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HBVaxPro (hepatitis B, recombinant surface antigen) – Conditions or restrictions regarding supply and use - J07BC01

Updated on site: 07-Oct-2017

Medication nameHBVaxPro
ATC CodeJ07BC01
Substancehepatitis B, recombinant surface antigen
ManufacturerMSD VACCINS

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

Name and address of the manufacturer of the biological active substances

Merck Sharp & Dohme Corp.

Sumneytown Pike

West POINT,

Pennsylvania 19486

USA

Name and address of the manufacturer responsible for batch release

Merck Sharp & Dohme B.V.

Waaderweg 39,

2031 BN Haarlem

The Netherlands

B.CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE

Medicinal product subject to medical prescription

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.

C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION

Periodic Safety Update Reports

The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT

Risk Management Plan (RMP)

Not applicable.

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