Annex №1  

REPUBLIC OF BULGARIA  
MINISTRY OF HEALTH

BULGARIAN DRUG AGENCY  

 

Application

FOR MARKETING AUTHORISATION  

 
Product name: Atorvastatin Calcium Tablets
International non-proprietary name(s) (INN) of active substance(s): Atorvastatin Calcium  

Indications:

Atorvastatin is indicated as an adjunct to diet for reduction of elevated total cholesterol, LDL-cholesterol, apolipoprotein B, and triglycerides in patients with primary hypercholesterolaemia, heterozygous familial hypercholesterolaemia or combined (mixed) hyperlipidaemia when response to diet and other nonpharmacological measures is inadequate.

АТС code: C10AA05  
Pharmaceutical form and strength: Tablet      10 mg/tablet
Route(s) of administration:  Oral  
Type of packaging    
Immediate packaging:  

Blister pack of 10 tablets

Secondary packaging:  

10 blister packs per carton

Package size: Blister pack of 10 tablets

Shelf life:

18 months

Shelf life:

(after first opening container)

NA  

Shelf life:

(after reconstitution or dilution): 

NA  

 
Storage conditions: Store in a cool dry place  
Dispensing/classification:

subject to medical prescription
not subject to medical prescription

For products subject to medical prescriptions:

  product on prescription which may not be renewed

  product on prescription which may be renewed

  product on special prescription

  product on restricted prescription
Qualitative and quantitative composition of a medicinal product  
Name of substance(s)  

Quantity Per tab  

 Reference standards  
active substance(s):  


excipient(s):  
 		   

Applicant (= future marketing authorisation holder )

Name:    

Address: 

Country:  

Telephone:                                                                                          Telefax: 

Manufacturer(s) of the medicinal product and site(s) of manufacture: (including a description of the steps they perform)

Name:     

Address:                         

                

Country:   

Telephone:   91-95250-2481403                                Telefax: 

description of the steps performed:  All stages of manufacture

Manufacturer(s) of the active substance(s):

  own manufacture

  bought from:

 

Name:

Address:

Country:

Telephone:                                      Telefax:  

Person authorised for communication, on behalf of the Applicant:

Name:    

Address:  
Telephone number:                                     Fax:

E-mail: