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Optaflu (influenza virus surface antigens (haemagglutinin...) – Packaging - J07BB02

Updated on site: 09-Oct-2017

Medication nameOptaflu
ATC CodeJ07BB02
Substanceinfluenza virus surface antigens (haemagglutinin and neuraminidase), inactivated, of the following strains:A/California/7/2009 (H1N1)pdm09 - like strain(A/Brisbane/10/2010, wild type)A/Switzerland/9715293/2013 (H3N2) - like strain(A/South Australia/55/201
ManufacturerSeqirus GmbH

Article Contents

MA (EU) Number

(Invented)

Strength

Pharmaceutical Form

Route of

Immediate

Content

Pack size

 

 

name

1

 

Administration

Packaging

(concentration)

 

EU/1/07/394/001

Optaflu

Suspension for

Intramuscular use

pre-filled syringe

0.5 ml

1 pre-filled syringe (Luer

--

 

 

 

injection

 

(glass)

 

 

Cone)

 

 

 

1

 

 

 

EU/1/07/394/002

Optaflu

Suspension for

Intramuscular use

pre-filled syringe

0.5 ml

10 pre-filled syringes

--

 

 

 

injection

 

(glass)

 

 

(Luer Cone)

 

 

 

1

 

 

 

EU/1/07/394/003

Optaflu

Suspension for

Intramuscular use

pre-filled syringe

0.5 ml

2 x 10 pre-filled syringes

--

 

 

 

injection

 

(glass)

 

 

(Luer Cone)

 

 

 

1

 

 

 

EU/1/07/394/004

Optaflu

Suspension for

Intramuscular use

pre-filled syringe

0.5 ml

1 pre-filled syringe (Luer

--

 

 

 

injection

 

(glass)

 

 

Cone) + 1 needle

 

 

 

1

 

 

 

EU/1/07/394/005

Optaflu

Suspension for

Intramuscular use

pre-filled syringe

0.5 ml

10 pre-filled syringes

--

 

 

 

injection

 

(glass)

 

 

(Luer Cone) + 10 needles

 

 

 

1

 

 

 

EU/1/07/394/006

Optaflu

Suspension for

Intramuscular use

p e-filled syringe

0.5 ml

2 x 10 pre-filled syringes

--

 

 

 

injection

 

(glass)

authorised(Luer Cone) + 20 needles

 

 

 

1

 

EU/1/07/394/007

Optaflu

Suspension for

Intramuscular use

pre-fill d syringe

0.5 ml

1 pre-filled syringe (Luer

--

 

 

 

injection

 

( lass)

 

 

Lock)

 

 

 

1

 

 

 

EU/1/07/394/008

Optaflu

Suspension for

Intramuscular use

pre-filled syringe

0.5 ml

10 pre-filled syringes

--

 

 

 

injection

 

(glass)

 

 

(Luer Lock)

 

 

 

1

 

 

 

EU/1/07/394/009

Optaflu

Suspension for

Intramuscu ar use

pre-filled syringe

0.5 ml

2 x 10 pre-filled syringes

--

 

 

 

injection

 

(glass)

 

 

(Luer Lock)

 

 

 

--1

 

 

 

EU/1/07/394/010

Optaflu

Suspension for

Intramuscu ar use

pre-filled syringe

0.5 ml

1 pre-filled syringe (Luer

 

 

 

 

injection

longer

 

Lock) + 1 needle

 

 

 

--1

 

(glass)

 

 

EU/1/07/394/011

Optaflu

Suspension for

I tramuscular use

pre-filled syringe

0.5 ml

10 pre-filled syringe

 

 

 

 

injection

no

(glass)

 

 

(Luer Lock) + 10 needles

--1

 

 

 

 

 

 

 

 

Influenza virus surface antigens (haemagglutinin and neuraminidase)*, inactivated, of the following strains:

 

 

 

A/California/7/2009 (H1N1)pdm09- like strain (A/Brisbane/10/2010, wild type)

 

15 micrograms HA**

 

A/Switzerland/9715293/2013 (H3N2) - like strain (A/S uth Australia/55/2014, wild type)

 

15 micrograms HA**

 

B/Phuket/3073/2013 – like strain (B/Utah/9/2014, wildproducttype)

 

 

15 micrograms HA**

 

 

 

 

 

 

 

 

per 0.5 ml dose

 

*

propagated in Madin Darby Ca i e Kid ey (MDCK) cells

 

 

 

 

 

**

haemagglutinin

 

 

 

 

 

 

 

 

 

Medicinal

 

1/1

 

 

 

 

 

 

 

 

 

 

 

 

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