - EMA - European Medicines Agency

23-10-2017

CORIFACT (Factor Xiii Concentrate (Human)) Kit [CSL Behring GmbH]

CORIFACT (Factor Xiii Concentrate (Human)) Kit [CSL Behring GmbH]

Updated Date: Oct 23, 2017 EST

US - DailyMed

2-10-2017

NOVOSEVEN RT (Coagulation Factor Viia (Recombinant)) Kit [Novo Nordisk]

NOVOSEVEN RT (Coagulation Factor Viia (Recombinant)) Kit [Novo Nordisk]

Updated Date: Oct 2, 2017 EST

US - DailyMed

15-9-2017

News and press releases:  Factor VIII medicines: no clear and consistent evidence of difference in risk of inhibitor development between classes

News and press releases: Factor VIII medicines: no clear and consistent evidence of difference in risk of inhibitor development between classes

EMA concludes review of human factor VIII medicines authorised in EU

Europe - EMA - European Medicines Agency

25-8-2017

EU/3/17/1909 (Vaximm GmbH)

EU/3/17/1909 (Vaximm GmbH)

EU/3/17/1909 (Active substance: Salmonella typhi Ty21a strain transfected with a plasmid vector encoding the human vascular endothelial growth factor receptor 2) - Orphan designation - Commission Decision (2017)5918 of Fri, 25 Aug 2017 European Medicines Agency (EMA) procedure number: EMA/OD/069/17

Europe -DG Health and Food Safety

25-8-2017

EU/3/17/1908 (Dorian Regulatory Affairs BV)

EU/3/17/1908 (Dorian Regulatory Affairs BV)

EU/3/17/1908 (Active substance: Recombinant truncated N-terminal fragment of human lens epithelium-derived growth factor) - Orphan designation - Commission Decision (2017)5917 of Fri, 25 Aug 2017 European Medicines Agency (EMA) procedure number: EMA/OD/086/17

Europe -DG Health and Food Safety

21-8-2017

EU/3/10/847 (Bayer AG)

EU/3/10/847 (Bayer AG)

EU/3/10/847 (Active substance: Pegylated B-domain-deleted sequence-modified recombinant human factor VIII) - Transfer of orphan designation - Commission Decision (2017)5793 of Mon, 21 Aug 2017 European Medicines Agency (EMA) procedure number: EMA/OD/128/10/T/01

Europe -DG Health and Food Safety