| 
                        
                            Pestigon
                        
                     | 
                    
                        
                                                            268 mg
                                                    
                     | 
                    
                        
                                                            V/DCP/12/0050
                                                    
                     | 
                    
                        
                                                            Norbrook Laboratories (Ireland) Limited, Īrija
                                                    
                     | 
                    
                        
                                                            QP53AX15
                                                    
                     | 
                    
                        
                                                                                                large dogs
                                                                                    
                     | 
                    
                                                
                                                    
                     | 
                
                
                    
                        
                            
                                Medicinal product information
                                
                                    
                                        | Pharmaceutical form: | 
                                        
                                                                                                                                                spot-on solution
                                                                                                                                     | 
                                     
                                    
                                        | International name (active substance): | 
                                        
                                                                                            Fipronil
                                                                                     | 
                                     
                                    
                                        | Distribution category: | 
                                        
                                                                                                                                                Nonprescription veterinary medicinal product
                                                                                                                                     | 
                                     
                                    
                                        | Manufacturer(s) responsible for batch release | 
                                        
                                                                                            Norbrook Laboratories Limited, Lielbritānija;Norbrook Laboratories Limited, Lielbritānija;Norbrook Manufacturing Limited, Īrija
                                                                                     | 
                                     
                                    
                                        | Date of authorisation/renewal: | 
                                        
                                                                                            04-Jul-2017
                                                                                     | 
                                     
                                    
                                        | Marketing authorisation valid until: | 
                                        
                                                                                            Unlimited time period
                                                                                     | 
                                     
                                    
                                        | Marketing authorisation procedure: | 
                                        
                                                                                                                                                DCP
                                                                                                                                     | 
                                     
                                    
                                        | Package leaflet: | 
                                        
                                            
                                                                                            
                                                                                                        
                                                    [PDF]                                                    072019LI (10-Jul-2019)                                                
                                                                                     | 
                                     
                                    
                                        | Labelling text: | 
                                        
                                            
                                                                                            
                                                                                                        
                                                    [PDF]                                                    290419M (29-Apr-2019)                                                
                                                                                     | 
                                     
                                    
                                        | Summary of product characteristics: | 
                                        
                                            
                                                                                            
                                                                                                        
                                                    [PDF]                                                    290419ZA (29-Apr-2019)                                                
                                                                                     | 
                                     
                                                                     
                                
                                                                Products
                                
                                    
                                        
                                            | ID | 
                                            Strength | 
                                            Package size | 
                                            Primary packaging | 
                                            
                                            Labelling | 
                                         
                                    
                                    
                                                                                    
                                                | V/DCP/12/0050-01 | 
                                                268 mg/deva | 
                                                1 | 
                                                Plastmasas pipete, 1 deva | 
                                                
                                                
                                                                                                            -
                                                                                                     | 
                                             
                                                                                    
                                                | V/DCP/12/0050-02 | 
                                                268 mg/deva | 
                                                2 | 
                                                Plastmasas pipete, 1 deva | 
                                                
                                                
                                                                                                            -
                                                                                                     | 
                                             
                                                                                    
                                                | V/DCP/12/0050-03 | 
                                                268 mg/deva | 
                                                3 | 
                                                Plastmasas pipete, 1 deva | 
                                                
                                                
                                                                                                            -
                                                                                                     | 
                                             
                                                                                    
                                                | V/DCP/12/0050-04 | 
                                                268 mg/deva | 
                                                4 | 
                                                Plastmasas pipete, 1 deva | 
                                                
                                                
                                                                                                            -
                                                                                                     | 
                                             
                                                                                    
                                                | V/DCP/12/0050-05 | 
                                                268 mg/deva | 
                                                6 | 
                                                Plastmasas pipete, 1 deva | 
                                                
                                                
                                                                                                            -
                                                                                                     | 
                                             
                                                                                    
                                                | V/DCP/12/0050-06 | 
                                                268 mg/deva | 
                                                8 | 
                                                Plastmasas pipete, 1 deva | 
                                                
                                                
                                                                                                            -
                                                                                                     | 
                                             
                                                                                    
                                                | V/DCP/12/0050-07 | 
                                                268 mg/deva | 
                                                12 | 
                                                Plastmasas pipete, 1 deva | 
                                                
                                                
                                                                                                            -
                                                                                                     | 
                                             
                                                                                    
                                                | V/DCP/12/0050-08 | 
                                                268 mg/deva | 
                                                24 | 
                                                Plastmasas pipete, 1 deva | 
                                                
                                                
                                                                                                            -
                                                                                                     | 
                                             
                                                                                    
                                                | V/DCP/12/0050-09 | 
                                                268 mg/deva | 
                                                30 | 
                                                Plastmasas pipete, 1 deva | 
                                                
                                                
                                                                                                            -
                                                                                                     | 
                                             
                                                                                    
                                                | V/DCP/12/0050-10 | 
                                                268 mg/deva | 
                                                60 | 
                                                Plastmasas pipete, 1 deva | 
                                                
                                                
                                                                                                            -
                                                                                                     | 
                                             
                                                                                    
                                                | V/DCP/12/0050-11 | 
                                                268 mg/deva | 
                                                90 | 
                                                Plastmasas pipete, 1 deva | 
                                                
                                                
                                                                                                            -
                                                                                                     | 
                                             
                                                                                    
                                                | V/DCP/12/0050-12 | 
                                                268 mg/deva | 
                                                120 | 
                                                Plastmasas pipete, 1 deva | 
                                                
                                                
                                                                                                            -
                                                                                                     | 
                                             
                                                                                    
                                                | V/DCP/12/0050-13 | 
                                                268 mg/deva | 
                                                150 | 
                                                Plastmasas pipete, 1 deva | 
                                                
                                                
                                                                                                            -
                                                                                                     | 
                                             
                                                                            
                                 
                                
                             
                         
                     |