תבנית:תרופה/בקסרו - Bexsero

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×§×××¦× ×¤×¨××§××××××ª (ATC4)	J07AH Meningococcal vaccines
××¨××× ×¤×¢×× (ATC5)	Â Neisseria meningitides group b strain nz98/254 25 MCG âJ07AH06 Neisseria meningitides group b strain nz98/254 25 MCG âJ07AH06 Neisseria meningitidis group b fhbp fusion protein 50 MCG âJ07AH06 Neisseria meningitidis group b nada protein 50 MCG âJ07AH06 Neisseria meningitidis group b nhba fusion protein 50 MCG âJ07AH06 Meningococcal vaccines J07AH âJ07AH06 Via fiorentina 1, 53100 SIENA, ITALY For NHBA, NadA, fHBP proteins: storage (backup) and quality control testing of Master and Working Seeds, quality control testing. For OMV: storage (backup and short term) and quality control testing of Master and Working Seeds, fermentation, harvesting, and purification of OMV and quality control testing. For the final product: quality control testing âJ07AH06 Bellaria-rosia, i-53018 sovicille (si), italy For NHBA, NadA, fHBP proteins: manufacture, storage, and quality control testing of Master and Working Seeds, quality control testing and batch release of concentrated bulk. For OMV: manufacture, storage, and quality control testing of Master and Working Seeds, fermentation, harvesting, and purification of OMV, sterile filtration of OMV, quality control testing and batch release of Drug Substance. For the final product: formulation, filling, inspection, labeling, and packaging, quality control testing and batch release of Drug Product. âJ07AH06 Biochemiestrasse 10, A-6250 KUNDL, AUSTRIA For NHBA, NadA, fHBP proteins: fermentation, harvesting, and purification of recombinant protein and quality control testing âJ07AH06 Neisseria meningitides group b strain nz98/254 25 MCG âJ07AH06 Neisseria meningitidis group b fhbp fusion protein 50 MCG âJ07AH06 Neisseria meningitidis group b nada protein 50 MCG âJ07AH06 Neisseria meningitidis group b nhba fusion protein 50 MCG âJ07AH06
×¦××¨×ª ××ª×	I.M
×¦××¨×ª ××× ××	SUSPENSION FOR INJECTION
××ª××××	Bexsero is indicated for active immunization of individuals from 2 months of age and older against invasive meningococcal disease caused by Neisseria meningitidis group B.
××ª×××ª ××× ××	Posology and method of administration
××ª×××××ª × ××	Contraindications
×ª××¤×¢××ª ×××××	Undesirable effects
×ª×××××ª ××× ×ª×¨××¤×ª×××ª	Interaction with other medicinal products and other forms of interaction
×©××××© ××××¨××× ××× ×§×	Pregnancy and Lactation
×¤×¨××§×××× ×××§×	Pharmacodynamic Properties
×¤×¨××§××§×× ×××§×	Pharmacokinetic Properties
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×©× ××¦×¨×	GLAXO SMITHKLINE VACCINES S.R.L., ITALY
×©× ××¢× ××¨××©××	GLAXO SMITH KLINE (ISRAEL) LTD
×¨××©×××	×ª××¨×× ×××©×: 01/2015. ×¨××©××× ××ª××¨××: 03/2016
×ª××¨×× ×¢×××× ×××¨××	14/05/19

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השינוי האחרון נעשה בֹ־6 באפריל 2021 ב־23:41

תבנית:תרופה/בקסרו - Bexsero

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