Evalon (vaccine against coccidiosis in chickens) – Conditions or restrictions regarding supply and use - QI01AN01

Updated on site: 09-Feb-2018

Název léku : Evalon
ATC: QI01AN01
Látka: vaccine against coccidiosis in chickens
Výrobce: Laboratorios Hipra, S.A.

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

Name and address of the manufacturer of the biological active substances

Laboratorios Hipra, S.A.

Avda. La Selva 135, Amer, 17170 Gerona, Spain

Laboratorios Hipra, S.A.

Crta. de Susqueda, Amer, 17170 Gerona, Spain

Laboratorios Hipra, S.A.

Carretera C-63, km 48.300,

Polígono Industrial El Rieral

Amer, 17170 Gerona, Spain

Name and address of the manufacturer responsible for batch release

Laboratorios Hipra, S.A.

Avda. La Selva 135, Amer, 17170 Gerona, Spain

B.CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE

Veterinary medicinal product subject to prescription.

C.STATEMENT OF THE MRLs

The active substances being principles of biological origin intended to produce active immunity are 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 considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.

D. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION

The MAH shall complete, within the stated timeframe, the following measures:

Description

Due date

Alignment of the manufacturers’ specifications for the plastic containers

Within 6 months of

with the applicant’s internal specifications for the plastic containers,

Commission Decision.

ensuring Ph. Eur. compliance. A copy of example certificates of analysis

 

should be provided to confirm compliance.

 

Alignment of the supplier’s specifications for Foetal Bovine Serum

Within 6 months of

(FBS) with the applicant’s internal specifications for FBS, ensuring Ph.

Commission Decision.

Eur. compliance. A copy of example certificates of analysis should be

 

provided to confirm compliance.

 

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