Imrestor (Pegbovigrastim) – Conditions or restrictions regarding supply and use - QL03AA90

A.MANUFACTURER RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturer responsible for batch release

Eli Lilly and Company Limited

Speke Operations

Fleming Road

Speke

Liverpool

UK-L24 2LN

B.CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE

Veterinary medicinal product subject to prescription.

C.STATEMENT OF THE MRLs

The active substance in Imrestor 15 mg solution for injection for cattle is an allowed substance as described in table 1 of the annex to Commission Regulation (EU) No 37/2010:

Pharmacologically

Marker

Animal

MRL

Target

Other

Therapeutic

active substance

residue

species

 

tissues

provisions

classification

Pegylated bovine

NOT

Bovine

No MRL

NOT

NO

Biological/

granulocyte colony

APPLIA

 

required

APPLICA

ENTRY

Immunomodulat

stimulating factor

BLE

 

 

BLE

 

or

The excipients 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 product.

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