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Quintanrix (diphtheria toxoid / tetanus toxoid /...) – Conditions or restrictions regarding supply and use - J07CA10

Updated on site: 09-Oct-2017

Medication nameQuintanrix
ATC CodeJ07CA10
Substancediphtheria toxoid / tetanus toxoid / inactivated Bordetella pertussis / hepatitis B surface antigen (rDNA) / Haemophilus influenzae type b polysaccharide
ManufacturerGlaxoSmithKline Biologicals S.A.

Article Contents

AMANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturer of the biological active substances

Diphtheria toxoid, tetanus toxoid, pertussis (whole cell):

authorised

 

Chiron-Behring GmbH & Co.

 

 

 

Postfach 1630-35006 Marburg

 

 

 

Germany

 

 

 

 

Tel: +49 6421 39 29 17

 

 

 

 

Fax: +49 6421 39 47 20

 

 

 

 

Haemophilus influenzae type b polysaccharide

 

 

 

GlaxoSmithKline Biologicals S.A.

 

 

 

2100 Gödöllö, Táncsics Mihály út 82

 

longer

 

Hungary

 

 

 

 

 

 

 

Tel: +36 28 511 960

 

 

 

 

Fax:+ 36 28 511 999

 

 

 

 

GlaxoSmithKline Biologicals S.A.

 

 

 

89 rue de I’Institut-1330 Rixensart

 

 

 

Belgium

 

 

 

 

Tel: +32 2 656 81 11

 

 

 

 

Fax:+32 2 656 80 00

 

 

 

 

Name and address of the manufacturer responsible for batch release

 

GlaxoSmithKline Biologicals S.A.

no

 

 

 

 

Product

 

 

89 rue de I’Institut-1330 Rixensart

 

 

Belgium

 

 

 

 

Tel: +32 2 656 81 11

 

 

 

 

Fax:+32 2 656 80 00

 

 

 

 

The printed package leaflet of the medicinal product must state the name and address of the

manufacturer responsible for the release of the concerned batch.

 

B CONDITIONS OF THE MARKETING AUTHORISATION

 

Medicinal

 

 

 

 

CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON

 

THE MARKETING AUTHORISATION HOLDER

 

Medicinal product subject to medical prescription

 

 

OTHER CONDITIONS

 

 

 

The holder of this marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by this decision.

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 designated for that purpose.

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