English
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

Pumarix (pandemic influenza vaccine (H5N1) (split...) – Conditions or restrictions regarding supply and use - J07BB02

Updated on site: 09-Oct-2017

Medication namePumarix
ATC CodeJ07BB02
Substancepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)
ManufacturerGlaxoSmithKline Biologicals S.A.  

A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturer of the biological active substance

 

IB Biomedical Corporation of Quebec doing business as

 

GlaxoSmithKline Biologicals North America

authorised

2323 du parc Technologique Blvd. Saint-Foy, Quebec,

Canada G1P 4R8

Name and address of the manufacturer responsible for batch release

GlaxoSmithKline Biologicals S.A. 89, rue de l'Institut

B-1330 Rixensart Belgium

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE

Medicinal product subject to medical prescription.

Pumarix can only be marketed when there is an official WHO/EU declaration of an influenza

pandemic, on the condition that the Marketing Authorisation Holder for Pumarix takes due account of

the officially declared pandemic strain.

no

longer

 

product

 

Official batch release

 

In accordance with Article 114 of Directive 2001/83/EC, the official batch release will be undertaken by a state laboratory or a laboratory esignated for that purpose.

C.OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION

MedicinalPharmacovigil nce system

The MAH must e sure that the system of pharmacovigilance, presented in Module 1.8.1 of the Marketing Authorisation, is in place and functioning before and whilst the medicinal product is on the market.

The MAH shall perform the studies and pharmacovigilance activities detailed in the Pharmacovigilance Plan and requested as specific obligations.

Risk Management plan (RMP)

The MAH shall perform the pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in the RMP presented in Module 1.8.2 of the Marketing Authorisation and any subsequent updates of the RMP agreed by the Committee for Medicinal Products for Human Use (CHMP).

As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).

In addition, an updated RMP should be submitted:

When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities

Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached

At the request of the European Medicines Agency

Outside of the pandemic period, the normal PSUR periodicity and format will be maintained, with a specific review of AESI and possible adverse events related to adjuvants. This should include data from ongoing studies, or actual use if applicable, of the ‘mock-up’ strains and any safety data elevant to the adjuvant system.

PSURsauthorised

During a pandemic situation (Phase 6 of the WHO global Influenza preparedness plan), bi-weekly "simplified PSUR" accompanied by a summary of vaccine distribution will be provided according to the cRMP guidance (Doc. Ref. EMEA/32706/2007 for pandemic):

During a pandemic situation, the frequency oflongersubmission of pe iodic s fety update reports specified in Article 24 of Regulation (EC) No 726/2004 will not be adequate for the safety monitoring of a pandemic vaccine for which high levels of xposure are expected within a short period of time. Such situation requires rapid notification of safety information that may have the greatest implications for risk-benefit bala ce in a pandemic. Prompt analysis of cumulative safety information, in light of extent f exp sure, will be crucial for regulatory decisions and protection of the population to be vaccinated. In addition, duration a pandemic, resources needed for an in-depth evaluation of Periodic Safety Update Reports in the format as defined in Volume 9a of the Rules GoverningnoMedicinal Product in the European Union may not be adequate for a rapid identification f a new safety issue.

Frequency of submission

- The clock will start from the first Monday after shipment of the first batch of vaccine. - First data-lock point is 14 days later.

- Report submission is no later than day 22 (i.e. the following Monday).

In consequence, as soon as the pandemic is declared (Phase 6 of the WHO global Influenza preparedness plan)productand the pandemic vaccine is used, the MAH shall submit periodic safety update reports with periodicity and format defined as follows:

- Reporting to be fortnightly for the first 3 months of the pandemic. Medicinal- Periodicity will be reviewed by the MAH and the (Co)Rapporteur at 3 monthly intervals.

When it has been agreed by the CHMP that the S-PSUR is no longer necessary, a full PSUR covering the period s e the data lock point of the last routine PSUR will be submitted within a time frame to be agreed with the Rapporteur.

Format

The r port shall include the following tables of aggregate data using the agreed templates:

1.Fatal and/or life-threatening reactions – for each Preferred Term (PT), including the proportion of fatal reports

2.Adverse Events of Special Interest (PTs)

3.Serious unexpected reactions (PTs)

4.All events occurring in the following age groups: 6-23 months, 2-8 years, 8-17 years, 18-60 years, >60 years

5.All events occurring in pregnant women

6.All events reported by patients that have been entered into the database by data-lock point

7.A cumulative overview of all events reported during the period, stratified according to type of reporter (patient or health care professional), seriousness, expectedness, and whether spontaneous or solicited.

Presentation of data will take into consideration the following recommendations:

- Serious expected reactions will be reviewed by the MAH as part of their signal detection

procedures and will only form part of the report if an issue of concern arises.

 

authorised

- All tables will be based on number of events (presented on PT level, sorted by System Organ Class

(SOC)) and not number of cases.

 

- Tables 1 to 4 will be based on events reported from healthcare professionals only.

- In Tables 1 to 5, numbers will be provided for events received during the reporting period and cumulatively.

- All tables will be based on generic and not product-specific data. Product-specific data can be evaluated during signal work-up.

- A measure of relative reporting rate of signals for each reported PT should be provided if possible (e.g. Proportional reporting ratio (PRR), Information Component (IC) or the Empirical Bayesian Geometric Mean (EBMG)); this is not mandatory as all MAHs do not yet h ve this capability.

- No line listings are required – these can be provided in signal evaluation reports as necessary.

signals) and appropriate timelines for submission of a full si nal evaluation report provided. All signal evaluation reports should be provided, i cludi g those that were subsequently not identified as being signals.

A short summary shall also be provided with thelongerperiodic saf ty update reports, in which any area of concern should be highlighted, signal work-up prioritis d (if the event of multiple

A summary of vaccine distribution shall be included and provide details of the number of doses of vaccine distributed in:

i)

EU member states for the repor ing period by batch number,

ii)

EU member states cumula ivelynoand

iii)the rest of the world

CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCTproduct

Not applicable.

Medicinal

SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES

This being an approval under exceptional circumstances and pursuant to Article 14(8) of Regulation (EC) No 726/2004, the MAH shall conduct, within the stated timeframe, the following measures:

Description

Due date

 

 

During the pandemic, the applicant will conduct a

Protocol of the registry will be

 

surveillance on the safety of the vaccine during

submitted as part of RMP, during the

 

pregnancy using dedicated registry.

pandemic

 

 

 

 

 

During the pandemic, the applicant will conduct a

Depending on and after

prospective cohort study as identified in the

implementation of vaccine strain,

 

Pharmacovigilance plan.

when first pandemic will ake place.

 

 

 

authorised

 

 

 

 

no

longer

 

product

 

Medicinal

 

 

 

 

 

 

 

 

longer

 

A. LABELLING

 

product

no

 

Medicinal

 

 

 

 

 

authorised

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

PACK CONTAINING 1 PACK OF 50 VIALS OF SUSPENSION AND 2 PACKS OF 25 VIALS OF EMULSION

1. NAME OF THE MEDICINAL PRODUCT

Pumarix suspension and emulsion for emulsion for injection.

Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)

2. STATEMENT OF ACTIVE SUBSTANCE(S)

 

 

 

 

 

 

 

 

 

After mixing, 1 dose (0.5 ml) contains:

 

 

 

authorised*

 

 

 

 

 

 

 

Split influenza virus inactivated, containing antigen equivalent to:

 

 

 

 

 

 

 

longer

 

 

 

A/Indonesia/05/2005 (H5N1) like strain used (PR8-IBCDC-RG2)

3.75 micrograms

 

AS03 adjuvant composed of squalene, DL-α-tocopherol a d polysorbate 80

*

haemagglutinin

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

no

 

 

 

 

 

3.

LIST OF EXCIPIENTS

 

 

 

 

 

 

Thiomersal

 

 

 

 

 

 

Sodium chloride (NaCl)

 

 

 

 

 

 

Disodium hydrogen phosphate (Na2HPO4)

 

 

 

 

 

 

Potassium dihydrogen phosphate (KH2PO4)

 

 

 

 

 

 

Potassium chloride (KCl)

 

 

 

 

 

 

Water for injections

 

 

 

 

 

 

 

 

 

 

 

 

Medicinal

 

 

 

 

 

 

product

 

 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS

 

 

 

Suspension a d emulsion for emulsion for injection

50 v als: suspension (antigen)

50 v als: emulsion (adjuvant)

The volume after mixing 1 vial of suspension (2.5 ml) with 1 vial of emulsion (2.5 ml) corresponds to 10 doses of vaccine (5 ml)

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Intramuscular use

Shake before use

Read the package leaflet before use

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

 

Suspension and emulsion to be mixed before administration

authorised

 

 

 

 

 

 

 

 

 

 

 

8.

EXPIRY DATE

 

 

 

 

 

EXP:

 

 

 

 

 

 

 

 

 

 

 

 

 

9.

SPECIAL STORAGE CONDITIONS

 

 

 

 

 

 

APPROPRIATE

 

longer

 

 

 

Store in a refrigerator

 

 

 

 

 

 

Do not freeze

 

 

 

 

 

 

Store in the original package in order to protect from light

 

 

 

10.

SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS

 

 

 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF

 

 

 

 

 

no

 

 

 

 

 

 

 

 

 

 

 

 

 

product

 

 

 

 

Dispose of in accordance with local regula io s

 

 

 

 

11.

NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

 

 

GlaxoSmithKline Biologicals s.a.

 

 

 

 

 

Rue de l’Institut 89

 

 

 

 

 

 

B-1330 Rixensart, Belgium

 

 

 

 

 

 

 

 

 

 

Medicinal

 

 

 

 

 

12.

MARKETING AUTHORISATION NUMBER(S)

 

 

 

EU/1/10/664/001

 

 

 

 

 

 

 

 

 

 

 

 

13.

BATCH NUMBER

 

 

 

 

 

Lot:

 

 

 

 

 

 

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Justification for not including Braille accepted

 

 

 

longer

authorised

 

 

no

 

 

product

 

 

Medicinal

 

 

 

 

 

 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

PACK OF 50 VIALS OF SUSPENSION (ANTIGEN)

1. NAME OF THE MEDICINAL PRODUCT

 

Suspension for emulsion for injection for Pumarix

authorised

 

 

 

 

Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)

 

 

 

 

 

 

 

 

2.

STATEMENT OF ACTIVE SUBSTANCE(S)

 

 

 

Split influenza virus, inactivated, containing antigen* equivalent to:

 

 

 

3.75 micrograms haemagglutinin/dose

 

 

 

 

*Antigen: A/Indonesia/5/2005 (H5N1) like strain used (PR8-IBCDC-RG2)

 

 

 

 

 

 

 

 

3.

LIST OF EXCIPIENTS

 

 

 

 

Excipients: Thiomersal, sodium chloride, disodium hydroge phosphate, potassium dihydrogen

 

phosphate, potassium chloride, water for injections

 

 

 

longer

 

 

 

4.

PHARMACEUTICAL FORM AND CONTENTS

 

 

 

Antigen suspension for injection

no

 

 

 

Shake before use

product

 

 

 

50 vials: suspension

 

 

 

 

2.5 ml/vial.

 

 

 

 

 

After mixing with adjuvant emulsion: 10 doses of 0.5 ml

 

 

 

5.

METHOD AND ROUTE(S) OF ADMINISTRATION

 

 

 

Intramuscular use

 

 

 

 

Medicinal

 

 

 

 

 

Read the pack ge le flet before use

 

 

 

 

6.

SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT

 

 

 

OF THE SIGHT AND REACH OF CHILDREN

 

 

 

K p out of the sight and reach of children.

 

 

 

 

 

 

 

 

7.

OTHER SPECIAL WARNING(S), IF NECESSARY

 

 

Suspension to be exclusively mixed with adjuvant emulsion before administration

8.EXPIRY DATE

EXP:

9. SPECIAL STORAGE CONDITIONS

Storage in a refrigerator.

 

 

Do not freeze.

 

 

Store in the original package in order to protect from light.

 

 

 

 

 

 

 

 

authorised

10.

SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS

 

 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF

 

 

APPROPRIATE

 

 

 

 

11.

NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

 

GSK Biologicals, Rixensart - Belgium

 

 

12. MARKETING AUTHORISATION NUMBER(S)

 

 

 

 

 

13.

BATCH NUMBER

 

longer

 

EU/1/10/664/001

 

 

 

 

Lot:

 

 

no

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

product

 

 

 

14.

GENERAL CLASSIFICATION FOR SUPPLY

 

Medicinal product subject to medical prescription.

 

 

 

 

 

 

15.

INSTRUCTIONS ON USE

 

 

 

 

 

 

 

 

Medicinal

 

 

 

 

16.

INFORMATION IN BRAILLE

 

 

Justif cat on for not including Braille accepted

PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACK OF 25 VIALS OF EMULSION (ADJUVANT)
1. NAME OF THE MEDICINAL PRODUCT
Emulsion for emulsion for injection for Pumarix

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Content: AS03 adjuvant composed of squalene (10.69 milligrams), DL-α-tocopherol (11.86 milligrams) and polysorbate 80 (4.86 milligrams)

authorised

3.LIST OF EXCIPIENTS

Excipients: Sodium chloride, disodium hydrogen phosphate, potassium dihydrogen phosphate, potassium chloride, water for injections

4. PHARMACEUTICAL FORM AND CONTENTS

 

Adjuvant emulsion for injection

no

longer

 

 

 

25 vials: emulsion

 

 

 

 

2.5 ml

 

 

 

 

 

 

 

 

 

 

 

 

 

product

 

 

 

5.

METHOD AND ROUTE(S) OF ADMINISTRATION

 

Intramuscular use

 

 

 

 

Shake before use

 

 

 

 

Read the package leaflet before use

 

 

 

 

 

 

 

Medicinal

 

 

 

 

6.

SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT

 

 

OF THE SIGHT AND REACH OF CHILDREN

 

Keep out of the sight and reach of children.

 

 

 

 

 

7.

OTHER SPECIAL WARNING(S), IF NECESSARY

Emulsion to be exclusively mixed with antigen suspension before administration

8.EXPIRY DATE

EXP:

9. SPECIAL STORAGE CONDITIONS

Storage in a refrigerator.

Do not freeze.

Store in the original package in order to protect from light.

 

10.

SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS

 

 

 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF

 

 

 

APPROPRIATE

 

 

 

 

 

 

 

11.

NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

 

 

GSK Biologicals, Rixensart - Belgium

 

 

 

 

 

 

 

 

 

12.

MARKETING AUTHORISATION NUMBER(S)

authorised

 

 

EU/1/10/664/001

 

 

 

 

 

 

 

 

 

 

 

 

13.

BATCH NUMBER

 

 

 

 

 

Lot:

 

 

 

longer

 

 

 

 

 

 

 

 

 

 

14.

GENERAL CLASSIFICATION FOR SUPPLY

 

 

 

 

 

 

no

 

 

 

 

Medicinal product subject to medical pres ription.

 

 

 

 

 

 

 

 

 

 

15.

INSTRUCTIONS ON USE

 

 

 

 

 

 

 

 

 

 

 

16.

INFORMATION IN BRAILLE

 

 

 

 

 

 

 

product

 

 

 

 

Medicinal

 

 

 

 

 

Justificat on for ot including Braille accepted

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

SUSPENSION VIAL

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Antigen suspension for Pumarix Pandemic influenza vaccine

A/Indonesia/5/2005 (H5N1) like strain used (PR8-IBCDC-RG2) I.M.

2. METHOD OF ADMINISTRATION

Mix with adjuvant emulsion before use

3. EXPIRY DATE

EXP

 

 

longer

 

 

 

After mixing: Use within 24 hours and do not store above 30°C.

Date and time of mixing:

no

 

4.

BATCH NUMBER

 

 

 

Lot

product

 

 

5.

 

 

CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

2.5 ml

After mixing with adjuvant emulsi n: 10 doses of 0.5 ml

Medicinal

6. OTHER

Storage (2ºC-8ºC), do not freeze, protect from light

authorised

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

EMULSION VIAL

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Adjuvant emulsion for Pumarix

I.M.

 

2.

METHOD OF ADMINISTRATION

 

 

 

 

 

Mix into Antigen suspension before use

 

 

 

 

 

 

 

 

 

 

 

 

3.

EXPIRY DATE

 

 

 

authorised

 

 

EXP

 

 

 

 

 

 

 

 

 

 

 

 

 

4.

BATCH NUMBER

 

 

 

 

 

Lot

 

 

 

longer

 

 

 

 

 

 

 

 

 

 

5.

CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

 

 

 

 

 

 

no

 

 

 

 

2.5 ml

 

 

 

 

 

 

 

 

 

 

 

 

 

 

6.

OTHER

 

 

 

 

 

 

Storage (2ºC-8ºC), do not freeze, protect from light

 

 

 

Medicinal

product

 

 

 

 

 

 

 

 

 

Comments

A B C D E F G H I J K L M N O P Q R S T U V W X Y Z
  • Help
  • Get it on Google Play
  • About
  • Info on site by:

  • Presented by RXed.eu

  • 27558

    prescription drugs listed