FluQuadri

Main information

  • Trade name:
  • FluQuadri Inactivated Quadrivalent Influenza Vaccine (Split Virion), Influenza virus haemagglutinin 60mcg, 0.5mL suspension for
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • FluQuadri Inactivated Quadrivalent Influenza Vaccine (Split Virion), Influenza virus haemagglutinin 60mcg, 0.5mL suspension for
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 213963
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

213963

FluQuadri Inactivated Quadrivalent Influenza Vaccine (Split Virion), Influenza virus haemagglutinin 60mcg,

0.5mL suspension for injection

ARTG entry for

Medicine Registered

Sponsor

Sanofi-Aventis Australia Pty Ltd

Postal Address

Locked Bag 2227,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

2/12/2014

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. FluQuadri Inactivated Quadrivalent Influenza Vaccine (Split Virion), Influenza virus haemagglutinin 60mcg,

0.5mL suspension for injection 2017

Product Type

Single Medicine Product

Effective date

20/07/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

FluQuadri and FluQuadri Junior are indicated for active immunisation of influenza disease caused by influenza A subtype viruses and type B viruses

contained in the vaccine.

FluQuadri is indicated for use in adults and children 3 years and older.

FluQuadri Junior is indicated for use in children aged 6 months to 35 months inclusive.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Syringe

Glass Type I Clear

12 Months

Store at 2 to 8

degrees Celsius

Neither child resistant

closure nor restricted

flow insert

Do not Freeze

Pack Size/Poison information

Pack Size

Poison Schedule

5 syringes per pack

(S4) Prescription Only Medicine

10 syringes per pack

(S4) Prescription Only Medicine

Components

1. FluQuadri Inactivated Quadrivalent Influenza Vaccine (Split Virion), Influenza virus haemagglutinin 60mcg, 0.5mL suspension for

injection

Dosage Form

Injection, suspension

Route of Administration

Intramuscular

Visual Identification

Clear and slightly opalescent in colour

Active Ingredients

Influenza virus haemagglutinin

15 microgram

Influenza virus haemagglutinin

15 microgram

Influenza virus haemagglutinin

15 microgram

Influenza virus haemagglutinin

15 microgram

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 26.11.2017 at 10:42:30 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

FluQuadri™;

FluQuadri™ Junior

Inactivated Quadrivalent Influenza Vaccine (Split Virion)

Consumer Medicine Information

What is in this leaflet

Read all of this leaflet carefully

before you are vaccinated.

Keep this leaflet. You may need

to read it again.

If you have any further questions,

ask your doctor or pharmacist.

This vaccine has been prescribed

for you. Do not pass it on to

others.

If any of the side effects gets

serious, or if you notice any side

effects not listed in this leaflet,

please tell your doctor or

pharmacist.

In this leaflet:

What FluQuadri/FluQuadri Junior

are and what they are used for

Before you are given FluQuadri/

FluQuadri Junior

How FluQuadri/FluQuadri Junior

are given

Possible side effects

Storing FluQuadri/FluQuadri

Junior

Further information

What FluQuadri/

FluQuadri Junior are

and what they are

used for

FluQuadri and FluQuadri Junior are

vaccines. Vaccines are used to

protect you against infectious

diseases.

FluQuadri and FluQuadri Junior are

recommended to help protect you

against influenza. FluQuadri may be

administered to persons aged 36

months and older, especially who run

an increased risk of influenza-

associated complications. FluQuadri

Junior is designed for use in children

aged 6 to 35 months.

Influenza (flu) is a disease caused by

different types of virus. Influenza

viruses can spread rapidly, especially

in homes or institutions, where it can

be very easy for someone to catch flu

and spread the disease. The greatest

risk of catching flu is during the cold

months between May and October.

Your doctor will be able to

recommend the best time for you to

be vaccinated. Flu is present every

year, even when epidemics or

outbreaks are not reported.

The vaccine will only help to prevent

flu if it is caused by one of the four

strains of virus contained in the

vaccine, or other strains closely

related to them. FluQuadri/FluQuadri

Junior will not prevent flu if you are

incubating the disease before

vaccination or if it is caused by

another virus.

You should also note that many

germs can cause influenza-like

illness and the vaccine will not

protect you against these.

Previous injections of flu vaccine are

unlikely to give you protection

against the current strains of flu virus

which are most common this year, so

you will need to receive a vaccine

against flu every year especially if

you are at risk.

How They Work

FluQuadri and FluQuadri Junior

work by helping the body to make

antibodies. These antibodies help the

body to recognise the flu virus and

prevent the infection. It takes a few

weeks for the body to produce these

antibodies. The vaccine will protect

you only against the influenza

viruses contained in the vaccine (or

other strains closely related to them).

It will not protect you from viruses

that are unrelated to those contained

in the vaccine.

Before you are given

FluQuadri/FluQuadri

Junior

When you or your child

must not be given it

Do not have FluQuadri/FluQuadri

Junior

If you or your child ever had a

severe allergic reaction to:

Eggs or egg products

Any of the other ingredients of

FluQuadri/FluQuadri Junior listed

in the FURTHER

INFORMATION section.

If you or your child ever had a

severe allergic reaction after

getting any flu vaccine.

Before speaking to your doctor, if

you or your child has an acute

illness with or without high

temperature.

FLUQUADRI™; FLUQUADRI™ JUNIOR

Take special care with

FluQuadri/FluQuadri Junior

Tell your doctor if you or your

child has or has had Guillain-

Barré syndrome (severe muscle

weakness) after getting a flu

vaccine

Tell your doctor if you or your

child has or has had an immune

response problem because the

immune response to the vaccine

may be diminished

Tell your doctor if you are

pregnant or breast feeding.

Your doctor will discuss the possible

risks and benefits of having

FluQuadri during pregnancy or

breastfeeding. Sanofi Pasteur is

collecting information on pregnancy

outcomes and the health of newborn

following vaccination with

FluQuadri during pregnancy. Women

who receive FluQuadri during

pregnancy are encouraged to contact

Sanofi Pasteur directly or have their

doctor contact Sanofi Pasteur at 1800

829 468 (in Australia) or 0800 727

838 (in New Zealand)

Your doctor should make sure the

benefits of vaccination outweigh the

risks when recommending

FluQuadri/FluQuadri Junior.

Taking other medicines

Medicines that may reduce your

immune response: such as

corticosteroids (for example

prednisone), medicines used to

treat cancer (chemotherapy),

radiotherapy or other medicines

affecting the immune system. Tell

your doctor if you have been

treated with such medicines.

Please tell your doctor or

pharmacist if you are taking or

have recently taken any other

medicines, including medicines

obtained without prescription.

Having other vaccines

Your doctor will advise you if

FluQuadri/FluQuadri Junior is to

be given with another vaccine.

How FluQuadri/

FluQuadri Junior are

given

FluQuadri/FluQuadri Junior is

administered to you by your doctor

or your nurse.

Dose and Schedule

Adults and children over 35 months:

A single 0.5 mL injection

Children 6 to 35 months: A single

0.25 mL injection

Some children require a second

injection a month later.

Method of Administration

FluQuadri/FluQuadri Junior is

injected into the muscles of the upper

arm (preferably). For infants, the

injection is normally given into the

muscle of the thigh.

Possible side effects

Like all medicines, FluQuadri/

FluQuadri Junior can cause side

effects, although not everybody gets

them.

The most common local side effects

of FluQuadri/FluQuadri Junior

include:

pain, tenderness, redness

(erythema), swelling, bruising

(ecchymosis) and hardness

(induration) at the injection site

Systemic side effects include:

feeling unwell (malaise)

muscle aches (myalgia)

headache

shivering

fever

irritability, abnormal crying,

drowsiness, appetite loss,

vomiting (in children)

These side effects usually clear up

within a few days. If events

continue or become severe, please

tell your doctor or pharmacist.

Other side effects not listed above

have been reported occasionally with

other flu vaccines and not directly

with FluQuadri/FluQuadri Junior:

inflammation of nerves leading to

weakness, such as weakness of

facial muscles (facial palsy) or

visual disturbances (optic

neuritis/neuropathy)

fainting (syncope), dizziness,

tingling or numbness of hands or

feet (paraesthesia)

temporary inflammation of nerves

causing pain, paralysis and

sensitivity disorders (Guillain-

Barré syndrome [GBS])

fits (convulsions) with or without

fever

severe allergic reaction

(anaphylaxis)

temporary reduction in the

number of blood particles called

platelets (thrombocytopenia),

swollen glands in neck, armpit or

groin (lymphadenopathy)

If any of the side effects gets

serious, or if you notice any side

effects not listed in this leaflet,

please tell your doctor or

pharmacist.

Storing FluQuadri/

FluQuadri Junior

FluQuadri/FluQuadri Junior is

usually stored in the doctor's surgery

or clinic, or at the pharmacy.

However, if you need to store

FluQuadri/FluQuadri Junior:

Keep out of reach and sight of

children.

Keep FluQuadri/FluQuadri Junior

in the original pack until it is time

for it to be given.

Keep it in the refrigerator,

store at 2°C to 8°C. Do not

freeze FluQuadri/FluQuadri

Junior.

FLUQUADRI™; FLUQUADRI™ JUNIOR

Do not use FluQuadri/FluQuadri

Junior after the expiry date which

is stated on the carton after EXP.

Do not have FluQuadri/FluQuadri

Junior if the packaging is torn or

shows signs of tampering.

Medicines should not be disposed of

via wastewater or household waste.

Ask your pharmacist how to dispose

of medicines no longer required.

These measures will help to protect

the environment.

Further Information

What FluQuadri/FluQuadri

Junior contain

Ingredients

Active Ingredients:

FluQuadri/FluQuadri Junior contains

4 killed influenza virus strains:

A/Michigan/45/2015

(H1N1)pdm09-like virus (A/

Michigan/45/2015 X-275)

A/Hong Kong/4801/2014

(H3N2)-like virus (A/Hong

Kong/4801/2014 X-263B)

B/Phuket/3073/2013-like virus

(B/Phuket/3073/2013)

B/Brisbane/60/2008-like virus (B/

Brisbane/60/2008)

The other ingredients include sodium

chloride, sodium phosphate dibasic

anhydrous, sodium phosphate

monobasic anhydrous, water for

injection, and traces of formaldehyde

and octoxinol-9.

Other Ingredients:

FluQuadri contains less than 1

microgram ovalbumin (egg protein)

per dose.

FluQuadri Junior contains less than

0.5 microgram ovalbumin (egg

protein) per dose.

FluQuadri/FluQuadri Junior does not

contain any antibiotics or

preservative.

What FluQuadri/FluQuadri

Junior look like and

contents of the pack

FluQuadri is supplied in:

Prefilled syringe (clear syringe

plunger rod), 0.5 mL, for persons

36 months of age and older.

FluQuadri Junior is supplied in:

Prefilled syringe (pink syringe

plunger rod), 0.25 mL, for

persons 6 months through 35

months of age.

Name and Address of

Australian Sponsor

sanofi-aventis australia pty ltd

Talavera Corporate Centre - Building

12-24 Talavera Road

Macquarie Park NSW 2113

Australia

Tel: 1800 829 468 (1800 Vaxin8)

Name and Address of New

Zealand Sponsor

sanofi-aventis new zealand pty ltd

Level 8

56 Cawley St

Ellerslie

Auckland

New Zealand

Tel: 0800 727 838

AUST R number

AUST R 213963 (FluQuadri)

AUST R 213964 (FluQuadri Junior)

Date of preparation

5 December 2016

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Europe - EMA - European Medicines Agency

18-3-2019


Poliovirus type 1 / poliovirus type 3 (oral, live, attenuated) vaccine - List of nationally authorised medicinal products - PSUSA/00010642/201807

Poliovirus type 1 / poliovirus type 3 (oral, live, attenuated) vaccine - List of nationally authorised medicinal products - PSUSA/00010642/201807

Poliovirus type 1 / poliovirus type 3 (oral, live, attenuated) vaccine - List of nationally authorised medicinal products - PSUSA/00010642/201807

Europe - EMA - European Medicines Agency

8-3-2019


Orphan designation: Adeno-associated virus serotype HSC15 expressing human phenylalanine hydroxylase, Treatment of phenylalanine hydroxylase deficiency, 14/12/2018, Positive

Orphan designation: Adeno-associated virus serotype HSC15 expressing human phenylalanine hydroxylase, Treatment of phenylalanine hydroxylase deficiency, 14/12/2018, Positive

Orphan designation: Adeno-associated virus serotype HSC15 expressing human phenylalanine hydroxylase, Treatment of phenylalanine hydroxylase deficiency, 14/12/2018, Positive

Europe - EMA - European Medicines Agency

28-2-2019

EU/3/16/1696 (Clinical Network Services (NL) B.V.)

EU/3/16/1696 (Clinical Network Services (NL) B.V.)

EU/3/16/1696 (Active substance: Autologous Epstein-Barr virus specific T-cells derived from peripheral blood mononuclear cells, expanded ex vivo) - Transfer of orphan designation - Commission Decision (2019)1747 of Thu, 28 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004066

Europe -DG Health and Food Safety

28-2-2019

EU/3/16/1695 (Clinical Network Services (NL) B.V.)

EU/3/16/1695 (Clinical Network Services (NL) B.V.)

EU/3/16/1695 (Active substance: Autologous Epstein-Barr virus specific T-cells derived from peripheral blood mononuclear cells, expanded ex vivo) - Transfer of orphan designation - Commission Decision (2019)1746 of Thu, 28 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004064

Europe -DG Health and Food Safety

28-2-2019

EU/3/19/2138 (Common Services Agency (National Health Services - Scotland))

EU/3/19/2138 (Common Services Agency (National Health Services - Scotland))

EU/3/19/2138 (Active substance: Anti-Epstein Barr virus cytotoxic lymphocytes) - Orphan designation - Commission Decision (2019)1730 of Thu, 28 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000002426

Europe -DG Health and Food Safety

27-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A/H1N1Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A/H3N2Influenza virus surface ant

Opinion/decision on a Paediatric investigation plan (PIP): Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A/H1N1Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A/H3N2Influenza virus surface ant

Opinion/decision on a Paediatric investigation plan (PIP): Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A/H1N1Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A/H3N2Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain B, decision type: , therapeutic area: , PIP number: P/208/2010

Europe - EMA - European Medicines Agency

27-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Optaflu,Influenza virus surface antigens (haemagglutinin and neuraminidase), inactivated, of the following strains: A/Solomon Islands/3/2006 (H1N1)-like strain (A/Solomon Islands/3/2006, IVR-145)

Opinion/decision on a Paediatric investigation plan (PIP): Optaflu,Influenza virus surface antigens (haemagglutinin and neuraminidase), inactivated, of the following strains: A/Solomon Islands/3/2006 (H1N1)-like strain (A/Solomon Islands/3/2006, IVR-145)

Opinion/decision on a Paediatric investigation plan (PIP): Optaflu,Influenza virus surface antigens (haemagglutinin and neuraminidase), inactivated, of the following strains: A/Solomon Islands/3/2006 (H1N1)-like strain (A/Solomon Islands/3/2006, IVR-145); A/Wisconsin/67/2005 (H3N2)-like strain (A/Wisconsin/67/2005, NYMC X161B); B/Malaysia/2506/2004-like strain (B/Malaysia/2506/2004), decision type: , therapeutic area: , PIP number: P/0210/2012

Europe - EMA - European Medicines Agency

27-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Covalently closed DNA plasmids coding for cytomegalovirus phosphoprotein 65 and glycoprotein B genes (ASP0113), decision type: , therapeutic area: , PIP number: P/0338/2014

Opinion/decision on a Paediatric investigation plan (PIP): Covalently closed DNA plasmids coding for cytomegalovirus phosphoprotein 65 and glycoprotein B genes (ASP0113), decision type: , therapeutic area: , PIP number: P/0338/2014

Opinion/decision on a Paediatric investigation plan (PIP): Covalently closed DNA plasmids coding for cytomegalovirus phosphoprotein 65 and glycoprotein B genes (ASP0113), decision type: , therapeutic area: , PIP number: P/0338/2014

Europe - EMA - European Medicines Agency

25-2-2019

Zulvac BTV (Zoetis Belgium S.A.)

Zulvac BTV (Zoetis Belgium S.A.)

Zulvac BTV (Active substance: Bluetongue virus vaccine (inactivated) (multistrain: 1 strain out of a set of 3)) - Centralised - Variation - Commission Decision (2019)1607 of Mon, 25 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/V/C/4185/X/01

Europe -DG Health and Food Safety

25-2-2019

BLUEVAC BTV8 (CZ Veterinaria, S.A.)

BLUEVAC BTV8 (CZ Veterinaria, S.A.)

BLUEVAC BTV8 (Active substance: Bluetongue virus inactivated, serotype 8) - Centralised - Yearly update - Commission Decision (2019)1610 of Mon, 25 Feb 2019

Europe -DG Health and Food Safety

21-2-2019


Orphan designation: Covalently closed DNA plasmids coding for cytomegalovirus phosphoprotein 65 and glycoprotein B genes, Prevention of cytomegalovirus disease in patients with impaired cell-mediated immunity deemed at..., 09/08/2012, Withdrawn

Orphan designation: Covalently closed DNA plasmids coding for cytomegalovirus phosphoprotein 65 and glycoprotein B genes, Prevention of cytomegalovirus disease in patients with impaired cell-mediated immunity deemed at..., 09/08/2012, Withdrawn

Orphan designation: Covalently closed DNA plasmids coding for cytomegalovirus phosphoprotein 65 and glycoprotein B genes, Prevention of cytomegalovirus disease in patients with impaired cell-mediated immunity deemed at..., 09/08/2012, Withdrawn

Europe - EMA - European Medicines Agency

20-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Nanobody directed towards the fusion protein of human respiratory syncytial virus (ALX-0171), decision type: , therapeutic area: , PIP number: P/0367/2018

Opinion/decision on a Paediatric investigation plan (PIP): Nanobody directed towards the fusion protein of human respiratory syncytial virus (ALX-0171), decision type: , therapeutic area: , PIP number: P/0367/2018

Opinion/decision on a Paediatric investigation plan (PIP): Nanobody directed towards the fusion protein of human respiratory syncytial virus (ALX-0171), decision type: , therapeutic area: , PIP number: P/0367/2018

Europe - EMA - European Medicines Agency

20-2-2019

Silgard (Merck Sharp and Dohme Limited)

Silgard (Merck Sharp and Dohme Limited)

Silgard (Active substance: Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, adsorbed)) - Centralised - Withdrawal - Commission Decision (2019)1516 of Wed, 20 Feb 2019

Europe -DG Health and Food Safety

20-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A (H1N1),Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A (H3N2),Influenza virus surfa

Opinion/decision on a Paediatric investigation plan (PIP): Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A (H1N1),Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A (H3N2),Influenza virus surfa

Opinion/decision on a Paediatric investigation plan (PIP): Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A (H1N1),Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A (H3N2),Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain B (Yamagata lineage),Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain B (Victoria lineage) [QIVc], decision type: , therapeutic area: , PIP number: P/0387/2018

Europe - EMA - European Medicines Agency

14-2-2019

EU/3/18/2012 (IDEA Innovative Drug European Associates (Ireland) Limited)

EU/3/18/2012 (IDEA Innovative Drug European Associates (Ireland) Limited)

EU/3/18/2012 (Active substance: Genetically modified replication-incompetent herpes simplex virus-1 expressing collagen VII) - Transfer of orphan designation - Commission Decision (2019)1356 of Thu, 14 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003115

Europe -DG Health and Food Safety

12-2-2019

Vaxxitek HVT + IBD (Merial)

Vaxxitek HVT + IBD (Merial)

Vaxxitek HVT + IBD (Active substance: Live vHVT013-69 recombinant virus) - Centralised - Yearly update - Commission Decision (2019)1098 of Tue, 12 Feb 2019

Europe -DG Health and Food Safety

5-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Influenza virus surface antigens - A/turkey/Turkey/1/05 (H5N1), decision type: , therapeutic area: , PIP number: P/0249/2018

Opinion/decision on a Paediatric investigation plan (PIP): Influenza virus surface antigens - A/turkey/Turkey/1/05 (H5N1), decision type: , therapeutic area: , PIP number: P/0249/2018

Opinion/decision on a Paediatric investigation plan (PIP): Influenza virus surface antigens - A/turkey/Turkey/1/05 (H5N1), decision type: , therapeutic area: , PIP number: P/0249/2018

Europe - EMA - European Medicines Agency

31-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Foclivia,Pandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted), decision type: , therapeutic area: , PIP number: P/0260/2018

Opinion/decision on a Paediatric investigation plan (PIP): Foclivia,Pandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted), decision type: , therapeutic area: , PIP number: P/0260/2018

Opinion/decision on a Paediatric investigation plan (PIP): Foclivia,Pandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted), decision type: , therapeutic area: , PIP number: P/0260/2018

Europe - EMA - European Medicines Agency

28-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A (H3N2),Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain B (Yamagata lineage),Influenza

Opinion/decision on a Paediatric investigation plan (PIP): Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A (H3N2),Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain B (Yamagata lineage),Influenza

Opinion/decision on a Paediatric investigation plan (PIP): Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A (H3N2),Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain B (Yamagata lineage),Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain B (Victoria lineage),Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A (H1N1), decision type: , therapeutic area: , PIP number: P/0341/2018

Europe - EMA - European Medicines Agency

25-1-2019

Infanrix hexa (GlaxoSmithKline Biologicals S.A.)

Infanrix hexa (GlaxoSmithKline Biologicals S.A.)

Infanrix hexa (Active substance: diphtheria (d), tetanus (t), pertussis (acellular, component) (pa), hepatitis b (rdna) (hbv), poliomyelitis (inactivated) (ipv) and haemophilus influenzae type b (hib) conjugate vaccine (adsorbed)) - Centralised - Yearly update - Commission Decision (2019)676 of Fri, 25 Jan 2019

Europe -DG Health and Food Safety

16-1-2019

Vepacel (Ology Bioservices Ireland LTD)

Vepacel (Ology Bioservices Ireland LTD)

Vepacel (Active substance: Prepandemic influenza vaccine (A/H5N1) (whole virion, Vero cell derived, inactivated)) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)196 of Wed, 16 Jan 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/2089/T/19

Europe -DG Health and Food Safety

11-1-2019

Syvazul BTV (LABORATORIOS SYVA, S.A.U.)

Syvazul BTV (LABORATORIOS SYVA, S.A.U.)

Syvazul BTV (Active substance: Bluetongue virus vaccine (inactivated) (multistrain: 1-2 strains out of a set of 3)) - New authorisation - Commission Decision (2019)135 of Fri, 11 Jan 2019 European Medicines Agency (EMA) procedure number: EMEA/V/C/V/C/4611

Europe -DG Health and Food Safety

11-1-2019

Parvoduk (Merial)

Parvoduk (Merial)

Parvoduk (Active substance: Muscovy duck parvovirus vaccine (live)) - Centralised - Renewal - Commission Decision (2019)133 of Fri, 11 Jan 2019 European Medicines Agency (EMA) procedure number: EMEA/V/C/2740/R/6

Europe -DG Health and Food Safety

9-1-2019


Guideline on data requirements for multi-strain dossiers for inactivated vaccines against avian influenza (AI), Bluetongue (BT) and Foot-and-Mouth disease (FMD) - Revision 1

Guideline on data requirements for multi-strain dossiers for inactivated vaccines against avian influenza (AI), Bluetongue (BT) and Foot-and-Mouth disease (FMD) - Revision 1

Guideline on data requirements for multi-strain dossiers for inactivated vaccines against avian influenza (AI), Bluetongue (BT) and Foot-and-Mouth disease (FMD) - Revision 1

Europe - EMA - European Medicines Agency

7-1-2019


Scientific recommendation on classification of advanced therapy medicines: Allogeneic Epstein-Barr Virus specific cytotoxic T lymphocytes

Scientific recommendation on classification of advanced therapy medicines: Allogeneic Epstein-Barr Virus specific cytotoxic T lymphocytes

Scientific recommendation on classification of advanced therapy medicines: Allogeneic Epstein-Barr Virus specific cytotoxic T lymphocytes

Europe - EMA - European Medicines Agency

7-1-2019


Scientific recommendation on classification of advanced therapy medicinal products: Recombinant adeno-associated virus serotype 9 vector encoding the soluble lysosomal enzyme TPP1

Scientific recommendation on classification of advanced therapy medicinal products: Recombinant adeno-associated virus serotype 9 vector encoding the soluble lysosomal enzyme TPP1

Scientific recommendation on classification of advanced therapy medicinal products: Recombinant adeno-associated virus serotype 9 vector encoding the soluble lysosomal enzyme TPP1

Europe - EMA - European Medicines Agency

20-12-2018

Nobilis IB Primo QX (Intervet International B.V.)

Nobilis IB Primo QX (Intervet International B.V.)

Nobilis IB Primo QX (Active substance: Live avian infectious bronchitis virus, strain D388) - Centralised - Yearly update - Commission Decision (2018)9136 of Thu, 20 Dec 2018

Europe -DG Health and Food Safety

19-12-2018

Hexacima (Sanofi Pasteur)

Hexacima (Sanofi Pasteur)

Hexacima (Active substance: Diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type b conjugate vaccine (adsorbed)) - Centralised - Yearly update - Commission Decision (2018)9062 of Wed, 19 Dec 2018

Europe -DG Health and Food Safety

19-12-2018

Hexyon (Sanofi Pasteur)

Hexyon (Sanofi Pasteur)

Hexyon (Active substance: diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type b conjugate vaccine (adsorbed)) - Centralised - Yearly update - Commission Decision (2018)9061 of Wed, 19 Dec 2018

Europe -DG Health and Food Safety

18-12-2018

EU/3/18/2109 (Yes Pharmaceutical Development Services GmbH)

EU/3/18/2109 (Yes Pharmaceutical Development Services GmbH)

EU/3/18/2109 (Active substance: Adeno-associated virus serotype HSC15 expressing human phenylalanine hydroxylase) - Orphan designation - Commission Decision (2018)9024 of Tue, 18 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/153/18

Europe -DG Health and Food Safety

18-12-2018

Pandemic influenza vaccine H5N1 BAXTER (Ology Bioservices Ireland LTD)

Pandemic influenza vaccine H5N1 BAXTER (Ology Bioservices Ireland LTD)

Pandemic influenza vaccine H5N1 BAXTER (Active substance: Pandemic influenza vaccine (H5N1 whole virion, Vero cell derived, inactivated)) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8926 of Tue, 18 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1200/T/26

Europe -DG Health and Food Safety

14-12-2018

Flucelvax Tetra (Seqirus Netherlands B.V.)

Flucelvax Tetra (Seqirus Netherlands B.V.)

Flucelvax Tetra (Active substance: influenza vaccine (surface antigen, inactivated, prepared in cell cultures)) - Centralised - Authorisation - Commission Decision (2018)8911 of Fri, 14 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4814

Europe -DG Health and Food Safety

12-12-2018


Scientific recommendation on classification of advanced therapy medicinal products: Non-replicating recombinant adeno-associated virus carrying a fragment of the Channelrhodopsin-2 (ChR2) protein

Scientific recommendation on classification of advanced therapy medicinal products: Non-replicating recombinant adeno-associated virus carrying a fragment of the Channelrhodopsin-2 (ChR2) protein

Scientific recommendation on classification of advanced therapy medicinal products: Non-replicating recombinant adeno-associated virus carrying a fragment of the Channelrhodopsin-2 (ChR2) protein

Europe - EMA - European Medicines Agency

12-12-2018


Scientific recommendation on classification of advanced therapy medicinal products: Adeno-associated virus (AAV) vector encoding genes from an algae channel rhodopsin

Scientific recommendation on classification of advanced therapy medicinal products: Adeno-associated virus (AAV) vector encoding genes from an algae channel rhodopsin

Scientific recommendation on classification of advanced therapy medicinal products: Adeno-associated virus (AAV) vector encoding genes from an algae channel rhodopsin

Europe - EMA - European Medicines Agency

27-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Purified inactivated rabies virus (WISTAR PM/WI 38-1503-3M strain), decision type: , therapeutic area: , PIP number: P/0219/2018

Opinion/decision on a Paediatric investigation plan (PIP): Purified inactivated rabies virus (WISTAR PM/WI 38-1503-3M strain), decision type: , therapeutic area: , PIP number: P/0219/2018

Opinion/decision on a Paediatric investigation plan (PIP): Purified inactivated rabies virus (WISTAR PM/WI 38-1503-3M strain), decision type: , therapeutic area: , PIP number: P/0219/2018

Europe - EMA - European Medicines Agency

27-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Split influenza virus, inactivated containing antigens equivalent to the A/H1N1-like strain / split influenza virus, inactivated containing antigens equivalent to the A/H3N2-like strain / split i

Opinion/decision on a Paediatric investigation plan (PIP): Split influenza virus, inactivated containing antigens equivalent to the A/H1N1-like strain / split influenza virus, inactivated containing antigens equivalent to the A/H3N2-like strain / split i

Opinion/decision on a Paediatric investigation plan (PIP): Split influenza virus, inactivated containing antigens equivalent to the A/H1N1-like strain / split influenza virus, inactivated containing antigens equivalent to the A/H3N2-like strain / split influenza virus, inactivated containing antigens equivalent to the B-like strain, decision type: , therapeutic area: , PIP number: P/0155/2018

Europe - EMA - European Medicines Agency

27-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Influenza virus surface antigens (haemagglutinin and neuraminidase) of the following strains: A/(H1N1), A/(H3N2), B/Yamagata lineage, B/Victoria lineage, decision type: , therapeutic area: , PIP

Opinion/decision on a Paediatric investigation plan (PIP): Influenza virus surface antigens (haemagglutinin and neuraminidase) of the following strains: A/(H1N1), A/(H3N2), B/Yamagata lineage, B/Victoria lineage, decision type: , therapeutic area: , PIP

Opinion/decision on a Paediatric investigation plan (PIP): Influenza virus surface antigens (haemagglutinin and neuraminidase) of the following strains: A/(H1N1), A/(H3N2), B/Yamagata lineage, B/Victoria lineage, decision type: , therapeutic area: , PIP number: P/0211/2018

Europe - EMA - European Medicines Agency