Eravac (Inactivated rabbit haemorrhagic disease...) – Conditions or restrictions regarding supply and use - QI08AA01

Updated on site: 09-Feb-2018

Gyógyszerkészítmény neve: Eravac
ATC: QI08AA01
Hatóanyag: Inactivated rabbit haemorrhagic disease type 2 virus (RHDV2)
Gyártó: Laboratorios Hipra, 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

Laboratorios Hipra, S.A.

Carretera C-63, km 48.300,

Polígono Industrial El Rieral

17170 Amer

SPAIN

Name and address of the manufacturer responsible for batch release

Laboratorios Hipra, S.A.

Avda. La Selva, 135

17170 Amer

SPAIN

B.CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE

Veterinary medicinal product subject to prescription

C.STATEMENT OF THE MRLs

The active substance being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009.

The excipients (including adjuvants) listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.

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