Miljöpåverkan
Influensavirus A/Darwin/9/2021 (H3N2)-liknande stam (A/Norway/16606/2021, MEDI 355293), levande försvagat
Miljörisk:
Användning av vacciner bedöms inte medföra någon miljöpåverkan.
Läs mer
Detaljerad miljöinformation
Fluenz Tetra consists of our live attenuated (weakened), vaccine strains of type A/H1N1, type A/H3N2 and 2 type B virus strains. As the exact type of strain may be adjusted based on annual advice issued by the WHO (World Health Organisation), the precise combination of strains can be found in the product information.
According to the European Medicines Agency guideline (Ref. 1) on environmental risk assessments for pharmaceuticals (EMA/CHMP/SWP/4447/00), vitamins, electrolytes, amino acids, peptides, proteins, carbohydrates, lipids, vaccines and herbal medicinal products are exempted because they are unlikely to result in significant risk to the environment.
Enligt den europeiska läkemedelsmyndigheten EMA:s riktlinjer för miljöriskbedömningar av läkemedelssubstanser (EMA/CHMP/SWP/4447/00), är vitaminer, elektrolyter, aminosyror, peptider, proteiner, kolhydrater, lipider, vacciner och växtbaserade läkemedel undantagna då de inte bedöms medföra någon betydande risk för miljön.
Even though biomolecules are exempted from environmental risk classification it should be remembered that these molecules may be biologically active.
In Swedish: Även om biomolekyler är undantagna från miljöriskklassificering bör det beaktas att dessa molekyler kan vara biologiskt aktiva.
As the vaccine virus strains in Fluenz Tetra are classed as genetically modified organisms under European guidance, a full assessment has been conducted according to the European Union (EU) Directive 2001/18/EC to identify and evaluate potential adverse effects on human health (other than the intended recipients) and the environment, which may result from the placing on the market of the genetically modified organism (GMO). This assessment concluded that the overall risk from Fluenz Tetra is negligible and the conclusions of this assessment are unlikely to be impacted by any annual strain updates.
This justifies the phrase:
Use of Fluenz Tetra has been considered to result in insignificant environmental impact.
In Swedish: Användning av Fluenz Tetra bedöms inte medföra någon miljöpåverkan.
References
-
Committee for Medicinal Products for Human Use (CHMP). Guideline on the Environmental Risk Assessment of Medicinal Products for Human Use. EMEA/CPMP/SWP/4447/00 corr2. 1 June 2006
Influensavirus B/Austria/1359417/2021-liknande stam (B/Austria/1359417/2021, MEDI 355292), levande försvagat
Miljörisk:
Användning av vacciner bedöms inte medföra någon miljöpåverkan.
Läs mer
Detaljerad miljöinformation
Fluenz Tetra consists of our live attenuated (weakened), vaccine strains of type A/H1N1, type A/H3N2 and 2 type B virus strains. As the exact type of strain may be adjusted based on annual advice issued by the WHO (World Health Organisation), the precise combination of strains can be found in the product information.
According to the European Medicines Agency guideline (Ref. 1) on environmental risk assessments for pharmaceuticals (EMA/CHMP/SWP/4447/00), vitamins, electrolytes, amino acids, peptides, proteins, carbohydrates, lipids, vaccines and herbal medicinal products are exempted because they are unlikely to result in significant risk to the environment.
Enligt den europeiska läkemedelsmyndigheten EMA:s riktlinjer för miljöriskbedömningar av läkemedelssubstanser (EMA/CHMP/SWP/4447/00), är vitaminer, elektrolyter, aminosyror, peptider, proteiner, kolhydrater, lipider, vacciner och växtbaserade läkemedel undantagna då de inte bedöms medföra någon betydande risk för miljön.
Even though biomolecules are exempted from environmental risk classification it should be remembered that these molecules may be biologically active.
In Swedish: Även om biomolekyler är undantagna från miljöriskklassificering bör det beaktas att dessa molekyler kan vara biologiskt aktiva.
As the vaccine virus strains in Fluenz Tetra are classed as genetically modified organisms under European guidance, a full assessment has been conducted according to the European Union (EU) Directive 2001/18/EC to identify and evaluate potential adverse effects on human health (other than the intended recipients) and the environment, which may result from the placing on the market of the genetically modified organism (GMO). This assessment concluded that the overall risk from Fluenz Tetra is negligible and the conclusions of this assessment are unlikely to be impacted by any annual strain updates.
This justifies the phrase:
Use of Fluenz Tetra has been considered to result in insignificant environmental impact.
In Swedish: Användning av Fluenz Tetra bedöms inte medföra någon miljöpåverkan.
References
-
Committee for Medicinal Products for Human Use (CHMP). Guideline on the Environmental Risk Assessment of Medicinal Products for Human Use. EMEA/CPMP/SWP/4447/00 corr2. 1 June 2006
Influensavirus B/Phuket/3073/2013-liknande stam (B/Phuket/3073/2013, MEDI 306444), levande försvagat
Miljörisk:
Användning av vacciner bedöms inte medföra någon miljöpåverkan.
Läs mer
Detaljerad miljöinformation
Fluenz Tetra consists of our live attenuated (weakened), vaccine strains of type A/H1N1, type A/H3N2 and 2 type B virus strains. As the exact type of strain may be adjusted based on annual advice issued by the WHO (World Health Organisation), the precise combination of strains can be found in the product information.
According to the European Medicines Agency guideline (Ref. 1) on environmental risk assessments for pharmaceuticals (EMA/CHMP/SWP/4447/00), vitamins, electrolytes, amino acids, peptides, proteins, carbohydrates, lipids, vaccines and herbal medicinal products are exempted because they are unlikely to result in significant risk to the environment.
Enligt den europeiska läkemedelsmyndigheten EMA:s riktlinjer för miljöriskbedömningar av läkemedelssubstanser (EMA/CHMP/SWP/4447/00), är vitaminer, elektrolyter, aminosyror, peptider, proteiner, kolhydrater, lipider, vacciner och växtbaserade läkemedel undantagna då de inte bedöms medföra någon betydande risk för miljön.
Even though biomolecules are exempted from environmental risk classification it should be remembered that these molecules may be biologically active.
In Swedish: Även om biomolekyler är undantagna från miljöriskklassificering bör det beaktas att dessa molekyler kan vara biologiskt aktiva.
As the vaccine virus strains in Fluenz Tetra are classed as genetically modified organisms under European guidance, a full assessment has been conducted according to the European Union (EU) Directive 2001/18/EC to identify and evaluate potential adverse effects on human health (other than the intended recipients) and the environment, which may result from the placing on the market of the genetically modified organism (GMO). This assessment concluded that the overall risk from Fluenz Tetra is negligible and the conclusions of this assessment are unlikely to be impacted by any annual strain updates.
This justifies the phrase:
Use of Fluenz Tetra has been considered to result in insignificant environmental impact.
In Swedish: Användning av Fluenz Tetra bedöms inte medföra någon miljöpåverkan.
References
-
Committee for Medicinal Products for Human Use (CHMP). Guideline on the Environmental Risk Assessment of Medicinal Products for Human Use. EMEA/CPMP/SWP/4447/00 corr2. 1 June 2006