Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2016 to 31 July 2016 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)
Date: 2016-08-26
Institutions: European Commission
Subjects: EU Member State, drug surveillance, market approval, marketing standard, medicinal product, veterinary drug








C_2016312EN.01001001.xml










26.8.2016   


EN


Official Journal of the European Union


C 312/10





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2016 to 31 July 2016
(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) or Article 38 of Directive 2001/82/EC (2))
(2016/C 312/02)
—   Issuing, maintenance or modification of a national marketing authorization











Date of the decision


Name(s) of the medicinal product


INN (International Non-Proprietary Name)


Holder(s) of the marketing authorization


Member State concerned


Date of notification




8.8.2016


Saizen (and associated names) and Humatrope (and associated names)


somatropin


Not applicable


Not applicable


9.8.2016




—   Revocation of a national marketing authorization











Date of the decision


Name(s) of the medicinal product


INN (International Non-Proprietary Name)


Holder(s) of the marketing authorization


Member State concerned


Date of notification




14.7.2016


Colistin combinations


colistin


See Annex I


See Annex I


15.7.2016






(1)  OJ L 311, 28.11.2001, p. 67.

(2)  OJ L 311, 28.11.2001, p. 1.


ANNEX
List of the names, pharmaceutical forms, strengths of the veterinary medicinal products, animal species, route of administration, and marketing authorisation holders in the Member States












Member State EU/EEA


Marketing authorisation holder


Name


INN


Strength


Pharmaceutical form


Animal species


Route of administration




Bulgaria


Farma vet Ltd
40 Otec Paisii str.
Shumen
Bulgaria


Колитетравит/COLI — TETRAVIT


Oxytetracycline hydrochloride
Colistin sulphate


5,0  g
3 500 000  UI


Oral solution


Chickens and pigs


Oral administration




Bulgaria


COOPHAVET S.A.S.
B.P. 7 Saint Herblon
44153 ANCENIS Cedex
France


Колисултрикс/COLISULTRIX


Trimethoprim
Colistin sulphate


3,75  g
50 MIU


Oral powder


Chickens, rabbits, pigs, calves and lambs


Oral administration




Croatia


Arnika Veterina d.o.o.
Vodovodna 20a
10000 Zagreb
Croatia


COLISULTRIX


Trimethoprim
Colistin sulphate


3,75  g
50 MIU


Oral powder


Calves, lambs, kids, piglets, poultry and rabbits


Oral




Croatia


Ceva Santé Animale
10 Avenue de la Ballastière
33500 Libourne
France


QUINOCOL


Enrofloxacin
Colistin sulphate


100 g
41,67  g


Oral solution


Chicken, turkey


Oral




Cyprus


FATRO S.p.A.
Via Emilia, 285
40064 Ozzano Emilia (Bologna)
Italy


BACOLAM powder for oral solution for calves, sheep, goats, pigs, foals, chickens, turkeys (excluding layers)


Amoxicillin trihydrate
Colistin sulphate


100 mg
500 000  I.U.


Powder for oral solution


Calves, sheep, goats, pigs, foals, chickens, turkeys (excluding layers)


Administer the dose subdivided into two administrations each day, dissolved in drinking water or in milk.




Cyprus


Vetoquinol Italia S.R.L
Via Piana, 265
47032 Bertinoro
Italy


ZEMAMIX premix for medicated feedingstuff for pigs


Amoxicillin trihydrate
Colistin sulphate


11,48  g
4,00  g


Premix for medicated feedingstuff


Pigs


Premix for medicated feedingstuff in insoluble powder, to be administered orally properly mixed in solid feed.




Czech Republic


LAVET Pharmaceuticals Ltd
Ottó u.14
1161 Budapest
Hungary


AMOXYCOL plv.sol.


Amoxicillin trihydrate
Colistin sulphate


640 mg/g
3 200 000  IU/g


Powder for oral solution for use in drinking water or in feed


Pigs, chicken (broilers)


Oral




Czech Republic


COOPHAVET S.A.S.
B.P. 7 Saint Herblon
44153 ANCENIS Cedex
France


BELCOSPIRA ORAL prášek pro přípravu perorálního roztoku


Colistin sulphate Spiramycin adipate


500 000  IU
650 000  IU


Powder for oral solution


Calves, piglets, foals, chicken


Oral




Czech Republic


COOPHAVET S.A.S.
B.P. 7 Saint Herblon
44153 ANCENIS Cedex
France


COLISULTRIX plv. sol.


Trimethoprim
Colistin sulphate


37,5  mg
500 000  IU/g


Powder for oral solution


Chicken


Oral




Czech Republic


Industria Italiana Integratori Trei S.p.A.
Via Corassori, 62
41100 Modena
Italy


MICROAMOX COLI premix pro medikaci krmiva


Amoxicillin trihydrate
Colistin sulphate


100 mg/g
600 000  IU/g


Premix for medicated feed


Pigs


Oral




France


MERIAL
29 avenue Tony Garnier
69007 LYON
France


BELCOSPIRA ORAL


Colistin sulphate
Spiramycin adipate


500 000  IU/g
650 000  IU/g


Powder for oral use


Cattle, pigs, poultry


Oral use




France


LABORATOIRES BIOVE
3 Rue de Lorraine
62510 Arques
France


COLAMPI B


Ampicillin trihydrate
Colistin sulphate


25 mg/g
0,075  MIU/g


Powder for oral use


Pigs, calves


Oral use




France


LABORATOIRES BIOVE
3 Rue de Lorraine
62510 Arques
France


COLAMPI O


Ampicillin trihydrate
Colistin sulphate


1 g/tablet
1 MIU/tablet


Tablet


Calves


Oral use




France


VETOQUINOL
Magny Vernois
70200 Lure
France


COLIDIARYL


Colistin sulphate Erythromycin estolate


83 400  IU/g
16 600  IU/g


Powder for oral use


Lamb, goat, piglets, foals, calves


Oral use




France


MERIAL
29 avenue Tony Garnier
69007 LYON
France


COLISULTRIX POUDRE


Colistin sulphate
Trimethoprim


500 000  IU/g
37,5  mg/g


Powder for oral use


Lamb, goat, rabbits, pigs, calves, poultry


Oral use




France


VIRBAC
1ere Avenue 2065m L.I.D.
06516 Carros Cedex
France


ENTEROGEL 30


Colistin sulphate
Scopolamine
Sulfaguanidine


10,5  MIU/syringe
0,216  g/syringe
4,2  g/syringe


Oral paste


Foals, calves


Oral use




France


VIRBAC
1ere Avenue 2065m L.I.D.
06516 Carros Cedex
France


INTESTIVO


Colistin sulphate
Sulfaguanidine


2,5  MIU/tablet
1 g/tablet


Tablet


Lamb, goat, calve


Oral use




France


MERIAL
29 avenue Tony Garnier
69007 LYON
France


N.P. 8


Colistin sulphate
Neomycin sulfate


300 000  IU/g
60 000  IU/g


Powder for oral use


Lamb, goat, rabbits, pigs, calves, poultry


Oral use




France


QALIAN
34 rue Jean Monnet
ZI D’Etiché
BP20341
49503 Segré Cedex
France


OXYCOLI


Colistin sulphate
Oxytetracycline hydrochloride


200 000  IU/g
0,07  g/g


Premix for medicated feed


Pigs, calves


Oral use




France


Ceva Santé Animale
10 Avenue de la Ballastière
33500 Libourne
France


PHADILACT


Ampicillin trihydrate
Colistin sulphate


5,00  mg/g
1 000 000  IU/g


Powder for oral use


Lamb, goat, calves, poultry


Oral use




France


QALIAN
34 rue Jean Monnet
ZI D’Etiché
BP20341
49503 Segré Cedex
France


PRÉMELANGE MÉDICAMENTEUX CS FRANVET


Colistin sulphate
Sulfadimethoxine


700 000  IU/g
210 mg/g


Premix


Lamb, calves


Oral use




France


VETOQUINOL
Magny Vernois
70200 Lure
France


SEPTOTRYL-COLISTINE


Colistin sulphate
Sulfamethoxypyridazine


2 MIU/tablet
1 g/tablet


Tablet


Lamb, dogs, foals, calves


Oral use




Hungary


Lavet Gyógyszergyártó Kft.
Ottó u. 14
1161 Budapest
Hungary


Amoxycol por belsőleges oldathoz A.U.V.


Amoxicillin trihydrate
Colistin sulphate


640,0  mg/g
133,3  mg/g


Powder for oral solution


Pigs, chickens


In drinking water use




Hungary


Industria Italiana Integratori Trei S.p.A.
Viale Corassori, 62
41100 Modena
Italy


BETAMICYN gyógypremix sertések részére A.U.V.


Amoxicillin trihydrate
Colistin sulphate


100 g/kg
600 MIU/kg


Premix for medicated feeding stuff


Pigs


In feed use




Hungary


Rhone Vet Kft.
Petőfi u. 9.
2053 Herceghalom
Hungary


Colisutrix belsőleges por


Trimethoprim
Colistin sulphate


3,75  g/100 g
50 MIU/100 g


Powder for oral solution


Cattle (calves), sheep (lambs), pigs and chickens, rabbit, goat


In drinking water use




Italy


Fatro S.p.a.
Via Emilia, 285
40064 Ozzano Emilia
Italy


COMBOMIX


Amoxicillin trihydrate
Colistin sulphate


115 mg/g
40 mg/g


Premix for medicated feeding stuff


Pigs, chickens (other than laying hens in lay)


Oral




Italy


Industria Italiana Integratori Trei S.P.A.
Via Affarosa, 4
42010 — Rio Saliceto
Italy


BETAMICYN


Amoxicillin trihydrate
Colistin sulphate


100 g/kg
600 MIU/kg


Premix for medicated feeding stuff


Pigs


Oral




Italy


Doxal Italia S.p.a.
largo Donegani 2
20121 — Milano
Italy


CLOVER BMP


Amoxicillin trihydrate
Colistin sulphate


115 g/kg
40 g/kg


Premix for medicated feeding stuff


Pigs


Oral




Italy


Industria Italiana Integratori Trei S.P.A.
Via Affarosa, 4
42010 — Rio Saliceto
Italy


DUOBAN


Doxycycline hyclate
Colistin sulphate


60 mg/g
1 200 000  UI/g


Premix for medicated feeding stuff


Pigs, rabbits


Oral




Italy


Virbac S.r.l.
Via Caldera 21
20153 Milano
Italy


DUALMIX


Amoxicillin trihydrate
Colistin sulphate


115 mg/g
4 mg/g (20 000  UI/mg)


Premix for medicated feeding stuff


Pigs, chickens (except hens producing eggs for human consumption)


Oral




Italy


Fatro S.p.a.
Via Emilia, 285
40064 Ozzano Emilia
Italy


BACOLAM


Amoxicillin trihydrate
Colistin sulphate


500 mg/g
2 500 000  IU/g


Powder for oral solution


Calves, sheep and goats, pigs, ponies, chickens, turkeys (excluding hens)


Oral




Italy


Intervet Productions S.r.l.
Via Nettunense, km 20,300 
04011 — Aprilia
Italy


NADASIN


Amoxicillin trihydrate
Colistin sulphate


500 mg/g
200 mg/g


Oral powder for use in drinking water or liquid feed


Calves, pigs, chickens (other than laying hens), turkeys


Oral




Italy


Vetoquinol Italia S.r.l.
Via Piana, 265
47032 Bertinoro
Italy


NEOMIX COMPLEX


Neomycin sulfate
Colistin sulphate


200 mg/g
20 000  IU/g


Oral powder, for use in drinking water or liquid feed


Calves, piglets, broilers and turkeys


Oral




Italy


Vétoquinol Italia S.r.l.
Via Piana 265
47032 Bertinoro
Italy


ZEMAMIX


Amoxicillin trihydrate
Colistin sulphate


100 mg/g
40 mg/g


Oral powder


Pigs


Oral use




Italy


Virbac S.r.l.
Via Caldera 21
20153 Milano
Italy


STABOX COLI


Amoxicillin trihydrate
Colistin sulphate


100 mg/g
800 000  IU/g


Premix for medicated feeding


Pigs, chickens (except hens producing eggs for human consumption)


Oral




Latvia


Ceva Santé Animale
10 Avenue de la Ballastière
33500 Libourne
France


Quinocol Oral Solution


Enrofloxacin
Colistin sulphate


100 g
41,67  g


Solution for oral use


Chicken, turkeys


Oral use




Lithuania


Lavet Pharmaceuticals Ltd
Ottó u. 14.
H-1161 Budapest
Hungary


AMOXYCOL, geriamieji milteliai


Amoxicillin trihydrate
Colistin sulphate


640 mg/ml
3 200 000  IU/ml


Water soluble oral solution


Pig, chicken


Oral




Lithuania


COOPHAVET S.A.S.
B.P. 7 Saint Herblon
44153 ANCENIS Cedex
France


COLISULTRIX, geriamieji milteliai


Trimethoprim
Colistin sulphate


3,75  g/100 g
50 MIU/100 g


Oral powder


Calves, lamb, kid, piglets, poultry and rabbits


Oral




Lithuania


COOPHAVET S.A.S.
B.P. 7 Saint Herblon
44153 ANCENIS Cedex
France


BELCOSPIRA ORAL, geriamieji milteliai


Spiramycin adipate
Colistin sulphate


65 MIU/100 g
50 MIU/100 g


Oral powder


Calves, lamb, kid, foals, piglets, poultry and rabbits.


Oral




Luxembourg


VETOQUINOL
Magny Vernois
70200 Lure
France


COLIDIARYL


Erythromycin estolate
Colistin sulphate


83 400  UI/g
16 600  UI/g


Powder for oral use


Lamb, goat, piglets, foals, calves


Oral use




Luxembourg


VETOQUINOL
Magny Vernois
70200 Lure
France


SEPTOTRYL-COLISTINE


Colistin sulphate
Sulfamethoxypyridazine


2 MIU/tablet
1 g/tablet


Tablet


Lamb, dogs, foals, calves


Oral use




Netherlands


Dopharma B.V.
Zalmweg 24
4941 VX Raamsdonksveer
The Netherlands


AMOXY-COL WSP


Amoxicillin trihydrate
Colistin sulphate


150 mg/g
500 000  IU/g


Powder for oral use via drinking water


Pigs


Oral, via drinking water




Poland


Dopharma B.V.
Zalmweg 24
4941 VX Raamsdonksveer
The Netherlands


Amoxy-col WSP


Amoxicillin trihydrate
Colistin sulphate


150 mg/g
500 000  IU/g


Powder for oral solution


Pigs


Oral use




Poland


Fatro S.p.A.
Via Emilia
285-40064
Ozzano Emilia
Italy


Bacolam


Amoxicillin trihydrate
Colistin sulphate


100 mg/g
500 000  IU/g


Powder for administration in drinking water or milk


Cattle, chickens, pigs


Oral use




Poland


SkanVet Poland Sp. z o.o.
Skiereszewo, ul. Kiszkowska 9
62-200 Gniezno
Poland


Colamox 3200/640


Amoxicillin trihydrate
Colistin sulphate


640 mg/g
3 200 000  IU/g


Powder for oral solution


Chicken, pigs


Oral use




Poland


Drwalewskie Zakłady Przemysłu
Bioweterynaryjnego S.A
ul. Grójecka 6
05-651 Drwalew
Poland


Spiracol AD


Spiramycin adipate
Colistin sulphate


100 000  IU/g
130 000  IU/g


Powder for use in drinking water


Cattle, chickens, pigs


Oral use




Portugal


DIVASA FARMAVIC DE PORTUGAL Produtos e Equipamentos Veterinários, Lda.
Praceta Jaime Cortesão, No 1 — R/C Loja Esq.
2625-170 Póvoa de Santa Iria
Portugal


NUTRIVET TOTAL, pó para suspensão oral, para vitelos e cordeiros


Ampicillin trihydrate
Colistin sulphate


0,7  g
1 500 000  IU


Powder for oral suspension for administration in drinking water


Calves and lambs


Oral




Portugal


VETLIMA-Sociedade Distribuidora de Produtos Agro-Pecuários, S.A.
Centro Empresarial da Rainha, Lote 27
2050-501 Vila Nova da Rainha
Portugal


COLIMIX (116 g/kg/40 g/kg), pré-mistura medicamentosa para alimento medicamentoso para suínos


Amoxicillin trihydrate
Colistin sulphate


116 g/kg
40 g/kg


Premix for medicated feeding stuff


Pigs


Oral




Portugal


Fatro S.p.A
Via Emilia No 285
Ozzano Emilia
Italy


Premaxol, 100 mg/g + 40 mg/g de pré-mistura medicamentosa para alimento medicamentoso para suínos, frangos e galinhas (excepto poedeiras)


Amoxicillin trihydrate
Colistin sulphate


100 mg/g
40 mg/g


Premix for medicated feeding stuff


Pigs and chickens (except laying)


Oral




Romania


Industria Italiana Integratori Trei S.p.A
Viale Corassori, 62
41100 Modena
Italy


DUOBAN


Doxycycline hyclate
Colistin sulphate


60 mg/g
1 200 000  IU/g


Premix


Pigs


Mixed in feeding stuffs




Romania


Industria Italiana Integratori Trei S.p.A
Viale Corassori, 62
41100 Modena
Italy


MICROAMOX COLI


Amoxicillin trihydrate
Colistin sulphate


100 mg/g
600 000  IU/g


Premix


Pigs


Mixed in feeding stuffs




Romania


COOPHAVET SAS
Herblon
44150 Ancenis
France


COLISULTRIX


Trimethoprim
Colistin sulphate


37,5  mg
500 000  IU


Powder for oral solution


Calves, lambs, kids, pigs, rabbits and poultry


Oral administration in drinking water or liquid feed




Romania


SC ROMVAC COMPANY SA
Sos. Centurii nr.7
077194 Voluntari
Romania


GALIPROTECT C


Oxytetracycline hydrochloride
Colistin sulphate


12 mg/tablet
5 mg/tablet


Tablets


Poultry (grouse and web-footed)


Oral administration individually




Romania


Lavet Pharmecuticals LTD.
Otto u.14.
H-1161 Budapest
Hungary


AMOXYCOL


Amoxicillin trihydrate
Colistin sulphate


640 mg/g
3 200 000  IU/g


Powder for oral solution


Pigs, chickens


Oral administration in drinking water




Slovakia


Pharmagal spol. s.r.o.
Murgašova 5
949 01 Nitra
Slovakia


Amikol perorálny prášok


Amoxicillin trihydrate
Colistin sulphate


57,5  mg/g
8,1  mg/g


Oral powder


Pig, calves, poultry (chicken, turkey), pigeon


Oral administration, after incorporation into the feed




Slovakia


Pharmagal spol. s.r.o.
Murgašova 5
949 01 Nitra
Slovakia


Amikol premix na medikáciu krmiva


Amoxicillin trihydrate
Colistin sulphate


57,5  mg/g
200 000  IU/g


Premix for medicated feeding stuff


Pig


Oral administration, after incorporation into the feed




Slovakia


Pharmagal spol. s.r.o.
Murgašova 5
949 01 Nitra
Slovakia


Amikol-S prášok na perorálny roztok


Amoxicillin trihydrate
Colistin sulphate


575 mg/g
81 mg/g


Powder for oral solution


Pig, calves, poultry (chicken, turkey), pigeon


Oral administration via drinking water




Slovakia


Pharmagal spol. s.r.o.
Murgašova 5
949 01 Nitra
Slovakia


SUTRICOL prášok na perorálny roztok


Colistin sulphate
Sulfadimidine sodium Trimethoprim


300 000  IU/g
50 mg/g
12,5  mg/g


Powder for oral solution


Broiler chicken, pig, rabbit, calve


Oral administration via drinking water




Slovakia


Pharmagal spol. s.r.o.
Murgašova 5
949 01 Nitra
Slovakia


TETRAKOL prášok na perorálny roztok


Chlortetracycline hydrochloride
Colistin sulphate


120 mg/g
120 000  IU/g


Powder for oral solution


Pig, calves, poultry (chicken)


Oral administration via drinking water




Spain


CENAVISA, S.A.
Camí Pedra Estela s/n. Reus (Tarragona)
43205
Spain


TRISOL


Ampicillin trihydrate
Colistin sulphate


200 mg/g
1 025 000  IU/g


Oral powder


Lambs


In drinking water use




Spain


LABORATORIOS MAYMO, S.A.
Via Augusta, 302.
Barcelona 08017
Spain


COLIPHUR 100 000 /1 200 000  UI/ml solución para administración en agua de bebida


Neomycin sulfate
Colistin sulphate


100 000  IU/ml
1 200 000  IU/ml


Solution for use in drinking water


Pig for fattening


In drinking water use