Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2010 to 30 June 2010 [Decisions taken pursuant to Article 34 of Directive 2001/83/CE or Article 38 of Directive 2001/82/CE]
Date: 2010-09-24
Institutions: European Commission
Subjects: EU Member State, market approval, marketing standard, medicinal product, pharmaceutical legislation








C_2010258EN.01003201.xml










24.9.2010   


EN


Official Journal of the European Union


C 258/32





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2010 to 30 June 2010
[Decisions taken pursuant to Article 34 of Directive 2001/83/CE (1) or Article 38 of Directive 2001/82/CE (2)]
(2010/C 258/02)
—   Issuing, maintenance or modification of a national marketing authorization









Date of the decision


Name(s) of the medicinal product


Holder(s) of the marketing authorization


MemberState concerned


Date of notification




2.6.2010


Clopidogrel Orion


See annex I


See annex I


3.6.2010




10.6.2010


Colistin sulfate


See annex II


See annex II


11.6.2010




19.4.2010


Diovan (1219)


See annex III


See annex III


20.4.2010




15.3.2010


Lescol


See annex IV


See annex IV


17.3.2010




19.4.2010


Diovan (1220)


See annex V


See annex V


20.4.2010




10.6.2010


Losec and associated names


See annex VI


See annex VI


14.6.2010




15.4.2010


Protium and associated names


See annex VII


See annex VII


16.4.2010




26.3.2010


Cevazuril 50 mg/ml oral suspension for piglets


See annex VIII


See annex VIII


30.3.2010




30.3.2010


Pantoprazole Bluefish


See annex IX


See annex IX


31.3.2010




30.3.2010


Pantoprazole Olinka (1169)


See annex X


See annex X


31.3.2010




30.3.2010


Pantoprazole Olinka (1170)


See annex XI


See annex XI


31.3.2010




26.5.2010


Valproate-ratiopharm chrono 300/500 mg Retardtabletten


See annex XII


See annex XII


27.5.2010




4.6.2010


Clopidogrel Teva and associated names


See annex XIII


See annex XIII


7.6.2010




14.6.2010


Doxycycline hyclate


See annex XIV


See annex XIV


15.6.2010




10.6.2010


Opgenra


Howmedica International S. de R. L., RaheenBusinessPark, Limerick, Ireland


This Decision is addressed to the Member States


14.6.2010




10.5.2010


Tysabri


Elan Pharma International Ltd., Monksland, Athlone, County Westmeath, Ireland


This Decision is addressed to the Member States


11.5.2010




10.5.2010


Ranexa


Menarini International Operations Luxembourg S.A., 1, Avenue de la Gare, L-1611 Luxembourg, Luxembourg


This Decision is addressed to the Member States


12.5.2010




11.3.2010


Revolade


GlaxoSmithKline Trading Services Limited, 6900 CorkAirportBusinessPark, Kinsale Road, Cork, Ireland


This Decision is addressed to the Member States


12.3.2010




11.3.2010


Stelara


Janssen-Cilag International NV, Turnhoutseweg, 30 - 2340 Beerse - België


This Decision is addressed to the Member States


12.3.2010




—   Refusal of a national marketing authorization









Date of the decision


Name(s) of the medicinal product


Holder(s) of the marketing authorization


MemberState concerned


Date of notification




27.4.2010


Vasotop


See annex XV


See annex XV


28.4.2010




—   Suspension of a national marketing authorization









Date of the decision


Name(s) of the medicinal product


Holder(s) of the marketing authorization


MemberState concerned


Date of notification




3.3.2010


Sibutramine


See annex XVI


See annex XVI


4.3.2010




14.6.2010


Dextropropoxyphene


See annex XVII


See annex XVII


15.6.2010




—   Revocation of a national marketing authorization









Date of the decision


Name(s) of the medicinal product


Holder(s) of the marketing authorization


MemberState concerned


Date of notification




14.6.2010


Dextropropoxyphene


See annex XVIII


See annex XVIII


15.6.2010




14.6.2010


benfluorex


See annex XIX


See annex XIX


15.6.2010






(1)  OJ L 311, 28.11.2001, p. 67.

(2)  OJ L 311, 28.11.2001, p. 1.


ANNEX I
LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ROUTE OF ADMINISTRATION, APPLICANT IN THE MEMBER STATES










MemberState EU/EEA


Applicant


(Invented) Name


Strength


Pharmaceutical Form


Route of administration




Czech Republic


Orion Corporation
Orionintie 1, FI-02200 Espoo
Finland


Clopidogrel Orion


75 mg


Film-coated tablet


Oral use




Denmark


Orion Corporation
Orionintie 1, FI-02200 Espoo
Finland


Clopidogrel Orion


75 mg


Film-coated tablet


Oral use




Finland


Orion Corporation
Orionintie 1, FI-02200 Espoo
Finland


Clopidogrel Orion


75 mg


Film-coated tablet


Oral use




Germany


Orion Corporation
Orionintie 1, FI-02200 Espoo
Finland


Clopidogrel Orion


75 mg


Film-coated tablet


Oral use




Latvia


Orion Corporation
Orionintie 1, FI-02200 Espoo
Finland


Clopidogrel Orion


75 mg


Film-coated tablet


Oral use




Lithuania


Orion Corporation
Orionintie 1, FI-02200 Espoo
Finland


Clopidogrel Orion


75 mg


Film-coated tablet


Oral use




Norway


Orion Corporation
Orionintie 1, FI-02200 Espoo
Finland


Clopidogrel Orion


75 mg


Film-coated tablet


Oral use




Slovak Republic


Orion Corporation
Orionintie 1, FI-02200 Espoo
Finland


Clopidogrel Orion


75 mg


Film-coated tablet


Oral use




Sweden


Orion Corporation
Orionintie 1, FI-02200 Espoo
Finland


Clopidogrel Orion


75 mg


Film-coated tablet


Oral use







ANNEX II
LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE VETERINARY MEDICINAL PRODUCTS, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, WITHDRAWAL PERIOD AND APPLICANTS/MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES














Member state/EEA


Applicant/Marketing Authorisation Holder


Product name


INN


Strength


Pharmaceutical form


Animal species


Frequency and route of administration


Recommended dose


Withdrawal period(s)




Austria


Ceva Santé Animale
Zone Industrielle La Ballastiere
B.P. 126
33500 Libourne
FRANCE


Colivet 2 000 000 IU/ml, Konzentrat für eine orale Lösung für Schweine und Geflügel


Colistin sulfate


2 MIU/ml


Concentrate for oral solution


Pigs
Poultry


For three consecutive days in drinking water


Pigs: 100 000 IU/kg bw/day in two equally divided doses per day
Poultry: 75 000 IU/kg bw/day


Pigs: meat: 1 day
Broilers and laying hens: 1 day
Other poultry: 7 days
Eggs: Zero days




Belgium


Divasa-FarmavicS.A.
Ctra San Hipolito km 71
08503 Gurb-Vic (Barcelona)
SPAIN


COLIPLUS 2 000 000 IU/ml concentrate for oral solution for use in drinking water for cattle, sheep, swine and chickens


Colistin sulfate


2 MIU/ml


Concentrate for oral solution


Calves
Lambs
Pigs
Poultry


Calves, Lambs, Pigs, Poultry: for three consecutive days in drinking water.


Calves and Lambs: 100 000 IU of colistin / kg bw/day divided in two identical doses, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days.
Pigs: 100 000 IU of colistin / kg bw/day, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days.
Poultry: 75 000 IU of colistin / kg bw/day, i.e. 37,5 ml of product/1 tone bw/day for 3 consecutive days.


Calves, Lambs: meat and offals 7 days.
Pigs: meat and offals 1 day.
Broiler and laying, hens: 1 day.
Eggs: Zero days.
Other Poultry: meat and offals - 7 days.
Eggs: Zero days




Bulgaria


Ceva Santé Animale
Zone Industrielle La Ballastiere
B.P. 126
33500 Libourne
FRANCE


Colivet oral solution


Colistin sulfate


2 MIU/ml


Oral solution


Pigs
Poutry


Orally: 3 days


Pigs: 100 000 IU/kg b.w./day
Poultry: 75 000 IU/kg/b.w./day


Meat: 1 days
Eggs: Zero days




Bulgaria


Divasa-FarmavicS.A.
Ctra San Hipolito km 71
08503 Gurb-Vic (Barcelona)
SPAIN


COLIPLUS 2 000 000 IU/ml concentrate for oral solution for use in drinking water for cattle, sheep, swine and chickens


Colistin sulfate


2 MIU/ml


Concentrate for oral solution


Calves
Lambs
Pigs
Poultry


Calves, Lambs, Pigs, Poultry: for three consecutive days in drinking water.


Calves and Lambs: 100 000 IU of colistin / kg bw/day divided in two identical doses, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days.
Pigs: 100 000 IU of colistin / kg bw/day, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days.
Poultry: 75 000 IU of colistin / kg bw/day, i.e. 37,5 ml of product/1 tone bw/day for 3 consecutive days.


Calves, Lambs: meat and offals 7 days.
Pigs: meat and offals 1 day.
Broiler and laying, hens: 1 day.
Eggs: Zero days.
Other poultry: meat and offals: 7 days.
Eggs: Zero days




Cyprus


Ceva Santé Animale
Zone Industrielle La Ballastiere
B.P. 126
33500 Libourne
FRANCE


COLIVET 2 000 000 IU/ml


Colistin sulfate


2 MIU/ml


Oral Solution


Pigs
Birds


Pigs: 100 000 IU/kg/day
Poultry: 75 000 IU/kg/day


Pigs: 0,50 ml of product per 10 kg of body weight per day for 3 consecutive days
Poultry: 37,5 ml of product per tonne of body weight per day for 3 consecutive days.


Meat and offal:
Pigs: 1 day
Broilers and laying hens: 1 day
Other poultry: 7 days
Eggs: Zero days




Czech Republic


Ceva Animal Health Slovakia s.r.o.
Račianska 77
831 02 Bratislava
SLOVAK REPUBLIC


Colivet Sol.


Colistin sulfate


2 MIU/ml


Oral solution


Pigs
Chicken (broilers)


Daily.Orally


Broilers: 75 000 IU colistin per kg of bodyweight (i.e. 0,37 ml of product per 10 kg of bodyweight per day for 3-5 days via drinking water)
Pigs: 50 000 IU colistin per kg of bodyweight per 12 hrs (i.e. 0,25 ml of product per 10 kg of bodyweight per 12 hrs for 3-5 days via drinking water or milk replacement).


Meat and offal:
Pigs and chicken broilers: 2 days.
Do not use in laying hens producing eggs for human consumption.




Denmark


Ceva Animal Health A/S
Andkærvej 19
7100 Vejle
DENMARK


Colivet


Colistin sulfate


2 MIU/ml


Oral Solution


Pigs


Daily.Orally


100 000 IU colistin / kg body weight daily for 3-5 days.


1 day




Denmark


Divasa-FarmavicS.A.
Ctra San Hipolito km 71
08503 Gurb-Vic (Barcelona)
SPAIN


COLIPLUS 2 000 000 IU/ml concentrate for oral solution for use in drinking water for cattle, sheep, swine and chickens


Colistin sulfate


2 MIU/ml


Concentrate for oral solution


Calves
Lambs
Pigs
Poultry


Calves, Lambs, Pigs, Poultry: for three consecutive days in drinking water.


Calves and Lambs: 100 000 IU of colistin / kg bw/day divided in two identical doses, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days.
Pigs: 100 000 IU of colistin / kg bw/day, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days.
Poultry: 75 000 IU of colistin / kg bw/day, i.e. 37,5 ml of product/1 tone bw/day for 3 consecutive days.


Meat and offal: 7 days
Eggs: Zero days




France


Ceva Santé Animale
Zone Industrielle La Ballastiere
B.P. 126
33500 Libourne
FRANCE


COLISTINE CEVA 2 MUI/ml concentré pour solution buvable pour porcins et volailles


Colistin sulfate


2 MIU/ml


Oral solution


Pigs
Poultry


3 days


Pigs: 100 000 IU of colistin per kg body weight per day for 3 consecutive days by oral route, i.e. 0,50 ml of product per 10 kg of body weight per day for 3 consecutive days.
Poultry: 75 000 IU of colistin per kg body weight per day for 3 consecutive days by oral route, i.e. 37,5 ml of product per tonne of body weight per day for 3 consecutive days.


Meat and offals:
Pigs: 1 day
Chickens and egg laying hens: 1 day
Other poultry: 7 days
Eggs: Zero days




France


Ceva Santé Animale
Zone Industrielle La Ballastiere
B.P. 126
33500 Libourne
FRANCE


COLIVET SOLUTION


Colistin sulfate


2 MIU/ml


Oral solution


Calves
Lambs
Pigs
Poultry


3 days


Calves, Lambs, Porcine: 100 000 UI/kg/day
Poultry: 75 000 UI/kg/day


Meat and offals:
Calves and lambs: 7 days
Porcine: 1 day
Chicken and egg-laying hens: 1 day
Other birds: 7 days
Eggs: Zero days




France


Coophavet S.A.S
Saint Herblion, B.P. 70089
44153 Ancenis Cedex
FRANCE


COFACOLI SOLUTION


Colistin sulfate


2 MIU/ml


Oral solution


Calves
Lambs
Pigs
Poultry


3 days


Calves, Lambs, Porcine: 100 000 UI/kg/day
Poultry: 75 000 UI/kg/day


Meat and offals: 7 days.
Eggs: Zero days




France


Franvet
Zone industrielle d'Etriche
Route d'Avire, BP 103
49500 Segré Cedex
FRANCE


MILICOLI


Colistin sulfate


2 MIU/ml


Oral solution


Calves
Lambs
Pigs
Poultry


3 days


Calves, Lambs, Porcine: 100 000 UI/kg/day
Poultry: 75 000 UI/kg/day


Meat and offals:Porcine, calves, chicken: 1 day
Lamb and poultry other than chicken: 7 days
Eggs: Zero days




France


Laboratoires Biové
3 rue de Lorraine
62510 Arques
FRANCE


ACTI COLI 2 MUI/ML


Colistin sulfate


2 MIU/ml


Oral solution


Calves
Lambs
Pigs
Poultry


3 days


Calves, Lambs, Porcine: 100 000 UI/kg/day
Poultry: 75 000 UI/kg/day


Meat and offals:
Pigs: 0 days
Chicken: 1 day
Other poultry: 7 days
Calves: 2 days
Lamb: 7 days
Eggs: Zero days




France


Laprovet
2 Chemin de la Milletière
B.P. 67562
37075 Tours Cedex 2
FRANCE


COLISTINE SOLUTION E.A.F.


Colistin sulfate


2 MIU/ml


Oral solution


Calves
Lambs
Pigs
Poultry


3 days


Calves, Lambs, Porcine: 100 000 UI/kg/day
Poultry: 75 000 UI/kg/day


Meat and offals: 7 days.
Eggs: Zero days




France


Sogeval
Zone Industrielle des Touches
200, avenue de Mayenne
B.P. 2227
53022 Laval Cedex 9
FRANCE


SOGECOLI 2 millions UI/ml solution buvable


Colistin sulfate


2 MIU/ml


Oral solution


Calves
Lambs
Pigs
Poultry


3 days


Calves, Lambs, Porcine: 100 000 UI/kg/day
Poultry: 75 000 UI/kg/day


Meat and offals:
Pigs: 0 day
Chicken: 1 day
Other poultry: 7 days.
Calves: 2 days.
Lamb: 7 days
Eggs: Zero days




France


Virbac S.A.
1ere Avenue 2065 M LID
B.P. 27
06516 Carros Cedex
FRANCE


COLISTINE SULFATE 2 MUI/ml buvable virbac


Colistin sulfate


2 MIU/ml


Oral solution


Calves
Lambs
Pigs
Poultry


3 days


Calves, Lambs, Porcine: 100 000 UI/kg/day
Poultry: 75 000 UI/kg/day


Meat and offals: 7 days.
Eggs: Zero days




Germany


Divasa-FarmavicS.A.
Ctra San Hipolito km 71
08503 Gurb-Vic (Barcelona)
SPAIN


Coliplus


Colistin sulfate


2 MIU/ml


Concentrate for oral solution


Calves
Lambs
Pigs
Poultry


Calves, Lambs, Pigs, Poultry: for three consecutive days in drinking water.


Calves and Lambs: 100 000 IU of colistin / kg bw/day divided in two identical doses, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days.
Pigs: 100 000 IU of colistin / kg bw/day, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days.
Poultry: 75 000 IU of colistin / kg bw/day, i.e. 37,5 ml of product/1 tone bw/day for 3 consecutive days.


Meat and offal: 7 days
Eggs: Zero days




Greece


Ceva Santé Animale
Zone Industrielle La Ballastiere
B.P. 126
33500 Libourne
FRANCE


Colivet


Colistin sulfate


2 MIU/ml


Concentrate for oral solution


Pigs
Poultry


Drinking water/per day


Pigs: 100 000 IU/Kg BW x 3 days
Poultry:75 000 IU/Kg BW X 3 days


Pigs: 1 day
Broilers and laying hens: 1 day
Other poultry: 7 days
Eggs: Zero days




Greece


Divasa-FarmavicS.A.
Ctra San Hipolito km 71
08503 Gurb-Vic (Barcelona)
SPAIN


COLISTIN 2 000 000 IU/ML/DIVASA-FARMANIC


Colistin sulfate


2 MIU/ml


Concentrate for oral solution


Calves
Lambs
Pigs
Poultry


Calves, Lambs, Pigs, Poultry: for three consecutive days in drinking water.


Calves and Lambs: 100 000 IU of colistin / kg bw/day divided in two identical doses, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days.
Pigs: 100 000 IU of colistin / kg bw/day, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days.
Poultry: 75 000 IU of colistin / kg bw/day, i.e. 37,5 ml of product/1 tone bw/day for 3 consecutive days.


Meat and offal: 7 days
Eggs: Zero days




Hungary


Divasa-Farmavic S.A.
Ctra San Hipolito km 71
08503 Gurb-Vic (Barcelona)
SPAIN


COLIPLUS 2 000 000 IU/ml concentrate for oral solution for use in drinking water for cattle, sheep, swine and chickens


Colistin sulfate


2 MIU/ml


Concentrate for oral solution


Calves
Lambs
Pigs
Poultry


Calves, Lambs, Pigs, Poultry: for three consecutive days in drinking water.


Calves and Lambs: 100 000 IU of colistin / kg bw/day divided in two identical doses, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days.
Pigs: 100 000 IU of colistin / kg bw/day, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days.
Poultry: 75 000 IU of colistin / kg bw/day, i.e. 37,5 ml of product/1 tone bw/day for 3 consecutive days.


Meat and offal: 7 days
Eggs: Zero days.




Hungary


Coophavet S.A.S
Saint Herblion, B.P. 70089
44153 Ancenis Cedex
FRANCE


Cofacoli oral solution


Colistin sulfate


2 MIU/ml


Oral solution


Cattle (suckling calf)
Pig
Chicken


Calf, Pig: 0,25 ml product/10 kg bw twice daily for 3-4 days
Chicken, Laying hen: 37,5 ml product/ton of living weight dissolved in drinking water for 3 days.


Calf, Pig: 50 000 IU/kg bw
Broiler chicken, laying hen: 75 000 IU/kg bw/day.


Calf: 3 days
Pig: 2 days
Chicken and laying hen: 2 days
Eggs: Zero days.




Ireland


Ceva Santé Animale
Zone Industrielle La Ballastiere
B.P. 126
33500 Libourne
FRANCE


COLISCOUR 2 000 000 IU/ml, concentrate for oral solution, pigs, poultry


Colistin sulfate


2 MIU/ml


Concentrate for oral solution


Pigs
Poultry


Daily for three consecutive days. Administration is by the oral route via drinking water.


Pigs: 100 000 IU of colistin per kg body weight per day i.e. 0,50 ml of product per 10 kg of body weight per day
Poultry: 75 000 IU of colistin per kg body weight per day i.e. 37,5 ml of product per tonne of body weight per day


Pigs: Meat and offal: 1 day
Broilers and laying hens: Meat and offal: 1 day
Other poultry: Meat and offal: 7 days.
Eggs: Zero days.




Italy


Divasa-FarmavicS.A.
Ctra San Hipolito km 71
08503 Gurb-Vic (Barcelona)
SPAIN


COLIPLUS 2 000 000 IU/ml concentrate for oral solution for use in drinking water for cattle, sheep, swine and chickens


Colistin sulfate


2 MIU/ml


Concentrate for oral solution


Calves
Lambs
Pigs
Poultry


Calves, Lambs, Pigs, Poultry: for three consecutive days in drinking water.


Calves and Lambs: 100 000 IU of colistin / kg bw/day divided in two identical doses, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days.
Pigs: 100 000 IU of colistin / kg bw/day, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days.
Poultry: 75 000 IU of colistin / kg bw/day, i.e. 37,5 ml of product/1 tone bw/day for 3 consecutive days.


Calves, Lambs: Meat and offals: 7 days.
Pigs: Meat and offals: 1 day.
Broiler and laying, hens: 1 day.
Eggs: Zero days.
Other Poultry: meat and offals: 7 days.
Eggs: Zero days




Latvia


Ceva Santé Animale
Zone Industrielle La Ballastiere
B.P. 126
33500 Libourne
FRANCE


Colivet oral solution


Colistin sulfate


2 MIU/ml


Oral solution


Pigs
Poultry


Oral use. Administration vis drinking water or milk or direct application by mouth. Twice a day for 3 to 5 consecutive days.


Chicken: 75 000 IU colistin per kg per day (0,37 ml of Colivet per 10 kg twice a day)
Pig: 50 000 IU of colistin per kg twice a day(0,25 ml Colivet per 10 kg twice a day).


Edible tissues: 1 day
Eggs: 1 day




Lithuania


Ceva Santé Animale
Zone Industrielle La Ballastiere
B.P. 126
33500 Libourne
FRANCE


COLIVET SOLUTION, geriamasis tirpalas


Colistin sulfate


2 MIU/ml


Oral solution


Pigs
Poultry


With drinking water or milk powder.
Orally via drinking water.


Pigs: 50 000 IU/kg of body weight, i.e. 0,25 ml Colivet Solution per 10 kg of body weight twice daily for 3-5 consecutive days.
Poultry: 75 000 IU/kg of body weight per day, i.e. approximately 0,37 ml of Colivet Solution per 10 kg of body weight per day for 3-5 consecutive days.


Meat: 1 day.
Poultry: meat and eggs: 1 day




Lithuania


Divasa-FarmavicS.A.
Ctra San Hipolito km 71
08503 Gurb-Vic (Barcelona)
SPAIN


Colistop, geriamasis tirpalas


Colistin sulfate


2 MIU/ml


Oral solution


Pigs
Poultry (broilers chickens)


For oral administration, usually via drinking water.
For 3 consecutive days.


Pigs: 102500 IU/kg BW every 12 hours, for 3 days (equivalent to 0,5 ml of Colistop Solution/10 kg BW every 12 hours, for 3 consecutive days).
Broilers chickens: 123 000 IU/kg BW/day, for 3 days (equivalent to 0,06 ml of Colistop Solution/kg BW/day, for 3 consecutive days)


Fattening pigs: 2 days.
Broilers chickens: 7 days




Lithuania


Divasa-FarmavicS.A.
Ctra San Hipolito km 71
08503 Gurb-Vic (Barcelona)
SPAIN


COLIPLUS 2 000 000 IU/ml concentrate for oral solution for use in drinking water for cattle, sheep, swine and chickens


Colistin sulfate


2 MIU/ml


Concentrate for oral solution


Calves
Lambs
Pigs
Poultry


Calves, Lambs, Pigs, Poultry: for three consecutive days in drinking water.


Calves and Lambs: 100 000 IU of colistin / kg bw/day divided in two identical doses, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days.
Pigs: 100 000 IU of colistin / kg bw/day, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days.
Poultry: 75 000 IU of colistin / kg bw/day, i.e. 37,5 ml of product/1 tone bw/day for 3 consecutive days.


Calves, Lambs: Meat and offals: 7 days.
Pigs: Meat and offals: 1 day.
Broiler and laying, hens: 1 day.
Eggs: Zero days.
Other Poultry: Meat and offals: 7 days.
Eggs: Zero days




Poland


Ceva Santé Animale
Zone Industrielle La Ballastiere
B.P. 126
33500 Libourne
FRANCE


Colivet solution


Colistin sulfate


2 MIU/ml


oral solution


Pig
Chickens


Administration via drinking water or milk. For 3-5 days


Chickens: 75 000 I.U. colistin/1 kg b.w./day for 3 - 5 days, (0,37 ml of product/10 kg b.w.twice daily for 3 - 5 days
Pigs: 50 000 I.U. colistin/1 kg b.w./day for 3 - 5 days, (0,25 ml of product/10 kg b.w. twice daily for 3 - 5 days.


Meat and offal: 1 day
Eggs: 1 day




Poland


DIVASA - FARMAVIC, S.A.
Ctra. Sant Hipòlit, km 71
08503 GURB - VIC
(Barcelona)
Spain


Coliplus 2 000 000 IU/ml Concentrate for Oral Solution for use in drinking water for Cattle, Sheep, Swine and Chickens


Colistin (as colistin sulfate)


2 MIU/ml


Concentrate for oral solution for use in drinking water


Cattle (calves), sheep (lambs), swine and chickens


Calves, Lambs, Pigs, Poultry: for three consecutive days in drinking water.


Calves and Lambs: 100 000 IU of colistin / kg bw/day divided in two identical doses, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days.
Pigs: 100 000 IU of colistin / kg bw/day, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days.
Poultry: 75 000 IU of colistin / kg bw/day, i.e. 37,5 ml of product/1 tone bw/day for 3 consecutive days.


Meat and offal: 7 days
Eggs: Zero days
Not permitted for use in animals producing milk for human consumption




Portugal


Ceva Saúde Animal - Produtos Farmacêuticos e Farmacológicos, Lda
Rua Doutor António Loureiro Borges, 9/9A - 9°A
Miraflores
1495-131 Algés
PORTUGAL


Colivet 2 000 000 UI/ml, concentrate for oral solution for pigs and birds


Colistin sulfate


2 MIU/ml


Concentrate for oral solution


Pigs
Domestic birds


3 days


Swine: 100 000 UI/kg BW/day
Birds: 75 000 UI/kg BW/day


Meat and offal:
Pigs: 1 day
Broilers and laying hens: 1 day,
Other birds: 7 days,
Eggs: Zero days




Portugal


Divasa-FarmavicS.A.
Ctra San Hipolito km 71
08503 Gurb-Vic (Barcelona)
SPAIN


COLIPLUS 2 000 000 IU/ml concentrate for oral solution for use in drinking water for cattle, sheep, swine and chickens


Colistin sulfate


2 MIU/ml


Concentrate for oral solution


Calves
Lambs
Pigs
Poultry


Calves, Lambs, Pigs, Poultry: for three consecutive days in drinking water.


Calves and Lambs: 100 000 IU of colistin / kg bw/day divided in two identical doses, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days.
Pigs: 100 000 IU of colistin / kg bw/day, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days.
Poultry: 75 000 IU of colistin / kg bw/day, i.e. 37,5 ml of product/1 tone bw/day for 3 consecutive days.


Calves, Lambs: Meat and offals: 7 days.
Pigs: Meat and offals: 1 day.
Broiler and laying, hens: 1 day.
Eggs: Zero days.
Other Poultry: Meat and offals: 7 days.
Eggs: Zero days




Romania


CENAVISA, S.A.
Camí Pedra Estela S/N
43205 Reus
SPAIN


ENTEROBAS SOLUCION


Colistin sulfate


2 MIU/ml


oral solution


Calves
Pigs
Poultry


Oral administration (drinking water or as milk replacer) treatment: 4-5 days


Calves and Pigs: 100 000 UI/kg b.w/day equivalent to 0,5 ml/10 kg b.w./day
Poultry: 100 000 UI/kg b.w./day equivalent to 0,5 ml/litre drinking water/day


Meat: calves - 2 days
Pigs: 5 days
Poultry: 3 days
Eggs: do not use in animals from which eggs are produced for human consumption




Romania


CEVA SANTE ANIMALE ROMANIA SRL
5 Chindiei, sector 4
040185 Bucharest
ROMANIA


COLIVET SOLUTION


Colistin sulfate


2 MIU/ml


Oral solution


Pigs
Poultry


Oral administration (drinking water) treatment: 3 consecutive days


Pigs: 100 000 I.U. of colistin (as sulfate) /1kg b.w. in two equally divided doses/day, i.e. 0,5 ml of product per 10 kg of body weight in two equally divided doses/day Poultry: 75 000 I.U. of colistin (as sulfate) /1kg b.w. per day, i.e. 37,5 ml of product per 1 tone of body weight/day


Meat and offal: pigs 1 day
Broilers and layers: 1 day
Eggs: Zero days




Romania


Divasa-Farmavic S.A.
Ctra San Hipolito km 71
08503 Gurb-Vic (Barcelona)
SPAIN


COLIPLUS 2 000 000 IU/ml concentrate for oral solution for use in drinking water for cattle, sheep, swine and chickens


Colistin sulfate


2 MIU/ml


Concentrate for oral solution


Calves
Lambs
Pigs
Poultry


Calves, Lambs, Pigs, Poultry: for three consecutive days in drinking water.


Calves and Lambs: 100 000 IU of colistin / kg bw/day divided in two identical doses, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days.
Pigs: 100 000 IU of colistin / kg bw/day, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days.
Poultry: 75 000 IU of colistin / kg bw/day, i.e. 37,5 ml of product/1 tone bw/day for 3 consecutive days.


Meat and offal: 7 day
Eggs: Zero days




Romania


Divasa-FarmavicS.A.
Ctra San Hipolito km 71
08503 Gurb-Vic (Barcelona)
SPAIN


COLIPLUS SOLUTION


Colistin sulfate


2 MIU/ml


Oral solution


Pigs,
Broilers


Oral administration (drinking water) treatment: 3 days


Poultry: 0,03 ml/kg b.w/day
Pigs: 0,5 ml/10 kg b.w. every 12 hours


Meat: 9 days




Romania


Franvet
Zone industrielle d'Etriche
Route d'Avire, BP 103
49500 Segré Cedex
FRANCE


MILICOLI


Colistin sulfate


2 MIU/ml


Oral solution


Calves
Lambs
Pigs
Poultry


Oral administration (drinking water or milk replacer) treatment: 3 - 4 days


Calves, Pigs and Lambs: 50 000 I.U./kg b.w. or 0,25 ml of product/10 kg b.w Poultry: 75 000 I.U./kg/day or 0,25 ml/1 litre water


Meat and offal: 7 days
Eggs: Zero days




Romania


S.C. CRIDA PHARM S.R.L.
Str. Stadionului nr. 1
Oltenita
ROMANIA


COLICRID


Colistin sulfate


2 MIU/ml


Oral solution


Pigs
Poultry


Oral administration (drinking water) treatment: 3 - 5 days


Pigs: 100 000 I.U. of colistin sulfate/1kg b.w./day, i.e. 0,05 ml of product/kg of body weight/day Poultry: 100 000 I.U. of colistin sulfate/1kg b.w./day, i.e. 0,05 ml of product/kg of body weight/day


Meat: pigs: 7 days
Poultry: 3 days




Romania


Sogeval
Zone Industrielle des Touches
200, avenue de Mayenne
B.P. 2227
53022 Laval Cedex 9
FRANCE


SOGECOLI


Colistin sulfate


2 MIU/ml


Oral solution


Calves
Lambs
Poultry


Oral administration treatment: 3 - 4 days


Calves, Lamb: 50 000 I.U./kg b.w. or 0,25 ml/10 kg b.w. twice a day, morning and evening Poultry: 75 000 I.U./ kg b.w. daily or 0,25 ml/1 litre water


Meat: 7 days




Slovak Republic


Ceva Animal Health Slovakia, spol. s.r.o.
Račianska 77
831 02 Bratislava
SLOVAK REPUBLIC


COLIVET sol. ad us.vet.


Colistin sulfate


2 MIU/ml


Oral solution


Pigs,
Chickens


3 - 5 days in drinking water, milk or direct administration


Pigs: 50 000 IU colistine sulfate/kg b.w. (0,25 ml product/10 kg b.w.) (2 times).
Chickens: 75 000 IU colistine sulfate/kg b.w. (0,37 ml product/10 kg b.w.


Meat: 1 day.
Eggs: 1 day.




Slovak Republic


Divasa-FarmavicS.A.
Ctra San Hipolito km 71
08503 Gurb-Vic (Barcelona)
SPAIN


COLIPLUS 2 000 000 IU/ml koncentrát na perorálny roztok na použitie v pitnej vode pre hovädzí dobytok, ovce, ošípané a kurčatá


Colistin sulfate


2 MIU/ml


Concentrate for oral solution


Calves
Lambs
Pigs
Poultry


Calves, Lambs, Pigs, Poultry: for three consecutive days in drinking water.


Calves and Lambs: 100 000 IU of colistin / kg bw/day divided in two identical doses, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days.
Pigs: 100 000 IU of colistin / kg bw/day, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days.
Poultry: 75 000 IU of colistin / kg bw/day, i.e. 37,5 ml of product/1 tone bw/day for 3 consecutive days.


Calves, Lambs: Meat and offals: 7 days.
Pigs: Meat and offals: 1 day.
Broiler and laying, hens: 1 day.
Eggs: Zero days.
Other Poultry: Meat and offals: Zero days.




Spain


CEVA SALUD ANIMAL, S.A.
Carabela La Niña no 12 5a planta
08017 Barcelona
SPAIN


COLIVET 2 000 000 UI/ML


Colistin sulfate


2 MIU/ml


Oral solution


Pigs
Birds


3 days. Orally


Pigs: 100 000 UI/Kgbw
Birds: 75 000 UI/Kg bw


1 day




Spain


Divasa-FarmavicS.A.
Ctra San Hipolito km 71
08503 Gurb-Vic (Barcelona)
SPAIN


COLIPLUS SOLUCION


Colistin sulfate


2 MIU/ml


Oral solution


Pigs
Birds (Chicken)


3 days. Orally


Pigs: 102 500 UI/Kg bw/12 hours
Birds: 123 000 UI/Kg bw/12 hours


Pigs: 2 days
Birds: 7 days




Spain


Divasa-FarmavicS.A.
Ctra San Hipolito km 71
08503 Gurb-Vic (Barcelona)
SPAIN


COLISTINA DIVASA 2 000 000 IU/ml concentrate for oral solution for use in drinking water for cattle, sheep, swine and chickens


Colistin sulfate


2 MIU/ml


Concentrate for oral solution


Calves
Lambs
Pigs
Poultry


Calves, Lambs, Pigs, Poultry: for three consecutive days in drinking water.


Calves and Lambs: 100 000 IU of colistin / kg bw/day divided in two identical doses, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days.
Pigs: 100 000 IU of colistin / kg bw/day, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days.
Poultry: 75 000 IU of colistin / kg bw/day, i.e. 37,5 ml of product/1 tone bw/day for 3 consecutive days.


Meat: 7 days
Eggs: Zero days




The Netherlands


Divasa-FarmavicS.A.
Ctra San Hipolito km 71
08503 Gurb-Vic (Barcelona)
SPAIN


COLIPLUS 2 000 000 IU/ml concentrate for oral solution for use in drinking water for cattle, sheep, swine and chickens


Colistin sulfate


2 MIU/ml


Concentrate for oral solution


Calves
Lambs
Pigs
Poultry


Calves, Lambs, Pigs, Poultry: for three consecutive days in drinking water.


Calves and Lambs: 100 000 IU of colistin / kg bw/day divided in two identical doses, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days.
Pigs: 100 000 IU of colistin / kg bw/day, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days.
Poultry: 75 000 IU of colistin / kg bw/day, i.e. 37,5 ml of product/1 tone bw/day for 3 consecutive days.


Meat: 7 days
Eggs: Zero days.




United Kingdom


Ceva Animal Health Ltd
90 The Broadway
Chesham
Buckinghamshire
HP5 1EG
UNITED KINGDOM


Colibird


Colistin sulfate


2 MIU/ml


Concentrate for oral solution


Poultry


For three consecutive days in drinking water


75 000 IU/kg bw/day


Meat: 7 days.
Eggs: Zero days.




United Kingdom


Ceva Animal Health Ltd
90 The Broadway
Chesham
Buckinghamshire
HP5 1EG
UNITED KINGDOM


Coliscour, oral solution of colistin sulphate 2 MIU/ml


Colistin sulfate


2 MIU/ml


Concentrate for oral solution


Pigs


Twice daily for five consecutive days (via drinking water or direct oral administration)


50 000 IU/kg bw given twice daily


Meat and offal: 1 day




United Kingdom


Divasa-FarmavicS.A.
Ctra San Hipolito km 71
08503 Gurb-Vic (Barcelona)
SPAIN


Coliplus 2 000 000 IU/ml Concentrate for Oral Solution for use in drinking water for Cattle, Sheep, Swine and Chickens


Colistin sulfate


2 MIU/ml


Concentrate for oral solution


Calves
Lambs
Pigs
Poultry


Calves, Lambs, Pigs, Poultry: for three consecutive days in drinking water.


Calves and Lambs: 100 000 IU of colistin / kg bw/day divided in two identical doses, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days.
Pigs: 100 000 IU of colistin / kg bw/day, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days.
Poultry: 75 000 IU of colistin / kg bw/day, i.e. 37,5 ml of product/1 tone bw/day for 3 consecutive days.


Meat: 7 days
Eggs: Zero days.







ANNEX III
LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES










Member State EU/EEA


Marketing Authorisation Holder


Invented name


Strength


Pharmaceutical Form


Route of administration




Austria


Novartis Pharma GmbH
Stella-Klein-Löw-Weg 17
A–1020 Wien
(Tel: + 43-1–8665 70)


Diovan 40 mg Filmtabletten


40 mg


film-coated tablets


Oral Use




Austria


Novartis Pharma GmbH
Stella-Klein-Löw-Weg 17
A–1020 Wien
(Tel: + 43-1–8665 70)


Angiosan 40 mg Filmtabletten


40 mg


film-coated tablets


Oral Use




Austria


Novartis Pharma GmbH
Stella-Klein-Löw-Weg 17
A–1020 Wien
(Tel: + 43-1–8665 70)


Diovan 80 mg Filmtabletten


80 mg


film-coated tablets


Oral Use




Austria


Novartis Pharma GmbH
Stella-Klein-Löw-Weg 17
A–1020 Wien
(Tel: + 43-1–8665 70)


Angiosan 80 mg Filmtabletten


80 mg


film-coated tablets


Oral Use




Austria


Novartis Pharma GmbH
Stella-Klein-Löw-Weg 17
A–1020 Wien
(Tel: + 43-1–8665 70)


Diovan 160 mg Filmtabletten


160 mg


film-coated tablets


Oral Use




Austria


Novartis Pharma GmbH
Stella-Klein-Löw-Weg 17
A–1020 Wien
(Tel: + 43-1–8665 70)


Angiosan 160 mg Filmtabletten


160 mg


film-coated tablets


Oral Use




Austria


Novartis Pharma GmbH
Stella-Klein-Löw-Weg 17
A–1020 Wien
(Tel: + 43-1–8665 70)


Diovan 320 mg Filmtabletten


320 mg


film-coated tablets


Oral Use




Austria


Novartis Pharma GmbH
Stella-Klein-Löw-Weg 17
A–1020 Wien
(Tel: + 43-1–8665 70)


Angiosan 320 mg Filmtabletten


320 mg


film-coated tablets


Oral Use




Belgium


N.V. Novartis Pharma S.A.
Medialaan 40, bus 1
B–1800 Vilvoorde
(Tel: +32-2-246 16 11)


Diovane 40 mg


40 mg


film-coated tablets


Oral Use




Belgium


N.V. Novartis Pharma S.A.
Medialaan 40, bus 1
B–1800 Vilvoorde
(Tel: +32-2-246 16 11)


Diovane 80 mg


80 mg


film-coated tablets


Oral Use




Belgium


N.V. Novartis Pharma S.A.
Medialaan 40, bus 1
B–1800 Vilvoorde
(Tel: +32-2-246 16 11)


Diovane 160 mg


160 mg


film-coated tablets


Oral Use




Belgium


N.V. Novartis Pharma S.A.
Medialaan 40, bus 1
B–1800 Vilvoorde
(Tel: +32-2-246 16 11)


Diovane 320 mg


320 mg


film-coated tablets


Oral Use




Bulgaria


Novartis Pharma GmbH
Roonstrasse 25
D–90429 Nürnberg
(Tel: +49-911-273-0)


Diovan 40 mg


40 mg


film-coated tablets


Oral Use




Bulgaria


Novartis Pharma GmbH
Roonstrasse 25
D–90429 Nürnberg
(Tel: +49-911-273-0)


Diovan 80 mg


80 mg


film-coated tablets


Oral Use




Bulgaria


Novartis Pharma GmbH
Roonstrasse 25
D–90429 Nürnberg
(Tel: +49-911-273-0)


Diovan 160 mg


160 mg


film-coated tablets


Oral Use




Bulgaria


Novartis Pharma GmbH
Roonstrasse 25
D–90429 Nürnberg
(Tel: +49-911-273-0)


Diovan 320 mg


320 mg


film-coated tablets


Oral Use




Cyprus


Novartis Pharmaceuticals UK Ltd
FrimleyBusinessPark
Frimley, Camberley
Surrey GU16 7SR
United Kingdom
(Tel: +44–1276-69 22 55)


Diovan 40 mg


40 mg


film-coated tablets


Oral Use




Cyprus


Novartis Pharmaceuticals UK Ltd
FrimleyBusinessPark
Frimley, Camberley
Surrey GU16 7SR
United Kingdom
(Tel: +44–1276-69 22 55)


Diovan 80 mg


80 mg


film-coated tablets


Oral Use




Cyprus


Novartis Pharmaceuticals UK Ltd
FrimleyBusinessPark
Frimley, Camberley
Surrey GU16 7SR
United Kingdom
(Tel: +44–1276-69 22 55)


Diovan 160 mg


160 mg


film-coated tablets


Oral Use




Cyprus


Novartis Pharmaceuticals UK Ltd
FrimleyBusinessPark
Frimley, Camberley
Surrey GU16 7SR
United Kingdom
(Tel: +44–1276-69 22 55)


Diovan 320 mg


320 mg


film-coated tablets


Oral Use




Czech Republic


NOVARTIS s.r.o. Pharma
Nagano III.
U Nákladového nádraží 10
130 00 Praha 3
(Tel +420-2–2577 51 11)


Diovan 40 mg


40 mg


film-coated tablets


Oral Use




Czech Republic


NOVARTIS s.r.o. Pharma
Nagano III.
U Nákladového nádraží 10
130 00 Praha 3
(Tel +420-2–2577 51 11)


Diovan 160 mg


160 mg


film-coated tablets


Oral Use




Denmark


Novartis Healthcare A/S
Lyngbyvej 172
DK–2100 København Ø
(Tel: +45-39-16 84 00)


Diovan 40 mg


40 mg


film-coated tablets


Oral Use




Denmark


Novartis Healthcare A/S
Lyngbyvej 172
DK–2100 København Ø
(Tel: +45-39-16 84 00)


Diovan 80 mg


80 mg


film-coated tablets


Oral Use




Denmark


Novartis Healthcare A/S
Lyngbyvej 172
DK–2100 København Ø
(Tel: +45-39-16 84 00)


Diovan 160 mg


160 mg


film-coated tablets


Oral Use




Denmark


Novartis Healthcare A/S
Lyngbyvej 172
DK–2100 København Ø
(Tel: +45-39-16 84 00)


Diovan 320 mg


320 mg


film-coated tablets


Oral Use




Estonia


Novartis Finland OY
Metsänneidonkuja 10
FIN–02130 Espoo
(Tel: + 358-9–6133 22 11)


Diovan


40 mg


film-coated tablets


Oral Use




Estonia


Novartis Finland OY
Metsänneidonkuja 10
FIN–02130 Espoo
(Tel: + 358-9–6133 22 11)


Diovan


80 mg


film-coated tablets


Oral Use




Estonia


Novartis Finland OY
Metsänneidonkuja 10
FIN–02130 Espoo
(Tel: + 358-9–6133 22 11)


Diovan


160 mg


film-coated tablets


Oral Use




Estonia


Novartis Finland OY
Metsänneidonkuja 10
FIN–02130 Espoo
(Tel: + 358-9–6133 22 11)


Diovan


320 mg


film-coated tablets


Oral Use




Finland


Novartis Finland Oy
Metsänneidonkuja 10
FIN–02130 Espoo
(Tel: + 358-9–6133 22 11)


Diovan 40 mg


40 mg


film-coated tablets


Oral Use




Finland


Novartis Finland Oy
Metsänneidonkuja 10
FIN–02130 Espoo
(Tel: + 358-9–6133 22 11)


Diovan 80 mg


80 mg


film-coated tablets


Oral Use




Finland


Novartis Finland Oy
Metsänneidonkuja 10
FIN–02130 Espoo
(Tel: + 358-9–6133 22 11)


Diovan 160 mg


160 mg


film-coated tablets


Oral Use




Finland


Novartis Finland Oy
Metsänneidonkuja 10
FIN–02130 Espoo
(Tel: + 358-9–6133 22 11)


Diovan 320 mg


320 mg


film-coated tablets


Oral Use




France


Novartis Pharma S.A.S.
2 and 4, rue Lionel Terray
92500 RUEIL-MALMAISON
France
(Tel: +33-1–5547 60 00)


Tareg 40 mg


40 mg


film-coated tablets


Oral Use




France


Novartis Pharma S.A.S.
2 and 4, rue Lionel Terray
92500 RUEIL-MALMAISON
France
(Tel: +33-1–5547 60 00)


Tareg 80 mg


80 mg


film-coated tablets


Oral Use




France


Novartis Pharma S.A.S.
2 and 4, rue Lionel Terray
92500 RUEIL-MALMAISON
France
(Tel: +33-1–5547 60 00)


Tareg 160 mg


160 mg


film-coated tablets


Oral Use




Germany


Novartis Pharma GmbH
Roonstrasse 25
D–90429 Nürnberg
(Tel: +49-911-273-0)


Diovan 40 mg


40 mg


film-coated tablets


Oral Use




Germany


Novartis Pharma GmbH
Roonstrasse 25
D–90429 Nürnberg
(Tel: +49-911-273-0)


Cordinate 40 mg


40 mg


film-coated tablets


Oral Use




Germany


Novartis Pharma GmbH
Roonstrasse 25
D–90429 Nürnberg
(Tel: +49-911-273-0)


Provas 40 mg


40 mg


film-coated tablets


Oral Use




Germany


Novartis Pharma GmbH
Roonstrasse 25
D–90429 Nürnberg
(Tel: +49-911-273-0)


Diovan 80 mg


80 mg


film-coated tablets


Oral Use




Germany


Novartis Pharma GmbH
Roonstrasse 25
D–90429 Nürnberg
(Tel: +49-911-273-0)


Cordinate 80 mg


80 mg


film-coated tablets


Oral Use




Germany


Novartis Pharma GmbH
Roonstrasse 25
D–90429 Nürnberg
(Tel: +49-911-273-0)


Provas 80 mg


80 mg


film-coated tablets


Oral Use




Germany


Novartis Pharma GmbH
Roonstrasse 25
D–90429 Nürnberg
(Tel: +49-911-273-0)


Diovan 160 mg protect


160 mg


film-coated tablets


Oral Use




Germany


Novartis Pharma GmbH
Roonstrasse 25
D–90429 Nürnberg
(Tel: +49-911-273-0)


Cordinate 160 mg


160 mg


film-coated tablets


Oral Use




Germany


Novartis Pharma GmbH
Roonstrasse 25
D–90429 Nürnberg
(Tel: +49-911-273-0)


Provas 160 mg


160 mg


film-coated tablets


Oral Use




Germany


Novartis Pharma GmbH
Roonstrasse 25
D–90429 Nürnberg
(Tel: +49-911-273-0)


Diovan 320 mg forte


320 mg


film-coated tablets


Oral Use




Germany


Novartis Pharma GmbH
Roonstrasse 25
D–90429 Nürnberg
(Tel: +49-911-273-0)


Cordinate 320 mg


320 mg


film-coated tablets


Oral Use




Germany


Novartis Pharma GmbH
Roonstrasse 25
D–90429 Nürnberg
(Tel: +49-911-273-0)


Provas 320 mg


320 mg


film-coated tablets


Oral Use




Greece


Novartis (Hellas) S.A.C.I.
National Road No. 1 (12th Km)
Metamorphosis
GR-144 51 Athens
(Tel: +30-210-281 17 12)


Diovan 40 mg


40 mg


film-coated tablets


Oral Use




Greece


Novartis (Hellas) S.A.C.I.
National Road No. 1 (12th Km)
Metamorphosis
GR-144 51 Athens
(Tel: +30-210-281 17 12)


Dalzad 40 mg


40 mg


film-coated tablets


Oral Use




Greece


Novartis (Hellas) S.A.C.I.
National Road No. 1 (12th Km)
Metamorphosis
GR-144 51 Athens
(Tel: +30-210-281 17 12)


Diovan 80 mg


80 mg


film-coated tablets


Oral Use




Greece


Novartis (Hellas) S.A.C.I.
National Road No. 1 (12th Km)
Metamorphosis
GR-144 51 Athens
(Tel: +30-210-281 17 12)


Dalzad 80 mg


80 mg


film-coated tablets


Oral Use




Greece


Novartis (Hellas) S.A.C.I.
National Road No. 1 (12th Km)
Metamorphosis
GR-144 51 Athens
(Tel: +30-210-281 17 12)


Diovan 160 mg


160 mg


film-coated tablets


Oral Use




Greece


Novartis (Hellas) S.A.C.I.
National Road No. 1 (12th Km)
Metamorphosis
GR-144 51 Athens
(Tel: +30-210-281 17 12)


Dalzad 160 mg


160 mg


film-coated tablets


Oral Use




Greece


Novartis (Hellas) S.A.C.I.
National Road No. 1 (12th Km)
Metamorphosis
GR-144 51 Athens
(Tel: +30-210-281 17 12)


Diovan 320 mg


320 mg


film-coated tablets


Oral Use




Greece


Novartis (Hellas) S.A.C.I.
National Road No. 1 (12th Km)
Metamorphosis
GR-144 51 Athens
(Tel: +30-210-281 17 12)


Dalzad 320 mg


320 mg


film-coated tablets


Oral Use




Hungary


Novartis Hungaria Kft.
Bartók Béla út 43-47
H–1114 Budapest
(Tel: +36-1-457 65 00)


Diovan 40 mg


40 mg


film-coated tablets


Oral Use




Hungary


Novartis Hungaria Kft.
Bartók Béla út 43-47
H–1114 Budapest
(Tel: +36-1-457 65 00)


Diovan 80 mg


80 mg


film-coated tablets


Oral Use




Hungary


Novartis Hungaria Kft.
Bartók Béla út 43-47
H–1114 Budapest
(Tel: +36-1-457 65 00)


Diovan 160 mg


160 mg


film-coated tablets


Oral Use




Hungary


Novartis Hungaria Kft.
Bartók Béla út 43-47
H–1114 Budapest
(Tel: +36-1-457 65 00)


Diovan 320 mg


320 mg


film-coated tablets


Oral Use




Iceland


Novartis Healthcare A/S
Lyngbyvej 172
DK–2100 København Ø
(Tel: +45-39-16 84 00)


Diovan 40 mg


40 mg


film-coated tablets


Oral Use




Iceland


Novartis Healthcare A/S
Lyngbyvej 172
DK–2100 København Ø
(Tel: +45-39-16 84 00)


Diovan 80 mg


80 mg


film-coated tablets


Oral Use




Iceland


Novartis Healthcare A/S
Lyngbyvej 172
DK–2100 København Ø
(Tel: +45-39-16 84 00)


Diovan 160 mg


160 mg


film-coated tablets


Oral Use




Iceland


Novartis Healthcare A/S
Lyngbyvej 172
DK–2100 København Ø
(Tel: +45-39-16 84 00)


Diovan 320 mg


320 mg


film-coated tablets


Oral Use




Ireland


Novartis Pharmaceuticals UK Ltd
FrimleyBusinessPark
Frimley, Camberley
Surrey GU16 7SR
United Kingdom
(Tel: +44–1276-69 22 55)


Diovan 40 mg


40 mg


film-coated tablets


Oral Use




Ireland


Novartis Pharmaceuticals UK Ltd
FrimleyBusinessPark
Frimley, Camberley
Surrey GU16 7SR
United Kingdom
(Tel: +44–1276-69 22 55)


Diovan 80 mg


80 mg


film-coated tablets


Oral Use




Ireland


Novartis Pharmaceuticals UK Ltd
FrimleyBusinessPark
Frimley, Camberley
Surrey GU16 7SR
United Kingdom
(Tel: +44–1276-69 22 55)


Diovan 160 mg


160 mg


film-coated tablets


Oral Use




Ireland


Novartis Pharmaceuticals UK Ltd
FrimleyBusinessPark
Frimley, Camberley
Surrey GU16 7SR
United Kingdom
(Tel: +44–1276-69 22 55)


Diovan 320 mg


320 mg


film-coated tablets


Oral Use




Italy


Novartis Farma S.p.A.
Largo Umberto Boccioni 1
I–21040 Origgio
(Tel: + 39-02–96542214)


Tareg 40 mg


40 mg


film-coated tablets


Oral Use




Italy


Novartis Farma S.p.A.
Largo Umberto Boccioni 1
I–21040 Origgio
(Tel: + 39-02–96542214)


Rixil 40 mg


40 mg


film-coated tablets


Oral Use




Italy


Novartis Farma S.p.A.
Largo Umberto Boccioni 1
I–21040 Origgio
(Tel: + 39-02–96542214)


Tareg 80 mg


80 mg


film-coated tablets


Oral Use




Italy


Novartis Farma S.p.A.
Largo Umberto Boccioni 1
I–21040 Origgio
(Tel: + 39-02–96542214)


Rixil 80 mg


80 mg


film-coated tablets


Oral Use




Italy


Novartis Farma S.p.A.
Largo Umberto Boccioni 1
I–21040 Origgio
(Tel: + 39-02–96542214)


Tareg 160 mg


160 mg


film-coated tablets


Oral Use




Italy


Novartis Farma S.p.A.
Largo Umberto Boccioni 1
I–21040 Origgio
(Tel: + 39-02–96542214)


Rixil 160 mg


160 mg


film-coated tablets


Oral Use




Italy


Novartis Farma S.p.A.
Largo Umberto Boccioni 1
I–21040 Origgio
(Tel: + 39-02–96542214)


Tareg 320 mg


320 mg


film-coated tablets


Oral Use




Italy


Novartis Farma S.p.A.
Largo Umberto Boccioni 1
I–21040 Origgio
(Tel: + 39-02–96542214)


Rixil 320 mg


320 mg


film-coated tablets


Oral Use




Latvia


Novartis Finland OY
Metsänneidonkuja 10
FIN–02130 Espoo
(Tel: + 358-9–6133 22 11)


Diovan 40 mg


40 mg


film-coated tablets


Oral Use




Latvia


Novartis Finland OY
Metsänneidonkuja 10
FIN–02130 Espoo
(Tel: + 358-9–6133 22 11)


Diovan 80 mg


80 mg


film-coated tablets


Oral Use




Latvia


Novartis Finland OY
Metsänneidonkuja 10
FIN–02130 Espoo
(Tel: + 358-9–6133 22 11)


Diovan 160 mg


160 mg


film-coated tablets


Oral Use




Latvia


Novartis Finland OY
Metsänneidonkuja 10
FIN–02130 Espoo
(Tel: + 358-9–6133 22 11)


Diovan 320 mg


320 mg


film-coated tablets


Oral Use




Lithuania


Novartis Finland Oy
Metsänneidonkuja 10
FIN–02130 Espoo
(Tel: + 358-9–6133 22 11)


Diovan 80 mg plėvele dengtos tabletės


80 mg


film-coated tablets


Oral Use




Lithuania


Novartis Finland Oy
Metsänneidonkuja 10
FIN–02130 Espoo
(Tel: + 358-9–6133 22 11)


Diovan 160 mg plėvele dengtos tabletės


160 mg


film-coated tablets


Oral Use




Lithuania


Novartis Finland Oy
Metsänneidonkuja 10
FIN–02130 Espoo
(Tel: + 358-9–6133 22 11)


Diovan 320 mg plėvele dengtos tabletės


320 mg


film-coated tablets


Oral Use




Luxembourg


Novartis Pharma GmbH
Roonstrasse 25
D–90429 Nürnberg
(Tel: +49-911-273-0)


Diovan 40 mg


40 mg


film-coated tablets


Oral Use




Luxembourg


Novartis Pharma GmbH
Roonstrasse 25
D–90429 Nürnberg
(Tel: +49-911-273-0)


Diovan 80 mg


80 mg


film-coated tablets


Oral Use




Luxembourg


Novartis Pharma GmbH
Roonstrasse 25
D–90429 Nürnberg
(Tel: +49-911-273-0)


Diovan 160 mg


160 mg


film-coated tablets


Oral Use




Luxembourg


Novartis Pharma GmbH
Roonstrasse 25
D–90429 Nürnberg
(Tel: +49-911-273-0)


Diovan 320 mg


320 mg


film-coated tablets


Oral Use




Malta


Novartis Pharmaceuticals UK Ltd
FrimleyBusinessPark
Frimley, Camberley
Surrey GU16 7SR
United Kingdom
(Tel: +44–1276-69 22 55)


Diovan 40 mg


40 mg


film-coated tablets


Oral Use




Malta


Novartis Pharmaceuticals UK Ltd
FrimleyBusinessPark
Frimley, Camberley
Surrey GU16 7SR
United Kingdom
(Tel: +44–1276-69 22 55)


Diovan 80 mg


80 mg


film-coated tablets


Oral Use




Malta


Novartis Pharmaceuticals UK Ltd
FrimleyBusinessPark
Frimley, Camberley
Surrey GU16 7SR
United Kingdom
(Tel: +44–1276-69 22 55)


Diovan 160 mg


160 mg


film-coated tablets


Oral Use




Malta


Novartis Pharmaceuticals UK Ltd
FrimleyBusinessPark
Frimley, Camberley
Surrey GU16 7SR
United Kingdom
(Tel: +44–1276-69 22 55)


Diovan 320 mg


320 mg


film-coated tablets


Oral Use




Netherlands


Novartis Pharma B.V.
Postbus 241
NL–6824 DP Arnhem
(Tel: + 31-26-378 21 00)


Diovan 40


40 mg


film-coated tablets


Oral Use




Netherlands


Novartis Pharma B.V.
Postbus 241
NL–6800 LZ Arnhem
(Tel: + 31-26-378 21 00)


Diovan 80


80 mg


film-coated tablets


Oral Use




Netherlands


Novartis Pharma B.V.
Postbus 241
NL–6824 DP Arnhem
(Tel: + 31-26-378 21 00)


Diovan 160


160 mg


film-coated tablets


Oral Use




Netherlands


Novartis Pharma B.V.
Postbus 241
NL–6824 DP Arnhem
(Tel: + 31-26-378 21 00)


Diovan 320


320 mg


film-coated tablets


Oral Use




Norway


Novartis Norge AS
Brynsalléen 4
Postboks 237 Økern
NO–0510 Oslo
(Tel: +47–2305 20 00)


Diovan 40 mg


40 mg


film-coated tablets


Oral Use




Norway


Novartis Norge AS
Brynsalléen 4
Postboks 237 Økern
NO–0510 Oslo
(Tel: +47–2305 20 00)


Diovan 80 mg


80 mg


film-coated tablets


Oral Use




Norway


Novartis Norge AS
Brynsalléen 4
Postboks 237 Økern
NO–0510 Oslo
(Tel: +47–2305 20 00)


Diovan 160 mg


160 mg


film-coated tablets


Oral Use




Norway


Novartis Norge AS
Brynsalléen 4
Postboks 237 Økern
NO–0510 Oslo
(Tel: +47–2305 20 00)


Diovan 320 mg


320 mg


film-coated tablets


Oral Use




Poland


Novartis Pharma GmbH
Roonstrasse 25
D–90429 Nürnberg
Germany
(Tel: +49-911-273-0)


Diovan


40 mg


film-coated tablets


Oral Use




Poland


Novartis Pharma GmbH
Roonstrasse 25
D–90429 Nürnberg
Germany
(Tel: +49-911-273-0)


Diovan


80 mg


film-coated tablets


Oral Use




Poland


Novartis Pharma GmbH
Roonstrasse 25
D–90429 Nürnberg
Germany
(Tel: +49-911-273-0)


Diovan


160 mg


film-coated tablets


Oral Use




Poland


Novartis Pharma GmbH
Roonstrasse 25
D–90429 Nürnberg
Germany
(Tel: +49-911-273-0)


Diovan


320 mg


film-coated tablets


Oral Use




Portugal


Novartis Farma - Produtos Farmacêuticos S.A.
Rua do Centro Empresarial, Edificio 8
Quinta da Beloura
P–2710-444 Sintra
(Tel: +351 21000 86 00)


Diovan


40 mg


film-coated tablets


Oral Use




Portugal


Laboratório Normal-Produtos Farmacêuticos, Lda
Rua do Centro Empresarial, Edificio 8
Quinta da Beloura
P–2710-444 Sintra
(Tel: +351 21000 86 00)


Tareg


40 mg


film-coated tablets


Oral Use




Portugal


Novartis Farma - Produtos Farmacêuticos S.A.
Rua do Centro Empresarial, Edificio 8
Quinta da Beloura
P–2710-444 Sintra
(Tel: +351 21000 86 00)


Diovan


80 mg


film-coated tablets


Oral Use




Portugal


Laboratório Normal-Produtos Farmacêuticos, Lda
Rua do Centro Empresarial, Edificio 8
Quinta da Beloura
P–2710-444 Sintra
(Tel: +351 21000 86 00)


Tareg


80 mg


film-coated tablets


Oral Use




Portugal


Novartis Farma - Produtos Farmacêuticos S.A.
Rua do Centro Empresarial, Edificio 8
Quinta da Beloura
P–2710-444 Sintra
(Tel: +351 21000 86 00)


Diovan


160 mg


film-coated tablets


Oral Use




Portugal


Laboratório Normal-Produtos Farmacêuticos, Lda
Rua do Centro Empresarial, Edificio 8
Quinta da Beloura
P–2710-444 Sintra
(Tel: +351 21000 86 00)


Tareg


160 mg


film-coated tablets


Oral Use




Portugal


Novartis Farma - Produtos Farmacêuticos S.A.
Rua do Centro Empresarial, Edificio 8
Quinta da Beloura
P–2710-444 Sintra
(Tel: +351 21000 86 00)


Diovan


320 mg


film-coated tablets


Oral Use




Romania


Novartis Pharma GmbH
Roonstrasse 25
D–90429 Nürnberg
(Tel: +49-911-273-0)


Diovan 40 mg,
film coated tablets


40 mg


film-coated tablets


Oral Use




Romania


Novartis
Pharma GmbH
Roonstrasse 25
D–90429 Nürnberg
(Tel: +49-911-273-0)


Diovan 80 mg, film coated tablets


80 mg


film-coated tablets


Oral Use




Romania


Novartis Pharma GmbH
Roonstrasse 25
D–90429 Nürnberg
(Tel: +49-911-273-0)


Diovan 160 mg, film coated tablets


160 mg


film-coated tablets


Oral Use




Slovak Republic


NOVARTIS s.r.o. Pharma
Nagano III.
U Nákladového nádraží 10
130 00 Praha 3
Czech Republic
(Tel +420-2–2577 51 11)


Diovan 40 mg


40 mg


film-coated tablets


Oral Use




Slovak Republic


NOVARTIS s.r.o. Pharma
Nagano III.
U Nákladového nádraží 10
130 00 Praha 3
Czech Republic
(Tel +420-2–2577 51 11)


Diovan 80 mg


80 mg


film-coated tablets


Oral Use




Slovak Republic


NOVARTIS s.r.o. Pharma
Nagano III.
U Nákladového nádraží 10
130 00 Praha 3
Czech Republic
(Tel +420-2–2577 51 11)


Diovan 160 mg


160 mg


film-coated tablets


Oral Use




Slovak Republic


NOVARTIS s.r.o. Pharma
Nagano III.
U Nákladového nádraží 10
130 00 Praha 3
Czech Republic
(Tel +420-2–2577 51 11)


Diovan 320 mg


320 mg


film-coated tablets


Oral Use




Slovenia


Novartis Pharma GmbH
Roonstrasse 25
D–90429 Nürnberg
(Tel: +49-911-273-0)


Diovan 40 mg filmsko obložene tablete


40 mg


film-coated tablets


Oral Use




Slovenia


Novartis Pharma GmbH
Roonstrasse 25
D–90429 Nürnberg
(Tel: +49-911-273-0)


Diovan 80 mg filmsko obložene tablete


80 mg


film-coated tablets


Oral Use




Slovenia


Novartis Pharma GmbH
Roonstrasse 25
D–90429 Nürnberg
(Tel: +49-911-273-0)


Diovan 160 mg filmsko obložene tablete


160 mg


film-coated tablets


Oral Use




Slovenia


Novartis Pharma GmbH
Roonstrasse 25
D–90429 Nürnberg
(Tel: +49-911-273-0)


Diovan 320 mg filmsko obložene tablete


320 mg


film-coated tablets


Oral Use




Spain


Novartis Farmacéutica, S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
(Tel: +34-93-306 42 00)


Diován Cardio 40 mg comprimidos recubiertos con película


40 mg


film-coated tablets


Oral Use




Spain


Novartis Farmacéutica, S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
(Tel: +34-93-306 42 00)


Kalpress Cardio 40 mg comprimidos recubiertos con película


40 mg


film-coated tablets


Oral Use




Spain


Novartis Farmacéutica, S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
(Tel: +34-93-306 42 00)


Miten Cardio 40 mg comprimidos recubiertos con película


40 mg


film-coated tablets


Oral Use




Spain


Novartis Farmacéutica, S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
(Tel: +34-93-306 42 00)


Diován 80 mg comprimidos recubiertos con película


80 mg


film-coated tablets


Oral Use




Spain


Novartis Farmacéutica, S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
(Tel: +34-93-306 42 00)


Kalpress 80 mg comprimidos recubiertos con película


80 mg


film-coated tablets


Oral Use




Spain


Novartis Farmacéutica, S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
(Tel: +34-93-306 42 00)


Miten 80 mg comprimidos recubiertos con película


80 mg


film-coated tablets


Oral Use




Spain


Novartis Farmacéutica, S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
(Tel: +34-93-306 42 00)


Diován 160 mg comprimidos recubiertos con película


160 mg


film-coated tablets


Oral Use




Spain


Novartis Farmacéutica, S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
(Tel: +34-93-306 42 00)


Kalpress 160 mg comprimidos recubiertos con película


160 mg


film-coated tablets


Oral Use




Spain


Novartis Farmacéutica, S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
(Tel: +34-93-306 42 00)


Miten 160 mg comprimidos recubiertos con película


160 mg


film-coated tablets


Oral Use




Spain


Novartis Farmacéutica, S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
(Tel: +34-93-306 42 00)


Diován 320 mg comprimidos recubiertos con película


320 mg


film-coated tablets


Oral Use




Spain


Novartis Farmacéutica, S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
(Tel: +34-93-306 42 00)


Kalpress 320 mg comprimidos recubiertos con película


320 mg


film-coated tablets


Oral Use




Spain


Novartis Farmacéutica, S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
(Tel: +34-93-306 42 00)


Miten 320 mg comprimidos recubiertos con película


320 mg


film-coated tablets


Oral Use




Sweden


Novartis Sverige AB
Kemistvägen 1B
P.O. Box 1150
SE-183 11 Täby
(Tel: + 46-8-732 32 00)


Diovan


40 mg


film-coated tablets


Oral Use




Sweden


Novartis Sverige AB
Kemistvägen 1B
P.O. Box 1150
SE-183 11 Täby
(Tel: + 46-8-732 32 00)


Angiosan


40 mg


film-coated tablets


Oral Use




Sweden


Novartis Sverige AB
Kemistvägen 1B
P.O. Box 1150
SE-183 11 Täby
(Tel: + 46-8-732 32 00)


Valsartan Novartis


40 mg


film-coated tablets


Oral Use




Sweden


Novartis Sverige AB
Kemistvägen 1B
P.O. Box 1150
SE-183 11 Täby
(Tel: + 46-8-732 32 00)


Diovan


80 mg


film-coated tablets


Oral Use




Sweden


Novartis Sverige AB
Kemistvägen 1B
P.O. Box 1150
SE-183 11 Täby
(Tel: + 46-8-732 32 00)


Angiosan


80 mg


film-coated tablets


Oral Use




Sweden


Novartis Sverige AB
Kemistvägen 1B
P.O. Box 1150
SE-183 11 Täby
(Tel: + 46-8-732 32 00)


Valsartan Novartis


80 mg


film-coated tablets


Oral Use




Sweden


Novartis Sverige AB
Kemistvägen 1B
P.O. Box 1150
SE-183 11 Täby
(Tel: + 46-8-732 32 00)


Diovan


160 mg


film-coated tablets


Oral Use




Sweden


Novartis Sverige AB
Kemistvägen 1B
P.O. Box 1150
SE-183 11 Täby
(Tel: + 46-8-732 32 00)


Angiosan


160 mg


film-coated tablets


Oral Use




Sweden


Novartis Sverige AB
Kemistvägen 1B
P.O. Box 1150
SE-183 11 Täby
(Tel: + 46-8-732 32 00)


Valsartan Novartis


160 mg


film-coated tablets


Oral Use




Sweden


Novartis Sverige AB
Kemistvägen 1B
P.O. Box 1150
SE-183 11 Täby
(Tel: + 46-8-732 32 00)


Diovan


320 mg


film-coated tablets


Oral Use




Sweden


Novartis Sverige AB
Kemistvägen 1B
P.O. Box 1150
SE-183 11 Täby
(Tel: + 46-8-732 32 00)


Angiosan


320 mg


film-coated tablets


Oral Use




Sweden


Novartis Sverige AB
Kemistvägen 1B
P.O. Box 1150
SE-183 11 Täby
(Tel: + 46-8-732 32 00)


Valsartan Novartis


320 mg


film-coated tablets


Oral Use




United Kingdom


Novartis Pharmaceuticals UK Ltd
FrimleyBusinessPark
Frimley, Camberley
Surrey GU16 7SR
United Kingdom
(Tel: +44–1276-69 22 55)


Diovan 40 mg


40 mg


film-coated tablets


Oral Use




United Kingdom


Novartis Pharmaceuticals UK Ltd
FrimleyBusinessPark
Frimley, Camberley
Surrey GU16 7SR
United Kingdom
(Tel: +44–1276-69 22 55)


Diovan 80 mg


80 mg


film-coated tablets


Oral Use




United Kingdom


Novartis Pharmaceuticals UK Ltd
FrimleyBusinessPark
Frimley, Camberley
Surrey GU16 7SR
United Kingdom
(Tel: +44–1276-69 22 55)


Diovan 160 mg


160 mg


film-coated tablets


Oral Use




United Kingdom


Novartis Pharmaceuticals UK Ltd
FrimleyBusinessPark
Frimley, Camberley
Surrey GU16 7SR
United Kingdom
(Tel: +44–1276-69 22 55)


Diovan 320 mg


320 mg


film-coated tablets


Oral Use







ANNEX IV
LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES










Member State EU/EEA


Marketing Authorisation Holder


Invented name


Strength


Pharmaceutical Form


Route of administration




Austria


Novartis Pharma GmbH, Brunner Strasse 59
1235 Wien,
Austria


Lescol 20 mg - Kapseln


20 mg


Capsule, hard


Oral use




Austria


Novartis Pharma GmbH, Brunner Strasse 59
1235 Wien,
Austria


Lescol 40 mg - Kapseln


40 mg


Capsule, hard


Oral use




Austria


Novartis Pharma GmbH, Brunner Strasse 59
1235 Wien,
Austria


Fluvastatin ‘Novartis’ 20 mg-Kapseln


20 mg


Capsule, hard


Oral use




Austria


Novartis Pharma GmbH, Brunner Strasse 59
1235 Wien,
Austria


Fluvastatin ‘Novartis’ 40 mg-Kapseln


40 mg


Capsule, hard


Oral use




Austria


Novartis Pharma GmbH, Brunner Strasse 59
1235 Wien,
Austria


Lescol MR 80 mg – Filmtabletten


80 mg


Film-coated tablet


Oral use




Austria


Novartis Pharma GmbH, Brunner Strasse 59
1235 Wien,
Austria


Fluvastatin ‘Novartis’ MR 80 mg – Filmtabletten


80 mg


Film-coated tablet


Oral use




Belgium


Novartis Pharma N.V.
Medialaan, 40 bus 1,
1800 Vilvoorde,
Belgium


Lescol 20 mg, hard capsules


20 mg


Capsule, hard


Oral use




Belgium


Novartis Pharma N.V.
Medialaan, 40 bus 1,
1800 Vilvoorde,
Belgium


Lescol 40, hard capsules


40 mg


Capsule, hard


Oral use




Belgium


Novartis Pharma N.V.
Medialaan, 40 bus 1,
1800 Vilvoorde,
Belgium


Lescol Exel 80 mg prolonged-release tablet


80 mg


Prolonged-release tablet


Oral use




Bulgaria


Novartis Pharma GmbH
Roonstrasse 25,
90429 Nuremberg,
Germany


Lescol caps. 40 mg


40 mg


Capsule, hard


Oral use




Bulgaria


Novartis Pharma GmbH
Roonstrasse 25,
90429 Nuremberg,
Germany


Lescol XL prolonged release tablet 80 mg


80 mg


Prolonged-release tablet


Oral use




Cyprus


Demetriades & Papaellinas Ltd.,
Kasou 21, 1086 Nicosia,
Cyprus


Lescol Capsule, 20mg


20 mg


Capsule, hard


Oral use




Cyprus


Demetriades & Papaellinas Ltd.,
Kasou 21, 1086 Nicosia,
Cyprus


Lescol Capsule, 40mg


40 mg


Capsule, hard


Oral use




Cyprus


Demetriades & Papaellinas Ltd.,
Kasou 21, 1086 Nicosia,
Cyprus


Lescol XL Prolonged release tablet 80mg


80 mg


Film-coated tablet


Oral use




Czech Republic


Novartis, s.r.o.
Na Pankráci 1724/129
140 00 Praha 4 - Nusle,
Czech Republic


Lescol 20 mg


20 mg


Capsule, hard


Oral use




Czech Republic


Novartis, s.r.o.
Na Pankráci 1724/129
140 00 Praha 4 - Nusle,
Czech Republic


Lescol 40 mg


40 mg


Capsule, hard


Oral use




Czech Republic


Novartis, s.r.o.
Na Pankráci 1724/129
140 00 Praha 4 - Nusle,
Czech Republic


Lescol XL


80 mg


Film-coated tablet


Oral use




Denmark


Novartis Healthcare A/S
Lyngbyvej 172,
2100 København Ø,
Denmark


Lescol


20 mg


Capsule, hard


Oral use




Denmark


Novartis Healthcare A/S
Lyngbyvej 172,
2100 København Ø,
Denmark


Lescol


40 mg


Capsule, hard


Oral use




Denmark


Novartis Healthcare A/S
Lyngbyvej 172
2100 Kopenhagen Ø,
Denmark


Lescol Depot


80 mg


Prolonged-release tablet


Oral use




Estonia


Novartis Finland OY
Metsänneidonkuja 10
FIN–02130 Espoo
Finland


Lescol 40 mg


40 mg


Capsule


Oral use




Estonia


Novartis Finland OY
Metsänneidonkuja 10
FIN–02130 Espoo
Finland


Lescol XL


80 mg


Prolonged-release tablet


Oral use




Finland


Novartis Finland Oy
Metsänneidonkuja 10
FI–02130 Espoo
Finland


Lescol 20 mg


20 mg


Capsule, hard


Oral use




Finland


Novartis Finland Oy
Metsänneidonkuja 10
FI–02130 Espoo
Finland


Lescol 40 mg


40 mg


Capsule, hard


Oral use




Finland


Novartis Finland Oy
Metsänneidonkuja 10
FI–02130 Espoo
Finland


Lescol Depot 80 mg


80 mg


Prolonged-release tablet


Oral use




France


Novartis Pharma S.A.S. 2 & 4, rue Lionel Terray, 92500 Rueil Malmaison Cédex,
France


LESCOL 20 mg


20 mg


Capsule, hard


Oral use




France


Novartis Pharma S.A.S. 2 & 4, rue Lionel Terray, 92500 Rueil Malmaison Cédex,
France


LESCOL 40 mg


40 mg


Capsule, hard


Oral use




France


Pierre FABRE MEDICAMENT
45, place Abel Gance
92100 Boulogne,
France


Fractal 20 mg


20 mg


Capsule, hard


Oral use




France


Pierre FABRE MEDICAMENT
45, place Abel Gance
92100 Boulogne,
France


Fractal 40 mg


40 mg


Capsule, hard


Oral use




France


Novartis Pharma S.A.S. 2 & 4, rue Lionel Terray, 92500 Rueil Malmaison Cédex,
France


Lescol LP 80 mg


80 mg


Film-coated, modified-release tablet


Oral use




France


Pierre FABRE MEDICAMENT
45, place Abel Gance
92100 Boulogne
France


Fractal LP 80 mg


80 mg


Film-coated, modified-release tablet


Oral use




Germany


Novartis Pharma GmbH
Roonstrasse 25
90429 Nürnberg,
Germany


Locol 20 mg Hartkapsel


20 mg


Capsules, hard


Oral use




Germany


Novartis Pharma GmbH
Roonstrasse 25
90429 Nürnberg,
Germany


Locol 40 mg Hartkapsel


40 mg


Capsules, hard


Oral use




Germany


Novartis Pharma GmbH
Roonstrasse 25
90429 Nürnberg,
Germany


Cranoc 20 mg Hartkapsel


20 mg


Capsules, hard


Oral use




Germany


Novartis Pharma GmbH
Roonstrasse 25
90429 Nürnberg,
Germany


Cranoc 40 mg Hartkapsel


40 mg


Capsules, hard


Oral use




Germany


Novartis Pharma GmbH
Roonstrasse 25
90429 Nürnberg,
Germany


Locol 80 mg Retardtabletten


80 mg


Prolonged-release tablet


Oral use




Germany


Novartis Pharma GmbH
Roonstrasse 25
90429 Nürnberg,
Germany


Cranoc 80mg
Retardtabletten


80 mg


Prolonged-release tablet


Oral use




Germany


Grünwalder Gesundheitsproducte GmbH
Ruhlandstrasse 5, 83646 Bad Töltz,
Germany


Fluvastatin-Novartis 80 mg


80 mg


Prolonged-release tablet


Oral use




Greece


Novartis (Hellas) S.A.C.I.
National Road No. 1 (12th Km), Metamorphosis
GR-144 51 Athens
Greece


Lescol® Capsule, hard 20mg


20 mg


Capsule, hard


Oral use




Greece


Novartis (Hellas) S.A.C.I.
National Road No. 1 (12th Km)
Metamorphosis
GR-144 51 Athens,
Greece


Lescol® Capsule, hard 40mg


40 mg


Capsule, hard


Oral use




Greece


Novartis (Hellas) S.A.C.I.
National Road No. 1 (12th Km)
Metamorphosis
GR-144 51 Athens,
Greece


Lescol®XL Prolonged-release tablet 80mg


80 mg


Prolonged release tablet


Oral use




Hungary


Novartis Hungária Kft. Pharma
Bartók Béla út 43-47, 5th Floor,
1114 Budapest,
Hungary


Lescol 40 mg hard caps


40 mg


Capsule, hard


Oral use




Hungary


Novartis Hungária Kft. Pharma
Bartók Béla út 43-47, 5th Floor,
1114 Budapest,
Hungary


Lescol XL 80 mg retard tablet


80 mg


Prolonged-release tablet


Oral use




Iceland


Novartis Healthcare A/S
Lyngbyvej 172,
2100 København Ø,
Denmark


Lescol 20 mg hard caps


20 mg


Capsule, hard


Oral use




Iceland


Novartis Healthcare A/S
Lyngbyvej 172,
2100 København Ø,
Denmark


Lescol 40 mg hard caps


40 mg


Capsule, hard


Oral use




Iceland


Novartis Healthcare A/S
Lyngbyvej 172,
2100 København Ø,
Denmark


Lescol Depot 80 mg


80 mg


Prolonged-release tablet


Oral use




Ireland


Novartis Pharmaceuticals UK Limited
Frimley Business Park,
Frimley, Camberley, Surrey GU16 7SR,
United Kingdom


Lescol 20mg Capsules


20 mg


Capsule, hard


Oral use




Ireland


Novartis Pharmaceuticals UK Limited
Frimley Business Park,
Frimley, Camberley, Surrey GU16 7SR,
United Kingdom


Lescol 40mg Capsules


40 mg


Capsule, hard


Oral use




Ireland


Novartis Pharmaceuticals UK Limited
Frimley Business Park,
Frimley, Camberley, Surrey GU16 7SR,
United Kingdom


Lescol XL 80mg prolonged release tablets


80 mg


Prolonged release tablet


Oral use




Italy


Novartis Farma S.p.A.
Largo Boccioni, 1,
21040 Origgio (VA),
Italy


Lescol


20 mg


Capsule, hard


Oral use




Italy


Novartis Farma S.p.A.
Largo Boccioni, 1,
21040 Origgio (VA),
Italy


Lescol


40 mg


Capsule, hard


Oral use




Italy


ITALFARMACO S.p.A.
Viale Fulvio Testi, 330
20126 Milano
Italy


Lipaxan


20 mg


Capsule, hard


Oral use




Italy


ITALFARMACO S.p.A.
Viale Fulvio Testi, 330
20126 Milano
Italy


Lipaxan


40 mg


Capsule, hard


Oral use




Italy


UCB PHARMA S.p.A
Via Gadames, 57
20151 Milano
Italy


Primesin


20 mg


Capsule, hard


Oral use




Italy


UCB PHARMA S.p.A
Via Gadames, 57
20151 Milano
Italy


Primesin


40 mg


Capsule, hard


Oral use




Italy


SANDOZ S.p.A
Address: Largo Umberto Boccioni 1
I–21040 Origgio / VA
Italy


FLUVASTATINA Sandoz


20 mg


Capsule, hard


Oral use




Italy


SANDOZ S.p.A
Address: Largo Umberto Boccioni 1
I–21040 Origgio / VA
Italy


FLUVASTATINA Sandoz 40 mg hard capsules


40 mg


Capsule, hard


Oral use




Italy


Novartis Farma S.p.A.
Largo Boccioni, 1,
21040 Origgio (VA),
Italy


Lescol 80 mg


80 mg


Prolonged-release tablet


Oral use




Italy


ITALFARMACO S.p.A.
Viale Fulvio Testi, 330
20126 Milano
Italy


Lipaxan 80 mg


80 mg


Prolonged-release tablet


Oral use




Italy


UCB PHARMA S.p.A
Via Gadames, 57
20151 Milano
Italy


Primesin 80 mg


80 mg


Prolonged-release tablet


Oral use




Latvia


Novartis Finland OY
Metsänneidonkuja 10
FIN–02130 Espoo
Finland


Lescol XL 80 mg


80 mg


Prolonged-release tablet


Oral use




Lithuania


Novartis Finland Oy
Metsänneidonkuja 10
FIN–02130 Espoo,
Finland


Lescol XL


80 mg


Prolonged-release tablet


Oral use




Luxembourg


Novartis Pharma GmbH
Roonstrasse 25
D–90429 Nürnberg,
Germany


Locol 20 mg hard caps


20 mg


Capsules, hard


Oral use




Luxembourg


Novartis Pharma GmbH
Roonstrasse 25
D–90429 Nürnberg,
Germany


Locol 40 mg hard caps


40 mg


Capsules, hard


Oral use




Luxembourg


Novartis Pharma GmbH
Roonstrasse 25
D–90429 Nürnberg,
Germany


Locol 80 mg Retard tablet


80 mg


Prolonged-release tablet


Oral use




Malta


Novartis Pharmaceuticals UK Limited
Frimley Business Park,
Frimley, Camberley, Surrey GU16 7SR,
United Kingdom


Lescol


20 mg


Capsule, hard


Oral use




Malta


Novartis Pharmaceuticals UK Limited
Frimley Business Park,
Frimley, Camberley, Surrey GU16 7SR,
United Kingdom


Lescol


40 mg


Capsule, hard


Oral use




Malta


Novartis Pharmaceuticals UK Limited
Frimley Business Park,
Frimley, Camberley, Surrey GU16 7SR,
United Kingdom


Lescol XL


80 mg


Film-coated tablet


Oral use




Norway


Novartis Norge AS,
Postboks 237 Økern, 0510 Oslo,
Norway


LESCOL


20 mg


Capsule, hard


Oral use




Norway


Novartis Norge AS,
Postboks 237 Økern, 0510 Oslo,
Norway


LESCOL


40 mg


Capsule, hard


Oral use




Norway


Novartis Norge AS,
Postboks 237 Økern, 0510 Oslo,
Norway


LESCOL DEPOT 80 mg


80 mg


Prolonged-release tablet


Oral use




Netherlands


Novartis Pharma B.V.
P.O. Box 241
6800 LZ Arnhem
The Netherlands


Lescol 20 mg, capsules


20 mg


Capsule, hard


Oral use




Netherlands


Novartis Pharma B.V.
Raapopseweg 1,
6824 DP Arnhem,
The Netherlands


Lescol 40 mg, capsules


40 mg


Capsule, hard


Oral use




Netherlands


Novartis Pharma B.V.
Raapopseweg 1,
6824 DP Arnhem,
The Netherlands


Lescol XL 80, tablet


80 mg


Film-coated tablet


Oral use




Poland


Novartis Pharma GmbH
Roonstrasse 25,
D–90429Nürnberg,
Germany


Lescol


20 mg


Capsule, hard


Oral use




Poland


Novartis Pharma GmbH
Roonstrasse 25,
D–90429 Nürnberg,
Germany


Lescol


40 mg


Capsule, hard


Oral use




Poland


Novartis Pharma GmbH
Roonstrasse 25,
D–90429 Nürnberg,
Germany


Lescol XL


80 mg


Prolonged-release tablet


Oral use




Portugal


Novartis Farma - Produtos Farmacêuticos S.A.
Rua do Centro Empresarial, Edif. 8, Quinta de Beloura 2710-444, Sintra,
Portugal


Lescol


20 mg


Capsule, hard


Oral use




Portugal


Novartis Farma - Produtos Farmacêuticos S.A.
Rua do Centro Empresarial, Edif. 8, Quinta de Beloura 2710-444, Sintra,
Portugal


Lescol


40 mg


Capsule, hard


Oral use




Portugal


Bialport – Produtos Farmacêuticos, S.A.
À Av. da Siderurgia Nacional – 4745-457 S. Mamede do Coronado
Portugal


Cardiol 20


20 mg


Capsule, hard


Oral use




Portugal


Bialport – Produtos Farmacêuticos, S.A.
À Av. da Siderurgia Nacional – 4745-457 S. Mamede do Coronado
Portugal


Cardiol 40


40 mg


Capsule, hard


Oral use




Portugal


Laboratório Normal - Produtos Farmacêuticos, S.A.
Rua do Centro empresarial, Edifício 8,
Quinta da Beloura
2710-444 Sintra
Portugal


Canef


20 mg


Capsule, hard


Oral use




Portugal


Laboratório Normal - Produtos Farmacêuticos, S.A.
Rua do Centro empresarial, Edifício 8,
Quinta da Beloura
2710-444 Sintra
Portugal


Canef


40 mg


Capsule, hard


Oral use




Portugal


Novartis Farma - Produtos Farmacêuticos S.A.
Rua do Centro Empresarial, Edif. 8,
Quinta de Beloura 2710-444, Sintra,
Portugal


Lescol XL


80 mg


Prolonged-release tablet


Oral use




Portugal


Bialport – Produtos Farmacêuticos, S.A.
À Av. da Siderurgia Nacional – 4745-457 S. Mamede do Coronado
Portugal


Cardiol XL


80 mg


Prolonged-release tablet


Oral use




Portugal


Laboratório Normal - Produtos Farmacêuticos, S.A.
Rua do Centro empresarial, Edifício 8,
Quinta da Beloura
2710-444 Sintra
Portugal


Canef 80 mg


80 mg


Prolonged-release tablet


Oral use




Romania


NOVARTIS PHARMA GmbH
Roonstrasse 25, D–90429 Nürnberg,
Germany


LESCOL 20 mg


20 mg


Capsule, hard


Oral use




Romania


NOVARTIS PHARMA GmbH
Roonstrasse 25, D–90429 Nürnberg,
Germany


LESCOL 40 mg


40 mg


Capsule, hard


Oral use




Romania


NOVARTIS PHARMA GmbH
Roonstrasse 25, D–90429 Nürnberg,
Germany


LESCOL XL


80 mg


Prolonged-release tablet


Oral use




Slovak Republic


Novartis, s.r.o.
U Nákladového nádraží 10,
13000 Prague 3,
Czech Republic


Lescol 20 mg


20 mg


Capsule, hard


Oral use




Slovak Republic


Novartis, s.r.o.
U Nákladového nádraží 10,
13000 Prague 3,
Czech Republic


Lescol 40 mg


40 mg


Capsule, hard


Oral use




Slovak Republic


Novartis, s.r.o.
U Nákladového nádraží 10,
13000 Prague 3,
Czech Republic


Lescol XL 80 mg


80 mg


Prolonged-release tablet


Oral use




Slovenia


Novartis Pharma GmbH
Roonstrasse 25, D–90429 Nürnberg,
Germany


Lescol 40 mg trde kapsule


40 mg


Capsule, hard


Oral use




Slovenia


Novartis Pharma GmbH
Roonstrasse 25, D–90429 Nürnberg,
Germany


Lescol XL 80 mg tablete s podaljšanim sproščanjem


80 mg


Prolonged-release tablet


Oral use




Spain


Novartis Farmacéutica S.A.
Gran Via de les Corts Catalanas, N° 764, 08013, Barcelona,
Spain


Lescol 20 mg caps


20 mg


Capsule, hard


Oral use




Spain


Novartis Farmacéutica S.A.
Gran Via de les Corts Catalanas, N° 764, 08013, Barcelona,
Spain


Lescol 40 mg caps


40 mg


Capsule, hard


Oral use




Spain


Novartis Farmacéutica, S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona,
Spain


Liposit 20 mg caps


20 mg


Capsule, hard


Oral use




Spain


Novartis Farmacéutica, S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona,
Spain


Liposit 40 mg caps


40 mg


Capsule, hard


Oral use




Spain


Novartis Farmacéutica, S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona,
Spain


Vaditon 20 mg caps


20 mg


Capsule, hard


Oral use




Spain


Novartis Farmacéutica, S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona,
Spain


Vaditon 40 mg caps


40 mg


Capsule, hard


Oral use




Spain


Novartis Farmacéutica, S.A.
Av. Diagonal, 507
08029 Barcelona,
Spain


Digaril 20 mg caps


20 mg


Capsule, hard


Oral use




Spain


Novartis Farmacéutica, S.A.
Av. Diagonal, 507
08029 Barcelona,
Spain


Digaril 40 mg caps


40 mg


Capsule, hard


Oral use




Spain


GRÜNENTHAL PHARMA, S.A.
Doctor Zamenhof no 36
28027 Madrid,
Spain


Lymetel 20 mg caps


20 mg


Capsule, hard


Oral use




Spain


GRÜNENTHAL PHARMA, S.A.
Doctor Zamenhof no 36
28027 Madrid,
Spain


Lymetel 40 mg caps


40 mg


Capsule, hard


Oral use




Spain


Novartis Farmacéutica S.A.
Gran Via de les Corts Catalanas, N° 764, 08013, Barcelona,
Spain


Lescol prolib 80 mg


80 mg


Prolonged-release tablet


Oral use




Spain


Novartis Farmacéutica, S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
Spain


Liposit Prolib 80


80 mg


Prolonged-release tablet


Oral use




Spain


Novartis Farmacéutica, S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
Spain


Vaditon Prolib 80 mg


80 mg


Prolonged-release tablet


Oral use




Spain


Novartis Farmacéutica, S.A.
Av. Diagonal, 507
08029 Barcelona
Spain


Digaril Prolib 80 mg


80 mg


Prolonged-release tablet


Oral use




Spain


Laboratorios Andrómaco, S.A.
Doctor Zamenhof no 36
28027 Madrid
Spain


Lymetel Prolib 80 mg


80 mg


Prolonged-release tablet


Oral use




Sweden


Novartis Sverige AB
Box 1150,
18311 Täby,
Sweden


Lescol


20 mg


Capsule, hard


Oral use




Sweden


Novartis Sverige AB
Box 1150,
18311 Täby,
Sweden


Lescol


40 mg


Capsule, hard


Oral use




Sweden


Novartis Sverige AB
Box 1150,
18311 Täby,
Sweden


Lescol Depot


80 mg


Prolonged-release tablet


Oral use




United Kingdom


Novartis Pharmaceuticals UK Ltd
(Trading as Sandoz Pharmaceuticals)
FrimleyBusinessPark
Frimley, Camberley
Surrey GU16 7SR
United Kingdom


LESCOL CAPSULES 20MG


20 mg


Capsule, hard


Oral use




United Kingdom


Novartis Pharmaceuticals UK Ltd
(Trading as Sandoz Pharmaceuticals)
FrimleyBusinessPark
Frimley, Camberley
Surrey GU16 7SR
United Kingdom


LESCOL CAPSULES 40MG


40 mg


Capsule, hard


Oral use




United Kingdom


Novartis Pharmaceuticals UK Ltd
(Trading as Sandoz Pharmaceuticals)
FrimleyBusinessPark
Frimley, Camberley
Surrey GU16 7SR
United Kingdom


LESCOLXL 80 mg Prolonged Release Tablets


80 mg


Prolonged-release tablet


Oral use







ANNEX V
LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES










Member State EU/EEA


Marketing Authorisation Holder


Invented name


Strength


Pharmaceutical Form


Route of administration




Austria


Novartis Pharma GmbH
Stella-Klein-Löw-Weg 17
A–1020 Wien
(Tel: + 43-1–8665 70)


Diovan 40 mg Filmtabletten


40 mg


film-coated tablets


Oral Use




Austria


Novartis Pharma GmbH
Stella-Klein-Löw-Weg 17
A–1020 Wien
(Tel: + 43-1–8665 70)


Angiosan 40 mg Filmtabletten


40 mg


film-coated tablets


Oral Use




Austria


Novartis Pharma GmbH
Stella-Klein-Löw-Weg 17
A–1020 Wien
(Tel: + 43-1–8665 70)


Diovan 80 mg Filmtabletten


80 mg


film-coated tablets


Oral Use




Austria


Novartis Pharma GmbH
Stella-Klein-Löw-Weg 17
A–1020 Wien
(Tel: + 43-1–8665 70)


Angiosan 80 mg Filmtabletten


80 mg


film-coated tablets


Oral Use




Austria


Novartis Pharma GmbH
Stella-Klein-Löw-Weg 17
A–1020 Wien
(Tel: + 43-1–8665 70)


Diovan 160 mg Filmtabletten


160 mg


film-coated tablets


Oral Use




Austria


Novartis Pharma GmbH
Stella-Klein-Löw-Weg 17
A–1020 Wien
(Tel: + 43-1–8665 70)


Angiosan 160 mg Filmtabletten


160 mg


film-coated tablets


Oral Use




Austria


Novartis Pharma GmbH
Stella-Klein-Löw-Weg 17
A–1020 Wien
(Tel: + 43-1–8665 70)


Diovan 320 mg Filmtabletten


320 mg


film-coated tablets


Oral Use




Austria


Novartis Pharma GmbH
Stella-Klein-Löw-Weg 17
A–1020 Wien
(Tel: + 43-1–8665 70)


Angiosan 320 mg Filmtabletten


320 mg


film-coated tablets


Oral Use




Belgium


N.V. Novartis Pharma S.A.
Medialaan 40, bus 1
B–1800 Vilvoorde
(Tel: +32-2-246 16 11)


Diovane 40 mg


40 mg


film-coated tablets


Oral Use




Belgium


N.V. Novartis Pharma S.A.
Medialaan 40, bus 1
B–1800 Vilvoorde
(Tel: +32-2-246 16 11)


Diovane 80 mg


80 mg


film-coated tablets


Oral Use




Belgium


N.V. Novartis Pharma S.A.
Medialaan 40, bus 1
B–1800 Vilvoorde
(Tel: +32-2-246 16 11)


Diovane 160 mg


160 mg


film-coated tablets


Oral Use




Belgium


N.V. Novartis Pharma S.A.
Medialaan 40, bus 1
B–1800 Vilvoorde
(Tel: +32-2-246 16 11)


Diovane 320 mg


320 mg


film-coated tablets


Oral Use




Bulgaria


Novartis Pharma GmbH
Roonstrasse 25
D–90429 Nürnberg
Germany
(Tel: +49-911-273-0)


Diovan 40 mg


40 mg


film-coated tablets


Oral Use




Bulgaria


Novartis Pharma GmbH
Roonstrasse 25
D–90429 Nürnberg
Germany
(Tel: +49-911-273-0)


Diovan 80 mg


80 mg


film-coated tablets


Oral Use




Bulgaria


Novartis Pharma GmbH
Roonstrasse 25
D–90429 Nürnberg
Germany
(Tel: +49-911-273-0)


Diovan 160 mg


160 mg


film-coated tablets


Oral Use




Bulgaria


Novartis Pharma GmbH
Roonstrasse 25
D–90429 Nürnberg
Germany
(Tel: +49-911-273-0)


Diovan 320 mg


320 mg


film-coated tablets


Oral Use




Cyprus


Novartis Pharmaceuticals UK Ltd
FrimleyBusinessPark
Frimley, Camberley
Surrey GU16 7SR
United Kingdom
(Tel: +44–1276-69 22 55)


Diovan 40 mg


40 mg


film-coated tablets


Oral Use




Cyprus


Novartis Pharmaceuticals UK Ltd
FrimleyBusinessPark
Frimley, Camberley
Surrey GU16 7SR
United Kingdom
(Tel: +44–1276-69 22 55)


Diovan 80 mg


80 mg


film-coated tablets


Oral Use




Cyprus


Novartis Pharmaceuticals UK Ltd
FrimleyBusinessPark
Frimley, Camberley
Surrey GU16 7SR
United Kingdom
(Tel: +44–1276-69 22 55)


Diovan 160 mg


160 mg


film-coated tablets


Oral Use




Cyprus


Novartis Pharmaceuticals UK Ltd
FrimleyBusinessPark
Frimley, Camberley
Surrey GU16 7SR
United Kingdom
(Tel: +44–1276-69 22 55)


Diovan 320 mg


320 mg


film-coated tablets


Oral Use




Czech Republic


NOVARTIS s.r.o. Pharma
Nagano III.
U Nákladového nádraží 10
130 00 Praha 3
(Tel +420-2–2577 51 11)


Diovan 40 mg


40 mg


film-coated tablets


Oral Use




Czech Republic


NOVARTIS s.r.o. Pharma
Nagano III.
U Nákladového nádraží 10
130 00 Praha 3
(Tel +420-2–2577 51 11)


Diovan 160 mg


160 mg


film-coated tablets


Oral Use




Denmark


Novartis Healthcare A/S
Lyngbyvej 172
DK–2100 København Ø
(Tel: +45-39-16 84 00)


Diovan 40 mg


40 mg


film-coated tablets


Oral Use




Denmark


Novartis Healthcare A/S
Lyngbyvej 172
DK–2100 København Ø
(Tel: +45-39-16 84 00)


Diovan 80 mg


80 mg


film-coated tablets


Oral Use




Denmark


Novartis Healthcare A/S
Lyngbyvej 172
DK–2100 København Ø
(Tel: +45-39-16 84 00)


Diovan 160 mg


160 mg


film-coated tablets


Oral Use




Denmark


Novartis Healthcare A/S
Lyngbyvej 172
DK–2100 København Ø
(Tel: +45-39-16 84 00)


Diovan 320 mg


320 mg


film-coated tablets


Oral Use




Estonia


Novartis Finland OY
Metsänneidonkuja 10
FIN–02130 Espoo
Finland
(Tel: + 358-9–6133 22 11)


Diovan


40 mg


film-coated tablets


Oral Use




Estonia


Novartis Finland OY
Metsänneidonkuja 10
FIN–02130 Espoo
Finland
(Tel: + 358-9–6133 22 11)


Diovan


80 mg


film-coated tablets


Oral Use




Estonia


Novartis Finland OY
Metsänneidonkuja 10
FIN–02130 Espoo
Finland
(Tel: + 358-9–6133 22 11)


Diovan


160 mg


film-coated tablets


Oral Use




Estonia


Novartis Finland OY
Metsänneidonkuja 10
FIN–02130 Espoo
Finland
(Tel: + 358-9–6133 22 11)


Diovan


320 mg


film-coated tablets


Oral Use




Finland


Novartis Finland Oy
Metsänneidonkuja 10
FIN–02130 Espoo
(Tel: + 358-9–6133 22 11)


Diovan 40 mg


40 mg


film-coated tablets


Oral Use




Finland


Novartis Finland Oy
Metsänneidonkuja 10
FIN–02130 Espoo
(Tel: + 358-9–6133 22 11)


Diovan 80 mg


80 mg


film-coated tablets


Oral Use




Finland


Novartis Finland Oy
Metsänneidonkuja 10
FIN–02130 Espoo
(Tel: + 358-9–6133 22 11)


Diovan 160 mg


160 mg


film-coated tablets


Oral Use




Finland


Novartis Finland Oy
Metsänneidonkuja 10
FIN–02130 Espoo
(Tel: + 358-9–6133 22 11)


Diovan 320 mg


320 mg


film-coated tablets


Oral Use




France


Novartis Pharma S.A.S.
2 and 4, rue Lionel Terray
92500 RUEIL-MALMAISON
(Tel: +33-1–5547 60 00)


Tareg 40 mg


40 mg


film-coated tablets


Oral Use




France


Novartis Pharma S.A.S.
2 and 4, rue Lionel Terray
92500 RUEIL-MALMAISON
(Tel: +33-1–5547 60 00)


Tareg 80 mg


80 mg


film-coated tablets


Oral Use




France


Novartis Pharma S.A.S.
2 and 4, rue Lionel Terray
92500 RUEIL-MALMAISON
(Tel: +33-1–5547 60 00)


Tareg 160 mg


160 mg


film-coated tablets


Oral Use




Germany


Novartis Pharma GmbH
Roonstrasse 25
D–90429 Nürnberg
(Tel: +49-911-273-0)


Diovan 40 mg


40 mg


film-coated tablets


Oral Use




Germany


Novartis Pharma GmbH
Roonstrasse 25
D–90429 Nürnberg
(Tel: +49-911-273-0)


Cordinate 40 mg


40 mg


film-coated tablets


Oral Use




Germany


Novartis Pharma GmbH
Roonstrasse 25
D–90429 Nürnberg
(Tel: +49-911-273-0)


Provas 40 mg


40 mg


film-coated tablets


Oral Use




Germany


Novartis Pharma GmbH
Roonstrasse 25
D–90429 Nürnberg
(Tel: +49-911-273-0)


Diovan 80 mg


80 mg


film-coated tablets


Oral Use




Germany


Novartis Pharma GmbH
Roonstrasse 25
D–90429 Nürnberg
(Tel: +49-911-273-0)


Cordinate 80 mg


80 mg


film-coated tablets


Oral Use




Germany


Novartis Pharma GmbH
Roonstrasse 25
D–90429 Nürnberg
(Tel: +49-911-273-0)


Provas 80 mg


80 mg


film-coated tablets


Oral Use




Germany


Novartis Pharma GmbH
Roonstrasse 25
D–90429 Nürnberg
(Tel: +49-911-273-0)


Diovan 160 mg protect


160 mg


film-coated tablets


Oral Use




Germany


Novartis Pharma GmbH
Roonstrasse 25
D–90429 Nürnberg
(Tel: +49-911-273-0)


Cordinate 160 mg


160 mg


film-coated tablets


Oral Use




Germany


Novartis Pharma GmbH
Roonstrasse 25
D–90429 Nürnberg
(Tel: +49-911-273-0)


Provas 160 mg


160 mg


film-coated tablets


Oral Use




Germany


Novartis Pharma GmbH
Roonstrasse 25
D–90429 Nürnberg
(Tel: +49-911-273-0)


Diovan 320 mg forte


320 mg


film-coated tablets


Oral Use




Germany


Novartis Pharma GmbH
Roonstrasse 25
D–90429 Nürnberg
(Tel: +49-911-273-0)


Cordinate 320 mg


320 mg


film-coated tablets


Oral Use




Germany


Novartis Pharma GmbH
Roonstrasse 25
D–90429 Nürnberg
(Tel: +49-911-273-0)


Provas 320 mg


320 mg


film-coated tablets


Oral Use




Greece


Novartis (Hellas) S.A.C.I.
National Road No. 1 (12th Km)
Metamorphosis
GR-144 51 Athens
(Tel: +30-210-281 17 12)


Diovan 40 mg


40 mg


film-coated tablets


Oral Use




Greece


Novartis (Hellas) S.A.C.I.
National Road No. 1 (12th Km)
Metamorphosis
GR-144 51 Athens
(Tel: +30-210-281 17 12)


Dalzad 40 mg


40 mg


film-coated tablets


Oral Use




Greece


Novartis (Hellas) S.A.C.I.
National Road No. 1 (12th Km)
Metamorphosis
GR-144 51 Athens
(Tel: +30-210-281 17 12)


Diovan 80 mg


80 mg


film-coated tablets


Oral Use




Greece


Novartis (Hellas) S.A.C.I.
National Road No. 1 (12th Km)
Metamorphosis
GR-144 51 Athens
(Tel: +30-210-281 17 12)


Dalzad 80 mg


80 mg


film-coated tablets


Oral Use




Greece


Novartis (Hellas) S.A.C.I.
National Road No. 1 (12th Km)
Metamorphosis
GR-144 51 Athens
(Tel: +30-210-281 17 12)


Diovan 160 mg


160 mg


film-coated tablets


Oral Use




Greece


Novartis (Hellas) S.A.C.I.
National Road No. 1 (12th Km)
Metamorphosis
GR-144 51 Athens
(Tel: +30-210-281 17 12)


Dalzad 160 mg


160 mg


film-coated tablets


Oral Use




Greece


Novartis (Hellas) S.A.C.I.
National Road No. 1 (12th Km)
Metamorphosis
GR-144 51 Athens
(Tel: +30-210-281 17 12)


Diovan 320 mg


320 mg


film-coated tablets


Oral Use




Greece


Novartis (Hellas) S.A.C.I.
National Road No. 1 (12th Km)
Metamorphosis
GR-144 51 Athens
(Tel: +30-210-281 17 12)


Dalzad 320 mg


320 mg


film-coated tablets


Oral Use




Hungary


Novartis Hungaria Kft.
Bartók Béla út 43-47
H–1114 Budapest
(Tel: +36-1-457 65 00)


Diovan 40 mg


40 mg


film-coated tablets


Oral Use




Hungary


Novartis Hungaria Kft.
Bartók Béla út 43-47
H–1114 Budapest
(Tel: +36-1-457 65 00)


Diovan 80 mg


80 mg


film-coated tablets


Oral Use




Hungary


Novartis Hungaria Kft.
Bartók Béla út 43-47
H–1114 Budapest
(Tel: +36-1-457 65 00)


Diovan 160 mg


160 mg


film-coated tablets


Oral Use




Hungary


Novartis Hungaria Kft.
Bartók Béla út 43-47
H–1114 Budapest
(Tel: +36-1-457 65 00)


Diovan 320 mg


320 mg


film-coated tablets


Oral Use




Iceland


Novartis Healthcare A/S
Lyngbyvej 172
DK–2100 København Ø
Denmark
(Tel: +45-39-16 84 00)


Diovan 40 mg


40 mg


film-coated tablets


Oral Use




Iceland


Novartis Healthcare A/S
Lyngbyvej 172
DK–2100 København Ø
Denmark
(Tel: +45-39-16 84 00)


Diovan 80 mg


80 mg


film-coated tablets


Oral Use




Iceland


Novartis Healthcare A/S
Lyngbyvej 172
DK–2100 København Ø
Denmark
(Tel: +45-39-16 84 00)


Diovan 160 mg


160 mg


film-coated tablets


Oral Use




Iceland


Novartis Healthcare A/S
Lyngbyvej 172
DK–2100 København Ø
Denmark
(Tel: +45-39-16 84 00)


Diovan 320 mg


320 mg


film-coated tablets


Oral Use




Ireland


Novartis Pharmaceuticals UK Ltd
FrimleyBusinessPark
Frimley, Camberley
Surrey GU16 7SR
United Kingdom
(Tel: +44–1276-69 22 55)


Diovan 40 mg


40 mg


film-coated tablets


Oral Use




Ireland


Novartis Pharmaceuticals UK Ltd
FrimleyBusinessPark
Frimley, Camberley
Surrey GU16 7SR
United Kingdom
(Tel: +44–1276-69 22 55)


Diovan 80 mg


80 mg


film-coated tablets


Oral Use




Ireland


Novartis Pharmaceuticals UK Ltd
FrimleyBusinessPark
Frimley, Camberley
Surrey GU16 7SR
United Kingdom
(Tel: +44–1276-69 22 55)


Diovan 160 mg


160 mg


film-coated tablets


Oral Use




Ireland


Novartis Pharmaceuticals UK Ltd
FrimleyBusinessPark
Frimley, Camberley
Surrey GU16 7SR
United Kingdom
(Tel: +44–1276-69 22 55)


Diovan 320 mg


320 mg


film-coated tablets


Oral Use




Italy


Novartis Farma S.p.A.
Largo Umberto Boccioni 1
I–21040 Origgio
(Tel: + 39-02–96542214)


Tareg 40 mg


40 mg


film-coated tablets


Oral Use




Italy


Novartis Farma S.p.A.
Largo Umberto Boccioni 1
I–21040 Origgio
(Tel: + 39-02–96542214)


Rixil 40 mg


40 mg


film-coated tablets


Oral Use




Italy


Novartis Farma S.p.A.
Largo Umberto Boccioni 1
I–21040 Origgio
(Tel: + 39-02–96542214)


Tareg 80 mg


80 mg


film-coated tablets


Oral Use




Italy


Novartis Farma S.p.A.
Largo Umberto Boccioni 1
I–21040 Origgio
(Tel: + 39-02–96542214)


Rixil 80 mg


80 mg


film-coated tablets


Oral Use




Italy


Novartis Farma S.p.A.
Largo Umberto Boccioni 1
I–21040 Origgio
(Tel: + 39-02–96542214)


Tareg 160 mg


160 mg


film-coated tablets


Oral Use




Italy


Novartis Farma S.p.A.
Largo Umberto Boccioni 1
I–21040 Origgio
(Tel: + 39-02–96542214)


Rixil 160 mg


160 mg


film-coated tablets


Oral Use




Italy


Novartis Farma S.p.A.
Largo Umberto Boccioni 1
I–21040 Origgio
(Tel: + 39-02–96542214)


Tareg 320 mg


320 mg


film-coated tablets


Oral Use




Italy


Novartis Farma S.p.A.
Largo Umberto Boccioni 1
I–21040 Origgio
(Tel: + 39-02–96542214)


Rixil 320 mg


320 mg


film-coated tablets


Oral Use




Latvia


Novartis Finland OY
Metsänneidonkuja 10
FIN–02130 Espoo
Finland
(Tel: + 358-9–6133 22 11)


Diovan 40 mg


40 mg


film-coated tablets


Oral Use




Latvia


Novartis Finland OY
Metsänneidonkuja 10
FIN–02130 Espoo
Finland
(Tel: + 358-9–6133 22 11)


Diovan 80 mg


80 mg


film-coated tablets


Oral Use




Latvia


Novartis Finland OY
Metsänneidonkuja 10
FIN–02130 Espoo
Finland
(Tel: + 358-9–6133 22 11)


Diovan 160 mg


160 mg


film-coated tablets


Oral Use




Latvia


Novartis Finland OY
Metsänneidonkuja 10
FIN–02130 Espoo
Finland
(Tel: + 358-9–6133 22 11)


Diovan 320 mg


320 mg


film-coated tablets


Oral Use




Lithuania


Novartis Finland Oy
Metsänneidonkuja 10
FIN–02130 Espoo
Finland
(Tel: + 358-9–6133 22 11)


Diovan 80 mg plėvele dengtos tabletės


80 mg


film-coated tablets


Oral Use




Lithuania


Novartis Finland Oy
Metsänneidonkuja 10
FIN–02130 Espoo
Finland
(Tel: + 358-9–6133 22 11)


Diovan 160 mg plėvele dengtos tabletės


160 mg


film-coated tablets


Oral Use




Lithuania


Novartis Finland Oy
Metsänneidonkuja 10
FIN–02130 Espoo
Finland
(Tel: + 358-9–6133 22 11)


Diovan 320 mg plėvele dengtos tabletės


320 mg


film-coated tablets


Oral Use




Luxembourg


Novartis Pharma GmbH
Roonstrasse 25
D–90429 Nürnberg
Germany
(Tel: +49-911-273-0)


Diovan 40 mg


40 mg


film-coated tablets


Oral Use




Luxembourg


Novartis Pharma GmbH
Roonstrasse 25
D–90429 Nürnberg
Germany
(Tel: +49-911-273-0)


Diovan 80 mg


80 mg


film-coated tablets


Oral Use




Luxembourg


Novartis Pharma GmbH
Roonstrasse 25
D–90429 Nürnberg
Germany
(Tel: +49-911-273-0)


Diovan 160 mg


160 mg


film-coated tablets


Oral Use




Luxembourg


Novartis Pharma GmbH
Roonstrasse 25
D–90429 Nürnberg
Germany
(Tel: +49-911-273-0)


Diovan 320 mg


320 mg


film-coated tablets


Oral Use




Malta


Novartis Pharmaceuticals UK Ltd
FrimleyBusinessPark
Frimley, Camberley
Surrey GU16 7SR
United Kingdom
(Tel: +44–1276-69 22 55)


Diovan 40 mg


40 mg


film-coated tablets


Oral Use




Malta


Novartis Pharmaceuticals UK Ltd
FrimleyBusinessPark
Frimley, Camberley
Surrey GU16 7SR
United Kingdom
(Tel: +44–1276-69 22 55)


Diovan 80 mg


80 mg


film-coated tablets


Oral Use




Malta


Novartis Pharmaceuticals UK Ltd
FrimleyBusinessPark
Frimley, Camberley
Surrey GU16 7SR
United Kingdom
(Tel: +44–1276-69 22 55)


Diovan 160 mg


160 mg


film-coated tablets


Oral Use




Malta


Novartis Pharmaceuticals UK Ltd
FrimleyBusinessPark
Frimley, Camberley
Surrey GU16 7SR
United Kingdom
(Tel: +44–1276-69 22 55)


Diovan 320 mg


320 mg


film-coated tablets


Oral Use




Netherlands


Novartis Pharma B.V.
Postbus 241
NL–6824 DP Arnhem
(Tel: + 31-26-378 21 00)


Diovan 40


40 mg


film-coated tablets


Oral Use




Netherlands


Novartis Pharma B.V.
Postbus 241
NL–6800 LZ Arnhem
(Tel: + 31-26-378 21 00)


Diovan 80


80 mg


film-coated tablets


Oral Use




Netherlands


Novartis Pharma B.V.
Postbus 241
NL–6824 DP Arnhem
(Tel: + 31-26-378 21 00)


Diovan 160


160 mg


film-coated tablets


Oral Use




Netherlands


Novartis Pharma B.V.
Postbus 241
NL–6824 DP Arnhem
(Tel: + 31-26-378 21 00)


Diovan 320


320 mg


film-coated tablets


Oral Use




Norway


Novartis Norge AS
Brynsalléen 4
Postboks 237 Økern
NO–0510 Oslo
(Tel: +47–2305 20 00)


Diovan 40 mg


40 mg


film-coated tablets


Oral Use




Norway


Novartis Norge AS
Brynsalléen 4
Postboks 237 Økern
NO–0510 Oslo
(Tel: +47–2305 20 00)


Diovan 80 mg


80 mg


film-coated tablets


Oral Use




Norway


Novartis Norge AS
Brynsalléen 4
Postboks 237 Økern
NO–0510 Oslo
(Tel: +47–2305 20 00)


Diovan 160 mg


160 mg


film-coated tablets


Oral Use




Norway


Novartis Norge AS
Brynsalléen 4
Postboks 237 Økern
NO–0510 Oslo
(Tel: +47–2305 20 00)


Diovan 320 mg


320 mg


film-coated tablets


Oral Use




Poland


Novartis Pharma GmbH
Roonstrasse 25
D–90429 Nürnberg
Germany
(Tel: +49-911-273-0)


Diovan


40 mg


film-coated tablets


Oral Use




Poland


Novartis Pharma GmbH
Roonstrasse 25
D–90429 Nürnberg
Germany
(Tel: +49-911-273-0)


Diovan


80 mg


film-coated tablets


Oral Use




Poland


Novartis Pharma GmbH
Roonstrasse 25
D–90429 Nürnberg
Germany
(Tel: +49-911-273-0)


Diovan


160 mg


film-coated tablets


Oral Use




Poland


Novartis Pharma GmbH
Roonstrasse 25
D–90429 Nürnberg
Germany
(Tel: +49-911-273-0)


Diovan


320 mg


film-coated tablets


Oral Use




Portugal


Novartis Farma - Produtos Farmacêuticos S.A.
Rua do Centro Empresarial, Edificio 8
Quinta da Beloura
P–2710-444 Sintra
(Tel: +351 21000 86 00)


Diovan


40 mg


film-coated tablets


Oral Use




Portugal


Laboratório Normal-Produtos Farmacêuticos, Lda
Rua do Centro Empresarial, Edificio 8
Quinta da Beloura
P–2710-444 Sintra
(Tel: +351 21000 86 00)


Tareg


40 mg


film-coated tablets


Oral Use




Portugal


Novartis Farma - Produtos Farmacêuticos S.A.
Rua do Centro Empresarial, Edificio 8
Quinta da Beloura
P–2710-444 Sintra
(Tel: +351 21000 86 00)


Diovan


80 mg


film-coated tablets


Oral Use




Portugal


Laboratório Normal-Produtos Farmacêuticos, Lda
Rua do Centro Empresarial, Edificio 8
Quinta da Beloura
P–2710-444 Sintra
(Tel: +351 21000 86 00)


Tareg


80 mg


film-coated tablets


Oral Use




Portugal


Novartis Farma - Produtos Farmacêuticos S.A.
Rua do Centro Empresarial, Edificio 8
Quinta da Beloura
P–2710-444 Sintra
(Tel: +351 21000 86 00)


Diovan


160 mg


film-coated tablets


Oral Use




Portugal


Laboratório Normal-Produtos Farmacêuticos, Lda
Rua do Centro Empresarial, Edificio 8
Quinta da Beloura
P–2710-444 Sintra
(Tel: +351 21000 86 00)


Tareg


160 mg


film-coated tablets


Oral Use




Portugal


Novartis Farma - Produtos Farmacêuticos S.A.
Rua do Centro Empresarial, Edificio 8
Quinta da Beloura
P–2710-444 Sintra
(Tel: +351 21000 86 00)


Diovan


320 mg


film-coated tablets


Oral Use




Romania


Novartis Pharma GmbH
Roonstrasse 25
D–90429 Nürnberg
Germany
(Tel: +49-911-273-0)


Diovan 40 mg,
film coated tablets


40 mg


film-coated tablets


Oral Use




Romania


Novartis Pharma GmbH
Roonstrasse 25
D–90429 Nürnberg
Germany
(Tel: +49-911-273-0)


Diovan 80 mg, film coated tablets


80 mg


film-coated tablets


Oral Use




Romania


Novartis Pharma GmbH
Roonstrasse 25
D–90429 Nürnberg
Germany
(Tel: +49-911-273-0)


Diovan 160 mg, film coated tablets


160 mg


film-coated tablets


Oral Use




Slovak Republic


NOVARTIS s.r.o. Pharma
Nagano III.
U Nákladového nádraží 10
130 00 Praha 3
Czech Republic
(Tel +420-2–2577 51 11)


Diovan 40 mg


40 mg


film-coated tablets


Oral Use




Slovak Republic


NOVARTIS s.r.o. Pharma
Nagano III.
U Nákladového nádraží 10
130 00 Praha 3
Czech Republic
(Tel +420-2–2577 51 11)


Diovan 80 mg


80 mg


film-coated tablets


Oral Use




Slovak Republic


NOVARTIS s.r.o. Pharma
Nagano III.
U Nákladového nádraží 10
130 00 Praha 3
Czech Republic
(Tel +420-2–2577 51 11)


Diovan 160 mg


160 mg


film-coated tablets


Oral Use




Slovak Republic


NOVARTIS s.r.o. Pharma
Nagano III.
U Nákladového nádraží 10
130 00 Praha 3
Czech Republic
(Tel +420-2–2577 51 11)


Diovan 320 mg


320 mg


film-coated tablets


Oral Use




Slovenia


Novartis Pharma GmbH
Roonstrasse 25
D–90429 Nürnberg
Germany
(Tel: +49-911-273-0)


Diovan 40 mg filmsko obložene tablete


40 mg


film-coated tablets


Oral Use




Slovenia


Novartis Pharma GmbH
Roonstrasse 25
D–90429 Nürnberg
Germany
(Tel: +49-911-273-0)


Diovan 80 mg filmsko obložene tablete


80 mg


film-coated tablets


Oral Use




Slovenia


Novartis Pharma GmbH
Roonstrasse 25
D–90429 Nürnberg
Germany
(Tel: +49-911-273-0)


Diovan 160 mg filmsko obložene tablete


160 mg


film-coated tablets


Oral Use




Slovenia


Novartis Pharma GmbH
Roonstrasse 25
D–90429 Nürnberg
Germany
(Tel: +49-911-273-0)


Diovan 320 mg filmsko obložene tablete


320 mg


film-coated tablets


Oral Use




Spain


Novartis Farmacéutica, S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
(Tel: +34-93-306 42 00)


Diován Cardio 40 mg comprimidos recubiertos con película


40 mg


film-coated tablets


Oral Use




Spain


Novartis Farmacéutica, S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
(Tel: +34-93-306 42 00)


Kalpress Cardio 40 mg comprimidos recubiertos con película


40 mg


film-coated tablets


Oral Use




Spain


Novartis Farmacéutica, S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
(Tel: +34-93-306 42 00)


Miten Cardio 40 mg comprimidos recubiertos con película


40 mg


film-coated tablets


Oral Use




Spain


Novartis Farmacéutica, S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
(Tel: +34-93-306 42 00)


Diován 80 mg comprimidos recubiertos con película


80 mg


film-coated tablets


Oral Use




Spain


Novartis Farmacéutica, S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
(Tel: +34-93-306 42 00)


Kalpress 80 mg comprimidos recubiertos con película


80 mg


film-coated tablets


Oral Use




Spain


Novartis Farmacéutica, S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
(Tel: +34-93-306 42 00)


Miten 80 mg comprimidos recubiertos con película


80 mg


film-coated tablets


Oral Use




Spain


Novartis Farmacéutica, S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
(Tel: +34-93-306 42 00)


Diován 160 mg comprimidos recubiertos con película


160 mg


film-coated tablets


Oral Use




Spain


Novartis Farmacéutica, S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
(Tel: +34-93-306 42 00)


Kalpress 160 mg comprimidos recubiertos con película


160 mg


film-coated tablets


Oral Use




Spain


Novartis Farmacéutica, S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
(Tel: +34-93-306 42 00)


Miten 160 mg comprimidos recubiertos con película


160 mg


film-coated tablets


Oral Use




Spain


Novartis Farmacéutica, S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
(Tel: +34-93-306 42 00)


Diován 320 mg comprimidos recubiertos con película


320 mg


film-coated tablets


Oral Use




Spain


Novartis Farmacéutica, S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
(Tel: +34-93-306 42 00)


Kalpress 320 mg comprimidos recubiertos con película


320 mg


film-coated tablets


Oral Use




Spain


Novartis Farmacéutica, S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
(Tel: +34-93-306 42 00)


Miten 320 mg comprimidos recubiertos con película


320 mg


film-coated tablets


Oral Use




Sweden


Novartis Sverige AB
Kemistvägen 1B
P.O. Box 1150
SE-183 11 Täby
(Tel: + 46-8-732 32 00)


Diovan


40 mg


film-coated tablets


Oral Use




Sweden


Novartis Sverige AB
Kemistvägen 1B
P.O. Box 1150
SE-183 11 Täby
(Tel: + 46-8-732 32 00)


Angiosan


40 mg


film-coated tablets


Oral Use




Sweden


Novartis Sverige AB
Kemistvägen 1B
P.O. Box 1150
SE-183 11 Täby
(Tel: + 46-8-732 32 00)


Valsartan Novartis


40 mg


film-coated tablets


Oral Use




Sweden


Novartis Sverige AB
Kemistvägen 1B
P.O. Box 1150
SE-183 11 Täby
(Tel: + 46-8-732 32 00)


Diovan


80 mg


film-coated tablets


Oral Use




Sweden


Novartis Sverige AB
Kemistvägen 1B
P.O. Box 1150
SE-183 11 Täby
(Tel: + 46-8-732 32 00)


Angiosan


80 mg


film-coated tablets


Oral Use




Sweden


Novartis Sverige AB
Kemistvägen 1B
P.O. Box 1150
SE-183 11 Täby
(Tel: + 46-8-732 32 00)


Valsartan Novartis


80 mg


film-coated tablets


Oral Use




Sweden


Novartis Sverige AB
Kemistvägen 1B
P.O. Box 1150
SE-183 11 Täby
(Tel: + 46-8-732 32 00)


Diovan


160 mg


film-coated tablets


Oral Use




Sweden


Novartis Sverige AB
Kemistvägen 1B
P.O. Box 1150
SE-183 11 Täby
(Tel: + 46-8-732 32 00)


Angiosan


160 mg


film-coated tablets


Oral Use




Sweden


Novartis Sverige AB
Kemistvägen 1B
P.O. Box 1150
SE-183 11 Täby
(Tel: + 46-8-732 32 00)


Valsartan Novartis


160 mg


film-coated tablets


Oral Use




Sweden


Novartis Sverige AB
Kemistvägen 1B
P.O. Box 1150
SE-183 11 Täby
(Tel: + 46-8-732 32 00)


Diovan


320 mg


film-coated tablets


Oral Use




Sweden


Novartis Sverige AB
Kemistvägen 1B
P.O. Box 1150
SE-183 11 Täby
(Tel: + 46-8-732 32 00)


Angiosan


320 mg


film-coated tablets


Oral Use




Sweden


Novartis Sverige AB
Kemistvägen 1B
P.O. Box 1150
SE-183 11 Täby
(Tel: + 46-8-732 32 00)


Valsartan Novartis


320 mg


film-coated tablets


Oral Use




United Kingdom


Novartis Pharmaceuticals UK Ltd
FrimleyBusinessPark
Frimley, Camberley
Surrey GU16 7SR
(Tel: +44–1276-69 22 55)


Diovan 40 mg


40 mg


film-coated tablets


Oral Use




United Kingdom


Novartis Pharmaceuticals UK Ltd
FrimleyBusinessPark
Frimley, Camberley
Surrey GU16 7SR
(Tel: +44–1276-69 22 55)


Diovan 80 mg


80 mg


film-coated tablets


Oral Use




United Kingdom


Novartis Pharmaceuticals UK Ltd
FrimleyBusinessPark
Frimley, Camberley
Surrey GU16 7SR
(Tel: +44–1276-69 22 55)


Diovan 160 mg


160 mg


film-coated tablets


Oral Use




United Kingdom


Novartis Pharmaceuticals UK Ltd
FrimleyBusinessPark
Frimley, Camberley
Surrey GU16 7SR
(Tel: +44–1276-69 22 55)


Diovan 320 mg


320 mg


film-coated tablets


Oral Use







ANNEX VI
LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES











Member State EU/EEA


Marketing Authorisation Holder


(Invented) name


Strength


Pharmaceutical Form


Route of administration


Content
(concentration)




Austria


AstraZeneca Österreich GmbH,
Schwarzenbergplatz 7,
A-1037 Wien
Austria


Losec 10mg – Kapseln


10 mg


capsule, hard


Oral use


 




Austria


AstraZeneca Österreich GmbH,
Schwarzenbergplatz 7,
A-1037 Wien
Austria


Losec 20mg – Kapseln


20 mg


capsule, hard


Oral use


 




Austria


AstraZeneca Österreich GmbH,
Schwarzenbergplatz 7,
A-1037 Wien
Austria


Losec 40 mg -Trockenstechampulle mit Lösungsmittel


40 mg


Powder for solution for injection


Intravenous use


40 mg




Belgium


NV AstraZeneca SA
Egide Van Ophemstraat 110
1180 Brussels
Belgium


Losec 40mg Forte, harde maagsapresistente capsules


40 mg


Hard Gastroresistant capsules


Oral use


 




Belgium


NV AstraZeneca SA
Egide Van Ophemstraat 110
1180 Brussels
Belgium


Losec 40 mg, poeder voor oplossing voor intraveneuze infusie


40 mg


Powder for solution for infusion


Intravenous use


40 mg




Belgium


NV AstraZeneca SA
Egide Van Ophemstraat 110
1180 Brussels
Belgium


Losec-Mups 10mg, 10 mg, maagsapresistente tabletten


10 mg


Gastroresistant tablets


Oral use


 




Belgium


NV AstraZeneca SA
Egide Van Ophemstraat 110
1180 Brussels
Belgium


Losec-Mups 20mg, 20 mg, maagsapresistente tabletten


20 mg


Gastroresistant tablets


Oral use


 




Belgium


NV AstraZeneca SA
Egide Van Ophemstraat 110
1180 Brussels
Belgium


Losec-Mups 40mg, 40 mg, maagsapresistente tabletten


40 mg


Gastroresistant tablets


Oral use


 




Belgium


NV AstraZeneca SA
Egide Van Ophemstraat 110
1180 Brussel
Belgium


Omeprazole AstraZeneca 20mg, harde maagsapresistente capsules


20 mg


Hard Gastroresistant capsules


Oral use


 




Belgium


NV AstraZeneca SA
Egide Van Ophemstraat 110
1180 Brussel
Belgium


Omeprazole AstraZeneca 40mg Forte, harde maagsapresistente capsules


40 mg


Hard Gastroresistant capsules


Oral use


 




Belgium


NV AstraZeneca SA
Egide Van Ophemstraat 110
1180 Brussels
Belgium


Omeprazole AstraZeneca 40mg, poeder voor oplossing voor intraveneuze infusie


40 mg


Powder for solution for infusion


Intravenous use


40 mg




Belgium


NV AstraZeneca SA
Egide Van Ophemstraat 110
1180 Brussels
Belgium


Logastric 10mg, maagsapresistente capsules


10 mg


Hard Gastroresistant capsules


Oral use


 




Belgium


NV AstraZeneca SA
Egide Van Ophemstraat 110
1180 Brussels
Belgium


Logastric 20mg, maagsapresistente capsules


20 mg


Hard Gastroresistant capsules


Oral use


 




Belgium


NV AstraZeneca SA
Egide Van Ophemstraat 110
1180 Brussels
Belgium


Logastric 40mg Forte, maagsapresistente capsules


40 mg


Hard Gastroresistant capsules


Oral use


 




Belgium


NV AstraZeneca SA
Egide Van Ophemstraat 110
1180 Brussels
Belgium


Logastric-Mups 40mg, 40 mg, maagsapresistente tabletten


40 mg


Gastroresistant tablets


Oral use


 




Cyprus


AstraZeneca AB,
151 85 Södertälje
Sweden


Losec Mups


10mg


Gastro-resistant tablets


Oral use


 




Cyprus


AstraZeneca AB,
151 85 Södertälje
Sweden


Losec Mups


20mg


Gastro-resistant tablets


Oral use


 




Czech Republic


AstraZeneca UK Ltd., Silk Road Business Park, SK10 2NA Macclesfield, Cheshire, United Kingdom


LOSEC 20 mg


20 mg


Gastro-resistant capsule, hard


Oral use


 




Czech Republic


AstraZeneca UK Ltd., Silk Road Business Park, SK10 2NA Macclesfield, Cheshire, United Kingdom


LOSEC 40 mg


40 mg


Powder for solution for infusion


Intravenous use


 




Denmark


AstraZeneca A/S
Roskildevej 22
2620 Albertslund
Denmark


Losec


10 mg


Gastroresistant tablets


Oral use


 




Denmark


AstraZeneca A/S
Roskildevej 22
2620 Albertslund
Denmark


Losec


20 mg


Gastroresistant tablets


Oral use


 




Denmark


AstraZeneca A/S
Roskildevej 22
2620 Albertslund
Denmark


Losec


40 mg


Gastroresistant tablets


Oral use


 




Denmark


AstraZeneca A/S
Roskildevej 22
2620 Albertslund
Denmark


Losec


40 mg/ml


Powder and Solvens for solution for injection


Intravenous use


40 mg




Denmark


AstraZeneca A/S
Roskildevej 22
2620 Albertslund
Denmark


Losec


40 mg/ml


Powder for solution for infusion


Intravenous use


40 mg




Estonia


AstraZeneca AB,
S-151 85 Södertälje Sweden


Losec MUPS


20 mg


Gastroresistant tablets


Oral use


 




Estonia


AstraZeneca AB,
S-151 85 Södertälje Sweden


Losec 40 MG


40 mg


Powder for solution for infusion


Intravenous use


40 mg




Finland


AstraZeneca Oy
Luomanportti 3
FI-02200 Espoo
Finland


Losec Mups 10 mg enterotabletti


10 mg


Gastroresistant tablet


Oral use


 




Finland


AstraZeneca Oy
Luomanportti 3
FI-02200 Espoo
Finland


Losec Mups 20 mg enterotabletti


20 mg


Gastroresistant tablet


Oral use


 




Finland


AstraZeneca Oy
Luomanportti 3
FI-02200 Espoo
Finland


Losec Mups 40 mg enterotabletti


40 mg


Gastroresistant tablet


Oral use


 




France


AstraZeneca
1, Place Renault
92844 RUEIL-MALMAISON Cedex
France


MOPRAL® 20 mg microgranules gastrorésistants en gélule


20 mg


Capsules


Oral use


 




France


AstraZeneca
1, Place Renault
92844 RUEIL-MALMAISON Cedex
France


MOPRAL® 10 mg microgranules gastrorésistants en gélule


10 mg


Capsules


Oral use


 




France


AstraZeneca
1, Place Renault
92844 RUEIL-MALMAISON Cedex
France


ZOLTUM® 20 mg microgranules gastrorésistants en gélule


20 mg


Capsules


Oral use


 




France


AstraZeneca
1, Place Renault
92844 RUEIL-MALMAISON Cedex
France


ZOLTUM® 10 mg microgranules gastrorésistants en gélule


10 mg


Capsules


Oral use


 




France


AstraZeneca
1, Place Renault
92844 RUEIL-MALMAISON Cedex
France


MOPRAL 40 mg, lyophilisat pour perfusion (IV).


40 mg


Lyophylizat for perfusion


Intravenous use


40 mg




Germany


AstraZeneca GmbH
22876 Wedel
Germany


Antra pro infusione


40 mg


Powder for solution for infusion


Intravenous use


40 mg




Germany


AstraZeneca GmbH
22876 Wedel
Germany


Antra MUPS 10 mg


10 mg


Gastro-resistant tablets


Oral use


 




Germany


AstraZeneca GmbH
22876 Wedel
Germany


Antra MUPS 20 mg


20 mg


Gastro-resistant tablets


Oral use


 




Germany


AstraZeneca GmbH
22876 Wedel
Germany


Antra MUPS 40 mg


40 mg


Gastro-resistant tablets


Oral use


 




Greece


AstraZeneca S.A.
4 Theotokopoulou & Astronafton str
151 25 Maroussi Athens
Greece


Losec®, Γαστροανθεκτικό καψάκιο σκληρό 10 mg/CAP


10 mg


Gastro-resistant capsules, hard


Oral use


 




Greece


AstraZeneca S.A.
4 Theotokopoulou & Astronafton str
151 25 Maroussi Athens
Greece


Losec®, Γαστροανθεκτικό καψάκιο σκληρό 20 mg/CAP


20 mg


Gastro-resistant capsules, hard


Oral use


 




Greece


AstraZeneca S.A.
4 Theotokopoulou & Astronafton str
151 25 Maroussi Athens
Greece


Losec®, Γαστροανθεκτικό καψάκιο σκληρό 40 mg/CAP


40 mg


Gastro-resistant capsules, hard


Oral use


 




Greece


AstraZeneca S.A.
4 Theotokopoulou & Astronafton str
151 25 Maroussi Athens
Greece


Losec MUPS®, Γαστροανθεκτικό δισκίο 10 mg/TAB


10 mg


Gastro-resistant tablets


Oral use


 




Greece


AstraZeneca S.A.
4 Theotokopoulou & Astronafton str
151 25 Maroussi Athens
Greece


Losec MUPS®, Γαστροανθεκτικό δισκίο 20 mg/TAB


20 m


Gastro-resistant tablets


Oral use


 




Greece


AstraZeneca S.A.
4 Theotokopoulou & Astronafton str
151 25 Maroussi Athens
Greece


Losec MUPS®, Γαστροανθεκτικό δισκίο 40 mg/TAB


40 mg


Gastro-resistant tablets


Oral use


 




Greece


AstraZeneca S.A.
4 Theotokopoulou & Astronafton str
151 25 Maroussi Athens
Greece


Losec®, Ενέσιμο λυόφιλο 40 mg/VIAL


40 mg


Powder and solvent for solution for injection


Intravenous use


40 mg




Greece


AstraZeneca S.A.
4 Theotokopoulou & Astronafton str
151 25 Maroussi Athens
Greece


Losec®, Ενέσιμο λυόφιλο για ενδοφλέβια έγχυση 40 mg/VIAL


40 mg


Powder for solution for infusion


Intravenous use


40 mg




Hungary


AstraZeneca Kft.
H-2045 Törökbálint, Park u. 3.
Hungary


Losec 10 mg kapszula


10 mg


Capsule, hard


Oral use


 




Hungary


AstraZeneca Kft.
H-2045 Törökbálint, Park u. 3.
Hungary


Losec 20 mg kapszulaz


20 mg


Capsule, hard


Oral use


 




Hungary


AstraZeneca Kft.
H-2045 Törökbálint, Park u. 3.
Hungary


Losec 40 mg por infúzióhoz


40 mg


Powder for solution for infusion


Intravenous use


40 mg




Iceland


AstraZeneca A/S
Roskildevej 22
DK-2620 Albertslund
Denmark


Losec


10 mg


Gastroresistant tablets


Oral use


 




Iceland


AstraZeneca A/S
Roskildevej 22
DK-2620 Albertslund
Denmark


Losec


20 mg


Gastroresistant tablets


Oral use


 




Iceland


AstraZeneca A/S
Roskildevej 22
DK-2620 Albertslund
Denmark


Losec


40 mg


Powder for solution for infusion


Intravenous use


40 mg




Ireland


AstraZeneca UK Limited
600 Capability Green
Luton LU1 3LU
United Kingdom


Losec MUPS Tablets 10mg


10mg


Gastro-resistant, film-coated tablet


Oral use


 




Ireland


AstraZeneca UK Limited
600 Capability Green
Luton LU1 3LU
United Kingdom


Losec MUPS Tablets 20mg


20mg


Gastro-resistant, film-coated tablet


Oral use


 




Ireland


AstraZeneca UK Limited
600 Capability Green
Luton LU1 3LU
United Kingdom


Losec MUPS Tablets 40mg


40mg


Gastro-resistant, film-coated tablet


Oral use


 




Ireland


AstraZeneca UK Limited
600 Capability Green
Luton LU1 3LU
United Kingdom


Losec Losec 40mg Powder for Solution for Infusion


40mg


Powder for solution for infusion


Intravenous use


40 mg




Ireland


AstraZeneca UK Limited
600 Capability Green
Luton LU1 3LU
United Kingdom


Losec IV 40mg Powder and Solvent for Solution for Injection


40mg


Powder and solvent for solution for injection


Intravenous use


40 mg




Italy


AstraZeneca S.p.A.
Via F. Sforza
Palazzo Volta
20080 Basiglio (MI)
Italy


Antra 10 mg capsule rigide a rilascio modificato


10 mg


Hard modified release capsules


Oral use


 




Italy


AstraZeneca S.p.A.
Via F. Sforza
Palazzo Volta
20080 Basiglio (MI)
Italy


Antra 20 mg capsule rigide a rilascio modificato


20 mg


Hard modified release capsules


Oral use


 




Italy


AstraZeneca S.p.A.
Via F. Sforza
Palazzo Volta
20080 Basiglio (MI)
Italy


Antra 40 mg capsule rigide a rilascio modificato


40 mg


Hard modified release capsules


Oral use


 




Italy


AstraZeneca S.p.A.
Via F. Sforza
Palazzo Volta
20080 Basiglio (MI)
Italy


Antra 40 mg polvere per soluzione per infusione


40 mg


Powder for solution for infusion


Intravenous use


40 mg




Italy


AstraZeneca AB,
S-151 85 Södertälje
Sweden


Losec 10 mg capsule rigide a rilascio modificato


10 mg


Hard modified release capsules


Oral use


 




Italy


AstraZeneca AB,
S-151 85 Södertälje
Sweden


Losec 20 mg capsule rigide a rilascio modificato


20 mg


Hard modified release capsules


Oral use


 




Italy


AstraZeneca AB,
S-151 85 Södertälje
Sweden


Losec 40 mg capsule rigide a rilascio modificato


40 mg


Hard modified release capsules


Oral use


 




Italy


AstraZeneca AB,
S-151 85 Södertälje
Sweden


Losec 40 mg polvere per soluzione per infusione


40 mg


Powder for solution for infusion


Intravenous use


40 mg




Italy


Bracco S.p.A.
Via E. Folli 50
20134 Milano
Italy


Mepral 10 mg capsule rigide a rilascio modificato


10 mg


Hard modified release capsules


Oral use


 




Italy


Bracco S.p.A.
Via E. Folli 50
20134 Milano
Italy


Mepral 20 mg capsule rigide a rilascio modificato


20 mg


Hard modified release capsules


Oral use


 




Italy


Bracco S.p.A.
Via E. Folli 50
20134 Milano
Italy


Mepral 40 mg capsule rigide a rilascio modificato


40 mg


Hard modified release capsules


Oral use


 




Italy


Bracco S.p.A.
Via E. Folli 50
20134 Milano
Italy


Mepral 40 mg polvere per soluzione per infusione


40 mg


Powder for solution for infusion


Intravenous use


40 mg




Italy


Malesci Istituto Farmacobiologico S.p.A.
Via Lungo l'Ema 7
50015 Bagno a Ripoli (FI)
Italy


Omeprazen 10 mg capsule rigide a rilascio modificato


10 mg


Hard modified release capsules


Oral use


 




Italy


Malesci Istituto Farmacobiologico S.p.A.
Via Lungo l'Ema 7
50015 Bagno a Ripoli (FI)
Italy


Omeprazen 20 mg capsule rigide a rilascio modificato


20 mg


Hard modified release capsules


Oral use


 




Italy


Malesci Istituto Farmacobiologico S.p.A.
Via Lungo l'Ema 7
50015 Bagno a Ripoli (FI)
Italy


Omeprazen 40 mg capsule rigide a rilascio modificato


40 mg


Hard modified release capsules


Oral use


 




Italy


Malesci Istituto Farmacobiologico S.p.A.
Via Lungo l'Ema 7
50015 Bagno a Ripoli (FI)
Italy


Omeprazen 40 mg polvere per soluzione per infusione


40 mg


Powder for solution for infusion


Intravenous use


40 mg




Latvia


AstraZeneca AB,
S-151 85 Södertälje Sweden


Losec 40 mg pulveris infūziju šķīduma pagatavošanai


40 mg


Powder for solution for infusion


Intravenous use


40 mg




Luxembourg


NV AstraZeneca SA
Egide Van Ophemstraat 110
1180 Brussels
Belgium


Losec Forte Gelules 40mg


40 mg


Hard gastroresis-tant capsules


Oral use


 




Luxembourg


NV AstraZeneca SA
Egide Van Ophemstraat 110
1180 Brussels
Belgium


Losec poudre pour perfusion 40 mg


40 mg


Powder for solution for intravenous infusion


Intravenous use


40 mg




Luxembourg


NV AstraZeneca SA
Egide Van Ophemstraat 110
1180 Brussels
Belgium


Losec-Mups 10mg


10 mg


Gastroresistant tablets


Oral use


 




Luxembourg


NV AstraZeneca SA
Egide Van Ophemstraat 110
1180 Brussels
Belgium


Losec-Mups 20mg


20 mg


Gastroresistant tablets


Oral use


 




Luxembourg


NV AstraZeneca SA
Egide Van Ophemstraat 110
1180 Brussels
Belgium


Losec-Mups 40mg


40 mg


Gastroresistant tablets


Oral use


 




Malta


AstraZeneca AB
S-151 85 Södertälje
Sweden


Losec MUPS Tablets 10mg


10mg


Gastro-resistant, film-coated tablet


Oral use


 




Malta


AstraZeneca AB
S-151 85 Södertälje
Sweden


Losec MUPS Tablets 20mg


20mg


Gastro-resistant, film-coated tablet


Oral use


 




Netherlands


AstraZeneca BV
Postbus 599
2700 AN, Zoetermeer
The Netherlands


Losec 10


10 mg


Gstroresistant capsules


Oral use


 




Netherlands


AstraZeneca BV
Postbus 599
2700 AN, Zoetermeer
The Netherlands


Losec 20


20 mg


Gastroresistant capsules


Oral use


 




Netherlands


AstraZeneca BV
Postbus 599
2700 AN, Zoetermeer
The Netherlands


Losec 40


40 mg


Gastroresistant capsules


Oral use


 




Netherlands


AstraZeneca BV
Postbus 599
2700 AN, Zoetermeer
The Netherlands


Losec


40 mg


Powder and solvent for solution for injection


Intravenous use


40 mg




Netherlands


AstraZeneca BV
Postbus 599
2700 AN, Zoetermeer
The Netherlands


Losec Infuus


40 mg


Powder for solution for intravenous infusion


Intravenous use


40 mg




Netherlands


AstraZeneca BV
Postbus 599
2700 AN, Zoetermeer
The Netherlands


Losec MUPS 10


10 mg


Gastroresistant tablets


Oral use


 




Netherlands


AstraZeneca BV
Postbus 599
2700 AN, Zoetermeer
The Netherlands


Losec MUPS 20


20 mg


Gastroresistant tablets


Oral use


 




Netherlands


AstraZeneca BV
Postbus 599
2700 AN, Zoetermeer
The Netherlands


Losec MUPS 40


40 mg


Gastroresistant tablets


Oral use


 




Norway


AstraZeneca AS,
Postboks 200 Vinderen, 0319 OSLO
Norway


Losec® MUPS®



10 mg


Gastroresistant tablets


Oral use


 




Norway


AstraZeneca AS,
Postboks 200 Vinderen, 0319 OSLO
Norway


Losec® MUPS®



20 mg


Gastroresistant tablets


Oral use


 




Norway


AstraZeneca AS,
Postboks 200 Vinderen, 0319 OSLO
Norway


Losec®



40mg


Powder for solution for infusion


Intravenous use


40 mg




Poland


AstraZeneca AB
S-151 85 Södertälje
Sweden


Losec 10


10mg


Capsules


Oral use


 




Poland


AstraZeneca AB
S-151 85 Södertälje
Sweden


Losec


20mg


Capsules


Oral use


 




Poland


AstraZeneca AB
S-151 85 Södertälje
Sweden


Losec


40mg


Powder for solution for infusion


Intravenous use


40 mg




Portugal


AstraZeneca Produtos Farmacêuticos, Lda.
Rua Humberto Madeira, n.o 7, Valejas
2745-663 Barcarena
Portugal


Losec


20 mg


Gastroresistant capsules


Oral use


 




Portugal


AstraZeneca Produtos Farmacêuticos, Lda.
Rua Humberto Madeira, n.o 7, Valejas
2745-663 Barcarena
Portugal


Losec


40 mg


Powder for solution for infusion


Intravenous use


40 mg




Portugal


AstraZeneca Produtos Farmacêuticos, Lda.
Rua Humberto Madeira, n.o 7, Valejas
2745-663 Barcarena
Portugal


Losec


40 mg


Powder and solvent for injectable solution


Intravenous use


40 mg




Romania


AstraZeneca AB,
S-151 85 Södertälje
Sweden


Losec MUPS 10 mg coprimate filmate gastrorezistente


10 mg


Film-coated gastroresistant tablets


Oral use


 




Romania


AstraZeneca AB,
S-151 85 Södertälje
Sweden


Losec MUPS 20 mg
comprimate filmate gastrorezistene


20mg


Film-coated gastroresistant tablets


Oral use


 




Romania


AstraZeneca AB,
S-151 85 Södertälje
Sweden


Losec 40mg liofilizat pentru solutie perfuzabila


40mg


Lyophilisate for solution for infusion


Intravenous use


40 mg




Slovak Republic


AstraZeneca AB,
S-151 85 Södertälje
Sweden


Losec®



40 mg


Powder for solution for infusion


Intravenous use


40 mg




Spain


Laboratorio Tau, S.A.
C/Serrano Galvache, 56 Edificio Roble
28033 Madrid
Spain


LOSEC infusión i.v.


40 mg


Powder for infusion


Intravenous use


40 mg




Spain


Laboratorio Tau, S.A.
C/Serrano Galvache, 56 Edificio Roble
28033 Madrid
Spain


LOSEC cápsulas 20 mg


20 mg


Capsules, hard


Oral use


 




Sweden


AstraZeneca AB
S-151 85 Södertälje
Sweden


Losec


10 mg


Gastro-resistant tablets


Oral use


 




Sweden


AstraZeneca AB
S-151 85 Södertälje
Sweden


Losec


20 mg


Gastro-resistant tablets


Oral use


 




Sweden


AstraZeneca AB
S-151 85 Södertälje
Sweden


Losec


40 mg


Gastro-resistant tablets


Oral use


 




Sweden


AstraZeneca AB
S-151 85 Södertälje
Sweden


Losec


40 mg


Powder for solution for injection


Intravenous use


40 mg




Sweden


AstraZeneca AB
S-151 85 Södertälje
Sweden


Losec


40 mg


Powder for solution for infusion


Intravenous use


40 mg




United Kingdom


AstraZeneca UK Limited
600 Capability Green
Luton LU1 3LU
United Kingdom


Losec MUPS Tablets 10mg


10mg


Film-coated Tablet


Oral use


 




United Kingdom


AstraZeneca UK Limited
600 Capability Green
Luton LU1 3LU
United Kingdom


Losec MUPS Tablets 20mg


20mg


Film-coated Tablet


Oral use


 




United Kingdom


AstraZeneca UK Limited
600 Capability Green
Luton LU1 3LU
United Kingdom


Losec MUPS Tablets 40mg


40mg


Film-coated Tablet


Oral use


 




United Kingdom


AstraZeneca UK Limited
600 Capability Green
Luton LU1 3LU
United Kingdom


Losec Capsules 10mg


10mg


Hard gelatin capsules


Oral use


 




United Kingdom


AstraZeneca UK Limited
600 Capability Green
Luton LU1 3LU
United Kingdom


Losec Capsules 20mg


20mg


Hard gelatin capsules


Oral use


 




United Kingdom


AstraZeneca UK Limited
600 Capability Green
Luton LU1 3LU
United Kingdom


Losec Capsules 40mg


40mg


Hard gelatine capsules


Oral use


 




United Kingdom


AstraZeneca UK Limited
600 Capability Green
Luton LU1 3LU
United Kingdom


Losec Infusion 40mg


40mg


Powder for solution for infusion


Intravenous use


40 mg




United Kingdom


AstraZeneca UK Limited
600 Capability Green
Luton LU1 3LU
United Kingdom


Losec IV Injection 40mg


40mg


Powder and solvent for solution for injection


Intravenous use


40 mg







ANNEX VII
LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES











Member State EU/EEA


Marketing Authorisation Holder


(Invented) name


Strength


Pharmaceutical Form


Route of administration


Content
(concentration)




Austria


Nycomed Pharma GmbH
Euro Plaza Gebäude F Technologiestrasse 5
1120 Vienna
Austria


Pantoloc 20 mg -Filmtabletten


20 mg


Gastro-resistant tablet


oral use


 




Austria


Nycomed Pharma GmbH
Euro Plaza Gebäude F Technologiestrasse 5
1120 Vienna
Austria


Pantoloc 40 mg -Filmtabletten


40 mg


Gastro-resistant tablet


oral use


 




Austria


Nycomed Pharma GmbH
Euro Plaza Gebäude F Technologiestrasse 5
1120 Vienna
Austria


Pantoloc 40 mg -Trockenstech-
ampulle


40 mg


Powder for solution for injection


intravenous use


40 mg




Austria


Nycomed Austria GmbH
St. Peter Strasse 25
4020 Linz
Austria


Zurcal 20 mg -Filmtabletten


20 mg


Gastro-resistant tablet


oral use


 




Austria


Nycomed Austria GmbH
St. Peter Strasse 25
4020 Linz
Austria


Zurcal 40 mg -Filmtabletten


40 mg


Gastro-resistant tablet


oral use


 




Austria


Nycomed Austria GmbH
St. Peter Strasse 25
4020 Linz
Austria


Zurcal 40 mg -Trockenstech-
ampulle


40 mg


Powder for solution for injection


intravenous use


40 mg




Belgium


Nycomed Belgium SCA/CVA
Gentsesteenweg 615
1080 Brussels
Belgium


Pantozol


40 mg


Gastro-resistant tablet


oral use


 




Belgium


Nycomed Belgium
SCA/CVA
Gentsesteenweg 615
1080 Brussels
Belgium


Pantozol


20 mg


Gastro-resistant tablet


oral use


 




Belgium


Nycomed Belgium
SCA/CVA
Gentsesteenweg 615
1080 Brussels
Belgium


Pantozol IV


40 mg


Powder for solution for injection


intravenous use


40 mg




Belgium


Nycomed Belgium SCA/CVA
Gentsesteenweg 615
1080 Brussels
Belgium


Zurcale


40 mg


Gastro-resistant tablet


oral use


 




Belgium


Nycomed Belgium SCA/CVA
Gentsesteenweg 615
1080 Brussels
Belgium


Zurcale 20 mg


20 mg


Gastro-resistant tablet


oral use


 




Belgium


Nycomed Belgium SCA/CVA
Gentsesteenweg 615
1080 Brussels
Belgium


Zurcale IV


40 mg


Powder for solution for injection


intravenous use


40 mg




Bulgaria


Nycomed GmbH
Byk-Gulden-Str.2
78467 Constance
Germany


Controloc


20 mg


Gastro-resistant tablet


oral use


 




Bulgaria


Nycomed GmbH
Byk-Gulden-Str.2
78467 Constance
Germany


Controloc


40 mg


Gastro-resistant tablet


oral use


 




Cyprus


Mundipharma Pharmaceuticals Ltd.
Othellos str. 13
Dhali Industrial Zone
1685 Nicosia
Cyprus


Controloc


20 mg


Gastro-resistant tablet


oral use


 




Cyprus


Mundipharma Pharmaceuticals Ltd.
Othellos str. 13
Dhali Industrial Zone
1685 Nicosia
Cyprus


Controloc


40 mg


Gastro-resistant tablet


oral use


 




Cyprus


Mundipharma Pharmaceuticals Ltd.
Othellos str. 13
Dhali Industrial Zone
1685 Nicosia
Cyprus


Controloc i.v.


40 mg


Powder for solution for injection


intravenous use


40 mg




Czech Republic


Nycomed GmbH
Byk-Gulden-Str.2
78467 Konstanz
Germany


Controloc 20 mg


20 mg


Gastro-resistant tablet


oral use


 




Czech Republic


Nycomed GmbH
Byk-Gulden-Str.2
78467 Konstanz
Germany


Controloc 40 mg


40 mg


Gastro-resistant tablet


oral use


 




Czech Republic


Nycomed GmbH
Byk-Gulden-Str.2
78467 Konstanz
Germany


Controloc i.v.


40 mg


Powder for solution for injection


intravenous use


40 mg




Denmark


Nycomed Denmark ApS
Langebjerg 1
4000 Roskilde
Denmark


Pantoloc


20 mg


Gastro-resistant tablet


oral use


 




Denmark


Nycomed Denmark ApS
Langebjerg 1
4000 Roskilde
Denmark


Pantoloc


40 mg


Gastro-resistant tablet


oral use


 




Denmark


Nycomed Denmark ApS
Langebjerg 1
4000 Roskilde
Denmark


Pantoloc


40 mg


Powder for solution for injection


intravenous use


40 mg




Estonia


Nycomed GmbH
Byk-Gulden-Str.2
78467 Konstanz
Germany


Controloc 20 mg


20 mg


Gastro-resistant tablet


oral use


 




Estonia


Nycomed GmbH
Byk-Gulden-Str.2
78467 Konstanz
Germany


Controloc 40 mg


40 mg


Gastro-resistant tablet


oral use


 




Finland


Nycomed GmbH
Byk-Gulden-Str.2
78467 Constance
Germany


Somac 20 mg enterotabletti


20 mg


Gastro-resistant tablet


oral use


 




Finland


Nycomed GmbH
Byk-Gulden-Str.2
78467 Constance
Germany


Somac 40 mg enterotabletti


40 mg


Gastro-resistant tablet


oral use


 




Finland


Nycomed GmbH
Byk-Gulden-Str.2
78467 Constance
Germany


Somac 40 mg injektiokuiva-aine, liuosta varten


40 mg


Powder for solution for injection


intravenous use


40 mg




France


Nycomed France
13, rue Watt
75013 Paris
France


Eupantol 20 mg,
comprimé gastro-
résistant


20 mg


Gastro-resistant tablet


oral use


 




France


Nycomed France
13, rue Watt
75013 Paris
France


Eupantol 40 mg,
comprimé gastro-
résistant


40 mg


Gastro-resistant tablet


oral use


 




France


Nycomed France
13, rue Watt
75013 Paris
France


Eupantol 40 mg poudre pour solution injectable IV


40 mg


Powder for solution for injection


intravenous use


40 mg




France


Nycomed France
13, rue Watt
75013 Paris
France


Inipomp 20 mg,
comprimé gastro-
résistant


20 mg


Gastro-resistant tablet


oral use


 




France


Nycomed France
13, rue Watt
75013 Paris
France


Inipomp 40 mg,
comprimé gastro-
résistant


40 mg


Gastro-resistant tablet


oral use


 




France


Nycomed France
13, rue Watt
75013 Paris
France


Inipomp 40 mg; poudre pour IV


40 mg


Powder for solution for injection


intravenous use


40 mg




France


Nycomed France
13, rue Watt
75013 Paris
France


Pantec 20 mg, comprimé gastro-
résistant


20 mg


Gastro-resistant tablet


oral use


 




France


Nycomed France
13, rue Watt
75013 Paris
France


Pantec 40 mg,
comprimé gastro-
résistant


40 mg


Gastro-resistant tablet


oral use


 




France


Nycomed France
13, rue Watt
75013 Paris
France


Pantipp 20 mg,
comprimé gastro-
résistant


20 mg


Gastro-resistant tablet


oral use


 




France


Nycomed France
13, rue Watt
75013 Paris
France


Pantipp 40 mg,
comprimé gastro-
résistant


40 mg


Gastro-resistant tablet


oral use


 




Germany


Nycomed GmbH
Byk-Gulden-Str.2
78467 Constance
Germany


Pantoprazol NYC 20 mg


20 mg


Gastro-resistant tablet


oral use


 




Germany


Nycomed GmbH
Byk-Gulden-Str.2
78467 Constance
Germany


Pantoprazol NYC 40 mg


40 mg


Gastro-resistant tablet


oral use


 




Germany


Nycomed GmbH
Byk-Gulden-Str.2
78467 Constance
Germany


Pantoloc i.v.


40 mg


Powder for solution for injection


intravenous use


40 mg




Germany


Nycomed GmbH
Byk-Gulden-Str.2
78467 Constance
Germany


Pantoprazol 20 mg Byk


20 mg


Gastro-resistant tablet


oral use


 




Germany


Nycomed GmbH
Byk-Gulden-Str.2
78467 Constance
Germany


Pantoprazol-Byk i.v.


40 mg


Powder for solution for injection


intravenous use


 




Germany


Nycomed GmbH
Byk-Gulden-Str.2
78467 Constance
Germany


Pantozol 20 mg


20 mg


Gastro-resistant tablet


oral use


 




Germany


Nycomed GmbH
Byk-Gulden-Str.2
78467 Constance
Germany


Pantozol 40 mg


40 mg


Gastro-resistant tablet


oral use


 




Germany


Nycomed GmbH
Byk-Gulden-Str.2
78467 Constance
Germany


Pantozol i.v.


40 mg


Powder for solution for injection


intravenous use


40 mg




Germany


Nycomed GmbH
Byk-Gulden-Str.2
78467 Constance
Germany


PantoLomberg
20 mg


20 mg


Gastro-resistant tablet


oral use


 




Germany


Nycomed GmbH
Byk-Gulden-Str.2
78467 Constance
Germany


Pantoprazole Lomberg 20 mg


20 mg


Gastro-resistant tablet


oral use


 




Germany


Nycomed GmbH
Byk-Gulden-Str.2
78467 Constance
Germany


Rifun 20 mg


20 mg


Gastro-resistant tablet


oral use


 




Germany


Nycomed GmbH
Byk-Gulden-Str.2
78467 Constance
Germany


Rifun 40 mg


40 mg


Gastro-resistant tablet


oral use


 




Germany


Byk Tosse Arzneimittel GmbH, Moltkestr. 4
78467 Constance
Germany


Zurcal S 20 mg magensaftresistente Tabletten


20 mg


Gastro-resistant tablet


oral use


 




Germany


Byk Tosse Arzneimittel GmbH,
Moltkestr. 4
78467 Constance
Germany


Zurcal S 40 mg magensaftresistente Tabletten


40 mg


Gastro-resistant tablet


oral use


 




Greece


Sanofi-Aventis Greece
348, Syngrou Avenue
Building A
176 74 Kallithea
Greece


Controloc 20 mg


20 mg


Gastro-resistant tablet


oral use


 




Greece


Sanofi-Aventis Greece
348, Syngrou Avenue
Building A
176 74 Kallithea
Greece


Controloc


40 mg


Gastro-resistant tablet


oral use


 




Greece


Sanofi-Aventis Greece
348, Syngrou Avenue
Building A
176 74 Kallithea
Greece


Controloc i.v.


40 mg


Powder for solution for injection


intravenous use


40 mg




Greece


Nycomed Hellas S.A.
196, Kifissias Ave.
152 31 Chalandri
Athens
Greece


Zurcazol 20 mg


20 mg


Gastro-resistant tablet


oral use


 




Greece


Nycomed Hellas S.A.
196, Kifissias Ave.
152 31 Chalandri
Athens
Greece


Zurcazol


40 mg


Gastro-resistant tablet


oral use


 




Greece


Nycomed Hellas S.A.
196, Kifissias Ave.
152 31 Chalandri
Athens
Greece


Zurcazol i.v.


40 mg


Powder for solution for injection


intravenous use


40 mg




Hungary


Nycomed GmbH
Byk-Gulden-Str.2
78467 Konstanz
Germany


Controloc 20 mg


20 mg


Gastro-resistant tablet


oral use


 




Hungary


Nycomed GmbH
Byk-Gulden-Str.2
78467 Constance
Germany


Controloc 40 mg


40 mg


Gastro-resistant tablet


oral use


 




Hungary


Nycomed GmbH
Byk-Gulden-Str.2
78467 Constance
Germany


Controloc i.v.


40 mg


Powder for solution for injection


intravenous use


40 mg




Ireland


Nycomed GmbH
Byk-Gulden-Str.2
78467 Constance
Germany


Protium


40 mg


Gastro-resistant tablet


oral use


 




Ireland


Nycomed GmbH
Byk-Gulden-Str.2
78467 Constance
Germany


Protium 20 mg


20 mg


Gastro-resistant tablet


oral use


 




Ireland


Nycomed GmbH
Byk-Gulden-Str.2
78467 Constance
Germany


Protium i.v.


40 mg


Powder for solution for injection


intravenous use


40 mg




Italy


Nycomed Italia S.r.l
via Libero Temolo 4
20126 Milan
Italy


Pantecta


40 mg


Gastro-resistant tablet


oral use


 




Italy


Nycomed Italia S.r.l
via Libero Temolo 4
20126 Milan
Italy


Pantecta


20 mg


Gastro-resistant tablet


oral use


 




Italy


Almirall S.p.A
via Messina, 38 Torre C
20154 Milan
Italy


Pantopan


40 mg


Gastro-resistant tablet


oral use


 




Italy


Almirall S.p.A
via Messina, 38 Torre C
20154 Milan
Italy


Pantopan


20 mg


Gastro-resistant tablet


oral use


 




Italy


Nycomed S.p.A.
Via Temolo 4
20126 Milan
Italy


Pantorc


40 mg


Gastro-resistant tablet


oral use


 




Italy


Nycomed S.p.A.
Via Temolo 4
20126 Milan
Italy


Pantorc


20 mg


Gastro-resistant tablet


oral use


 




Italy


Nycomed S.p.A.
Via Temolo 4
20126 Milan
Italy


Pantorc.


40 mg


Powder for solution for injection


intravenous use


40 mg




Italy


Recordati Industria Chimica e Farmaceutica S.p.A
Via M. Civitali 1
20148 Milan
Italy


Peptazol


40 mg


Gastro-resistant tablet


oral use


 




Italy


Recordati Industria Chimica e Farmaceutica S.p.A
Via M. Civitali 1
20148 Milan
Italy


Peptazol


20 mg


Gastro-resistant tablet


oral use


 




Latvia


Nycomed GmbH
Byk-Gulden-Str.2
78467 Constance
Germany


Controloc 20 mg


20 mg


Gastro-resistant tablet


oral use


 




Latvia


Nycomed GmbH
Byk-Gulden-Str.2
78467 Constance
Germany


Controloc 40 mg


40 mg


Gastro-resistant tablet


oral use


 




Lithuania


Nycomed GmbH
Byk-Gulden-Str.2
78467 Konstanz
Germany


Controloc


20 mg


Gastro-resistant tablet


oral use


 




Lithuania


Nycomed GmbH
Byk-Gulden-Str.2
78467 Konstanz
Germany


Controloc


40 mg


Gastro-resistant tablet


oral use


 




Luxembourg


Nycomed Belgium SCA/CVA
Gentsesteenweg 615
1080 Brussels
Belgium


Panto-Byk-20


20 mg


Gastro-resistant tablet


oral use


 




Luxembourg


Nycomed Belgium SCA/CVA
Gentsesteenweg 615
1080 Brussels
Belgium


Panto-Byk-40


40 mg


Gastro-resistant tablet


oral use


 




Luxembourg


Nycomed Belgium
SCA/CVA
Gentsesteenweg 615
1080 Brussels
Belgium


Panto-Byk-IV


40 mg


Powder for solution for injection


intravenous use


40 mg




Luxembourg


Nycomed Belgium SCA/CVA
Gentsesteenweg 615
1080 Brussels
Belgium


Pantozol-20


20 mg


Gastro-resistant tablet


oral use


 




Luxembourg


Nycomed Belgium SCA/CVA
Gentsesteenweg 615
1080 Brussels
Belgium


Pantozol 40


40 mg


Gastro-resistant tablet


oral use


 




Luxembourg


Nycomed Belgium SCA/CVA
Gentsesteenweg 615
1080 Brussels
Belgium


Pantozol-IV


40 mg


Powder for solution for injection


intravenous use


40 mg




Netherlands


Nycomed bv
Jupiterstraat 250
2132 HK Hoofddorp
Netherlands


Pantozol 20


20 mg


Gastro-resistant tablet


oral use


 




Netherlands


Nycomed bv
Jupiterstraat 250
2132 HK Hoofddorp
Netherlands


Pantozol 40


40 mg


Gastro-resistant tablet


oral use


 




Netherlands


Nycomed bv
Jupiterstraat 250
2132 HK Hoofddorp
Netherlands


Pantozol i.v.


40 mg


Powder for solution for injection


intravenous use


40 mg




Netherlands


Nycomed bv
Jupiterstraat 250
2132 HK Hoofddorp
Netherlands


Pantoprazol Nycomed 40 mg


40 mg


Gastro-resistant tablet


oral use


 




Norway


Nycomed GmbH
Byk-Gulden-Str.2
78467 Constance
Germany


Somac


20 mg


Gastro-resistant tablet


oral use


 




Norway


Nycomed GmbH
Byk-Gulden-Str.2
78467 Constance
Germany


Somac


40 mg


Gastro-resistant tablet


oral use


 




Norway


Nycomed GmbH
Byk-Gulden-Str.2
78467 Constance
Germany


Somac


40 mg


Powder for solution for injection


intravenous use


40 mg




Poland


Nycomed Pharma Sp.z o.o.
Al. Jerozolimskie 146A
02-305 Warsaw
Poland


Controloc 20


20 mg


Gastro-resistant tablet


oral use


 




Poland


Nycomed Pharma Sp.z o.o.
Al. Jerozolimskie 146A
02-305 Warsaw
Poland


Controloc 40


40 mg


Gastro-resistant tablet


oral use


 




Poland


Nycomed Pharma Sp.z o.o.
Al. Jerozolimskie 146A
02-305 Warsaw
Poland


Controloc


40 mg


Powder for solution for injection


intravenous use


40 mg




Portugal


Laboratórios Delta, Lda.
Rua Direita, 148
Massamá
2745-751 QUELUZ
Portugal


Apton 40 mg


40 mg


Gastro-resistant tablet


oral use


 




Portugal


Laboratórios Delta, Lda.
Rua Direita, 148
Massamá
2745-751 QUELUZ
Portugal


Apton


20 mg


Gastro-resistant tablet


oral use


 




Portugal


Nycomed Portugal
Produtos Farmaceuticos, Lda.
Quinta da Fonte Edificio
Gil Eanes Paço D'Arcos
2770-192 Paço D'Arcos
Portugal


Pantoc 40 mg


40 mg


Gastro-resistant tablet


oral use


 




Portugal


Nycomed Portugal - Produtos Farmacêuticos, Lda.
Quinta da Fonte Edificio
Gil Eanes Paço D'Arcos
2770-192 Paço D'Arcos
Portugal


Pantoc


20 mg


Gastro-resistant tablet


oral use


 




Portugal


Nycomed Portugal - Produtos Farmacêuticos, Lda.
Quinta da Fonte Edificio
Gil Eanes Paço D'Arcos
2770-192 Paço D'Arcos
Portugal


Pantoc IV


40 mg


Powder for solution for injection


intravenous use


40 mg




Portugal


Nycomed Portugal - Produtos Farmacêuticos, Lda.
Quinta da Fonte Edificio
Gil Eanes Paço D'Arcos
2770-192 Paço D'Arcos
Portugal


Zurcal


20 mg


Gastro-resistant tablet


oral use


 




Portugal


Nycomed Portugal
Produtos Farmaceuticos, Lda.
Quinta da Fonte Edificio
Gil Eanes Paço D'Arcos
2770-192 Paço D'Arcos
Portugal


Zurcal 40 mg


40 mg


Gastro-resistant tablet


oral use


 




Portugal


Nycomed Portugal - Produtos Farmacêuticos, Lda.
Quinta da Fonte Edificio
Gil Eanes Paço D'Arcos
2770-192 Paço D'Arcos
Portugal


Pantoprazole ALTANA 20 mg


20 mg


Gastro-resistant tablet


oral use


 




Portugal


Nycomed Portugal - Produtos Farmacêuticos, Lda.
Quinta da Fonte Edificio
Gil Eanes Paço D'Arcos
2770-192 Paço D'Arcos
Portugal


Pantoprazole ALTANA 40 mg


40 mg


Gastro-resistant tablet


oral use


 




Romania


Nycomed GmbH
Byk-Gulden-Str.2
78467 Konstanz
Germany


Controloc 20 mg


20 mg


Gastro-resistant tablet


oral use


 




Romania


Nycomed GmbH
Byk-Gulden-Str.2
78467 Konstance
Germany


Controloc 40 mg


40 mg


Gastro-resistant tablet


oral use


 




Romania


Nycomed GmbH
Byk-Gulden-Str.2
78467 Konstance
Germany


Controloc i.v.


40 mg


Powder for solution for injection


intravenous use


40 mg




Slovak Republic


Nycomed GmbH
Byk-Gulden-Str.2
78467 Constance
Germany


Controloc 20 mg gastrorezistentné tablety


20 mg


Gastro-resistant tablet


oral use


 




Slovak Republic


Nycomed GmbH
Byk-Gulden-Str.2
78467 Constance
Germany


Controloc 40 mg


40 mg


Gastro-resistant tablet


oral use


 




Slovak Republic


Nycomed GmbH
Byk-Gulden-Str.2
78467 Constance
Germany


Controloc i.v.


40 mg


Powder for solution for injection


intravenous use


40 mg




Slovenia


Nycomed GmbH
Byk-Gulden-Str.2
78467 Constance
Germany


Controloc 20 mg gastrorezistentne tablete


20 mg


Gastro-resistant tablet


oral use


 




Slovenia


Nycomed GmbH
Byk-Gulden-Str.2
78467 Constance
Germany


Controloc 40 mg gastrorezistentne tablete


40 mg


Gastro-resistant tablet


oral use


 




Slovenia


Nycomed GmbH
Byk-Gulden-Str.2
78467 Constance
Germany


Controloc 40 mg prašek za raztopino za injiciranje


40 mg


Powder for solution for injection


intravenous use


40 mg




Spain


Nycomed GmbH
Byk-Gulden-Str.2
78467 Constance
Germany


Anagastra 20 mg Blister


20 mg


Gastro-resistant tablet


oral use


 




Spain


Nycomed GmbH
Byk-Gulden-Str.2
78467 Constance
Germany


Anagastra 40 mg blister


40 mg


Gastro-resistant tablet


oral use


 




Spain


Nycomed GmbH
Byk-Gulden-Str.2
78467 Constance
Germany


Anagastra 40 mg polvo para solución inyectable I.V.


40 mg


Powder for solution for injection


intravenous use


40 mg




Spain


Nycomed GmbH
Byk-Gulden-Str.2
78467 Constance
Germany


Pantecta 20 mg comprimidos gastrorresistentes Blister


20 mg


Gastro-resistant tablet


oral use


 




Spain


Nycomed GmbH
Byk-Gulden-Str.2
78467 Constance
Germany


Pantecta 40 mg Blister


40 mg


Gastro-resistant tablet


oral use


 




Spain


Nycomed GmbH
Byk-Gulden-Str.2
78467 Constance
Germany


Ulcotenal 20 mg comprimidos gastrorresistentes Blister


20 mg


Gastro-resistant tablet


oral use


 




Spain


Nycomed GmbH
Byk-Gulden-Str.2
78467 Konstanz
Germany


Ulcotenal 40 mg Blister


40 mg


Gastro-resistant tablet


oral use


 




Sweden


Nycomed AB
Box 27264
102 53 Stockholm
Sweden


Pantoloc


20 mg


Gastro-resistant tablet


oral use


 




Sweden


Nycomed AB
Box 27264
102 53 Stockholm
Sweden


Pantoloc


40 mg


Gastro-resistant tablet


oral use


 




Sweden


Nycomed AB
Box 27264
102 53 Stockholm
Sweden


Pantoloc


40 mg


Powder for solution for injection


intravenous use


40 mg




United Kingdom


Nycomed GmbH
Byk-Gulden-Str.2
78467 Konstance
Germany


Protium 20 mg


20 mg


Gastro-resistant tablet


oral use


 




United Kingdom


Nycomed GmbH
Byk-Gulden-Str.2
78467 Konstance
Germany


Protium 40 mg


40 mg


Gastro-resistant tablet


oral use


 




United Kingdom


Nycomed GmbH
Byk-Gulden-Str.2
78467 Konstance
Germany


Protium i.v.


40 mg


Powder for solution for injection


intravenous use


40 mg







ANNEX VIII
LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE VETERINARY MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, APPLICANT/MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES











Member State


Applicant/Marketing Authorisation Holder


Invented name


Pharmaceutical form


Strength


Animal species


Frequency and route of administration




Austria


Ceva Santé Animale
Z.I. La Ballastière
33500 Libourne
FRANCE


CEVAZURIL 50 mg/ml, Suspension zum Eingeben für Ferkel


Oral suspension


50 mg toltrazuril/ml


Piglets


Individual animal treatment. Each piglet to be treated on day 3-5 of life with a single oral dose of 20 mg toltrazuril/kg body weight corresponding to 0,4 ml oral suspension per kg body weight.




Belgium


Ceva Santé Animale
Z.I. La Ballastière
33500 Libourne
FRANCE


CEVAZURIL 50 mg/ml, orale suspensie voor biggen


Oral suspension


50 mg toltrazuril/ml


Piglets


Individual animal treatment. Each piglet to be treated on day 3-5 of life with a single oral dose of 20 mg toltrazuril/kg body weight corresponding to 0,4 ml oral suspension per kg body weight.




Bulgaria


Ceva Santé Animale
Z.I. La Ballastière
33500 Libourne
FRANCE


СЕВАЗУРИЛ 50 мг/мл, суспензия за перорално прилагане при прасета


Oral suspension


50 mg toltrazuril/ml


Piglets


Individual animal treatment. Each piglet to be treated on day 3-5 of life with a single oral dose of 20 mg toltrazuril/kg body weight corresponding to 0,4 ml oral suspension per kg body weight.




Cyprus


Ceva Santé Animale
Z.I. La Ballastière
33500 Libourne
FRANCE


CEVAZURIL 50 mg/ml, πόσιμο εναιώρημα για χοιρίδια


Oral suspension


50 mg toltrazuril/ml


Piglets


Individual animal treatment. Each piglet to be treated on day 3-5 of life with a single oral dose of 20 mg toltrazuril/kg body weight corresponding to 0,4 ml oral suspension per kg body weight.




Czech Republic


Ceva Santé Animale
Z.I. La Ballastière
33500 Libourne
FRANCE


CEVAZURIL 50 mg/ml,
Perorální suspense pro selata


Oral suspension


50 mg toltrazuril/ml


Piglets


Individual animal treatment. Each piglet to be treated on day 3-5 of life with a single oral dose of 20 mg toltrazuril/kg body weight corresponding to 0,4 ml oral suspension per kg body weight.




Denmark


Ceva Santé Animale
Z.I. La Ballastière
33500 Libourne
FRANCE


Cevazuril 50mg/ml, oral suspension til spædgrise


Oral suspension


50 mg toltrazuril/ml


Piglets


Individual animal treatment. Each piglet to be treated on day 3-5 of life with a single oral dose of 20 mg toltrazuril/kg body weight corresponding to 0,4 ml oral suspension per kg body weight.




Estonia


Ceva Santé Animale
Z.I. La Ballastière
33500 Libourne
FRANCE Bristol
UK


CEVAZURIL 50 mg/ml, Suukaudne suspension jaoks põrsad


Oral suspension


50 mg toltrazuril/ml


Piglets


Individual animal treatment. Each piglet to be treated on day 3-5 of life with a single oral dose of 20 mg toltrazuril/kg body weight corresponding to 0,4 ml oral suspension per kg body weight.




France


Ceva Santé Animale
Z.I. La Ballastière
33500 Libourne
FRANCE


CEVAZURIL 50 mg/ml, suspension buvable pour porcelets (1)



Oral suspension


50 mg toltrazuril/ml


Piglets


Individual animal treatment. Each piglet to be treated on day 3-5 of life with a single oral dose of 20 mg toltrazuril/kg body weight corresponding to 0,4 ml oral suspension per kg body weight.




Germany


Ceva Santé Animale
Z.I. La Ballastière
33500 Libourne
FRANCE


CEVAZURIL 50 mg/ml, Suspension zum Eingeben für Ferkel


Oral suspension


50 mg toltrazuril/ml


Piglets


Individual animal treatment. Each piglet to be treated on day 3-5 of life with a single oral dose of 20 mg toltrazuril/kg body weight corresponding to 0,4 ml oral suspension per kg body weight.




Greece


Ceva Santé Animale
Z.I. La Ballastière
33500 Libourne
FRANCE


CEVAZURIL 50 mg/ml, πόσιμο εναιώρημα για χοιρίδια


Oral suspension


50 mg toltrazuril/ml


Piglets


Individual animal treatment. Each piglet to be treated on day 3-5 of life with a single oral dose of 20 mg toltrazuril/kg body weight corresponding to 0,4 ml oral suspension per kg body weight.




Hungary


Ceva Santé Animale
Z.I. La Ballastière
33500 Libourne
FRANCE


CEVAZURIL 50 mg/ml, belsőleges szuszpenzió malacoknak


Oral suspension


50 mg toltrazuril/ml


Piglets


Individual animal treatment. Each piglet to be treated on day 3-5 of life with a single oral dose of 20 mg toltrazuril/kg body weight corresponding to 0,4 ml oral suspension per kg body weight.




Ireland


Ceva Santé Animale
Z.I. La Ballastière
33500 Libourne
FRANCE


CEVAZURIL 50 mg/ml, oral suspension for piglets


Oral suspension


50 mg toltrazuril/ml


Piglets


Individual animal treatment. Each piglet to be treated on day 3-5 of life with a single oral dose of 20 mg toltrazuril/kg body weight corresponding to 0,4 ml oral suspension per kg body weight.




Italy


Ceva Santé Animale
Z.I. La Ballastière
33500 Libourne
FRANCE


CEVAZURIL 50 mg/ml, sospensione orale per suinetti


Oral suspension


50 mg toltrazuril/ml


Piglets


Individual animal treatment. Each piglet to be treated on day 3-5 of life with a single oral dose of 20 mg toltrazuril/kg body weight corresponding to 0,4 ml oral suspension per kg body weight.




Latvia


Ceva Santé Animale
Z.I. La Ballastière
33500 Libourne
FRANCE


CEVAZURIL 50 mg/ml, Suspensija iekšķīgai lietošanai dēļ sivēni


Oral suspension


50 mg toltrazuril/ml


Piglets


Individual animal treatment. Each piglet to be treated on day 3-5 of life with a single oral dose of 20 mg toltrazuril/kg body weight corresponding to 0,4 ml oral suspension per kg body weight.




Lithuania


Ceva Santé Animale
Z.I. La Ballastière
33500 Libourne
FRANCE


CEVAZURIL 50 mg/ml, Geriamoji suspensija dèl paršeliai


Oral suspension


50 mg toltrazuril/ml


Piglets


Individual animal treatment. Each piglet to be treated on day 3-5 of life with a single oral dose of 20 mg toltrazuril/kg body weight corresponding to 0,4 ml oral suspension per kg body weight.




Luxembourg


Ceva Santé Animale
Z.I. La Ballastière
33500 Libourne
FRANCE


CEVAZURIL 50 mg/ml, suspension buvable pour porcelets (1)



Oral suspension


50 mg toltrazuril/ml


Piglets


Individual animal treatment. Each piglet to be treated on day 3-5 of life with a single oral dose of 20 mg toltrazuril/kg body weight corresponding to 0,4 ml oral suspension per kg body weight.




Malta


Ceva Santé Animale
Z.I. La Ballastière
33500 Libourne
FRANCE


CEVAZURIL 50 mg/ml Suspensjoni orali għal ħnienes


Oral suspension


50 mg toltrazuril/ml


Piglets


Individual animal treatment. Each piglet to be treated on day 3-5 of life with a single oral dose of 20 mg toltrazuril/kg body weight corresponding to 0,4 ml oral suspension per kg body weight.




The Netherlands


Ceva Santé Animale
Z.I. La Ballastière
33500 Libourne
FRANCE


CEVAZURIL 50 mg/ml, orale suspensie voor biggen


Oral suspension


50 mg toltrazuril/ml


Piglets


Individual animal treatment. Each piglet to be treated on day 3-5 of life with a single oral dose of 20 mg toltrazuril/kg body weight corresponding to 0,4 ml oral suspension per kg body weight.




Poland


Ceva Santé Animale
Z.I. La Ballastière
33500 Libourne
FRANCE


CEVAZURIL 50 mg/ml, zawiesina doustna dla prosiąt


Oral suspension


50 mg toltrazuril/ml


Piglets


Individual animal treatment. Each piglet to be treated on day 3-5 of life with a single oral dose of 20 mg toltrazuril/kg body weight corresponding to 0,4 ml oral suspension per kg body weight.




Portugal


Ceva Santé Animale
Z.I. La Ballastière
33500 Libourne
FRANCE


CEVAZURIL 50 mg/ml, suspensão oral para leitões


Oral suspension


50 mg toltrazuril/ml


Piglets


Individual animal treatment. Each piglet to be treated on day 3-5 of life with a single oral dose of 20 mg toltrazuril/kg body weight corresponding to 0,4 ml oral suspension per kg body weight.




Romania


Ceva Santé Animale
Z.I. La Ballastière
33500 Libourne
FRANCE


CEVAZURIL 50 mg/ml, Suspensie orală pentru purceii


Oral suspension


50 mg  toltrazuril/ml


Piglets


Individual animal treatment. Each piglet to be treated on day 3-5 of life with a single oral dose of 20 mg toltrazuril/kg body weight corresponding to 0.4 ml oral suspension per kg body weight.




Slovakia


Ceva Santé Animale
Z.I. La Ballastière
33500 Libourne
FRANCE


CEVAZURIL 50 mg/ml, Perorálna suspenzia pre prasiatka


Oral suspension


50 mg  toltrazuril/ml


Piglets


Individual animal treatment. Each piglet to be treated on day 3-5 of life with a single oral dose of 20 mg toltrazuril/kg body weight corresponding to 0.4 ml oral suspension per kg body weight.




Spain


Ceva Santé Animale
Z.I. La Ballastière
33500 Libourne
FRANCE


CEVAZURIL 50 mg/ml, Suspensión Oral para lechones


Oral suspension


50 mg  toltrazuril/ml


Piglets


Individual animal treatment. Each piglet to be treated on day 3-5 of life with a single oral dose of 20 mg toltrazuril/kg body weight corresponding to 0.4 ml oral suspension per kg body weight.




United Kingdom


Ceva Santé Animale
Z.I. La Ballastière
33500 Libourne
FRANCE


CEVAZURIL 50 mg/ml, oral suspension for piglets


Oral suspension


50 mg  toltrazuril/ml


Piglets


Individual animal treatment. Each piglet to be treated on day 3-5 of life with a single oral dose of 20 mg toltrazuril/kg body weight corresponding to 0.4 ml oral suspension per kg body weight.






(1)  Marketing Authorisation granted



ANNEX IX
LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS IN THE MEMBER STATES










Member State EU/EEA


Applicant


(Invented) Name


Strength


Pharmaceutical Form


Route of administration




Austria


Bluefish Pharmaceuticals AB
Torsgatan 11
SE-111 23 Stockholm
Sweden


Pantoprazol
Bluefish 20 mg/40 mg magensaftresistente
Tabletten


20 mg and 40 mg


Gastro-resistant tablet


Oral use




Denmark


Bluefish Pharmaceuticals AB
Torsgatan 11
SE-111 23 Stockholm
Sweden


Pantoprazole Bluefish


20 mg and 40 mg


Gastro-resistant tablet


Oral use




Finland


Bluefish Pharmaceuticals AB
Torsgatan 11
SE-111 23 Stockholm
Sweden


Pantoprazole Bluefish
20 mg/40 mg enterotabletia/entero-tabletter


20 mg and 40 mg


Gastro-resistant tablet


Oral use




France


Bluefish Pharmaceuticals AB
Torsgatan 11
SE-111 23 Stockholm
Sweden


Pantoprazole Bluefish 20 mg/40 mg comprimé gastro-
resistant


20 mg and 40 mg


Gastro-resistant tablet


Oral use




Germany


Bluefish Pharmaceuticals AB
Torsgatan 11
SE-111 23 Stockholm
Sweden


Pantoprazole Bluefish
20 mg/40 mg magensaftresistente
tabletten


20 mg and 40 mg


Gastro-resistant tablet


Oral use




Hungary


Bluefish Pharmaceuticals AB
Torsgatan 11
SE-111 23 Stockholm
Sweden


Pantoprazole Bluefish
20 mg/40 mg bélben oldódó tabletta


20 mg and 40 mg


Gastro-resistant tablet


Oral use




Ireland


Bluefish Pharmaceuticals AB
Torsgatan 11
SE-111 23 Stockholm
Sweden


Pantoprazole Bluefish
20 mg/40 mg gastro-resistant tablet


20 mg and 40 mg


Gastro-resistant tablet


Oral use




Italy


Bluefish Pharmaceuticals AB
Torsgatan 11
SE-111 23 Stockholm
Sweden


Pantoprazolo Bluefish


20 mg and 40 mg


Gastro-resistant tablet


Oral use




Netherlands


Bluefish Pharmaceuticals AB
Torsgatan 11
SE-111 23 Stockholm
Sweden


Pantoprazol Bluefish
20 mg/40 mg maagsapresistente-tabletten


20 mg and 40 mg


Gastro-resistant tablet


Oral use




Norway


Bluefish Pharmaceuticals AB
Torsgatan 11
SE-111 23 Stockholm
Sweden


Pantoprazol Bluefish enterotabletter


20 mg and 40 mg


Gastro-resistant tablet


Oral use




Poland


Bluefish Pharmaceuticals AB
Torsgatan 11
SE-111 23 Stockholm
Sweden


Pantoprazole Bluefish


20 mg and 40 mg


Gastro-resistant tablet


Oral use




Portugal


Bluefish Pharmaceuticals AB
Torsgatan 11
SE-111 23 Stockholm
Sweden


Pantoprazole Bluefish


20 mg and 40 mg


Gastro-resistant tablet


Oral use




Spain


Bluefish Pharmaceuticals AB
Torsgatan 11
SE-111 23 Stockholm
Sweden


Pantoprazole Bluefish
20 mg/40 mg comprimidos gastro-resistentes


20 mg and 40 mg


Gastro-resistant tablet


Oral use




Sweden


Bluefish Pharmaceuticals AB
Torsgatan 11
SE-111 23 Stockholm
Sweden


Pantoprazole Bluefish


20 mg and 40 mg


Gastro-resistant tablet


Oral use







ANNEX X
LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS IN THE MEMBER STATES










Member State EU/EEA


Applicant


(Invented) Name


Strength


Pharmaceutical Form


Route of administration




Czech Republic


Olinka (UK) Limited
38/40 Chamberlayne Road
London, United Kingdom
NW10 3JE


Pantoprazole 20 mg Gastro-resistant tablets


20 mg


Gastro-resistant tablet


Oral use




Czech Republic


Olinka (UK) Limited
38/40 Chamberlayne Road
London, United Kingdom
NW10 3JE


Pantoprazole 40 mg Gastro-resistant tablets


40 mg


Gastro-resistant tablet


Oral use




Germany


Olinka (UK) Limited
38/40 Chamberlayne Road
London, United Kingdom
NW10 3JE


Pantoprazole 20 mg Gastro-resistant tablets


20 mg


Gastro-resistant tablet


Oral use




Germany


Olinka (UK) Limited
38/40 Chamberlayne Road
London, United Kingdom
NW10 3JE


Pantoprazole 40 mg Gastro-resistant tablets


40 mg


Gastro-resistant tablet


Oral use




Poland


Olinka (UK) Limited
38/40 Chamberlayne Road
London, United Kingdom
NW10 3JE


Pantoprazole Olinka


20 mg


Gastro-resistant tablet


Oral use




Poland


Olinka (UK) Limited
38/40 Chamberlayne Road
London, United Kingdom
NW10 3JE


Pantoprazole Olinka


40 mg


Gastro-resistant tablet


Oral use




Slovak Republic


Olinka (UK) Limited
38/40 Chamberlayne Road
London, United Kingdom
NW10 3JE


Pantoprazole Olinka 20 mg Gastrorezistentne tablety


20 mg


Gastro-resistant tablet


Oral use




Slovak Republic


Olinka (UK) Limited
38/40 Chamberlayne Road
London, United Kingdom
NW10 3JE


Pantoprazole Olinka 40 mg Gastrorezistentne tablety


40 mg


Gastro-resistant tablet


Oral use




United Kingdom


Olinka (UK) Limited
38/40 Chamberlayne Road
London, United Kingdom
NW10 3JE


Pantoprazole 20 mg Gastro-resistant tablets


20 mg


Gastro-resistant tablet


Oral use




United Kingdom


Olinka (UK) Limited
38/40 Chamberlayne Road
London, United Kingdom
NW10 3JE


Pantoprazole 40 mg Gastro-resistant tablets


40 mg


Gastro-resistant tablet


Oral use







ANNEX XI
LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS IN THE MEMBER STATES










Member State EU/EEA


Applicant


(Invented) Name


Strength


Pharmaceutical Form


Route of administration




Germany


Olinka (UK) Limited
38/40 Chamberlayne Road
London, United Kingdom
NW10 3JE


Pantoprazole 20 mg Volkspharma Gastro-resistant tablets


20 mg


Gastro-resistant tablet


Oral use




Germany


Olinka (UK) Limited
38/40 Chamberlayne Road
London, United Kingdom
NW10 3JE


Pantoprazole 40 mg Volkspharma Gastro-resistant tablets


40 mg


Gastro-resistant tablet


Oral use




Poland


Olinka (UK) Limited
38/40 Chamberlayne Road
London, United Kingdom
NW10 3JE


Pantoprazole Phargem


20 mg


Gastro-resistant tablet


Oral use




Poland


Olinka (UK) Limited
38/40 Chamberlayne Road
London, United Kingdom
NW10 3JE


Pantoprazole Phargem


40 mg


Gastro-resistant tablet


Oral use




United Kingdom


Olinka (UK) Limited
38/40 Chamberlayne Road
London, United Kingdom
NW10 3JE


Pantoprazole 20 mg Gastro-resistant tablets


20 mg


Gastro-resistant tablet


Oral use




United Kingdom


Olinka (UK) Limited
38/40 Chamberlayne Road
London, United Kingdom
NW10 3JE


Pantoprazole 40 mg Gastro-resistant tablets


40 mg


Gastro-resistant tablet


Oral use







ANNEX XII
LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES (EU/EEA)










Member State (EU/EEA)


Marketing Authorisation Holder


Product Name


Strength


Pharmaceutical Form


Route of administration




Czech Republic


Ratiopharm GmbH
Graf Arco Strasse 3
89079
Ulm, Germany


Valproat-Ratiopharm Chrono 300 mg


300 mg


Prolonged-release tablet


Oral use




Czech Republic


Ratiopharm GmbH
Graf Arco Strasse 3
89079
Ulm, Germany


Valproat-Ratiopharm Chrono 500 mg


500 mg


Prolonged-release tablet


Oral use




Germany


Ratiopharm GmbH
Graf Arco Strasse 3
89079
Ulm, Germany


Valproinsäure-ratiopharm chrono 300 mg Retardtabletten


300 mg


Prolonged-release tablet


Oral use




Germany


Ratiopharm GmbH
Graf Arco Strasse 3
89079
Ulm, Germany


Valproinsäure-ratiopharm chrono 500 mg Retardtabletten


500 mg


Prolonged-release tablet


Oral use




Italy


Ratiopharm GmbH
Graf Arco Strasse 3
89079
Ulm, Germany


Acido valproico E sodio Valproato Ratiopharm


300 mg


Prolonged-release tablet


Oral use




Italy


Ratiopharm GmbH
Graf Arco Strasse 3
89079
Ulm, Germany


Acido valproico E sodio Valproato Ratiopharm


500 mg


Prolonged-release tablet


Oral use




Luxembourg


Ratiopharm GmbH
Postfach 3380
89070 Ulm, Germany


Valproinsäure Ratiopharm Chrono


300 mg


Prolonged-release tablet


Oral use




Luxembourg


Ratiopharm GmbH
Postfach 3380
89070 Ulm
Germany


Valproinsäure Ratiopharm Chrono


500 mg


Prolonged-release tablet


Oral use




The Netherlands


Ratiopharm Nederland B.V.
Florapark 4
2012HK Haarlem
The Netherlands


Natriumvalproaat ratiopharm chrono 300 mg


300 mg


Prolonged-release tablet


Oral use




The Netherlands


Ratiopharm Nederland B.V.
Florapark 4
2012HK Haarlem
The Netherlands


Natriumvalproaat ratiopharm chrono 500 mg


500 mg


Prolonged-release tablet


Oral use




Poland


Ratiopharm GmbH
Graf-Arco-Strasse 3
89079 Ulm
Germany


Valpro-ratiopharm Chrono 300 mg


199,8 mg + 87 mg


Prolonged-release tablet


Oral use




Poland


Ratiopharm GmbH
Graf-Arco-Strasse 3
89079 Ulm
Germany


Valpro-ratiopharm Chrono 500 mg


333 mg + 145 mg


Prolonged-release tablet


Oral use




Portugal


Ratiopharm – Comércio e Indústria de Produtos Farmacêuticos, Lda.
Rua Quinta do Pinheiro – Edifício Tejo 6° Piso
Carnaxide
P-2790-143


Ácido Valpróico Ratiopharm 300 mg Comprimidos de libertação prolongada


300 mg


Prolonged-release tablet


Oral use




Portugal


Ratiopharm – Comércio e Indústria de Produtos
Farmacêuticos, Lda.
Rua Quinta do Pinheiro – Edifício Tejo 6° Piso
Carnaxide P-2790-143
Portugal


Ácido Valpróico Ratiopharm 500 mg Comprimidos de libertação prolongada


500 mg


Prolonged-release tablet


Oral use




Slovakia


Ratiopharm GmbH
Graf-Arco-Strasse 3
89079 Ulm
Germany


Valpro ratiopharm Chrono


500 mg


Prolonged-release tablet


Oral use




United Kingdom


Ratiopharm GmbH
Graf-Arco-Strasse 3
89079 Ulm
Germany


Valprotek CR 300 mg (prolonged release) tablets


300 mg


Prolonged-release tablet


Oral use




United Kingdom


Ratiopharm GmbH
Graf-Arco-Strasse 3
89079 Ulm
Germany


Valprotek CR 500 mg (prolonged release) tablets


500 mg


Prolonged-release tablet


Oral use







ANNEX XIII
LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ROUTE OF ADMINISTRATION, APPLICANT IN THE MEMBER STATES










Member State EU/EEA


Applicant company name, address


(Invented) Name


Strength


Pharmaceutical Form


Route of administration




Austria


TEVA Pharma B.V.
Computerweg 10,
3542 DR Utrecht
The Netherlands


Clopidogrel Teva 75 mg Filmtabletten


75 mg


Film-coated tablet


Oral Use




Belgium


TEVA Pharma B.V.
Computerweg10,
3542DR Utrecht
The Netherlands


Clopidogrel 75 mg film-coated tablets


75 mg


Film-coated tablet


Oral Use




Bulgaria


TEVA Pharma B.V.,
Computerweg 10
3542 DR Utrecht
The Netherlands


Clopix 75 mg film-coated tablets


75 mg


Film-coated tablet


Oral Use




Cyprus


TEVA Pharma BV
Computerweg 10,
3542 DR Utrecht
The Netherlands


Clopidogrel 75 mg film-coated tablets


75 mg


Film-coated tablet


Oral Use




Czech Republic


Teva Pharmaceuticals CR, s.r.o.,
Radlická 3185/1c,
150 00 Praha 5,
Czech Republic


Teclop 75 mg film-coated tablets


75 mg


Film-coated tablet


Oral Use




Denmark


Dr. Reddy's Laboratories (UK) Ltd.
6 Riverview Road, Beverley, East Yorkshire, HU17 0LD
United Kingdom


Clopix


75 mg


Film-coated tablet


Oral Use




Estonia


Dr. Reddy's Laboratories (UK) Ltd.
6 Riverview Road, Beverley, East Yorkshire, HU17 0LD
United Kingdom


Clopidogrel Dr. Reddy's 75 mg


75 mg


Film-coated tablet


Oral Use




Finland


Teva Sweden AB
Jarnvägsgatan 11
Box 1070
25110 Helsingborg
Sweden


Tevaplat 75 mg film-coated tablets


75 mg


Film-coated tablet


Oral Use




France


TEVA Classics
Immeuble Palatin 1
1 cours du Triangle
92836 PARISLA DEFENSE
FRANCE


Clopidogrel TEVA CLASSICS 75 mg film-coated tablets


75 mg


Film-coated tablet


Oral Use




Germany


Dr. Reddy's Laboratories (UK) Ltd.
6 Riverview Road, Beverley,
East Yorkshire, HU17 0LD
United Kingdom


Clopidogrel 75 mg film-coated tablets


75 mg


Film-coated tablet


Oral Use




Greece


Dr. Reddy's Laboratories (UK) Ltd.
6 Riverview Road, Beverley, East Yorkshire, HU17 0LD
United Kingdom


Clopidogrel 75 mg film-coated tablets


75 mg


Film-coated tablet


Oral Use




Hungary


Dr. Reddy's Laboratories (UK) Ltd.
6 Riverview Road, Beverley, East Yorkshire, HU17 0LD
United Kingdom


ALVADAVIX 75 mg film-coated tablets


75 mg


Film-coated tablet


Oral Use




Ireland


TEVA Generics B.V.
Computerweg 10, 3542DR Utrecht
The Netherlands


Clopidogrel 75 mg film-coated tablets


75 mg


Film-coated tablet


Oral Use




Italy


Dr. Reddy's Laboratories (UK) Ltd.
6 Riverview Road, Beverley, East Yorkshire, HU17 0LD
United Kingdom


Clopidogrel 75 mg film-coated tablets


75 mg


Film-coated tablet


Oral Use




Latvia


Dr. Reddy's Laboratories (UK) Ltd.
6 Riverview Road, Beverley, East Yorkshire, HU17 0LD
United Kingdom


Clopidogrel Dr. Reddy's 75 mg film-coated tablets


75 mg


Film-coated tablet


Oral Use




Lithuania


Dr. Reddy's Laboratories (UK) Ltd.
6 Riverview Road, Beverley, East Yorkshire, HU17 0LD
United Kingdom


Clopidogrel Dr. Reddy's 75 mg film-coated tablets


75 mg


Film-coated tablet


Oral Use




Luxembourg


Teva Pharma BV
Computerweg 10
NL- 3542 DR Utrecht
The Netherlands


Clopidophar


75 mg


Film-coated tablet


Oral Use




The Netherlands


Dr. Reddy's Laboratories (UK) Ltd.
6 Riverview Road, Beverley, East Yorkshire, HU17 0LD
United Kingdom


Clopidogrel 75 mg filmomhulde tabletten


75 mg


Film-coated tablet


Oral Use




Norway


Teva Sweden AB
Järnvägsgatan 11, Box 1070
251 10 Helsingborg


Tevaplat 75 mg film-coated tablets


75 mg


Film-coated tablet


Oral Use




Poland


Teva Pharma B.V.
Computerweg 10, 3542 DR Utrecht
The Netherlands


Clopidogrel Teva Pharma


75 mg


Film-coated tablet


Oral Use




Romania


Dr. Reddy's Laboratories (UK) Ltd.
6 Riverview Road, Beverley, East Yorkshire, HU17 0LD
United Kingdom


XOVAL 75 mg comprimate filmate


75 mg


Film-coated tablet


Oral Use




Slovak Republic


Dr. Reddy's Laboratories (UK) Ltd.
6 Riverview Road, Beverley, East Yorkshire, HU17 0LD
United Kingdom


Clopidogrel 75 mg film-coated tablets


75 mg


Film-coated tablet


Oral Use




Spain


TEVA GENERICOS ESPAÑOLA, S.L. Guzmán el Bueno 133,
Edificio Britania 4oIzq.
28003 MADRID,
Spain


Clopidogrel TEVAGEN 75 mg film-coated tablets


75 mg


Film-coated tablet


Oral Use




Sweden


Dr. Reddy's Laboratories (UK) Ltd.
6 Riverview Road, Beverley, East Yorkshire, HU17 0LD
United Kingdom


Clopidogrel Reddy's


75 mg


Film-coated tablet


Oral Use




United Kingdom


Teva Pharma BV.
Computerweg 10,
Utrecht NL–3542DR
Netherlands


Clopidogrel 75 mg film-coated tablets


75 mg


Film-coated tablet


Oral Use







ANNEX XIV
LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE VETERINARY MEDICINAL PRODUCTS, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, INDICATIONS/WITHDRAWAL PERIODS AND APPLICANTS/MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES














Member state/EEA


Applicant/Marketing Authorisation Holder


Product name


INN


Strength


Pharmaceutical form


Animal species


Frequency and route of administration


Recommended dose


Withdrawal period(s)/Indications




Austria


Chevita Tierarzneimittel
Gesellschaft
m.b.H. Kaplanstraße 10 AT
4600 Wels
AUSTRIA


Doxymax 500 mg/g - Pulver zur Herstellung einer Lösung zum Einnehmen für Schweine und Hühner


Doxycycline hyclate


500 mg/g


Oral powder


Pigs,
Chicken (broiler)


Chicken:
3-5 days, oral via drinking water


Chicken: 25mg doxycyclin hyclat/kg BW/day = 1g powder/20 kg/day


Meat and offal: Chicken (Broiler) 5 days,
Eggs: not for use in laying hen
Indications: infection of respiratory tract caused by Mycoplasma spp. (M.gallisepticum, Escherichia coli, Septicamia caused by Pasteurella multocida




Belgium


DOPHARMA B.V.
Zalmweg 24,
P.O. BOX 205
4940 AE Raamsdonksveer
THE NETHERLANDS


Doxycycline 50 % Dopharma


Doxycycline hyclate


500 mg/g


Water soluble powder


Calves, porcine, poultry


Poultry:
50mg/kg/day


3-5 days 500 g/1 000 L drinking water


Meat and offal: 6 days
Indications: infections by micro-organisms in respiratory or gastro-intestinal system




Belgium


VIRBAC S.A.
1ère avenue - 2065 m - L.I.D.
06516 CARROS
FRANCE


Pulmodox 50 %


Doxycycline hyclate


500 mg/g


Water soluble powder


Calves, porcine, poultry


Poultry: 50 mg/kg/day


3-5 days 500 g/1 000 L drinking water


Meat and offal: 6 days
Indications: infections by micro-organisms in respiratory or gastro-intestinal system




Belgium


Eurovet Animal Health B.V.
Handelsveg 25
PO Box 179
5530 AD Bladel
THE NETHERLANDS


Soludox 50 %


Doxycycline hyclate


500mg/g


Water soluble powder


Porcine, poultry


Poultry:
10-20mg/kg/day


3-4 days 100-200 g/1 000 L drinkwater


Meat and offal:
3 days/10mg/kg
12 days/20mg/kg
Indications: respiratory diseases




Belgium


Eurovet Animal Health B.V.
Handelsveg 25
PO Box 179
5530 AD Bladel
THE NETHERLANDS


Soludox 15 % ad. us. vet..


Doxycycline hyclate


150mg/g


Water soluble powder


Porcine, calves, poultry, fancy birds, pigeons


Poultry:
10-20mg/kg/day


3-5 days 500 g/1 000 L drinkwater


Meat and offal:
7 days
Indications: respiratory diseases caused by germs




Belgium


Huvepharma N.V.
Uitbreidingstraat 80
2600 Antwerpen
BELGIUM


Hydrodoxx 500 mg/g water-soluble powder


Doxycycline hyclate


500mg/g doxycycline hyclate


Powder for oral solution


Chickens (broilers) & Pigs (fattening pigs)


Oral (drinking water)


20 mg doxycycline (hyclate)/kg x 3-5 days


Meat and offal:
Chickens: 6 days
Do not use in laying birds producing eggs for human consumption
Indications: Chickens (broilers): Prevention and treatment of Chronic Respiratory Disease (CRD) caused by Mycoplasma gallisepticum.




Bulgaria


Farma Sis OOD
4 San Stefano Str.
Dobrich
BULGARIA


Doxinyl
10 % Oral Suspension


Doxycycline hyclate


100mg/ml


Oral Suspension


Poultry


Via drinking water


50 -100 ml Doxinyl 10 % in 100 l drinking water per day
(50-100 mg Doxycycline in 1 l drinking water) 3-5 days


Meat - 5 days




Bulgaria


Farma Sis OOD
4 San Stefano Str.
Dobrich
BULGARIA


Cyvadox 10 %


Doxycycline hyclate


100mg/ml


Oral Suspension


Poultry


Via drinking water


0,5-1 ml in 1 l drinking water per day \3-5 days\ 50-100 mg Doxycycline


Meat - 7 days




Bulgaria


DOPHARMA B.V.
Zalmweg 24,
P.O. BOX 205
4940 AE Raamsdonksveer
THE NETHERLANDS


Doxycycline 50 %
w.s.p.


Doxycycline hyclate


500mg/g


Water soluble powder


Poultry


Via drinking water


500g Doxycycline 50 % w.s.p. in 100 l drinking water/3-5 days/


Meat - 4 days




Bulgaria


Farmavet OOD
40 Otec Paisij Str.
Shumen
BULGARIA


Doxycycline 20 %
Pulvis solubilis


Doxycycline hyclate


200mg/g


Water soluble powder


Poultry


Via drinking water


50g Doxycycline 20 % in 100l drinking water/3-5 days/


Meat - 7 days




Bulgaria


Interchemie Werken
De Adelaar BV
Hosterweg 26a
5811 Ccastenray
THE NETHERLANDS


Doxy – WS


Doxycycline hyclate


200mg/g


Water soluble powder


Poultry


Via drinking water


1kg Doxy-WS in 2 000-4 000 l drinking water


Meat - 7 days




Bulgaria


Ceva Sante Animale France
La Balastiere
33501 Libourne Cedex
FRANCE


Doxyvit 50 %
WSP


Doxycycline hyclate


500 mg/g


Water soluble powder


Poultry


Via drinking water


2-3g Doxyvit 50 % WSP in 10 l. Drinking water - 5 days/equivalent to 100-150 mg Doxycycline in 1l water


Meat - 7 days




Bulgaria


Ceva Sante Animale France
La Balastiere
33501 Libourne Cedex
FRANCE


Doxyvit 100


Doxycycline hyclate


100 mg/g


Water soluble powder


Poultry


Via drinking water


10 mg Doxyvit per kg body weight per day


Meat - 7 days




Bulgaria


Vetpartners OOD
Ivan Asen Str.
4270 Parvomaj
BULGARIA


Polidoxichem 500/WSP


Doxycycline hyclate


500 mg/g


Water soluble powder


Poultry


Via drinking water


50-100 mg Doxycycline in 1l drinking water/3-5 days/ equivalent to 0,1-0,2g Polidoxichem 500 WSP in 1l drinking water per day


Meat - 7 days




Bulgaria


Biovet AD
39 Petar Rakov Str.
4550 Peshtera
BULGARIA


Vibravet 10 %
Water soluble premix


Doxycycline hyclate


100 mg/g


Water soluble powder


Poultry


Via drinking water


1g Vibravet 10 % in 1l drinking water /=67-100 mg Doxycycline/per day. 5 days


Meat - 7 days




Cyprus


PREMIER SHUKUROGLOU LTD


HIPRADOXI -S


Doxycycline hyclate


100 mg


Oral solution


Pigs, Chicken (broiler)


By oral route, via drinking water


Broilers: 50-100 mg doxycycline hyclaye/L water for 3-5 days


Broilers: meat: 5 days Pigs: meat:6 days




Czech republic


Industria Italiana Integratori TREI S.p.A.
Viale Corassori 62
41100 Modena
ITALY


DOXIPAN 20


Doxycycline hyclate


20 g/100 g


Powder for oral solution


Chicken-broiler, turkey


Administer orally via drinking water for 5 days.


Broiler:
5-7,5 g of product/10 l drinking water
turkey:
10 – 20 mg doxycycline/kg bodyweight


Chicken broiler: Meat and offal: 5 days.
Turkey: meat and offal: 10 days
Indications:
Chicken broilers: Chronic respiratory diseases and associated infections.
Turkeys: Diseases caused G+ and G- micro-organisms and mycoplasmas, especially respiratory and articular syndrome caused by mycoplasmas and/or staphylococcus.




Czech republic


Pharmagal s.r.o.,
Murgašova 5,
949 01 Nitra,
SLOVAK REPUBLIC


DOXYGAL


Doxycycline hyclate


50 mg/1 g


Powder for oral solution


Poultry


Administer orally via drinking water for 3-5 days.


Therapeutically- preventive: 50 mg doxycycline/1 l drinking water
Therapeutically: 100 mg doxycycline/1 l drinking water


Meat and offal: 7 days. Not permitted for use in laying hens from which eggs are produced for human consumption.
Indications: Used for the treatment of the secondary bacterial infections following to viral origin diseases. Poultry: CRD (mycoplasmosis), colibacillosis




Czech republic


Lavet Pharmaceuticals Ltd.,
1161 Budapest Ottó u. 14,
HUNGARY


DOXYVIT 40 %


Doxycicline hyclate


40g/100g


Powder for oral solution


Chicken-broiler, turkey


Administer orally via drinking water for 3-5 days.


1.Continuous therapy:
1,0g DOXYVIT 40 % per 3-6 L of drinking water
2.Pulse therapy:
10-20 mg doxycycline / kg b.w., intervals 4-8 hours.


Chicken broiler, turkey: Meat and offal: 4 days. Not permitted for use in laying hens from which eggs are produced for human consumption.
Indications:
Treatment and prevention of respiratory, intestinal and systemic infections caused by microorganisms susceptible to doxycycline in broilers and turkeys. Chronic respiratory disease (Mycoplasma gallisepticum, Escherichia coli) Aerosaculitis (Mycoplasma meleagridis) Infectious synovitis (Mycoplasma synoviae) Fowl cholera (Pasterella multocida) Bordetella turkey infections (Bordetella avium) Infectious coryza (Haemophilus paragallinarum) Colibacillosis (Eschrichia coli) Necrotic enteritidis (Clostridium perfringens) Chlamydiosis (Chlamydia psittaci)




Czech republic


Laboratorios Karizoo S.A
Polígono Industrial La Borda
Mas Pujades
11-12
08140 Caldes de Montbui
Barcelona
SPAIN


KARIDOX 100 mg/ml


Doxycycline hyclate


100 mg/1 ml


Oral solution


Chicken-broiler


Administer orally via drinking water for 3-5 days.


10-20 mg doxycycline/kg bodyweight/day (i.e.. 0,5-1,0 ml of product/l of drinking water/day).


Chickens(broilers): Meat and offal: 7 days. Not permitted for use in laying hens from which eggs are produced for human consumption
Indications: Prevention and treatment of chronic respiratory disease (CRD) and mycoplasmosis caused by microorganisms susceptible to doxycycline.




Czech republic


Tekro, spol. s.r.o.,
Višňová 2/484,
140 00 Praha 4,
CZECH REPUBLIC


MEDITEK DOX 100


Doxycycline hyclate


100g/kg


Powder for oral solution


Broiler


Administer orally via drinking water for 3-5 days.


10 mg Doxycycline hyclate/1kg bodyweight (1,0 kg of product / 1 000 l drinking water)


Chickens (broilers): Meat and offal: 7 days
Indications: Prevention and treatment of infection disease of the respiratory and gastrointestinal tract in pigs and broilers caused by the pathogens susceptible to doxycycline. It is efficient on the several bacteria resistant to first generation tetracyclines.




Czech republic


CHEMO IBERICA, S.A. Gran Via Carlos III, 98 7a Edificio Trade
08028 Barcelona SPAIN


ORIDOX 100 mg/ml, perorální roztok pro podání v pitné vodě pro brojlery a prasata


Doxycycline hyclate


100 mg/1ml


Oral solution


Chicken-broiler


Administer orally via drinking water for 3-5 days.


10-20 mg doxycycline/kg bodyweight/day (i.e.. 0,5-1,0 ml of product/ldrinking water/day


Chickens (broilers): Meat and offal: 7 days.
Eggs: Not permitted for use in laying hens from which eggs are produced for human consumption
Indications: Prevention and treatment of chronic respiratory disease (CRD) and mycoplasmosis caused by microorganisms susceptible to doxycycline.




Czech republic


VIRBAC S.A.
1ère avenue - 2065 m - L.I.D.
06516 CARROS
FRANCE


Pulmodox O.S.P. 5 %


Doxycycline hyclate


0,05 g/1g


Powder for oral solution


Poultry


Administer orally via drinking water for 3-5 days.


Poultry till 2 weeks: 1 g of the product per L of drinking water and day
Poultry over 2 weeks: 2 g of the product per L of drinking water and day
Duration of the treatment: 3 - 5 days.


Chicken (broilers): Meat and offal: 4 days, Not permitted for use in laying hens from which eggs are produced for human consumption.
Indications:
Treatment of respiratory infections caused by the pathogens susceptible to doxycycline and chickens (broilers).




Czech republic


KELA Laboratoria n.v.
Industrial Zone
De Kluis
St. Lenaartseweg 48
2320 Hoogstraten
BELGIUM


Respidox 5 %


Doxycycline hyclate


50 mg / 1 g


Powder for oral solution


Poultry


Administer orally via drinking water for 3 days.


2 g of product/l drinking water


Poultry: Meat and offal: 7 days
Not permitted for use in laying hens from which eggs are produced for human consumption.
Indications: Treatment of the infections caused by the microrganisms susceptible to doxycycline.
Poultry: CRD, colibacillosis, inflammation of nasal mucosa, synovitis, salmonelosis, fowl cholera, chlamydiosis




Czech republic


COOPHAVET
Saint Herblon
44150 Ancenis
FRANCE


RONAXAN P.S. 5 %


Doxycycline hyclate


50 mg / 1 g


Powder for oral solution


Chickens


Administer orally via drinking water for 5 days.


10 mg doxycycline / kg bodyweight. / day (i.e.. 1 g of product/5 kg bodyweight.)


Chicken (broilers): Meat and offal: 4 days,
Not permitted for use in laying hens from which eggs are produced for human consumption.
Indications: Treatment of respiratory infections caused by the pathogens susceptible to doxycycline in chickens (broilers).




Czech republic


LABORATORIOS CALIER, S.A.
BARCELONÉS, 26
08520 Les Franqueses del Valles
SPAIN


Doxycycline Calier 500 mg/g


Doxycycline hyclate


500 mg/g


Water soluble powder


Poultry
Pigs


Oral
3-5 days


20 mg/kg/day


6 days
Prevention and treatment of Chronic Respiratory Disease (CRD) caused by Mycoplasma gallisepticum




Czech republic


Ceva Animal Health Slovakia spol. s.r.o.
Račianska 77
831 02 Bratislava
SLOVENIA


DOXYVIT 100


Doxycycline hydrocloride


100 g/1 000 g


Powder for oral solution


Poultry (chicken, turkey, goose)


Administer orally via drinking water for 5 days.


10 mg doxycycline/kg bodyweight per day, i.e. 0,1 g DOXYVIT 100 / kg bodyweight


Meat and offal: 7 days. Not permitted for use in laying hens from which eggs are produced for human consumption.
Indications: Treatment and prevention of respiratory, intestinal and systemic infections caused by micro-organisms susceptible to doxycycline in hens, turkeys and gouses: chronical respiratory disease (Mycoplasma gallisepticum, Escherichia coli), aerosaculitis (Mycoplasma meleagridis), synovitis (Mycoplasma synoviae), fowl cholera (Pasteurella mul tocida), bordetela turkey infections (Bordetella avium), infectious coryza (Haemophilus paragallinarum), colibacillosis (Esccherichia coli), necrotic enteritis (Clostridium perfringens), chlamydiosis (Chlamydia psittaci), prevention in stress conditions (vaccination, changes in housing, transportation)




Denmark


Laborartorios Karizoo
S.A. Pol.Ind. La Borda c/Mas Pujades 11-12
Caldes de Montbui 08140
SPAIN


Karidox


Doxycycline hyclate


10 %


Oral solution


Chickens, swine


Orally (drinking water) for 3 to 5 days


In chickens: 10-20 mg doxycycline hyclate per kg bodyweight per day for 3 to 5 days (i.e. 0.5-1.0 ml product/litre water/day)


Chickens for slaughter: 7 days Eggs: May not be administered to egg laying poultry if the eggs are intended for human use.
Indications:Prevention and treatment of CRD and mycoplasmosis caused by microorgansisms sensitive to doxycycline.




Denmark


CHEMO IBERICA, S.A.
Gran Via Carlos III, 98 7a

Edificio Trade
08028 Barcelona
SPAIN


Oridox


Doxycycline hyclate


10 %


Oral solution


Chickens, swine


Orally (drinking water) for 3 to 5 days


In chickens: 10-20 mg doxycycline hyclate per kg bodyweight per day for 3 to 5 days (i.e. 0.5-1.0 ml product/litre water/day)


Chickens for slaughter: 7 days Eggs: May not be administered to egg laying poultry if the eggs are intended for human use.
Indications: Prevention and treatment of CRD and mycoplasmosis caused by microorgansisms sensitive to doxycycline.




Denmark


Huvepharma N.V.
Uitbreidingstraat 80
2600 Antwerpen
BELGIUM


HydroDoxx


Doxycycline hyclate


500 mg/g doxycycline hyclate


Powder for oral solution


Chickens (broilers) & Pigs (fattening pigs)


Oral (drinking water)


20 mg doxycycline (hyclate)/kg x 3-5 days


Meat and offal:
Chickens: 6 days
Do not use in laying birds producing eggs for human consumption
Indications: Chickens (broilers): Prevention and treatment of Chronic Respiratory Disease (CRD) caused by Mycoplasma gallisepticum.




Estonia


Laboratorios Hipra S.A.
Avda La Selva 135
17170 Amer (Girona)
SPAIN


Hipradoxi-S


Doxycycline hyclate


100 mg/ml


Concentrate for oral solution


chicken (broilers)


oral use via drinking water.


50 … 100 mg doxycycline/litre water


Meat and offal:
5 days. Not authorised for use in laying birds producing eggs for human consumption.
Indications: Colibacillosis, C.R.D. and associated infections.




Estonia


Laboratorios Hipra S.A.
Avda La Selva 135
17170 Amer (Girona)
SPAIN


Hipradoxi-P


Doxycycline hyclate


100 mg/g


powder for oral solution


chicken (broilers)


oral use via drinking water.


20 mg doxycycline/kg bw/day


Meat and offal:
5 days. Not authorised for use in laying birds producing eggs for human consumption.
Indications: Colibacillosis, C.R.D. and associated infections.




Estonia


Maxx Pharma OÜ
Kaluri tee 5
Haabneeme
74001 Viimsi
Harjumaa
ESTONIA


Doxyprim 40 %


Doxycycline hyclate


400 mg/g


powder for oral solution


chicken, turkeys


oral use via drinking water.


10 … 20 mg/kg bw/day 5 days


Meat and offal:
4 days. Not authorised for use in laying birds producing eggs for human consumption.
Indications: For the treatment of respiratory, intestinal and systemic infections caused by doxycycline-sensitive organisms.




Estonia


Zoovetvaru
uusaru 5
76505 Saue
Harjumaa
ESTONIA


Doxycin


Doxycycline hyclate


200 mg/g


powder for oral solution


chicken (broilers)


for oral administaration, via drinking water.


10 mg doxycycline/kg bw/day 3-5 days


Meat and offal:
6 days. Do not use in laying birds producing eggs for human consumption.
Indications: For the treatment of infections of the respiratory system and alimentary tract caused by microorganisms sensitive to doxycycline, including mycoplasmas, bordeteliosis, chlamydiosis, pasteurellosis anaerobic infections, salmonellosis, staphylococcosis, colibacillosis.




Estonia


Dutch Farm Veterinary Pharmaceuticals B.V.
Veemweg 1
3771 MT Barnevald
THE NETHERLANDS


Dutch Farm Doxycycline 20 % WSP


Doxycycline hyclate


200 mg/g


powder for oral solution


poultry


for oral administration, via drinking water.


15 mg Doxycycline hyclate/kg bw/day 3-5 days.


Meat and offal:
7 days. Do not use in laying birds producing eggs for human consumption.
Indications: For the treatment of infections caused by microorganisms sensitive to doxycycline, especially respiratory infections.




Germany


LABORATORIOS CALIER, S.A.
BARCELONÉS, 26
08520 Les Franqueses del Valles
SPAIN


DOXYCYCLINE CALIER 500 mg/g, Pulver zum Eingeben über das Trinkwasser für Huhn und Schwein


Doxycycline hyclate


500 mg/g


Water soluble powder


Poultry
Pigs


Oral
3-5 days


20 mg/kg/day


Meat and offal:
6 days
Indications: Prevention and treatment of Chronic Respiratory Disease (CRD) caused by Mycoplasma gallisepticum




Germany


Huvepharma N.V.
Uitbreidingstraat 80
2600 Antwerpen
BELGIUM


HydroDoxx 500 mg/g Pulver zum Eingeben über das Trinkwasser


Doxycycline hyclate


500 mg/g


Powder for oral solution


Chickens (broilers) & Pigs (fattening pigs)


Oral (drinking water)


20 mg doxycycline (hyclate)/kg x 3-5 days


Meat and offal:
Chickens: 6 days
Do not use in laying birds producing eggs for human consumption
Indications: Chickens (broilers): Prevention and treatment of Chronic Respiratory Disease (CRD) caused by Mycoplasma gallisepticum.




Greece


Durden Trading Limited
12, Kennedy Av.
Nicosia
CYPRUS


Stardox


Doxycycline hyclate


500 mg/g


Powder for oral solution


Chickens(broiler) Non –egg laying chickens Calves pigs


In drinking water


20 mg/kg X 4-7 days


Meat and offal:
14 days
Indications: CRD caused by Mycoplasma gallisepticum colibacilosis




Greece


NEW VET A.E
Fleming 15
15123 Marousi Attikis
GREECE


Nexyclin


Doxycycline hyclate


400 mg/g


Powder for oral solution


Chickens(broiler) Turkeys pigs


In drinking water


20 mg/kg


Meat and offal:
4 days
Indications: Respiratory infections caused by Mycoplasma gallisepticum, E.coli Pasteurella multocida, Chlamydia psittaci




Greece


VIRBAC S.A.
1ère avenue - 2065 m - L.I.D.
06516 CARROS
FRANCE


Pulmodox


Doxycycline hyclate


500 mg/g


Powder for oral solution


Chickens(broiler) Non –egg laying chickens Calves pigs


In drinking water


10 mg/kg X 3-5 days


Meat and offal:
9 days
Indications: Respiratory infections caused by Mycoplasma spp, E.coli, Haemophilus paragalinarum, Bordetella avium Enteritis caused by Clostridium perfringens and colinum




Greece


Nutri-Biomed Hellas LTD
1, V. Hugo & Chlois
Metamorfosi Attikis
14452 Athens
GREECE


Doxyveto


Doxycycline hyclate


500 mg/g


Powder for oral solution


Chickens(broiler) Non –egg laying chickens Calves pigs


In drinking water


25 mg/kg X 3-5 days


Meat and offal:
9 days
Indications: Respiratory infections caused by Mycoplasma spp, E.coli, Haemophilus paragalinarum, Bordetella avium Enteritis caused by Clostridium perfringens and colinum




Greece


DOPHARMA B.V.
Zalmweg 24,
P.O. BOX 205
4940 AE Raamsdonksveer
THE NETHERLANDS


Doxycyclin 50 Dopharma


Doxycycline hyclate


500 mg/g


Powder for oral solution


Chickens(broiler) Calves pigs


In drinking water


25 mg/kg X 3-5 days


Meat and offal:
9 days
Indications: Respiratory infections caused by Mycoplasma spp, E.coli, Haemophilus paragalinarum, Bordetella avium Enteritis caused by Clostridium perfringens and colinum




Greece


Durden Trading Limited
12, Kennedy Av.
Nicosia
CYPRUS


Doxycycline 150/Durden


Doxycycline hydrocloride


150 mg/g


Powder for oral solution


Chickens(broiler) Non –egg laying chickens Calves pigs


In drinking water


10 mg/kg X 3-5 days


Meat and offal:
4 days
Indications: Respiratory infections caused by Mycoplasma gallisepticum, E.coli, Haemophilus paragalinarum




Greece


AFOI TETOROU ABE
10 km National road Athens-Lamia
14451, Metamorfosi
GREECE


Doxycycline 150/Afoi Tetorou


Doxycycline hydrocloride


150 mg/g


Powder for oral solution


Chickens(broiler) Non –egg laying chickens Calves pigs


In drinking water


10 mg/kg X 3-5 days


Meat and offal:4 days
Indications: Respiratory infections caused by Mycoplasma gallisepticum, E.coli, Haemophilus paragalinarum




Spain


LAB. DR ESTEVE
Avda Mare de Deu de Montserrat
221 08041 Barcelona
SPAIN


DOX ESTEVE


Doxycycline hyclate


100 mg/g


Water soluble powder


Poultry Pigs Bovine


Oral 3-5 days


20 mg / Kg/day


Meat and offal:
9 days
Indications: Infections caused by Mycoplasma spp (Micoplasmosis, CRD) or Pasteurella multocida (Pasteurellosis).
Meat and offal:
Poultry: 5 days
Turkeys: 7 days
colibacilosis, C.R.D., micoplasmosis.




Spain


S.P. Veterinaria SA Crta. Reus
Vinyols Km 4.1
Apartado 60
Riudoms 43330 (Tarragona) SPAIN


DOXI 100 mg/ml POLVO ORAL


Doxycycline hyclate


10 g/100 g


Water soluble powder


Poultry
Turkeys Pigs


Oral
3-5 days (Poultry and turkeys) 5 days (Pigs)


50 – 100 mg/l drinking water/day (poultry and turkey) 10 mg/kg/day (pigs)


Meat and offal:
Broilers: 5 days Turkeys: 7 days Pigs: 4 days




Spain


FATRO URIACH VETERINARIA, S.L.
Constitucion, 1
08960 Sant Just Desvern
SPAIN


DOXIDOL


Doxycycline hyclate


10 g/100 g


Water soluble powder


Poultry
Pigs


Oral
3-5 days


7.5 – 15 mg/kg/day


Meat and offal:
7 days
Indications: Colibacilosis
CRD




Spain


DIVASA-FARMAVIC, S.A.
CTRA. SANT HIPOLIT, KM. 71
08503 GURB – VIC
SPAIN


DOXIVET 20


Doxycycline hyclate


200 mg/ml


Oral solution


Poultry
Pigs


Oral
3-5 days


10 - 20 mg/Kg/day


Meat and offal:
7 days
Indications: Colibacilosis, CRD, Micoplasmosis




Spain


MEVET, S. A.
POLIGONO INDUSTRIAL EL SEGRE, PARCELA409-410
25191 Lérida
SPAIN


DOXICIVALL POLVO


Doxycycline hyclate


500 mg/g


Water soluble powder


Poultry
Pigs


Oral
3-5 days


20 mg/kg/day


Meat and offal:
4 days
Indications: Colibacilosis, CRD, Micoplasmosis




Spain


Laboratorios Hipra S.A.
Avda La Selva 135
17170 Amer (Girona)
SPAIN


HIPRADOXI-S


Doxycycline hyclate


100 mg/ml


Oral solution


Poultry
Pigs


Oral
3-5 days


50 – 100 mg/l drinking water/day


Meat and offal:
5 days
Indications: colibacilosis, C.R.D., micoplasmosis




Spain


LAMONS, S.A.
POL.IND. MECANOVA, NAVES 27-28
25191 LLEIDA
SPAIN


DOXICICLINA 10 % LAMONS


Doxycycline hyclate


100 mg/ml


Oral solution


Poultry
Pigs


Oral
3-5 days


50 – 100 mg/l drinking water/day


Meat and offal:
5 days
Indications: colibacilosis, C.R.D., micoplasmosis




Spain


Laboratorios Hipra S.A.
Avda La Selva 135
17170 Amer (Girona)
SPAIN


HIPRADOXI-P


Doxycycline hyclate


100 mg/g


Water soluble powder


Poultry
Pigs


Oral
3-5 days


20 mg/Kg/day


Meat and offal:
5 days
Indications: colibacilosis, C.R.D., and associated infections




Spain


POLICHEM, S.A.
Ctra. Reus-Cambrils, Km. 3
43206 Reus
SPAIN


DOXICHEM


Doxycycline hyclate


500 mg/g


Water soluble powder


Poultry


Oral
3-5 days


50 – 100 mg/l drinking water/day


Meat and offal:
7 days
Indications: colibacilosis, C.R.D., micoplasmosis




Spain


SUPER'S DIANA, S.L
Ctra. Barcelona - Ripoll, Km 17
08150 Parets del Valles
SPAIN


DOXBRON


Doxycycline hyclate


500 mg/g


Water soluble powder


Poultry


Oral
3-5 days


50 – 100 mg/l drinking water/day


Meat and offal:
7 days
Indications: colibacilosis, C.R.D., micoplasmosis




Spain


COTECNICA -COOPERATIVA TECNICA AGROPECUARIA
Ctra. N II KM 494,5
25250 Bellpuig (Lerida)
SPAIN


DOXICICLINA 500 USO VETERINARIO COTECNICA


Doxycycline hyclate


500 mg/g


Water soluble powder


Poultry


Oral
3-5 days


50 – 100 mg/l drinking water/day


Meat and offal:
7 days
Indications: colibacilosis, C.R.D., micoplasmosis




Spain


CENAVISA, S.A.
Camí Pedra Estela S/N
43205 Reus
SPAIN


LAFIDOX POLVO ORAL


Doxycycline hyclate


500 mg/g


Water soluble powder


Poultry


Oral
3-5 days


50 – 100 mg/l drinking water/day


Meat and offal:
7 days
Indications: colibacilosis, C.R.D., micoplasmosis




Spain


LABORATORIOS SYVA, S.A.
PARROCO PABLO DIEZ, 49-57
24010 TROBAJO DEL CAMINO
SPAIN


SYVADOX 10 %


Doxycycline hyclate


100 mg/ml


Oral solution


Poultry
Pigs


Oral
3-5 days


50 – 100 mg/l drinking water/day


Meat and offal:
7 days
Indications: colibacilosis, C.R.D., micoplasmosis




Spain


INVESA INTERNACIONAL, S.A.
Esmeralda, 19 - 4o

08950 ESPLUGUES DE LLOBREGAT
SPAIN


DX-10


Doxycycline hyclate


100 mg/ml


Oral solution


Poultry
Pigs


Oral
3-5 days


50 – 100 mg/l drinking water/day


Meat and offal:
7 days
Indications: colibacilosis, C.R.D., micoplasmosis




Spain


CENAVISA, S.A.
Camí Pedra Estela S/N
43205 Reus
SPAIN


DOXICICLINA 500 GANADEXIL


Doxycycline hyclate


500 mg/g


Water soluble powder


Poultry
Turkeys


Oral
3-5 days


50 – 100 mg/l drinking water/day


Meat and offal:
7 days
Indications: colibacilosis, C.R.D., micoplasmosis




Spain


DIVASA-FARMAVIC, S.A.
CTRA. SANT HIPOLIT, KM. 71
08503 GURB – VIC
SPAIN


DOXIVET 5


Doxycycline hyclate


50 mg/g


Water soluble powder


Poultry
Turkeys


Oral
3-5 days


50 – 100 mg/l drinking water/day


Meat and offal:
7 days
Indications: colibacilosis, C.R.D., micoplasmosis




Spain


INDUSTRIAL VETERINARIA S.A.
Esmeralda, 19 - 4o

08950 ESPLUGUES DE LLOBREGAT
SPAIN


DOXINYL


Doxycycline hyclate


100 mg/ml


Oral solution


Poultry
Pigs


Oral
3-5 days


50 – 100 mg/l drinking water/day


Meat and offal:
7 days
Indications: colibacilosis, C.R.D., micoplasmosis




Spain


JAER, S.A.
Barcelona, 411
08620 San Vicens del Horts
SPAIN


MASTERMIX DOXICICLINA


Doxycycline hyclate


50 mg/g


Water soluble powder


Poultry
Turkeys


Oral
3-5 days


50 – 100 mg/l drinking water/day


Meat and offal:
7 days
Indications: colibacilosis, C.R.D., micoplasmosis




Spain


Laboratorios Karizoo S.A
Polígono Industrial La Borda
Mas Pujades
11-12
08140 Caldes de Montbui
Barcelona
SPAIN


KARIDOX


Doxycycline hyclate


100 mg/ml


Oral solution


Poultry
Pig


Oral
3-5 days


10 - 20 mg/Kg/day


Meat and offal:
7 days
Indications: C.R.D., micoplasmosis




Spain


CHEMO IBERICA, S.A.
Gran Via Carlos III, 98 7a

Edificio Trade
08028 Barcelona
SPAIN


SOLDOXIN


Doxycycline hyclate


100 mg/ml


Oral solution


Poultry
Pig


Oral
3-5 days


10 - 20 mg/Kg/day


Meat and offal:
7 days
Indications: C.R.D., micoplasmosis




Spain


LABORATORIOS CALIER, S.A.
BARCELONÉS, 26
08520 Les Franqueses del Valles
SPAIN


CALIERDOXINA 50 % P O


Doxycycline hyclate


500 mg/g


Water soluble powder


Poultry


Oral
5 days


20 mg/kg/day


Meat and offal:
7 days
Indications: C.R.D., micoplasmosis




Spain


LABORATORIOS CALIER, S.A.
BARCELONÉS, 26
08520 Les Franqueses del Valles
SPAIN


GANAMIX DOXICICLINA 50 % P O


Doxycycline hyclate


500 mg/g


Water soluble powder


Poultry


Oral
5 days


20 mg/kg/day


Meat and offal:
7 days
Indications: C.R.D., micoplasmosis




Spain


S.P. Veterinaria SA Crta. Reus
Vinyols Km 4.1
Apartado 60
Riudoms 43330 (Tarragona) SPAIN


HIDRODOX 10 %


Doxycycline hyclate


100 mg/ml


Oral solution


Poultry
Pigs


Oral
3-5 days


50 – 100 mg/l drinking water/day


Meat and offal:
7 days
Indications: colibacilosis, C.R.D., micoplasmosis




Spain


VIRBAC ESPAÑA, S.A.
Angel Guimera, 179-181
08950 Esplugues de Llobregat
SPAIN


PULMODOX P.O.S.


Doxycycline hyclate


500 mg/g


Water soluble powder


Poultry


Oral
3-5 days


50 – 100 mg/l drinking water/day


Meat and offal:
7 days
Indications: C.R.D., micoplasmosis




Spain


Huvepharma N.V.
Uitbreidingstraat 80
2600 Antwerpen
BELGIUM


DILUDOX


Doxycycline hyclate


500 mg/g doxycycline hyclate


Powder for oral solution


Chickens (broilers) & Pigs (fattening pigs)


Oral (drinking water)


20 mg doxycycline (hyclate)/kg x 3-5 days


Meat and offal:
Chickens: 6 days
Do not use in laying birds producing eggs for human consumption
Indications: Chickens (broilers): Prevention and treatment of Chronic Respiratory Disease (CRD) caused by Mycoplasma gallisepticum.




Spain


LABORATORIOS CALIER, S.A.
BARCELONÉS, 26
08520 Les Franqueses del Valles
SPAIN


DOXICICLINA CALIER 500 mg/g


Doxycycline hyclate


500 mg/g


Water soluble powder


Poultry
Pigs


Oral
3-5 days


20 mg/kg/day


Meat and offal:
6 days
Indications: Prevention and treatment of Chronic Respiratory Disease (CRD) caused by Mycoplasma gallisepticum




Spain


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


MAYDOX PS


Doxycycline hydrocloride


50 mg/g


Water soluble powder


Poultry
Turkeys


Oral
3-5 days


50 – 100 mg/l drinking water/day


Meat and offal:
7 days
Indications: colibacilosis, C.R.D., micoplasmosis




France


COOPHAVET
Saint Herblon
44150 Ancenis
FRANCE


RONAXAN P.S. 5 %


Doxycycline hyclate


50 mg/g


Water soluble powder


Turkey
Porcine
Broilers
Calves


Prevention
1 - 3 days
Curative treatment:
3 - 5 days


10 mg/kg/day


Meat and offal:
Turkey: 6 days
Broilers: 4 days
Indications: Broilers and turkey:
Preventive and treatment of infections in respiratory system




France


FRANVET
ZI d'Etriche-Route d'Avire
BP 103
49500 Segré Cedex
FRANCE


DOXY 5 FRANVET


Doxycycline hyclate


50 mg/g


Water soluble powder


Turkey,
Porcine
Hens
Calves


Prevention
1 - 3 days
Curative treatment:
3 - 5 days


10 mg/kg/day


Meat and offal:
Turkey: 6 days
Hens: 4 days
Indications: Prevention and treatment of infections in respiratory system




France


VIRBAC S.A.
1ère avenue - 2065 m - L.I.D.
06516 CARROS
FRANCE


PULMODOX P.O.S. 5 %


Doxycycline hyclate


50 mg/g


Water soluble powder


Porcine
Calves
Poultry


Prevention
1 - 3 days
Curative treatment:
3 - 5 days


10 mg/kg/day


Meat and offal:
Turkey: 6 days
Hens: 4 days
Indications: Prevention and treatment of infections in respiratory system




France


Sogeval Laboratoires
200 route De Mayenne
53022 Laval Cedex FRANCE


DOXYVAL 5 %


Doxycycline hyclate


50 mg/g


Water soluble powder


Turkey
Porcine
Broilers
Calves


Prevention
1 - 3 days
Curative treatment:
3 - 5 days


10 mg/kg/day


Meat and offal:
Turkey: 6 days
Hens: 4 days
Indications: Prevention and treatment of infections in respiratory system




France


Laboratoires Biove
3 rue de Lorraine
62510 Arques
FRANCE


ACTI DOXY 5


Doxycycline hyclate


50 mg/g


Water soluble powder


Dindon
Porcine
Broilers
Calves


Prevention
1 - 3 days
Curative treatment:
3 - 5 days


10 mg/kg/day


Meat and offal:
Turkey: 6 days
Hens: 4 days
Indications: Prevention and treatment of infections in respiratory system




France


Ceva Sante Animale France
La Balastiere
33501 Libourne Cedex
FRANCE


DOXYVIT


Doxycycline hyclate


50 mg/g


Water soluble powder


Turkeys
Porcine
Broilers
Calves


Prevention
1 - 3 days
Curative treatment:
3 - 5 days


10 mg/kg/day


Meat and offal:
Turkey: 6 days
Hens: 4 days
Indications: Prevention and treatment of infections in respiratory system




France


Noe
10 rue Clement Ader
ZA Le Patis
78120 Rambouillet
FRANCE


COMPOMIX V DOXYCYCLINE


Doxycycline hyclate


50 mg/g


Water soluble powder


Dindon
Porcine
Broilers
Calves


Prevention
1 - 3 days
Curative treatment:
3 - 5 days


10 mg/kg/day


Meat and offal:
Turkey: 6 days
Hens: 4 days
Indications: Prevention and treatment of infections in respiratory system




France


CHEMO IBERICA, S.A.
Gran Via Carlos III, 98 7a

Edificio Trade
08028 Barcelona
SPAIN


SOLDOXIN 100 MG/ML SOLUTION BUVABLE POUR POULES POULETS ET PORCINES


Doxycycline hyclate


100 mg/ml


Oral solution


Porcine
Hens
Broilers


CHICKEN (broilers): 10 - 20 mg of doxycycline / kg bw / day


3 - 5 days


Indications: CHICKENS (BROILERS) Prevention and treatment of chronic respiratory disease (CRD) and mycoplasmosis caused by microorganisms sensitive to doxycycline.




France


Laborartorios Karizoo
S.A. Pol.Ind. La Borda c/Mas Pujades 11-12
Caldes de Montbui 08140
SPAIN


DOXYSOL 10 %


Doxycycline hyclate


100 mg/ml


Oral solution


Porcine
Hens
Broilers


CHICKEN (broilers): 10 - 20 mg of doxycycline / kg bw / day


3 - 5 days


Indications: CHICKENS (BROILERS). Prevention and treatment of chronic respiratory disease (CRD) and mycoplasmosis caused by microorganisms sensitive to doxycycline.




France


Huvepharma N.V.
Uitbreidingstraat 80
2600 Antwerpen
BELGIUM


HYDRODOXX 500 MG/G poudre pour administration dans l'eau de boisson pour poulets et porcs


Doxycycline hyclate


500 mg/g doxycycline hyclate


Powder for oral solution


Chickens (broilers) & Pigs (fattening pigs)


Oral (drinking water)


20 mg doxycycline (hyclate)/kg x 3-5 days


Meat and offal:
Chickens: 6 days
Do not use in laying birds producing eggs for human consumption
Indications: Chickens (broilers): Prevention and treatment of Chronic Respiratory Disease (CRD) caused by Mycoplasma gallisepticum.




France


LABORATORIOS CALIER, S.A.
BARCELONÉS, 26
08520 Les Franqueses del Valles
SPAIN


DOXYCYCLINE CALIER 500 MG/G poudre pour administration dans l'eau de boisson pour poulets et porcins


Doxycycline hyclate


500 mg/g


Water soluble powder


Poultry
Pigs


Oral
3-5 days


20 mg/kg/day


Meat and offal:
6 days
Indications: Prevention and treatment of Chronic Respiratory Disease (CRD) caused by Mycoplasma gallisepticum




Hungary


COOPHAVET
Saint Herblon
44150 Ancenis
FRANCE


Ronaxan P.S. 5 % oldható por


Doxycycline hyclate


5 g/100 g


Powder for oral solution


Chicken


Chicken younger than 2 weeks: 1 g powder/1 litre of drinking water/day. Chicken older than 2 weeks: 2 g powder/1 litre of drinking water.


10 mg doxycycline/kg bw/day, for 3-5 days.


Meat and offal:
4 days
Indications: For the treatment of CRD and Mycoplasma diseases, and other infections




Hungary


DOPHARMA B.V.
Zalmweg 24,
P.O. BOX 205
4940 AE Raamsdonksveer
THE NETHERLANDS


Doxycycline 50 % WSP


Doxycycline hyclate


500 mg/g


Powder for oral solution


Chicken


500 g product dissolved in 1 000 litre of drinking water.


25 mg doxycycline/kg bw/day, for 3-5 days.


Meat and offal:
4 days
Indications: For the treatment and control of chicken respiratory diseases




Hungary


Kon-Pharma GmbH.
30625 Hannover
GERMANY


Doxy 50 % por belsőleges oldathoz


Doxycycline hyclate


500 mg/g


Powder for oral solution


Chicken, turkey


Chicken: 500 mg product dissolved in 1 litre of drinking water. Turkey: 400 mg product/1 litre of drinking water


30 mg doxycycline/kg bw/day, for 5 days.


Meat and offal:
Chicken and turkey: 11 days.




Hungary


V.M.D. Állatgyógyászati Kft.
1093 Budapest
HUNGARY


Doxyveto-50


Doxycycline hyclate


500 mg/g


Powder for oral solution


Chicken


Continuous treatment: 0,2 g product/1 litre of drinking water. Pulse treatment: calculated amount of the product should be dissolved in the drinking water consumed during 8 hours.


10 mg doxycycline/kg bw/day, for 5 days.


Meat and offal:
10 days
Indications: For the treatment of CRD and pasteurellosis; synovitis in turkey.




Hungary


Novartis Animal Health d.o.o.
Verovskava 57
1000 Ljubljana
SLOVENIA


Doxyril 50 % por belsőleges oldathoz


Doxycycline hyclate


500 mg/g


Powder for oral solution


Chicken


5 g product/100 kg bw/day, dissolved in the drinking water.


25 mg doxycycline/kg bw/day, for 3-5 days.


Meat and offal:
6 days
Indications: For the treatment of CRD, pasteurellosis, colibacillosis, Haemophilus and Clostridium infections




Hungary


Animal-Med Kft.
1029 Budapest
HUNGARY


Anidox 10 % por belsőleges oldathoz


Doxycycline hyclate


100 mg/g


Powder for oral solution


Chicken


1 000 g product dissolved in 1 000 litre of drinking water.


10 mg doxycycline/kg bw/day, for 5 days.


Meat and offal:
12 days
Indications: For the treatment of mycoplasmosis, pasteurellosis, colibacillosis.




Hungary


Animal-Med Kft.
1029 Budapest
HUNGARY


Anidox 100 % por belsőleges oldathoz


Doxycycline hyclate


1 000 mg/g


Powder for oral solution


Chicken


100 g product dissolved in 1 000 litre of drinking water.


10 mg doxycycline/kg bw/day, for 5 days.


Meat and offal:
12 days
Indications: For the treatment of infections caused by: Mycoplasma gallisepticum, E. coli, Bordetella avium, Haemophilus paragallinarum and Pasteurella multocida




Hungary


Lavet Pharmaceuticals Ltd.,
1161 Budapest Ottó u. 14,
HUNGARY


Doxyprim 40 % vízoldékony pulvis


Doxycycline hyclate


400 mg/g


Powder for oral solution


Chicken, turkey


Continuous treatment: 1 g product/3-6 litre of drinking water. Pulse treatment: calculated amount of the product should be dissolved in the drinking water consumed during 4-8 hours.


10-20 mg/doxycycline/kg bw/day, for 3-5 days.


Meat and offal:
4 days
Indications: For the treatment of infections caused by: Mycoplasma gallisepticum, E. coli, Bordetella avium, Haemophilus paragallinarum and Pasteurella multocida




Hungary


CHEMIFARMA S.p.A
Via Don Eugenio Servadei 16
47100 Forli
ITALY


Doxifarm 50 % WSP


Doxycycline hyclate


500 mg/g


Powder for oral solution


Chicken


40 g product/100 kg bw/100 litre of drinking water.


20 mg doxycycline/kg bw/day, for 5 days.


Meat and offal:
5 days
Indications: For the treatment of CRD, mycoplasmosis, synovitis, colibacillosis, ileitis (necroric and ulcerosus), haemophilus-infection.




Hungary


VIRBAC S.A.
1ère avenue - 2065 m - L.I.D.
06516 CARROS
FRANCE


Pulmodox 50 % WSP


Doxycycline hyclate


500 mg/g


Powder for oral solution


Chicken


500 g product dissolved in 1 000 litre of drinking water.


25 mg doxycycline/kg bw/day, for 3-5 days.


Meat and offal:
4 days
Indications: For the treatment of CRD and other respiratory diseases, caused by: Mycoplasma spp., Pasteurella spp., E. coli, and Chlamydia psittaci.




Hungary


Phylaxia Pharma Zrt.
8000 Székesfehérvár
HUNGARY


Doxyphyl SP


Doxycycline hyclate


300 mg/g


Powder for oral solution


chicken, turkey


40 g product/1 200 kg bw/day, calculated amount of the product should be dissolved in the drinking water consumed during 3 hours.


10 mg doxycycline/kg bw/day, for 3-5 days.


Meat and offal:
chicken: 7 days, turkey: 10 days.
Indications: For the treatment of respiratory infections caused by Mycoplasma spp., E. coli, Haemophilus paragallinarum, Bordetella avium, and ileitis caused by Clostridium perfringens and Cl. colinum.




Hungary


Eurovet Animal Health B.V.
Handelsveg 25
PO Box 179
5530 AD Bladel
THE NETHERLANDS


Soludox 50 % pulvis


Doxycycline hyclate


500 mg/g


Powder for oral solution


Chicken


Dissolved in the drinking water.


10 mg/kg bw and 20 mg/kg bw/day, for 4 days.


Meat and offal:
chicken treated with 10 mg/kg bw: 5 days, chicken treated with 20 mg/kg bw: 12 days.
Indications: For the treatment of respiratory and other diseases caused by doxycycline-sensitive bacteria.




Hungary


CHEMO IBERICA, S.A.
Gran Via Carlos III, 98 7a

Edificio Trade
08028 Barcelona
SPAIN


Oridox 100 mg/ml belsőleges oldat


Doxycycline hyclate


100 mg/ml


Concentrate for oral solution


Chicken


100 mg/ml oral concentrate dissolving in the drinking water.


10-20 mg/doxycycline/kg bw/day, for 3-5 days.


Meat and offal:
7 days
Indications: For the treatment of respiratory and other diseases caused by doxycycline-sensitive bacteria.




Hungary


Laboratorios Karizoo S.A
Polígono Industrial La Borda
Mas Pujades
11-12
08140 Caldes de Montbui
Barcelona
SPAIN


Karidox 100 mng/ml belsőleges oldat


Doxycycline hyclate


100 mg/ml


Concentrate for oral solution


Chicken


100 mg/ml oral concentrate dissolving in the drinking water.


10-20 mg/doxycycline/kg bw/day, for 3-5 days.


Meat and offal:
7 days
Indications: For the treatment and prevention of CRD or other Mycoplasma diseases




Hungary


CENAVISA, S.A.
Camí Pedra Estela S/N
43205 Reus
SPAIN


Doxycen belsőleges oldat


Doxycycline hyclate


200 mg/ml


Concentrate for oral solution


Chicken


1 ml/20 kg bw/day dissolved in the drinking water.


10 mg doxycycline/kg bw/day, for 5 days.


Meat and offal:
5 days
Indications: For the treatment of CRD, mycoplasmosis and colibacillosis.




Hungary


Lavet Pharmaceuticals Ltd.,
1161 Budapest Ottó u. 14,
HUNGARY


Doxyvit 100 WSP


Doxycycline hydrocloride


100 mg/g


Powder for oral solution


Chicken, turkey, goose


Continuous treatment: 1 g product/1 litre of drinking water. Pulse treatment: calculated amount of the product should be dissolved in the drinking water consumed during 6-8 hours.


10 mg/doxycycline/kg bw/day, for 3-5 days.


Meat and offal:
Chicken, turkey, goose 7 days
Indications: For the treatment of respiratory and enteric diseases in broiler chickens




Hungary


Industria Italiana Integratori TREI S.p.A.
Viale Corassori 62
41100 Modena
ITALY


Doxipan 20 WSP


Doxycycline hydrocloride


200 mg/g


Powder for oral solution


Chicken


5-7.5 g product dissolving in 10 litre of drinking water.


10-15 mg/doxycycline/kg bw/day, for 3-5 days.


Meat and offal:
5 days
Indications: For the treatment of CRD, mycoplasmosis, synovitis, colibacillosis, ileitis (necroric and ulcerosus), haemophilus-infection.




Hungary


Laboratorios Hipra S.A.
Avda La Selva 135
17170 Amer (Girona)
SPAIN


Hipradoxi-S oral solutio


Doxycycline hydrocloride


100 mg/ml


Concentrate for oral solution


Chicken


100 mg/ml oral concentrate dissolving in 1 litre of drinking water.


10 mg doxycycline/kg bw/day, for 5 days.


Meat and offal:
5 days
Indications: For the treatment and prevention of CRD or other Mycoplasma diseases




Ireland


S.P. Veterinaria SA Crta. Reus
Vinyols Km 4.1
Apartado 60
Riudoms 43330 (Tarragona) SPAIN


DOXIVEX 10 % Concentrate for oral solution.


Doxycycline hyclate


100 mg/ml


Concentrate for oral solution


Chickens (broilers) and Pigs


For oral administration via the drinking water. for 3-5 days


Chickens (broilers): 50 - 100 mg Doxycycline / litre of drinking water / day (equivalent to 0.5 - 1.0 ml DOXIVEX 10 % / litre of drinking water / day) for 3-5 days


Meat & offal: 7 days. Not permitted for use in laying birds producing eggs for human consumption
Indications: Treatment of colibacillosis, chronic respiratory disease (CRD) and mycoplasmosis caused by microorganisms sensitive to doxycycline




Ireland


Huvepharma N.V.
Uitbreidingstraat 80
2600 Antwerpen
BELGIUM


Aquadoxx 500 mg/g water-soluble powder


Doxycycline hyclate


500 mg/g doxycycline hyclate


Powder for oral solution


Chickens (broilers) & Pigs (fattening pigs)


Oral (drinking water)


20 mg doxycycline (hyclate)/kg x 3-5 days


Meat and offal:
Chickens: 6 days
Do not use in laying birds producing eggs for human consumption
Indications: Chickens (broilers): Prevention and treatment of Chronic Respiratory Disease (CRD) caused by Mycoplasma gallisepticum.




Italy


CEVA VETEM S.P.A.
Via Colleoni n.15
20041 Agrate Brianza (Milano)
ITALY


DOXICICLINA 20 % CEVA VETEM


Doxycycline hyclate


Doxycycline 200 g. per 1 kg. of product


Water soluble powder


broiler, turkey


drinking water


Broiler, Turkey: 1 g / 10 kg b.w per 5 days.


Meat and offal:
broiler: 7 days
turkey: 8 days
Indications: Broiler: Treatment of chronic respiratory disease
Turkey: Treatment of infective synusitis




Italy


CHEMIFARMA S.p.A
Via Don Eugenio Servadei 16
47100 Forli
ITALY


DOXICICLINA 50 % CHEMIFARMA


Doxycycline hyclate


Doxycycline 500 g. per 1 kg. of product


Water soluble powder


broiler, swine


drinking water


Broiler: 20 mg of doxycycline / per 1 kg b.w.(per 3 - 5 days) Swine: 20 mg of doxycycline / per 1 kg b.w per 3 - 5 days


Meat and offal:
broiler: 6 days Do not use in hens producing eggs for human consumption. swine: 5 days
Indications: Broiler: Chronic respiratory disease caused by: Pasteurella soo, Mycoplasma spp, Haemophilus gallinarum, Bordetella avium, ans Clamidia psittaci.




Italy


SINTOFARM S.P.A.
Via Togliatti n.5
42016 Guastalla (Reggio Emilia)
ITALY


DOXIFARM 50 %


Doxycycline hyclate


Doxycycline hyclate 500 mg. (equivalent to 433,3 mg of Doxiclina) per 1 g. of product


Water soluble powder


broiler, swine


drinking water


Broiler: 25 mg of doxycycline hyclate/per 1 kg b.w.(per 3 - 5 days) Swine: 20 mg of doxycycline hyclate/per 1 kg b.w per 5 days


Meat and offal:
broiler: 6 days Do not use in hens producing eggs for human consumption. swine: 4 days
Indications: Broiler: Treatment and control of respiratory disease caused by Mycoplasma spp, Haemophilus paragallinarum, Escherichia coli. Enteritis caused by Clostridium perfringens and Clostridium colinum




Italy


INDUSTRIA ITAILIANA INTEGRATORI TREI SpA
Via Affarosa n.4
42010 Rio Saliceto (Reggio Emilia) ITALY


DOXIPAN 54


Doxycycline hyclate


Doxycycline 500 g. per 1 kg. of product


Water soluble powder


broiler, turkey, swine


drinking water


Broiler: 10 mg of doxycycline / 1 kg b.w. Turkey: 20 mg of doxycycline / 1 kg b.w. Swine: 10 mg of doxycycline / 1 kg b.w per 5 days


Meat and offal:
broiler: 3 days Do not use in hens producing eggs for human consumption. turkey: 10 days swine: 4 days
Indications: Broiler:Chronic respiratory disease. Turkey:Respiratory and joints syndroms caused by Mycoplasms and/or Staphilococcus




Italy


INTERVET ITALIA S.R.L.
Via W. Tobagi n.7
20068 Peschiera Borromeo (Milano)
ITALY


NAXOCET


Doxycycline hyclate


Doxycycline hyclate 500 mg. per 1 g. of product


Water soluble powder


broiler


drinking water


Broiler: 20 mg of doxyclyne hyclate/1 kg b.w. per 5 days.


Meat and offal:
broiler: 8 days Do not use in hens producing eggs for human consumption.
Indications: Chronic respiratory disease caused by Mycoplasma spp.




Lithuania


DOPHARMA B.V.
Zalmweg 24,
P.O. BOX 205
4940 AE Raamsdonksveer
THE NETHERLANDS


DOXYCYCLINE 50 %, geriamieji milteliai


Doxycycline hyclate


500 mg/g


Oral powder


Calves, pigs and poultry.


4–7 days with drinking water


Poultry: 40 mg per 1 kg of body weight, or 200–400 g per 1 000 litres of drinking water, during 4–7 days.


Meat and offal:
Poultry – 4 days. Do not use in animals producing eggs for human consumption.
Indications: for the treatment of poultry: ornythosis, caused by Clamydia psittaci, colibacteriosis caused by E. coli, CRD caused by Mycoplasma gallisepticum




Lithuania


Lavet Pharmaceuticals Ltd.,
1161 Budapest Ottó u. 14,
HUNGARY


DOXYPRIM 40 % geriamieji milteliai


Doxycycline hyclate


400 mg/g


Oral powder


Chickens, turkeys and pigs.


Should be administered for a period of 5 days in chicken and turkeys together with drinking water.


Chicken and turkeys: 10–20 mg doxycycline hyclate per 1 kg of body weight daily, administrated pulse dosed when the daily requirement is given in limited quantity of water to be consumed by the birds within 4–8 hours or supplied continuously as 67–133 mg ml Doxycycline hyclate per 1 litre of drinking water.


Meat and offal:
Edible tissues of chickens and turkeys – 4 days.
Indications: In chickens and turkeys indications include: chronicle respiratoric diseases (Mycoplasma gallisepticum, E. coli), airsacculitis (Mycoplasma meleagridis), infectious synovitis (Mycoplasma synoviae), colibacillosis (E. coli), fowl cholera (Pasteurella multocida), turkey bordetellosis (Bordetella avium), infectious coryza (Haemophilus paragallinarum), necrotic enteritis (Clostridium perfringens), chlamydiosis (Chlamydia psittaci).




Lithuania


Eurovet Animal Health B.V.
Handelsveg 25
PO Box 179
5530 AD Bladel
THE NETHERLANDS


SOLUDOX 50 %, geriamieji milteliai


Doxycycline hyclate


500 mg/g


Oral powder


Pigs and chickens.


Should be administered orally with drinking water for a period of 4 days.


Chickens: 10* mg doxycycline hyclate per 1 kg of body weight daily for 4 days; 20* mg doxycycline hyclate per 1 kg of body weight daily for 4 days. * The highest dose is recommended in case of infections caused by strains which are moderately susceptible (MIC up to 2 µg/ml), whilst the lowest dosage maybe used for (highly) susceptible strains (MIC up to 0.5–1.0 µg/ml)


Indications: For the treatment of infections caused by micro-organisms susceptible to doxycycline, such as Pasteurella multocida and Ornithobacterium rhinotracheale in chickens.




The Netherlands


DOPHARMA B.V.
Zalmweg 24,
P.O. BOX 205
4940 AE Raamsdonksveer
THE NETHERLANDS


Doxycycline-hyclaat 50 %


Doxycycline hyclate


Per gram powder: 500 mg doxycycline hyclate.


Powder for oral solution


Calves, non-egg laying chickens and turkeys.


Non-egg laying chickens and turkeys: oral via drinking water. bodyweight per day for 4-7 days.


Non-egg laying chickens and turkeys: 20 mg doxycycline hyclate per kg


Turkeys - meat: 28 days.
Non-egg laying chickens - meat: 14 days.
Indications: Turkeys:






—


Ornithosis caused by Chlamydia psittaci










—


Colibacillosis caused by E. coli










—


CRD caused by Mycoplasma gallisepticum




Non-egg laying chikens Colibacillosis caused by E. coli




The Netherlands


Dutch Farm Veterinary Pharmaceuticals B.V.
Veemweg 1
3771 MT
Barneveld
THE NETHERLANDS


Doxycycline 20 % W.O.


Doxycycline hyclate


Per gram powder: 200 mg doxycycline hyclate


Powder for oral solution


Non-egg laying chickens


Oral via drinking water. for 3 days


10 mg doxycycline hyclate per kg bodyweight per day for 3 days


Meat: 7 days.
Indication non-egg laying chickens:






—


Polyarthritis caused by Mycoplasma synoviae;










—


CRD, amongst others caused by Mycoplasma gallisepticum;










—


Colibacillosis caused by Escherichia coli








The Netherlands


DOPHARMA B.V.
Zalmweg 24,
P.O. BOX 205
4940 AE Raamsdonksveer
THE NETHERLANDS


Doxycycline-hyclaat 20 %


Doxycycline hyclate


Per gram powder: 200 mg doxycycline hyclate.


Powder for oral solution


Calves, pigs, chickens and turkeys.


Chickens and turkeys: oral via drinking water for 4-7 days.


Chickens and turkeys: 20 mg doxycycline hyclate per kg bodyweight


Turkeys - meat: 28 days.
Chickens - meat: 14 days, eggs: 10 days.
Indication turkeys:






—


Ornithosis caused by Chlamydia psittaci










—


Colibacillosis caused by E. coli










—


CRD caused by Mycoplasma gallisepticumIndication




Indication chickens:






—


Colibacillosis caused by E. coli










—


CRD caused by Mycoplasma gallisepticum








The netherlands


Dutch Farm International B.V.
Nieuw Walden 112
1394 PE
Nederhorst den Berg
THE NETHERLANDS


Doxycycline 20 % W.O.


Doxycycline hyclate


Per gram powder: 200 mg doxycycline hyclate.


Powder for oral solution


Non-egg laying chickens (broilers).


Oral via drinking water.


10 mg doxycycline hyclate per kg bodyweight per day for 3 days.


Meat: 7 days. Do not administer to chickens producing eggs for human consumption. Indication non-egg laying chickens:






—


Polyarthritis caused by Mycoplasma synoviae;










—


CRD, amongst others caused by Mycoplasma gallisepticum;










—


Colibacillosis caused by Escherichia coli.








The Netherlands


DOPHARMA B.V.
Zalmweg 24,
P.O. BOX 205
4940 AE Raamsdonksveer
THE NETHERLANDS


Doxycycline-hyclaat 50 %


Doxycycline hyclate


Per gram powder: 500 mg doxycycline hyclate.


Powder for oral solution


Calves, pigs, non-egg laying chickens.


Non-egg laying chickens: oral via drinking water. for 4-5 days.


Non-egg laying chickens: 20 mg doxycycline hyclate per kg bodyweight per day for 4-5 days.


Non-egg laying chickens - meat: 14 days.
Indication non-egg laying chickens:






—


Colibacillosis caused by E. coli










—


CRD caused by Mycoplasma gallisepticum








The Netherlands


DOPHARMA B.V.
Zalmweg 24,
P.O. BOX 205
4940 AE Raamsdonksveer
THE NETHERLANDS


Doxycycline 50 % WSP


Doxycycline hyclate


Per gram powder: 500 mg doxycycline hyclate.


Powder for oral solution


Non-egg laying chickens.


Non-egg laying chickens: oral via drinking water.


Non-egg laying chickens: 25 mg doxycycline hyclate per kg bodyweight per day for 3-5 days.


Non-egg laying chickens - meat: 6 days.
Indication non-egg laying chickens:






—


Respiratory infections caused by Mycoplasma spp (M. gallisepticum, M.synoviae en M. meleagridis), E. coli and Haemophilus paragallinarum;










—


Enteritis caused by Clostridium perfringens en Clostridium colinum.








The Netherlands


Interchemie Werken
De Adelaar BV
Hosterweg 26a
5811 Ccastenray
THE NETHERLANDS


Doxy WS


Doxycycline hyclate


Per gram powder: 200 mg doxycycline hyclate.


Powder for oral solution


Non-egg laying chickens (broilers).


Oral via drinking water.


10 mg doxycycline hyclate per kg bodyweight per day for 3 days.


Meat: 7 days.
Indication non-egg laying chickens:






—


Polyarthritis caused by Mycoplasma synoviae;










—


CRD, amongst others caused by Mycoplasma gallisepticum;










—


Colibacillosis caused by Escherichia coli.








The Netherlands


Eurovet Animal Health B.V.
Handelsveg 25
PO Box 179
5530 AD Bladel
THE NETHERLANDS


Soludox 50 %


Doxycycline hyclate


Per gram powder: 500 mg doxycycline hyclate.


Powder for oral solution


Pigs and non-egg laying chickens.


Non-egg laying chickens: oral via drinking water.


Non-egg laying chickens: - Pasteurellosis caused by Pasteurella multocida: 10 mg doxycycline hyclate per kg bodyweight per day for 3-4 days.infections caused by Ornithobacterium rhinotracheale (ORT): 20 mg doxycycline hyclate per kg bodyweight per day for 3-4 days


Non-egg laying chickens: - Pasteurellosis – meat: 5 days.- ORT – meat: 12 days.
Do not administer to chickens producing eggs for human consumption




The Netherlands


Eurovet Animal Health B.V.
Handelsveg 25
PO Box 179
5530 AD Bladel
THE NETHERLANDS


Doxyfar 50 %


Doxycycline hyclate


Per gram powder: 500 mg doxycycline hyclate.


Powder for oral solution


Pigs and non-egg laying chickens.


Non-egg laying chickens: oral via drinking water.


Non-egg laying chickens: Pasteurellosis caused by Pasteurella multocida: 10 mg doxycycline hyclate per kg bodyweight per day for 3-4 - Respiratory infections caused by Ornithobacterium rhinotracheale (ORT): 20 mg doxycycline hyclate per kg bodyweight per day for 3-4 days


Non-egg laying chickens:






—


Pasteurellosis – meat: 5 days.










—


ORT – meat: 12 days.




Do not administer to chickens producing eggs for human consumption.




The Netherlands


Kepro B.V.
Maagdenburgstraat 38
7421 ZE
Deventer
THE NETHERLANDS


Doxy 200 W.S.P.


Doxycycline hyclate


Per gram powder: 200 mg doxycycline hyclate.


Powder for oral solution


Non-egg laying chickens (broilers).


Oral via drinking water.


10 mg doxycycline hyclate per kg bodyweight per day for 3 days.


Meat: 7 days.
Do not administer to chickens producing eggs for human consumption.
Indication:






—


Polyarthritis caused by Mycoplasma synoviae;










—


CRD, amongst others caused by Mycoplasma gallisepticum;










—


Colibacillosis caused by Escherichia coli.








The Netherlands


Eurovet Animal Health B.V.
Handelsveg 25
PO Box 179
5530 AD Bladel
THE NETHERLANDS


Soludox 50 %


Doxycycline hyclate


Per gram powder: 500 mg doxycycline hyclate.


Powder for oral solution


Pigs and non-egg laying chickens.


Non-egg laying chickens: oral via drinking water.


Non-egg laying chickens: 10 mg doxycycline hyclate per kg bodyweight per day for 3-4 days.


Non-egg laying chickens – meat: 5 days.
Indication: Pasteurellosis caused by Pasteurella multocida




The Netherlands


Laboratorios Karizoo S.A
Polígono Industrial La Borda
Mas Pujades
11-12
08140 Caldes de Montbui
Barcelona
SPAIN


Karidox 10 % Oral Solution


Doxycycline hyclate


Per ml: 100 mg doxycycline (as hyclate).


Oral solution


Pigs and chickens (broilers).


Chickens (broilers): oral via drinking water.


Chickens (broilers): 10-20 mg doxycycline per kg bodyweight per day for 3-5 days


Chickens (broilers) - meat: 7 days.
Indication: Prevention and treatment of CRD and mycoplasmosis caused by microorganisms sensitive to doxycycline.




The Netherlands


Huvepharma, Uitbreidingstraat 80
2600 Antwerpen
BELGIUM


HydroDoxx 500 mg/g


Doxycycline hyclate


Per g: 500 mg doxycycline hyclate.


Powder for oral solution


Pigs and chickens (broilers).


Chickens (broilers): oral via drinking water.


Chickens (broilers): 20 mg doxycycline per kg bodyweight per day for 3-5 days


Chickens (broilers) - meat: 6 days.
Do not administer to chickens producing eggs for human consumption.




The Netherlands


CHEMO IBERICA, S.A.
Gran Via Carlos III, 98 7a

Edificio Trade
08028 Barcelona
SPAIN


Soldoxin


Doxycycline hyclate


Per ml: 100 mg doxycycline (as hyclate).


Oral solution


Pigs and chickens (broilers).


Chickens (broilers): oral via drinking water.


Chickens (broilers): 10-20 mg doxycycline per kg bodyweight per day for 3-5 days


Chickens (broilers) - meat: 7 days.
Do not administer to chickens producing eggs for human consumption.
Indication: Prevention and treatment of CRD and mycoplasmosis caused by microorganisms sensitive to doxycycline.




Poland


DOPHARMA B.V.
Zalmweg 24,
P.O. BOX 205
4940 AE Raamsdonksveer THE NETHERLANDS


Doxymed 50


Doxycycline hyclate


500 mg/g


powder for oral solution


chickens


250-500 ml product/1 000 liter of drinking water


25 mg doxycyclini hyclate / kg bw/day for 3-5 days


Meat and offal:
4 days. Not for use in laying hens.




Poland


Eurovet Animal Health B.V.
Handelsveg 25
PO Box 179
5530 AD Bladel
THE NETHERLANDS


Soludox 50 %


Doxycycline hyclate


500 mg/g


Oral powder


chickens


2 g product/100 kg bw/day in case of Pasteurellosis or 4 g product / 100 kg bw/day in case of Ornithrobacterium rhinotracheale infection.


10 mg doxycycliny hyclate/kg bw/day in case of Pasteurellosis or 20 mg doxycyclini hyclate/kg bw/day in case of Ornithrobacterium rhinotracheale infection for 3-4 days


Meat and offal:
5 days in case of Pasteurellosis.
12 days in case of Ornithrobacterium rhinotracheale infection.
Not for use in laying hens.




Poland


Laboratorios Hipra S.A.
Avda La Selva 135
17170 Amer (Girona)
SPAIN


Hipradoxi-S


Doxycycline hyclate


100 mg/ml


Oral solution


chickens


0,5-1,0 ml product/1 liter of drinking water


50-100 mg doxycyclini hyclate/1 liter of drinking water for 3-5 days


Meat and offal:
5 days. Not for use in laying hens.




Poland


Oropharma n.v.
Dijkstraat 30
9140 Temse
BELGIUM


Ornicure


Doxycycline hyclate


300 mg/4 g


Oral powder


pigeon, parrot


pigeon: 4g prodyct/2 liters of drinking water, parrot: 4 g product/0,5 liter


15 mg/kg bw./ day for 5 days, in case of parrot desease or clinical ornitosis for 3-4 weeks


Not for use in pigeons for human consumption.




Poland


Novartis Animal Health d.o.o.
Verovskava 57
1000 Ljubljana
SLOVENIA


Doxiryl 50 %


Doxycycline hyclate


500 mg/g


powder for oral solution


chicken (broiler)


25 mg doxycyclini hyclate / kg bw/day


25 mg doxycyclini hyclate / kg bw/day for 3-5 days


Meat and offal:
4 days. Not for use in laying hens.




Poland


S.P. Veterinaria SA Crta. Reus
Vinyols Km 4.1 Apartado 60
Riudoms 43330 (Tarragona) SPAIN


Doxivex 10 %


Doxycycline hyclate


100 mg/ml


Concentrate for oral solution


chicken (broiler)


05-1,0 ml product/1 liter of drinking water


50-100 mg doxycyclini hyclas/1 liter of drinking water/day for 3-5 days


Meat and offal:
7 days. Not for use in laying hens.




Poland


CHEMO IBERICA, S.A.
Gran Via Carlos III, 98 7a

Edificio Trade
08028 Barcelona
SPAIN


Oridox


Doxycycline hyclate


100 mg/ml


Oral solution


chicken (broiler)


05-1,0 ml product/1 liter of drinking water


10-20 mg doxycyclini hyclas/kg bw/day for 3-5 days


Meat and offal:
7 days. Not for use in laying hens.




Poland


Laboratorios Karizoo S.A
Polígono Industrial La Borda
Mas Pujades
11-12
08140 Caldes de Montbui
Barcelona
SPAIN


Karidox


Doxycycline hyclate


100 mg/ml


Oral solution


chicken (broiler)


05-1,0 ml product/1 liter of drinking water


10 -20 mg doxycyclini hyclas/kg bw/day for 3-5 days


Meat and offal:
7 days. Not for use in laying hens.




Poland


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


Doxymina 20 %


Doxycycline hyclate


200 mg/g


Oral powder


chicken


25-50 g product/1 liter of drinking water


10 mg doxycyclini hyclate/kg bw/day, for 3-5 days


Meat and offal:
7 days. Not for use in laying hens.




Poland


V.M.D.n.v./ s.a.
Hoge Muew 900
2370 Arendonk
BELGIUM


Doxycycline hyclate 50 %


Doxycycline hyclate


500 mg


powder for oral solution


chicken


25 mg doxycyclini hyclate / kg bw/day


25 mg doxycyclini hyclate / kg bw/day for 3-5 days


Meat and offal:
5 days. Not for use in laying hens.




Poland


INDUSTRIAL VETERINARIA S.A.
Esmeralda, 19 - 4o

08950 ESPLUGUES DE LLOBREGAT SPAIN


Doxinyl


Doxycycline hyclate


100 mg/ml


Oral solution


chicken (broiler)


0,5-1,0 ml product/1 liter of drinking water/day


50-100 mg doxycyclini hyclate/1 liter of drinking water for 3-5 days


Meat and offal:
7 days. Not for use in laying hens.




Poland


Biofaktor Sp. z o.o.(Skierniewice)
Czysta 4
96-100 Skierniewice
POLAND


Doxycyclinum 20 %


Doxycycline hyclate


200 mg/ml


powder for oral solution


chicken, turkey


25-50 g product/1 liter of drinking water


10 mg doxycyclini hyclate/kg bw/day, for 3-5 days


1 Meat and offal:
4 days. Not for use in laying hens.




Poland


Tarchomińskie Zakłady Farmaceutyczne Polfa S.A.
Fleminga 2
03-176 Warszawa
POLAND


Doxycyclinum wet proszek


Doxycycline hyclate


200 mg/g


powder for oral solution


chicken, turkey,


25-50 g powder/1 liter of drinking water


10 mg doxycyclini hyclate/kg bw/day, for 3-5 days


Meat and offal:
7 days. Not for use in laying hens.




Poland


Sogeval Laboratoires
200 route De Mayenne
53022 Laval Cedex FRANCE


DOXYVAL 20 %


Doxycycline hyclate


20 g/100 g


Oral powder


chicken (broiler)


5 g produkt/100 kg bw/day or 0,5 g/1 liter of drinking water


10 mg doxycyclini hyclate/kg bw/day, for 3-5 days


Meat and offal:
4 days. Not for use in laying hens.




Poland


Eurovet Animal Health B.V.
Handelsveg 25
PO Box 179
5530 AD Bladel
THE NETHERLANDS


Soludox 15 %


Doxycycline hyclate


150 mg/g


Oral powder


chicken, turkey, pigeon, cage bird


10-20 mg doxycyclini hyclas/kg bw/day


10-20 mg/ kg bw/day for 3-5 days. In case of Chlamydia psittaci infection for 30-45 days.


Meat and offal:
7 days. Not for use in laying hens or in pigeons for human consumption.




Portugal


CEVA Saúde Animal –Produtos farmacêuticos e Imunológicos
Lda. Ceva Saúde Animal Lda.
Rua Doutor António
Loureiro Borges 9/9a 9o A Miraflores
1495-131 Algés
PORTUGAL


DOXYPRIM 400 mg / g Pó para Solução Oral para Suínos, Frangos e Perus.


Doxycycline hyclate


Doxycycline hyclate 400 mg / g


Powder for oral solution


Swine, Chicken, Turkey


For oral administration in drinking water


Broilers and Turkeys: 20 mg Doxycycline hyclate/kg bw, for 5 days.


Chicken (Broilers) meat and offal: 5 days; Tukeys meat and offal:6 days;
Not permitted for use in laying birds producing eggs for human consumption




Portugal


DIVASA FARMAVIC DE PORTUGAL
Produtos e Equipamentos Veterinários
Lda. Parque Empresarial de Vialonga
Armazém no 21
Casal do Bagulho
Granja de Alpriate
2625-607 Vialonga
PORTUGAL


DOXYVET-10


Doxycycline hyclate


Doxycycline hyclate 10g; Bromexin Cloridrate 1g


Oral solution


Bovine (Calves), Swine, Broilers, Turkeys, Ovine, Goat (Kid)


For oral administration in drinking water


Broilers and Turkeys: 50-100 mg/liter of water/day, for 3-5 days (Equivalent to 0,5-1 ml of DOXIVET-10 / liter of water/day


Meat and offal:
5 days




Portugal


DOPHARMA B.V.
Zalmweg 24,
P.O. BOX 205
4940 AE Raamsdonksveer
THE NETHERLANDS


VETADOXI 50


Doxycycline hyclate


Doxycycline hyclate 500 mg/g


Oral powder


Bovine (Calves), Swine and Birds


For oral administration in drinking water, milk or feed


25 mg/Kg bw in birds; 200 g/1 000 L water/day 3-5 days; 500 g/1 000 L drinking water birds


Meat and offal:
5 days; Not permitted for use in laying birds producing eggs for human consumption




Portugal


S.P. Veterinaria SA Crta. Reus
Vinyols Km 4.1
Apartado 60
Riudoms 43330 (Tarragona) SPAIN


Hidrodox 10 % Concentrado para solução oral para aves (frangos de carne) e suínos


Doxycycline hyclate


Doxycycline (as hyclate) 100 mg


Concentrate for Oral Solution


Chickens (broilers) and swine


For oral administration in drinking water


Broilers: 50 – 100 mg Doxycycline hyclate/L drinking water/day (0,5-1,0 ml of VMP/drinking water/day) 3-5 days.


Birds (Broilers) meat and offal: 7 days. Not permitted for use in laying birds producing eggs for human consumption




Portugal


Univete SA
Rua D. Jerónimo Osório, 5
B 1400-119 Lisboa
PORTUGAL


UNIDOXINA 200 mg/ml solução oral para suínos e aves


Doxycycline hyclate


Doxycycline (as hyclate) 200 mg


Oral solution


Chickens (broilers) and swine


For oral administration in drinking water


Broilers and Turkeys: 20 mg Doxycycline hyclate/kg bw, for 5 days.


Chicken (Broilers) meat and offal: 7 days. Not permitted for use in laying birds producing eggs for human consumption




Romania


DELOS IMPEX' 96 SRL
17, Pictor Ştefan Luchian
sector 2
Bucharest
ROMANIA


Doxidem 20


Doxycycline hyclate


200 mg/ml doxycycline hyclate


Oral solution


Poultry
(not for use in animals from which eggs are produced for human consumption)


Oral








—


75 ml of product/100 litres drinking water/day for 3-5 consecutive days in young poultry up to 4 weeks










—


150 ml of product/100 litres drinking water/day for 3-5 consecutive days in adult poultry






Meat and offal: 28 days
Indications:
Poultry For the treatment of mycoplasmosis, pasteurellosis, colibacillosis, staphylococcosis.
Chronic respiratory disease, infections caused by Pasteurella spp., Mycoplasma spp., Salmonella spp., E. coli., Haemophillus paragallinarium, Staphylococcus, hepatitis caused by Campylobacter and dermatitis.




Romania


DELOS IMPEX' 96 SRL
17, Pictor Ştefan Luchian
sector 2
Bucharest
ROMANIA


Doxidem 50


Doxycycline hyclate


500 mg/g
doxycycline hyclate


Water soluble powder


Poultry
(not for use in animals from which eggs are produced for human consumption)
Pigs


Oral
(drinking water)








—


20-40 mg of product/kg body weight/day for 5 consecutive days, per os;










—


200-300 g of product/1 000 litres of drinking water for 5 consecutive days






Meat and offal: 28 days
Indications: Chronic respiratory disease, infections caused by Pasteurella spp., Mycoplasma spp., Salmonella spp., E. coli., Haemophillus paragallinarium, Staphylococcus, hepatitis caused by Campylobacter, dermatitis and other diseases caused by microorganisms sensitives to doxycycline.




Romania


DOPHARMA B.V.
Zalmweg 24,
P.O. BOX 205
4940 AE Raamsdonksveer
THE NETHERLANDS


Doxycycline 50 % WSP


Doxycycline hyclate


500 mg/g
doxycycline hyclate


Water soluble powder


Poultry (not for use in animals from which eggs are produced for human consumption)
Calves
Pig


Oral
(drinking water)


40 mg/kg of body weight or 200-400 g/1 000 litres of drinking water for 4-7 days


Meat and offal: Poultry 4 days
Indications:






—


Ornithosis caused by Chlamydia psittaci in turkeys;










—


Colibacillosis caused by E. coli in chickens and turkeys;










—


CRD caused by Mycoplasma gallisepticum in chickens and turkeys;








Romania


FRANVET
ZI d'Etriche-Route d'Avire
BP 103
49500 Segré Cedex
FRANCE


Doxy 5 Franvet


Doxycycline hyclate


50 mg/g doxycycline (as hyclate)


Water soluble powder


Poultry (not for use in animals from which eggs are produced for human consumption) Calves Pig


Oral (drinking water or liquid feed)








—


1 g of product/1 litre drinking water/day for 3-5 days in poultry up to 2 weeks










—


2 g of product/1 litre drinking water/day for 3-5 days in poultry over 2 weeks






Meat and offal: Poultry 4 days
Indications: For the prevention and treatment of respiratory infections caused by doxycycline sensitive microorganisms.




Romania


INDUSTRIA ITAILIANA INTEGRATORI TREI SpA
Via Affarosa n.4
42010 Rio Saliceto (Reggio Emilia)
ITALY


Doxipan 20


Doxycycline hyclate


200 mg/g doxycycline hyclate


Water soluble powder


Poultry
pig


Oral (drinking water)


5-7,5 g of product for every 10 litres of drinking water


Meat and offal: Poultry 5 days
Indications: Chronic respiratory disease and associated complications.




Romania


PHYLAXIA PHARMA LTD
1103 Budapest
Gergely u.79
HUNGARY


Doxyphyl SP A.U.V.


Doxycycline hyclate


300 mg/g doxycycline hyclate


Water soluble powder


Poultry (chicken, hens, turkeys) v


Oral (drinking water)


10 mg/kg b.w. for 3-5 days or 100 mg of product/1 litre of drinking water


Chickens, hens: 7 days Turkey: 7 days (not for use in animals from which eggs are produced for human consumption)
Indications: For the prevention and treatment of several bacterial infections.




Romania


LABORATORIOS SYVA S.A.
Avda. Parroco Pablo Diez, 49-57
24010 Leon
SPAIN


Syvadox 10 %


Doxycycline hyclate


100 mg/1 ml doxycycline (as hyclate)


Oral solution


Chickens (not for use in animals from which eggs are produced for human consumption)


Oral (drinking water)


50-100 mg doxycycline/1 litre of drinking water/day (equivalent to 0,5-1,0 ml of product/1litre of drinking water/day for 3-5 days


Chickens 7 days (not for use in animals from which eggs are produced for human consumption)
Indications: Colibacillosis, CRD, mycoplasmosis – caused by previously mentioned germs sensitive to doxycycline.




Romania


VMD
Berendonk 74
2370 Arendonk
BELGIUM


Doxyveto 50S


Doxycycline hyclate


500 mg/g doxycycline (as hyclate)


Water soluble powder


Poultry Swine calves lambs


Oral (drinking water or feed)


20 mg doxycycline/kg b.w. /day in drinking water or 300 g of product/1 000 litres of drinking water or 600 g/1 000 kg of feed for 3-5 days


Poultry 8 days
Indications: CRD (Mycoplasma gallisepticum), Ornithosis (Chlamidia psittaci), Infectious synovitis (Mycoplasma synoviae), Fowl cholera (Pasteurella multocida).




Romania


CHEMIFARMA S.p.A
Via Don Eugenio Servadei 16
47100 Forli
ITALY


Doxiciclina 50 %


Doxycycline hyclate


500 mg/g doxycycline


Water soluble powder


Broiler chickens swine


Oral (per os, drinking water or liquid feed)


40 g of product/100 kg b.w. (20 mg of doxycycline/kg b.w) corresponding to about 15-30 g of product/100 litres of water for 3-5 days.


Broiler chickens 5 days
Indications: Chronic respiratory disease and other respiratory illnesses, specially produced by Pasteurella spp., Mycoplasma spp., Haemophilus gallinarium, Bordetella avium and Chlamidia psittaci.




Romania


Lavet Pharmaceuticals Ltd.,
1161 Budapest Ottó u. 14,
HUNGARY


Doxiprim 40 % Soluble Powder


Doxycycline hyclate


400 mg/g doxycycline hyclate


Water soluble powder


Chickens turkeys (not for use in animals from which eggs are produced for human consumption) pigs


Oral (drinking water)


20 mg doxycycline hyclate/kg b.w.


Chickens and turkeys 4 days (not for use in animals from which eggs are produced for human consumption)
Indications: treatment of respiratory, intestinal and systemic infections caused by doxycycline sensitive organisms: CRD (Mycoplasma gallisepticum, E. Coli), airsaculitis (Mycoplasma maleagridis), infectious synovitis (Mycoplasma synoviae), fowl cholera (Pasteurella multocida), infectious coryza (Haemophylus paragallinarum), colibacillosis (E. Coli), turkeys bordetellosis (Bordetella avium), necrotic enteritidis (Clostridium perfringens), chlamydiosis (Chlamidia psittaci). Prevention of secundary becterial infections due to stress conditions, vaccination, change of housing, transport.




Romania


Novartis Animal Health d.o.o.
Verovskava 57
1000 Ljubljana
SLOVENIA


Doxyril 50 %


Doxycycline hyclate


500 mg/g doxycycline hyclate


Water soluble powder


Poultry (not for use in animals from which eggs are produced for human consumption) pigs


Oral (drinking water)


25 mg doxycycline hyclate/kg b.w. during 3 to 5 consecutive days


Poultry 4 days (not for use in animals from which eggs are produced for human consumption)
Indication: Respiratory tract Infections caused by Mycoplasma spp. (M. gallisepticum, M. synoviae and M. melagridis), E. coli, Haemophylus paragallinarium and Ornithobacterium rhinotracheale. Enteritidis caused by Clostridium perfringens and Clostridium colinum. Septicemia caused by Pasteurella multocida.




Romania


CEVA SANTE ANIMALE ROMANIA SRL
5 Chindiei, sector 4,
Bucharest
ROMANIA


Doxyvit 50 % WSP


Doxycycline hyclate


500 mg/g doxycycline hyclate


Water soluble powder


Poultry (chickens and turkeys) (not for use in animals from which eggs are produced for human consumption) pigs


Oral (drinking water)


15 mg doxycycline/kg b.w. for 5 consecutive days or 2 g of product/10 litres drinking water and equivalent to 100 mg of doxycycline/litre of drinking water


Poultry (chickens and turkeys) 7 days (not for use in animals from which eggs are produced for human consumption)
Indications: Colibacillosis, CRD and mycoplasmosis, Clostridium perfringens, chlamydiosis, infectious coryza caused by Bordetella avium.




Romania


Laboratorios Karizoo S.A
Polígono Industrial La Borda
Mas Pujades
11-12
08140 Caldes de Montbui
Barcelona
SPAIN


Karidox 100 mg/ml oral solution for use in drinking water for chickens and pigs


Doxycycline hyclate


100 mg/ml doxycycline (as hyclate)


Oral solution


Poultry (chickens) (not for use in animals from which eggs are produced for human consumption) pigs


Oral (drinking water)


10-20 mg doxycycline/kg b.w. for 3 - 5 days.


Poultry (chickens) t days (not for use in animals from which eggs are produced for human consumption)
Indications:
Prevention and treatment of CRD and mycoplasmosis caused by microorganisms sensitive to doxycycline.




Romania


S.C. VIM SPECTRUM SRL
409 Sighisoarei
Targu Mures
ROMANIA


Vidoxim 10 % powder for oral solution for pigs and poultry


Doxycycline hyclate


100 mg/g doxycycline hyclate


Water soluble powder


Poultry (not for use in animals from which eggs are produced for human consumption) pigs


Oral (drinking water)


1 000 g of product/1 000 litres drinking water for 5 days


Poultry 10 days (not for use in animals from which eggs are produced for human consumption)
Indications:
Infections caused by Mycoplasma gallisepticum, E. coli, Bordetella avium, Haemophylus paragallinarium and Pasteurela multocida.




Romania


S.C. VIM SPECTRUM SRL
409 Sighisoarei
Targu Mures
ROMANIA


Vidoxim 100 % powder for oral solution for pigs and poultry


Doxycycline hyclate


1 000 mg/g doxycycline hyclate


Water soluble powder


Poultry (not for use in animals from which eggs are produced for human consumption) pigs


Oral (drinking water)


100 g of product/1 000 litres drinking water for 5 days


Poultry 10 days (not for use in animals from which eggs are produced for human consumption)
Indications: Infections caused by M. gallisepticum, E. coli, Bordetella avium, Haemophylus paragallinarium and P. multocida.




Romania


CHEMO IBERICA, S.A.
Gran Via Carlos III, 98 7a

Edificio Trade
08028 Barcelona
SPAIN


Oridox (Soldoxin) 100 mg/ml oral solution for use in drinking water for chickens and pigs


Doxycycline hyclate


100 mg/ml doxycycline (as hyclate)


Oral solution


Chickens (broilers) (not for use in animals from which eggs are produced for human consumption) pigs


Oral (drinking water)


10-20 mg doxycycline/kg b.w. for 3 - 5 days.


Poultry (chickens) 7 days (not for use in animals from which eggs are produced for human consumption) Prevention and treatment of CRD and mycoplasmosis caused by microorganisms sensitive to doxycycline.




Romania


Huvepharma N.V.
Uitbreidingstraat 80
2600 Antwerpen
BELGIUM


HydroDoxx 500 mg/g Water Soluble Powder


Doxycycline hyclate


500 mg/g doxycycline hyclate


Powder for oral solution


Chickens (broilers) & Pigs (fattening pigs)


Oral (drinking water)


20 mg doxycycline (hyclate)/kg x 3-5 days


Meat and offal:
Chickens: 6 days
Do not use in laying birds producing eggs for human consumption
Indications:
Chickens (broilers): Prevention and treatment of Chronic Respiratory Disease (CRD) caused by Mycoplasma gallisepticum.




Romania


CEVA PHYLAXIA VETERINARY BIOLOGICALS CO. LTD.
1107 Budapesta
Szallas u.5
HUNGARY


Doxivit 100


Doxycycline hydrocloride


100 mg/g doxycycline hydrochloride


Water soluble powder


Poultry (chickens, turkeys and goose) pigs


Oral (drinking water)


10 mg doxycycline hydrochloride/kg b.w. daily for 5 days


Poultry) 7 days (not for use in animals from which eggs are produced for human consumption)
Indications:
CRD (Mycoplasma gallisepticum, E. Coli), infectious coryza (Haemophylus paragallinarum), fowl cholera (Pasteurella multocida), colibacillosis (E. Coli), airsaculitis (Mycoplasma maleagridis), chlamydiosis (Chlamidia psittaci), necrotic enteritis (Clostridium perfringens).




Romania


PHARMATEKA BT
1046 Budapest
Szigyarto u. 10 / 20 Kossuth Str.
Pusztaberki, 2658
HUNGARY


DOXY H 10 %


Doxycycline hydrocloride


100 mg/g doxycycline hydrochloride


Water soluble powder


Poultry


Oral (drinking water)


1 g of product/1 litre of drinking water for 3-5 days


Poultry 10 days (not for use in animals from which eggs are produced for human consumption)




Romania


s.c. romvac company s.a.Şos.
Centurii, nr. 7
Voluntari
ROMANIA


Doxiciclina 10 %


Doxycycline hydrocloride


100 mg/g doxycycline hydrochloride


Water soluble powder


Poultry, including pigeons pigs bovine (calves)


Oral (drinking water)


2 g of product/10 kg b.w./day for 5-8 days


Poultry (chickens) 5 days (not for use in animals from which eggs are produced for human consumption)




Romania


S.C. Crida pharm s.r.l
2 Intrarea Vagonetului
Bl. 101, Ap. 47, sector 6
Bucharest
ROMANIA


Doxicol 60 %


Doxycycline hydrocloride


600 mg/g doxycycline hydrochloride


Water soluble powder


Poultry
pigs


Oral (drinking water or feed)


broiler 0-14 days:
50g/1 000 litres of water; broiler 15 -28 days: 100g/1 000 litres of water;broiler 29 -35 days: 120g/1 000 litres of water;


Poultry 5 days (not for use in animals from which eggs are produced for human consumption)
Indications:
prevention and treatment of colibacillosis, respiratory diseases, mycoplasmosis.




Slovenia


Novartis Veterina d.o.o.
Verovškova 57
1000 Ljubljana
SLOVENIA


DOXYRIL 50 %


Doxycycline hyclate


50 %
(500 mg/g)


powder for oral solution


pigs, poultry


Pigs and poultry: once a day, three to five days consecutively in drinking water


Pigs: 20 mg of doxycycline hycate per 1 kg of BW; Poultry 25 mg of doxycycline hycate per 1 kg of BW


Meat and offal:
poultry: 4 days;
Indications: respiratory infections (M gallisepticum, M, synoviae in M, melagridis), Escherichia coli, Haemophilus paragallinarum, Ornithobacterium rhinotracheale; Enteritis (Clostridium perfringens and Clostridium colinum; Septicemia (Pasteurella multocida)




Slovak republic


Trei Bio pharmaceutical division, Industria Italiana Integratori Trei
Via Affarosa n.4
42010 Rio Saliceto (Reggio Emilia)
ITALY


DOXIPAN 20 plv.sol. ad us.vet.


Doxycycline hyclate


20 g/100 g


Water soluble powder


Calves, pigs, poultry-broilers, turkey


for 5 days in drinking water


Poultry-broilers: 5-7,5 g product/10 litre of drinking water Turkey:10-20 mg active substance/b. w. corresponding to 50-100 g product/100 liter d.w. Calves, pigs: 10 mg active substance/b.w./day corresponding to 0,5 g product/10 kg b.w.


Meat: Broilers 5 days, turkeys 10 days,
Indications: Broilers: chronic respiratory disease and assotiated complications
Turkeys: infections caused by G-positive and G-negative germs, mycoplasmas sensitive to doxycycline especially respiratory and articular syndrom caused by mycoplasma and/or staphylococcus




Slovak republic


DIVASA-FARMAVIC, S.A.
CTRA. SANT HIPOLIT, KM. 71
08503 GURB – VIC
SPAIN


DOXIVET 10 % plv.sol. a.u.v.


Doxycycline hyclate


100 mg/ml


Water soluble powder


Poultry: (chickens and turkeys), bovine and swine


for 4 - 5 days in drinking water


0,5 ml of product/litre of drinking water


Meat: 5 days
Indications: Treatment of CRD, mycoplasmosis, porcine enzootic pneumonia, bronchopneumonias, chlamidiasis, unspecific diarheas.




Slovak republic


Novartis Animal Health d.o.o.
Verovskava 57
1000 Ljubljana
SLOVENIA


DOXYRIL 500 mg/g prášok na perorálny roztok ad us.vet.


Doxycycline hyclate


500 mg/g


Water soluble powder


Pigs, broilers


during 3 to 5 consecutive days in drinking water


Pigs: 20 mg doxycycline hyclate/kg b.w. Broilers: 25 mg doxycycline hyclate/kg b.w.


Eddible tissues: broilers 4 days.
Indications: Treatment of infections caused by microorganisms susceptible to doxycycline, particularly: Broilers: respiratory tract infections caused by Mycoplasma spp. (M.gallisepticum, M.synoviae and M.meleagridis), Escherichia coli, Haemophilus paragallinarum and Ornithobacterium rhinotracheale, enteritis caused by Clostridium perfringens and Clostridium colinum, septicemia caused by Pasteurella multocida




Slovak republic


Lavet Pharmaceuticals Ltd.,
1161 Budapest Ottó u. 14,
HUNGARY


DOXYVIT 40 % plv.sol.


Doxycycline hyclate


40 g/100 g


Water soluble powder


Poultry: (chickens and turkeys) and swine


3-5 days in drinking water, poutry in drinking water, pigs: in drinking water, in feed


Chickens and turkeys:10-20 mg active doxycyclini hyclate/kg b.w.)/day, continual treatment: 1 g product/3-6 litre of drinking water, repeated treatment: 25-50 mg product/kg b.w.(10-20 mg doxycycline hyclate/kg b.w.) in drinking water


Meat of chickens and turkey: 4 days,
Indications: Treatment and prophylaxis of respiratory, intestinal and systematic infections caused by doxycycline sensitive organism: Chickens, turkeys: chronic respiratory disease (Mycoplasma gallisepticum, E.coli), airsacculitis (M.meleagridis), infectious synovitis (M.synoviae), fowl cholera (P. multocida), turkey bordetellosis (Bordetella avium), infectious coryza (Haemophilus paragallinarum), collibacilosis (E.coli), necrotic enteritis (Clostridium prefringens), chlamydiiosis (CH. psittaci),




Slovak republic


Tekro, spol. s.r.o.,
Višňová 2/484,
140 00 Praha 4,
CZECH REPUBLIC


Meditek DOX 100 plv.sol. ad us.vet.


Doxycycline hyclate


100 g/1 000 g


Water soluble powder


Broilers, pigs


3-5 days in drinking water


Broilers: 10 mg doxycyclini hyclate/kg b.w (corresponding to 1 kg product/1 000 litre of drinking water)


Meat of broilers and pigs: 7 days.
Indications: Treatment and prevention of respiratory and gastrointestinal diseases caused by organism sensitive to doxycycline: broilers: CRD, mycoplasmosis, aerosaculitis, synovitis, pasteurellosis, infectious cholera, colibacillosis, chlamidiosis, necrotic enteritis




Slovak republic


Pharmagal s.r.o.,
Murgašova 5,
949 01 Nitra,
SLOVAK REPUBLIC


DOXYGAL plv.sol. ad us.vet.


Doxycycline hyclate


5 g/100 g


Water soluble powder


Pigs, poultry, calves, rabbits


Poultry: prevention 5 days, treatment 3 days, in drinking water Pigs, calves, rabbits: 5 days, in drinking water, in feed


Poultry: prevention: 50 mg active substance/1 litre of drinking water (1 g product/1 litre water), treatment: 100 mg active substance/1 litre water (2 g product/1 litre water)


Meat of poultry and rabbits: 7 days
Indications: Poultry: CRD (mycoplasmosis), colibacillosis.




Slovak republic


COOPHAVET
Saint Herblon
44150 Ancenis
FRANCE


RONAXAN 5 % plv.sol. ad us.vet.


Doxycycline hyclate


5 g/100 g


Water soluble powder


Pigs, poultry, calves


Prevention: 1-3 days, treatment: 3-5 days, in drinking, in feed


10 mg active substance/kg b.w./day (1 g product/5 kg b.w./day) Polutry:






—


less than 2 weeks old: 1 g product/litre of drinking water/day,










—


more than 2 weeks old: 2 g/litre water/day






Meat of poultry 4 days
Indications: Poultry: preventive and curative treatment of respiratory infections,




Slovak republic


Laboratorios Karizoo S.A
Polígono Industrial La Borda
Mas Pujades
11-12
08140 Caldes de Montbui
Barcelona
SPAIN


KARIDOX 100 mg/ml roztok pre podávanie hydine a ošípaným perorálne v pitnej vode


Doxycycline hyclate


100 mg/ml


Water soluble powder


Chicken (broilers), pigs


Broilers: 3-5 days, Pigs: 5 days, in drinking water


Broilers: 10 -20 mg of doxycycline/kg b.w./day, (0,5-1,0 ml of product/litre of drinking water),


Meat and offals: chicken (broilers) 7 days
Indications: Chicken (broilers): prevention and treatment of chronic respiratory disease (CRD) and mycoplasmosis caused by microorganism sensitive to doxycycline.




Slovak republic


CHEMO IBERICA, S.A.
Gran Via Carlos III, 98 7a

Edificio Trade
08028 Barcelona
SPAIN


ORIDOX 100 mg/ml roztok pre podávanie hydine a ošípaným perorálne v pitnej vode


Doxycycline hyclate


100 mg/ml


Water soluble powder


Chicken (broilers), pigs


Broilers: 3-5 days, Pigs. 5 days, in drinking water


Broilers: 10 -20 mg of doxycycline/kg b.w./day, (0,5-1,0 ml of product/litre of drinking water),


Meat and offals: chicken (broilers) 7 days,
Indications: Chicken (broilers): prevention and treatment of chronic respiratory disease (CRD) and mycoplasmosis caused by microorganism sensitive to doxycycline.




United kingdom


Laboratorios Karizoo S.A
Polígono Industrial La Borda
Mas Pujades
11-12
08140 Caldes de Montbui
Barcelona
SPAIN


Karidox 100 mg/ml Oral Solution for use in drinking water for Chickens and Pigs


Doxycycline hyclate


100 mg/ml doxycycline (as doxycycline hyclate)


Oral solution


Chickens (broilers) & Pigs


Oral (drinking water)


10-20 mg doxycycline/kg x 3-5 days


Meat & offal:
Chickens (broilers): 7 days
Indications: CHICKENS (BROILERS):
Prevention and treatment of chronic respiratory disease (CRD) and mycoplasmosis caused by microorganisms sensitive to doxycycline.




United kingdom


CHEMO IBERICA, S.A.
Gran Via Carlos III, 98 7a

Edificio Trade
08028 Barcelona
SPAIN


Soldoxin 100 mg/ml Oral Solution for use in drinking water for chickens and pigs


Doxycycline hyclate


100 mg/ml doxycycline (as doxycycline hyclate)


Oral solution


Chickens (broilers) & Pigs


Oral (drinking water)


10-20 mg doxycycline/kg x 3-5 days


Meat & offal:
Chickens (broilers): 7 days
Indications: CHICKENS (BROILERS):
Prevention and treatment of chronic respiratory disease (CRD) and mycoplasmosis caused by microorganisms sensitive to doxycycline.




United kingdom


Huvepharma N.V.
Uitbreidingstraat 80
2600 Antwerpen
BELGIUM


HydroDoxx 500 mg/g Water Soluble Powder


Doxycycline hyclate


500 mg/g doxycycline hyclate


Powder for oral solution


Chickens (broilers) & Pigs (fattening pigs)


Oral (drinking water)


20 mg doxycycline (hyclate)/kg x 3-5 days


Meat and offal:
Chickens: 6 days
Indications: Chickens (broilers): Prevention and treatment of Chronic Respiratory Disease (CRD) caused by Mycoplasma gallisepticum.




UNITED KINGDOM


VMD NV, HOGE MAUW
900-2370 Arendonk
BELGIUM


Doxyveto 50 s plus


Doxycycline hyclate


50 % w/w doxycycline hyclate


Powder for oral administration


Non-egg laying chickens


Oral (drinking water)


25 mg doxycycline (hyclate)/kg x 3-5 days


Meat and offal:6 days
Indications: Respiratory infections caused by Mycoplasma spp., E. coli and Haemophilus paragallinarum.
Enteritis caused by Clostridium perfringens and Clostridium colinum







ANNEX XV
LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE VETERINARY MEDICINAL PRODUCTS, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION Holder IN THE MEMBER STATES












Member State / EEA


Marketing Authorisation Holder


Invented name


Pharmaceutical form


Strength


Animal species


Frequency and route of administration


Recommended dose




Austria


Intervet International B.V.
P.O. Box 31
5830 AA Boxmeer
The Netherlands


Vasotop P 0,625 mg; Vasotop P 1,25 mg; Vasotop P 2,5 mg, tablet for dogs


Tablet


0,625; 1,25 or 2,5 mg of ramipril


Dogs


Daily, oral


0,125 mg/kg; 0,25 mg/kg if the animal does not respond after 2 weeks of treatment




Belgium


Intervet International B.V.
P.O. Box 31
5830 AA Boxmeer
The Netherlands


Vasotop P 0,625 mg; Vasotop P 1,25 mg; Vasotop P 2,5 mg, tablet for dogs


Tablet


0,625; 1,25 or 2,5 mg of ramipril


Dogs


Daily, oral


0,125 mg/kg; 0,25 mg/kg if the animal does not respond after 2 weeks of treatment




Denmark


Intervet International B.V.
P.O. Box 31
5830 AA Boxmeer
The Netherlands


Vasotop P 0,625 mg; Vasotop P 1,25 mg; Vasotop P 2,5 mg, tablet


Tablet


0,625; 1,25 or 2,5 mg of ramipril


Dogs


Daily, oral


0,125 mg/kg; 0,25 mg/kg if the animal does not respond after 2 weeks of treatment




Germany


Intervet International B.V.
P.O. Box 31
5830 AA Boxmeer
The Netherlands


Vasotop P 0,625 mg; Vasotop P 1,25 mg; Vasotop P 2,5 mg, tablet for dogs


Tablet


0,625; 1,25 or 2,5 mg of ramipril


Dogs


Daily, oral


0,125 mg/kg; 0,25 mg/kg if the animal does not respond after 2 weeks of treatment




Greece


Intervet International B.V.
P.O. Box 31
5830 AA Boxmeer
The Netherlands


Vasotop P 0,625 mg; Vasotop P 1,25 mg; Vasotop P 2,5 mg, tablet for dogs


Tablet


0,625; 1,25 or 2,5 mg of ramipril


Dogs


Daily, oral


0,125 mg/kg; 0,25 mg/kg if the animal does not respond after 2 weeks of treatment




Spain


Intervet International B.V.
P.O. Box 31
5830 AA Boxmeer
The Netherlands


Vasotop P 0,625 mg; Vasotop P 1,25 mg; Vasotop P 2,5 mg, tablet for dogs


Tablet


0,625; 1,25 or 2,5 mg of ramipril


Dogs


Daily, oral


0,125 mg/kg; 0,25 mg/kg if the animal does not respond after 2 weeks of treatment




Finland


Intervet International B.V.
P.O. Box 31
5830 AA Boxmeer
The Netherlands


Vasotop P 0,625 mg; Vasotop P 1,25 mg; Vasotop P 2,5 mg, tablet for dogs


Tablet


0,625; 1,25 or 2,5 mg of ramipril


Dogs


Daily, oral


0,125 mg/kg; 0,25 mg/kg if the animal does not respond after 2 weeks of treatment




Ireland


Intervet International B.V.
P.O. Box 31
5830 AA Boxmeer
The Netherlands


Vasotop P 0,625 mg; Vasotop P 1,25 mg; Vasotop P 2,5 mg, tablet


Tablet


0,625; 1,25 or 2,5 mg of ramipril


Dogs


Daily, oral


0,125 mg/kg; 0,25 mg/kg if the animal does not respond after 2 weeks of treatment




Luxemburg


Intervet International B.V.
P.O. Box 31
5830 AA Boxmeer
The Netherlands


Vasotop P 0,625 mg; Vasotop P 1,25 mg; Vasotop P 2,5 mg, tablet for dogs


Tablet


0,625; 1,25 or 2,5 mg of ramipril


Dogs


Daily, oral


0,125 mg/kg; 0,25 mg/kg if the animal does not respond after 2 weeks of treatment




The Netherlands


Intervet International B.V.
P.O. Box 31
5830 AA Boxmeer
The Netherlands


Vasotop P 0,625 mg; Vasotop P 1,25 mg; Vasotop P 2,5 mg, tablet for dogs


Tablet


0,625; 1,25 or 2,5 mg of ramipril


Dogs


Daily, oral


0,125 mg/kg; 0,25 mg/kg if the animal does not respond after 2 weeks of treatment




Norway


Intervet International B.V.
P.O. Box 31
5830 AA Boxmeer
The Netherlands


Vasotop P 0,625 mg; Vasotop P 1,25 mg; Vasotop P 2,5 mg, tablet


Tablet


0,625; 1,25 or 2,5 mg of ramipril


Dogs


Daily, oral


0,125 mg/kg; 0,25 mg/kg if the animal does not respond after 2 weeks of treatment




Portugal


Intervet International B.V.
P.O. Box 31
5830 AA Boxmeer
The Netherlands


Vasotop P 0,625 mg; Vasotop P 1,25 mg; Vasotop P 2,5 mg, tablet for dogs


Tablet


0,625; 1,25 or 2,5 mg of ramipril


Dogs


Daily, oral


0,125 mg/kg; 0,25 mg/kg if the animal does not respond after 2 weeks of treatment







ANNEX XVI
LIST OF THE INVENTED NAME, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES (EU/EEA)










Member State EU/EEA


Marketing Authorisation Holder


Invented Name


Strength


Pharmaceutical form


Route of administration




Austria


Abbott GmbH
Perfektastraße 84A
A–1230 Wien
Austria


Reductil 10 mg - Hartkapseln


10 mg


Capsule, hard


oral use




Austria


Abott GmbH
Perfektastraße 84A
A–1230 Wien
Austria


Reductil 15 mg - Hartkapseln


15 mg


Capsule, hard


oral use




Austria


Teva Pharma B.V.
Computerweg 10
3542 DR Utrecht
The Netherlands


Sibutramin Teva 10 mg Kapseln


10 mg


Capsule, hard


oral use




Austria


Teva Pharma B.V.
Computerweg 10
3542 DR Utrecht
The Netherlands


Sibutramin Teva 15 mg Kapseln


15 mg


Capsule, hard


oral use




Belgium


Abbott SA
rue du Bosquet 2
1348 Ottignies/LLN
Belgium


Reductil 10 mg


10 mg


Capsule, hard


oral use




Belgium


Abbott SA
rue du Bosquet 2
1348 Ottignies/LLN
Belgium


Reductil 15 mg


15 mg


Capsule, hard


oral use




Belgium


SandozNV
TelecomGardens
Medialaan 40
1800 Vilvoorde
Belgium


Sibutramin Sandoz 10 mg


10 mg


Capsule, hard


oral use




Belgium


SandozNV
TelecomGardens
Medialaan 40
1800 Vilvoorde
Belgium


Sibutramin Sandoz 15 mg


15 mg


Capsule, hard


oral use




Belgium


Teva pharma belgium
Laarstraat 16
2610 Wilrijk
Belgium


Sibutramin Teva 10 mg


10 mg


Capsule, hard


oral use




Belgium


Teva pharma belgium
Laarstraat 16
2610 Wilrijk
Belgium


Sibutramin Teva 15 mg


15 mg


Capsule, hard


oral use




Bulgaria


Abbott GmbH & Co KG
Max-Planck-Ring 2
65205 Wiesbaden
Germany


Reductil


10 mg


Capsule, hard


oral use




Bulgaria


Abbott GmbH & Co KG
Max-Planck-Ring 2
65205 Wiesbaden
Germany


Reductil


15 mg


Capsule, hard


oral use




Bulgaria


Sandoz d.d., Verovskova 57
SI - 1000 Ljubljana
Slovenia


Sibutramin Sandoz


10 mg


Capsule, hard


oral use




Bulgaria


Sandoz d.d.
Verovskova 57
SI-1000 Ljubljana
Slovenia


Sibutramin Sandoz


15 mg


Capsule, hard


oral use




Bulgaria


Zentiva k.s.
U kabelovny 130
102 37 Prague 10
Czech Republic


Lindaxa


10 mg


Capsule, hard


oral use




Bulgaria


Zentiva k.s.
U kabelovny 130
102 37 Prague 10
Czech Republic


Lindaxa


15 mg


Capsule, hard


oral use




Bulgaria


Teva Pharmaceuticals Bulgaria EOOD
15 N.V. Gogol str.
Sredetz district
1124 Sofia
Bulgaria


Meissa


10 mg


Capsule, hard


oral use




Bulgaria


Teva Pharmaceuticals Bulgaria EOOD
15 N.V. Gogol str.
Sredetz district
1124 Sofia
Bulgaria


Meissa


15 mg


Capsule, hard


oral use




Czech Republic


Abbott GmbH & Co.KG
Max-Planck-Ring-2
65202 Wiesbaden
Germany


MERIDIA 10 MG


10 mg


Capsule, hard


oral use




Czech Republic


Abbott GmbH & Co.KG
Max-Planck-Ring-2
65202 Wiesbaden
Germany


MERIDIA 15 MG


15 mg


Capsule, hard


oral use




Czech Republic


Zentiva, k.s.
U kabelovny 130, 102 37
Prague 10
Czech Republic


LINDAXA 10


10 mg


Capsule, hard


oral use




Czech Republic


Zentiva, k.s.
U kabelovny 130, 102 37
Prague 10
Czech Republic


LINDAXA 15


15 mg


Capsule, hard


oral use




Czech Republic


TEVA Pharmaceuticals ČR, s.r.o.
Radlická 3185/Ic
150 00 Prague 5
Czech Republic


SIBUTRAMIN-TEVA 10 MG TOBOLKY


10 mg


Capsule, hard


oral use




Czech Republic


TEVA Pharmaceuticals ČR, s.r.o.
Radlická 3185/Ic
150 00 Prague 5
Czech Republic


SIBUTRAMIN-TEVA 15 MG TOBOLKY


15 mg


Capsule, hard


oral use




Denmark


Abbott Scandinavia AB
Postboks 509
SE-169 29, Solna
Sweden


Reductil


10 mg


Capsule, hard


oral use




Denmark


Abbott Scandinavia AB
Postboks 509
SE-169 29, Solna
Sweden


Reductil


15 mg


Capsule, hard


oral use




Denmark


1A Farma A/S
Herstedøstervej 27-29
DK–2620 Albertslund
Denmark


Sibutramin ‘1A Farma’


10 mg


Capsule, hard


oral use




Denmark


1A Farma A/S
Herstedøstervej 27-29
DK–2620 Albertslund
Denmark


Sibutramin ‘1A Farma’


15 mg


Capsule, hard


oral use




Denmark


Sandoz A/S
C. F. Tietgens Boulevard 40
DK–5220 Odense SØ
Denmark


Sibutramin ‘Sandoz’


10 mg


Capsule, hard


oral use




Denmark


Sandoz A/S
C. F. Tietgens Boulevard 40
DK–5220 Odense SØ
Denmark


Sibutramin ‘Sandoz’


15 mg


Capsule, hard


oral use




Denmark


Teva Danmark A/S
Østergade 38
DK–1100 København K
Denmark


Sibutramin ‘Teva’


10 mg


Capsule, hard


oral use




Denmark


Teva Danmark A/S
Østergade 38
DK–1100 København K
Denmark


Sibutramin ‘Teva’


15 mg


Capsule, hard


oral use




Estonia


Abbott GmbH & Co. KG
Max-Planck-Ring 2
65205 Wiesbaden
Germany


REDUCTIL


10mg


Capsule, hard


oral use




Estonia


Abbott GmbH & Co. KG
Max-Planck-Ring 2
65205 Wiesbaden
Germany


REDUCTIL


15mg


Capsule, hard


oral use




Estonia


Sandoz d.d.
Verovskova 57
1000 Ljubljana
Slovenia


SIBUTRIL


10mg


Capsule, hard


oral use




Estonia


Sandoz d.d.
Verovskova 57
1000 Ljubljana
Slovenia


SIBUTRIL


15mg


Capsule, hard


oral use




Estonia


Zentiva, k.s.
U Kabelovny 130
Dolni Mecholupy
102 37 Prague 10
Czech Republic


LINDAXA 10


10mg


Capsule, hard


oral use




Estonia


Zentiva, k.s.
U Kabelovny 130
Dolni Mecholupy
102 37 Prague 10
Czech Republic


LINDAXA 15


15mg


Capsule, hard


oral use




Estonia


Teva Pharma B.V.
Computerweg 10
3542 DR Utrecht
The Netherlands


SIBUTRAMINE TEVA


10mg


Capsule, hard


oral use




Estonia


Teva Pharma B.V.
Computerweg 10
3542 DR Utrecht
The Netherlands


SIBUTRAMINE TEVA


15mg


Capsule, hard


oral use




Finland


Abbott ScandinaviaAB
P.O. Box 509
16929 Solna
Sweden


Reductil


10 mg, 15 mg


Capsule, hard


oral use




Finland


Sandoz A/S C.F.
Tietgens Boulevard 40
5220 Odense SØ
Denmark


Sibutramin Sandoz


10 mg, 15 mg


Capsule, hard


oral use




Finland


Teva Sweden AB
Järnvägsgatan 11
Box 1070
25110 Helsingborg
Sweden


Sibutramine Teva


10 mg, 15 mg


Capsule, hard


oral use




France


ABBOT France
10, RUE D'ARCUEIL
SILIC 233
94528 RUNGIS CEDEX
FRANCE


SIBUTRAL 10 mg, gélule


10 mg


capsule


oral use




France


ABBOT France
10, RUE D'ARCUEIL
SILIC 233
94528 RUNGIS CEDEX
FRANCE


SIBUTRAL 15 mg, gélule


15 mg


capsule


oral use




Germany


Abbott GmbH & Co. KG
Max-Planck-Ring 2
65205 Wiesbaden
Germany


Reductil 10 mg Hartkapseln


10 mg


Capsule, hard


oral use




Germany


Abbott GmbH & Co. KG
Max-Planck-Ring 2
65205 Wiesbaden
Germany


Reductil 15 mg Hartkapseln


15 mg


Capsule, hard


oral use




Germany


Abbott GmbH & Co. KG
Max-Planck-Ring 2
65205 Wiesbaden
Germany


Zelium 10 mg Hartkapseln


10 mg


Capsule, hard


oral use




Germany


Abbott GmbH & Co. KG
Max-Planck-Ring 2
65205 Wiesbaden
Germany


Zelium 15 mg Hartkapseln


15 mg


Capsule, hard


oral use




Germany


Abbott GmbH & Co. KG
Max-Planck-Ring 2
65205 Wiesbaden
Germany


Reduxade 10 mg Hartkapseln


10 mg


Capsule, hard


oral use




Germany


Abbott GmbH & Co. KG
Max-Planck-Ring 2
65205 Wiesbaden
Germany


Reduxade 15 mg Hartkapseln


15 mg


Capsule, hard


oral use




Germany


1 A Pharma GmbH
Keltenring 1 + 3
82041 Oberhaching
Germany


Sibutramin - 1A Pharma 10 mg Hartkapseln


10 mg


Capsule, hard


oral use




Germany


1 A Pharma GmbH
Keltenring 1 + 3
82041 Oberhaching
Germany


Sibutramin - 1A Pharma 15 mg Hartkapseln


15 mg


Capsule, hard


oral use




Germany


HEXAL AG
Postfach 1263
83602 Holzkirchen
Germany


Sibutramin-HEXAL 10 mg Hartkapseln


10 mg


Capsule, hard


oral use




Germany


HEXAL AG
Postfach 1263
83602 Holzkirchen
Germany


Sibutramin-HEXAL 15 mg Hartkapseln


15 mg


Capsule, hard


oral use




Greece


Abbott Laboratories (Hellas) S.A.
512, Vouliagmenis Avenue
GR 17456, Alimos
Athens
Greece


Reductil


10 mg


Capsule, hard


oral use




Greece


Abbott Laboratories (Hellas) S.A.
512, Vouliagmenis Avenue
GR 17456, Alimos
Athens
Greece


Reductil


15 mg


Capsule, hard


oral use




Greece


Teva Pharmaceuticals Europe B.V.
European Headquarters
Computerweg 10
3542 DR Utrecht
The Netherlands


Sibutramine/Teva


10mg


Capsule, hard


oral use




Greece


Teva Pharmaceuticals Europe B.V.
European Headquarters
Computerweg 10
3542 DR Utrecht
The Netherlands


Sibutramine/Teva


15 mg


Capsule, hard


oral use




Hungary


Zentiva k. s.
U Kabelovny 130
102 37 Praha 10
Czech Republic


LINDAXA


10mg


Capsule, hard


oral use




Hungary


Zentiva k. s.
U Kabelovny 130
102 37 Praha 10
Czech Republic


LINDAXA


15mg


Capsule, hard


oral use




Hungary


Teva Magyarország zrt.
Rákóczi út 70-72.
1074 Budapest
Hungary


MINIMECTIL


10mg


Capsule, hard


oral use




Hungary


Teva Magyarország zrt.
Rákóczi út 70-72.
1074 Budapest
Hungary


MINIMECTIL


15mg


Capsule, hard


oral use




Hungary


Abbott Laboratories Kft.
Teve u. 1/a-c
1139 Budapest
Hungary


REDUCTIL


10mg


Capsule, hard


oral use




Hungary


Abbott Laboratories Kft.
Teve u. 1/a-c
1139 Budapest
Hungary


REDUCTIL


15mg


Capsule, hard


oral use




Iceland


Abbott Scandinavia
Gårdsvägen 8
Box 5091
SE-169 29 Solna
Sweden


Reductil


10 mg


Capsule, hard


oral use




Iceland


Abbott Scandinavia
Gårdsvägen 8
Box 5091
SE-169 29 Solna
Sweden


Reductil


15 mg


Capsule, hard


oral use




Ireland


Teva Pharma B.V.
Computerweg 10
3542 Dr Utrecht
Netherlands


Sibutramine Teva 10 mg Capsules


10 mg


Capsule, hard


oral use




Ireland


Teva Pharma B.V.
Computerweg 10
3542 Dr Utrecht
Netherlands


Sibutramine Teva 15 mg Capsules


15 mg


Capsule, hard


oral use




Ireland


Abbot Laboratories Ireland Ltd
4051 Kingswood Drive
Citywest Business Campus
Dublin 24
Ireland


Reductil 10 mg capsules, hard


10 mg


Capsule, hard


oral use




Ireland


Abbot Laboratories Ireland Ltd
4051 Kingswood Drive
Citywest Business Campus
Dublin 24
Ireland


Reductil 15 mg capsules, hard


15 mg


Capsule, hard


oral use




Ireland


Rowex Ltd
Bantry
Co.Cork
Ireland


Sitrane 10 mg hard capsules


10 mg


Capsule, hard


oral use




Ireland


Rowex Ltd
Bantry
Co.Cork
Ireland


Sitrane 15 mg hard capsules


15 mg


Capsule, hard


oral use




Italy


ABBOTT srl
Via Pontina Km 52
04010 Campoverde di Aprilia
Italy


REDUXATE


10 mg


capsule


oral use




Italy


ABBOTT srl
Via Pontina Km 52
04010 Campoverde di Aprilia
Italy


REDUXATE


15 mg


capsule


oral use




Italy


ABBOTT srl
Via Pontina Km 52
04010 Campoverde di Aprilia
Italy


ECTIVA


10 mg


capsule


oral use




Italy


ABBOTT srl
Via Pontina Km 52
04010 Campoverde di Aprilia
Italy


ECTIVA


15 mg


capsule


oral use




Italy


ABBOTT srl
Via Pontina Km 52
04010 Campoverde di Aprilia
Italy


REDUCTIL


10 mg


capsule


oral use




Italy


ABBOTT srl
Via Pontina Km 52
04010 Campoverde di Aprilia
Italy


REDUCTIL


15 mg


capsule


oral use




Latvia


Abbott GmbH & Co. KG
Max-Planck-Ring 2
65205 Wiesbaden
Germany


Reductil 15 mg hard capsules


15 mg


Capsule, hard


oral use




Latvia


Abbott GmbH & Co. KG
Max-Planck-Ring 2
65205 Wiesbaden
Germany


Reductil 10 mg hard capsules


10 mg


Capsule, hard


oral use




Latvia


Sandoz d.d.
Verovškova 57
1000 Ljubljana
Slovenia


Sibutril 15 mg capsules, hard


15 mg


Capsule, hard


oral




Latvia


Sandoz d.d.
Verovškova 57
1000 Ljubljana
Slovenia


Sibutril 10 mg capsules, hard


10 mg


Capsule, hard


oral




Lithuania


Abbott GmbH & Co. KG
Max-Planck-Ring 2
65205 Wiesbaden
Germany


Reductil


10 mg


Capsule, hard


oral use




Lithuania


Abbott GmbH & Co. KG
Max-Planck-Ring 2
65205 Wiesbaden
Germany


Reductil


15 mg


Capsule, hard


oral use




Lithuania


Zentiva k. s.
U kabelovny 130
10237 Prague 10 Dolni Mecholupy Czech Republic


Lindaxa


10 mg


Capsule, hard


oral use




Lithuania


Zentiva k. s.
U kabelovny 130
10237 Prague 10 Dolni Mecholupy Czech Republic


Lindaxa


15 mg


Capsule, hard


oral use




Lithuania


Sandoz d.d.
Verovskova 57
1000 Ljubljana
Slovenia


Sibutril


10 mg


Capsule, hard


oral use




Lithuania


Sandoz d.d.
Verovskova 57
1000 Ljubljana
Slovenia


Sibutril


15 mg


Capsule, hard


oral use




Lithuania


Teva Pharma B.V.
Computerweg 10
3542 DR Utrecht
The Netherlands


Sibutramine Teva


10 mg


Capsule, hard


oral use




Lithuania


Teva Pharma B.V.
Computerweg 10
3542 DR Utrecht
The Netherlands


Sibutramine Teva


15 mg


Capsule, hard


oral use




Luxembourg


Abbott Laboratoires 2, rue du Bosquet B- 1348 Ottignies L.L.N.
Belgium


Reductil


10mg


capsule


oral use




Luxembourg


Abbott Laboratoires 2, rue du Bosquet B- 1348 Ottignies L.L.N.
Belgium


Reductil


15mg


capsules


oral use




Malta


Abbott Laboratories Limited Queenborough
Kent
ME11 5EL
United Kingdom


Reductil


10mg


Capsule, hard


oral use




Malta


Abbott Laboratories Limited Queenborough
Kent
ME11 5EL
United Kingdom


Reductil


15mg


Capsule, hard


oral use




Netherlands


Abbott B.V.
Siriusdreef 51
2132 WT, Hoofddorp
Netherlands


Reductil 10 mg, capsules, hard


10 mg


Capsule, hard


oral use




Netherlands


Abbott B.V.
Siriusdreef 51
2132 WT, Hoofddorp
Netherlands


Reductil 15 mg, capsules, hard


15 mg


Capsule, hard


oral use




Netherlands


Sandoz B.V.
Veluwezoom 22
1327 AH, Almere
Netherlands


Sibutramine HCL monohydraat Sandoz 10 mg, harde capsules


10 mg


Capsule, hard


oral use




Netherlands


Sandoz B.V.
Veluwezoom 22
1327 AH, Almere
Netherlands


Sibutramine HCL monohydraat Sandoz 15 mg, harde capsules


15 mg


Capsule, hard


oral use




Netherlands


Medcor Pharmaceuticals B.V. Ketelmeerstraat 142-144
8226 JX, Lelystad
Netherlands


Reductil 15 mg, capsules


15 mg


Capsule, hard


oral use




Netherlands


Medcor Pharmaceuticals B.V. Ketelmeerstraat 142-144
8226 JX, Lelystad
Netherlands


Reductil 10 mg, capsules


10 mg


Capsule, hard


oral use




Netherlands


Pharmachemie B.V.
Swensweg 5
2031 GA, Haarlem
Netherlands


Sibutramine HCL- monohydraat 10 mg PCH, capsules


10 mg


Capsule, hard


oral use




Netherlands


Pharmachemie B.V.
Swensweg 5
2031 GA, Haarlem
Netherlands


Sibutramine HCL- monohydraat 15 mg PCH, capsules


15 mg


Capsule, hard


oral use




Norway


Abbot Scandinavia
AB Box 509
169 29 Solna
Sweden


REDUCTIL


10 mg


Capsule, hard


oral use




Norway


Abbot Scandinavia
AB Box 509
169 29 Solna
Sweden


REDUCTIL


15 mg


Capsule, hard


oral use




Norway


Euromedica NorgeAS
Jerikoveien 28 C
1067 Oslo
Norway


REDUCTIL


10 mg


Capsule, hard


oral use




Norway


Euromedica NorgeAS
Jerikoveien 28 C
1067 Oslo
Norway


REDUCTIL


15 mg


Capsule, hard


oral use




Norway


Sandoz A/
Edvard Thomsens Vej 14
2300 København S
Danmark


SIBUTRAMIN SANDOZ


10 mg


Capsule, hard


oral use




Norway


Sandoz A/
Edvard Thomsens Vej 14
2300 København S
Danmark


SIBUTRAMIN SANDOZ


15 mg


Capsule, hard


oral use




Poland


Teva Pharmaceuticals Polska Sp. z o.o.
53 Emilii Plater St.
00-113 Warsaw
Poland


Afibron


10 mg


Capsule, hard


oral use




Poland


Teva Pharmaceuticals Polska Sp. z o.o.
53 Emilii Plater St.
00-113 Warsaw
Poland


Afibron


15 mg


Capsule, hard


oral use




Poland


Zentiva a.s.
U Kabelovny 130
Dolni Mecholupy
102 37 Praha 10
Czech Republic


Lindaxa 10


10 mg


Capsule, hard


oral use




Poland


Zentiva a.s.
U Kabelovny 130
Dolni Mecholupy
102 37 Praha 10
Czech Republic


Lindaxa 15


15 mg


Capsule, hard


oral use




Poland


Abbott Laboratories Poland Sp. z o. o.
ul. Postępu 18A
02-676 Warsaw
Poland


Meridia 10


10 mg


Capsule, hard


oral use




Poland


Abbott Laboratories Poland Sp. z o. o.
ul. Postępu 18A
02-676 Warsaw
Poland


Meridia 15


15 mg


Capsule, hard


oral use




Poland


Sandoz GmbH
Biochemiestrasse 10
A–6250 Kundl
Austria


Obesan


10 mg


Capsule, hard


oral use




Poland


Sandoz GmbH
Biochemiestrasse 10
A–6250 Kundl
Austria


Obesan


15 mg


Capsule, hard


oral use




Poland


1A Pharma GmbH
Keltenring 1 + 3
82041 Oberhaching


Sibutramine-1A Pharma


10 mg


Capsule, hard


oral use




Poland


1A Pharma GmbH
Keltenring 1 + 3
82041 Oberhaching
Germany


Sibutramine-1A Pharma


15 mg


Capsule, hard


oral use




Poland


Biofarm Sp. z o.o.
Wałbrzyska 13, 60-198
Poznan
Poland


Zelixa


10 mg


Film-coated tablet


oral use




Poland


Biofarm Sp. z o.o.
Wałbrzyska 13, 60-198
Poznan
Poland


Zelixa


15 mg


Film-coated tablet


oral use




Portugal


ABBOTT LABORATORIOS, LDA Estrada Alfragide 67-AlfraparK-Edifício D,
2610-008 AMADORA
Portugal


Zelium


10 mg


Capsule, hard


oral use




Portugal


ABBOTT LABORATORIOS, LDA Estrada Alfragide 67-AlfraparK-Edifício D,
2610-008 AMADORA
Portugal


Zelium


15 mg


Capsule, hard


oral use




Portugal


ABBOTT LABORATORIOS, LDA Estrada Alfragide 67-AlfraparK-Edifício D,
2610-008 AMADORA
Portugal


Reductil


10 mg


Capsule, hard


oral use




Portugal


ABBOTT LABORATORIOS, LDA Estrada Alfragide 67-AlfraparK-Edifício D,
2610-008 AMADORA
Portugal


Reductil


15 mg


Capsule, hard


oral use




Portugal


Teva Pharma –
Produtos Farmacêuticos, Lda.
EmpreendimentoLagoasPark
Edifício 1 - 3
2740-264 Porto Salvo
Portugal


Sibutramina Teva


10 mg


Capsule, hard


oral use




Portugal


Teva Pharma –
Produtos Farmacêuticos, Lda.
EmpreendimentoLagoasPark
Edifício 1 - 3
2740-264 Porto Salvo
Portugal


Sibutramina Teva


15 mg


Capsule, hard


oral use




Portugal


Solufarma - Produtos Farmacêuticos Unipessoal, Lda.
Rua do Tejo, 56 - 9o A Esq
2775-325 Parede
Portugal


Sibutramina Sibulaite


10 mg


Capsule, hard


oral use




Portugal


Solufarma - Produtos Farmacêuticos Unipessoal, Lda
Rua do Tejo, 56 - 9o A Esq
2775-325 Parede
Portugal


Sibutramina Sibulaite


15 mg


Capsule, hard


oral use




Portugal


Solufarma - Produtos Farmacêuticos Unipessoal, Lda
Rua do Tejo, 56 - 9o A Esq
2775-325 Parede
Portugal


Sibutramina Solufarma


10 mg


Capsule, hard


oral use




Portugal


Solufarma - Produtos Farmacêuticos Unipessoal, Lda
Rua do Tejo, 56 - 9o A Esq
2775-325 Parede
Portugal


Sibutramina Solufarma


15 mg


Capsule, hard


oral use




Portugal


Farmoz - Sociedade Técnico Medicinal, S.A.
Rua da Tapada Grande, 2
Abrunheira
2710-089 Sintra
Portugal


Sibutramina Farmoz


10 mg


Capsule, hard


oral use




Portugal


Farmoz - Sociedade Técnico Medicinal, S.A.
Rua da Tapada Grande, 2
Abrunheira
2710-089 Sintra
Portugal


Sibutramina Farmoz


15 mg


Capsule, hard


oral use




Portugal


Pentafarma - Sociedade Técnico-Medicinal, S.A.
Rua da Tapada Grande, no 2 -Abrunheira
2710-089 Sintra
Portugal


Sibutramina Egostar


10 mg


Capsule, hard


oral use




Portugal


Pentafarma - Sociedade Técnico-Medicinal, S.A.
Rua da Tapada Grande, no 2 Abrunheira
2710-089 Sintra
Portugal


Sibutramina Egostar


15 mg


Capsule, hard


oral use




Portugal


Pentafarma - Sociedade Técnico-Medicinal, S.A.
Rua da Tapada Grande, no 2 Abrunheira
2710-089 Sintra
Portugal


Sibutramina Blixie


10 mg


Capsule, hard


oral use




Portugal


Tecnimede - Sociedade Técnico-Medicinal, S.A.
Rua da Tapada Grande, 2
Abrunheira
2710-089 Sintra
Portugal


Sibutramina Blixie


15 mg


Capsule, hard


oral use




Portugal


Tecnimede - Sociedade Técnico-Medicinal, S.A.
Rua da Tapada Grande, 2
Abrunheira
2710-089 Sintra
Portugal


Sibutramina Atrolex


10 mg


Capsule, hard


oral use




Portugal


Tecnimede - Sociedade Técnico-Medicinal, S.A.
Rua da Tapada Grande, 2
Abrunheira
2710-089 Sintra
Portugal


Sibutramina Atrolex


15 mg


Capsule, hard


oral use




Portugal


Tecnimede - Sociedade Técnico-Medicinal, S.A.
Rua da Tapada Grande, 2
Abrunheira
2710-089 Sintra
Portugal


Sibutramina Argam


10 mg


Capsule, hard


oral use




Portugal


Tecnimede - Sociedade Técnico-Medicinal, S.A.
Rua da Tapada Grande, 2
Abrunheira
2710-089 Sintra
Portugal


Sibutramina Argam


15 mg


Capsule, hard


oral use




Portugal


Tecnimede - Sociedade Técnico-Medicinal, S.A.
Rua da Tapada Grande, 2
Abrunheira
2710-089 Sintra
Portugal


Sibutramina Orexinib


10 mg


Capsule, hard


oral use




Portugal


Tecnimede - Sociedade Técnico-Medicinal, S.A.
Rua da Tapada Grande, 2
Abrunheira
2710-089 Sintra
Portugal


Sibutramina Orexinib


15 mg


Capsule, hard


oral use




Portugal


Tecnimede - Sociedade Técnico-Medicinal, S.A.
Rua da Tapada Grande, 2
Abrunheira
2710-089 Sintra
Portugal


Sibutramina Snomas


10 mg


Capsule, hard


oral use




Portugal


Tecnimede - Sociedade Técnico-Medicinal, S.A.
Rua da Tapada Grande, 2
Abrunheira
2710-089 Sintra
Portugal


Sibutramina Snomas


15 mg


Capsule, hard


oral use




Portugal


Tecnimede - Sociedade Técnico-Medicinal, S.A.
Rua da Tapada Grande, 2
Abrunheira
2710-089 Sintra
Portugal


Sibutramina Arpedex


10 mg


Capsule, hard


oral use




Portugal


Tecnimede - Sociedade Técnico-Medicinal, S.A.
Rua da Tapada Grande, 2
Abrunheira
2710-089 Sintra
Portugal


Sibutramina Arpedex


15 mg


Capsule, hard


oral use




Portugal


Tecnimede - Sociedade Técnico-Medicinal, S.A.
Rua da Tapada Grande, 2
Abrunheira
2710-089 Sintra
Portugal


Sibutramina Marcoliz


10 mg


Capsule, hard


oral use




Portugal


Tecnimede - Sociedade Técnico-Medicinal, S.A.
Rua da Tapada Grande, 2
Abrunheira
2710-089 Sintra
Portugal


Sibutramina Marcoliz


15 mg


Capsule, hard


oral use




Portugal


Tecnimede - Sociedade Técnico-Medicinal, S.A.
Rua da Tapada Grande, 2
Abrunheira
2710-089 Sintra
Portugal


Sibutramina Ocram


10 mg


Capsule, hard


oral use




Portugal


Tecnimede - Sociedade Técnico-Medicinal, S.A.
Rua da Tapada Grande, 2
Abrunheira
2710-089 Sintra
Portugal


Sibutramina Ocram


15 mg


Capsule, hard


oral use




Portugal


Verum Pharma - Produtos Farmacêuticos - Unipessoal, Lda
Av. Sidónio Pais, n.o 24,
rés-do-chão esq
São Sebastião da Pedreira
1000 Lisboa
Portugal


Sibutramina Strami


10 mg


Capsule, hard


oral use




Portugal


Verum Pharma - Produtos Farmacêuticos - Unipessoal, Lda
Av. Sidónio Pais, n.o 24,
rés-do-chão esq,
São Sebastião da Pedreira
1000 Lisboa
Portugal


Sibutramina Strami


15 mg


Capsule, hard


oral use




Portugal


Tecnimede - Sociedade Técnico-Medicinal, S.A.
Rua da Tapada Grande, 2
Abrunheira
2710-089 Sintra
Portugal


Sibutramina Fililex


10 mg


Capsule, hard


oral use




Portugal


Tecnimede - Sociedade Técnico-Medicinal, S.A.
Rua da Tapada Grande, 2
Abrunheira
2710-089 Sintra
Portugal


Sibutramina Fililex


15 mg


Capsule, hard


oral use




Portugal


Tecnimede - Sociedade Técnico-Medicinal, S.A.
Rua da Tapada Grande, 2
Abrunheira
2710-089 Sintra
Portugal


Sibutramina West Pharma


10 mg


Capsule, hard


oral use




Portugal


Tecnimede - Sociedade Técnico-Medicinal, S.A.
Rua da Tapada Grande, 2
Abrunheira
2710-089 Sintra
Portugal


Sibutramina West Pharma


15 mg


Capsule, hard


oral use




Portugal


Generis Farmacêutica, S.A.
Office Park da Beloura,
Edifício 4,
Quinta da Beloura
2710-444 Sintra
Portugal


Sibutramina Generis


8,37 mg


Capsule, hard


oral use




Portugal


Generis Farmacêutica, S.A.
Office Park da Beloura,
Edifício 4,
Quinta da Beloura
2710-444 Sintra
Portugal


Sibutramina Generis


12 556 mg


Capsule, hard


oral use




Portugal


Sandoz Farmacêutica, Lda.
Alameda da Beloura,
Edifício 1, 2o - Escritório 15
2710-693 Sintra
Portugal


Sibutramina Sandoz


10 mg


Capsule, hard


oral use




Portugal


Sandoz Farmacêutica, Lda.
Alameda da Beloura, Edifício 1, 2o - Escritório 15
2710-693 Sintra
Portugal


Sibutramina Sandoz


15 mg


Capsule, hard


oral use




Romania


Abbott GmbH & Co.KG
Max-Planck-Ring 2
65205 Wiesbaden
Germany


REDUCTIL 10 mg, capsule


10 mg


Capsule, hard


oral use




Romania


Abbott GmbH & Co.KG
Max-Planck-Ring 2
65205 Wiesbaden
Germany


REDUCTIL 15 mg, capsule


15 mg


Capsule, hard


oral use




Romania


SANDOZ S.R.L. ROMÂNIA
Str. Livezeni nr. 7A,
Târgu Mureş,
Romania


MINIMACIN 10 mg, capsule


10 mg


Capsule, hard


oral use




Romania


SANDOZ S.R.L. ROMÂNIA
Str. Livezeni nr. 7A,
Târgu Mureş,
Romania


MINIMACIN 15 mg, capsule


15 mg


Capsule, hard


oral use




Romania


S.C. TERAPIA S.A.
Str. Fabricii, nr. 124,
Cluj-Napoca,
Romania


SILUTON 10 mg, capsule


10 mg


Capsule, hard


oral use




Romania


S.C. TERAPIA S.A.
Str. Fabricii, nr. 124,
Cluj-Napoca,
Romania


SILUTON 15 mg, capsule


15 mg


Capsule, hard


oral use




Romania


TEVA PHARMACEUTICALS S.R.L.
Str. Domniţa Ruxandra nr 12, parter,
Sector 2, Bucureşti
Romania


SIBUTRAMINĂ TEVA 10 mg, capsule


10 mg


Capsule, hard


oral use




Romania


TEVA PHARMACEUTICALS S.R.L.
Str. Domniţa Ruxandra nr 12, parter,
Sector 2, Bucureşti
Romania


SIBUTRAMINĂ TEVA 15 mg, capsule


15 mg


Capsule, hard


oral use




Romania


ZENTIVA a.s.,
U kabelovny 130,
102 37 Praga-10 Dolní Měcholupy, Czech Republic


LINDAXA 10 mg, capsule


10 mg


Capsule, hard


oral use




Romania


ZENTIVA a.s.,
U kabelovny 130,
102 37 Praga-10 Dolní Měcholupy
Czech Republic


LINDAXA 15 mg, capsule


15 mg


Capsule, hard


oral use




Slovakia


Zentiva, k.s.
Evropská 846/176a
160 00 Praha 6
Czech Republic


LINDAXA 10


10 mg


Capsule, hard


oral use




Slovakia


Zentiva, k.s. Evropská 846/176a
160 00 Praha 6
Czech Republic


LINDAXA 15


15 mg


Capsule, hard


oral use




Slovakia


TEVA Pharmaceuticals Slovakia s.r.o. Teslova 26, 821 02, Bratislava
Slovak Republic


Sibutramin - Teva 10 mg kapsuly


10 mg


Capsule, hard


oral use




Slovakia


TEVA Pharmaceuticals Slovakia s.r.o. Teslova 26, 821 02
Bratislava
Slovak Republic


Sibutramin - Teva 15 mg kapsuly


15 mg


Capsule, hard


oral use




Slovakia


Abbott Laboratories Slovakia s.r.o.
Karadžicova 10
821 08 Bratislava
Slovak Republic


Reductil 10 mg


10 mg


capsule


oral use




Slovakia


Abbott Laboratories Slovakia s.r.o.
Karadžicova 10
821 08 Bratislava
Slovak Republic


Reductil 15 mg


15 mg


capsule


oral use




Slovenia


Abbott Laboratories d.o.o.
Dolenjska c. 242c
SI–1000 Ljubljana
Slovenia


Reductil 10 mg trde kapsule


10 mg


Capsule, hard


oral use




Slovenia


Abbott Laboratories d.o.o.
Dolenjska c. 242c
SI–1000 Ljubljana
Slovenia


Reductil 15 mg trde kapsule


15 mg


Capsule, hard


oral use




Slovenia


Lek farmacevtska družba d.d., Verovškova c. 57
SI–1000 Ljubljana
Slovenia


Sibutramin Lek 10 mg trde kapsule


10 mg


Capsule, hard


oral use




Slovenia


Lek farmacevtska družba d.d., Verovškova c. 57
SI–1000 Ljubljana
Slovenia


Sibutramin Lek 15 mg trde kapsule


15 mg


Capsule, hard


oral use




Spain


ABBOTT LABORATORIES, S.A.
Avda. de Burgos
28050 Madrid
Spain


REDUCTIL


10mg


Capsule, hard


oral use




Spain


ABBOTT LABORATORIES, S.A.
Avda. de Burgos
28050 Madrid
Spain


REDUCTIL


15 mg


Capsule, hard


oral use




Spain


TEVA GENERICOS ESPAÑOLA, S.L.
Guzmán el Bueno 133
Edificio Britania 4oIzq.
28003 MADRID
Spain


SIBUTRAMINA TEVA


10mg


Capsule, hard


oral use




Spain


TEVA GENERICOS ESPAÑOLA, S.L.
Guzmán el Bueno 133
Edificio Britania 4oIzq.
28003 MADRID
Spain


SIBUTRAMINA TEVA


15 mg


Capsule, hard


oral use




Spain


IDIFARMA, DESARROLLO FARMACEUTICO
Polígono Mocholí. Plaza CEIN 5, Nave B-14Noain (Navarra)
Spain


SIBUTRAMINA IDIFARMA


10 mg


Capsule, hard


oral use




Spain


IDIFARMA, DESARROLLO FARMACEUTICO.
Polígono Mocholí. Plaza CEIN 5, Nave B-14Noain (Navarra)
Spain


SIBUTRAMINA IDIFARMA


15 mg


Capsule, hard


oral use




Sweden


Abbott ScandinaviaAB
Box 509169 29 Solna
Sweden


Reductil


10 mg


Capsule, hard


oral use




Sweden


Abbott ScandinaviaAB
Box 509169 29 Solna
Sweden


Reductil


15 mg


Capsule, hard


oral use




Sweden


Sandoz A/S, C.F.
Tietgens Boulevard 40
DK–5220 Odense SØ
Danmark


Sibutramin Sandoz


10 mg


Capsule, hard


oral use




Sweden


Sandoz A/S, C.F.
Tietgens Boulevard 40
DK–5220 Odense SØ
Danmark


Sibutramin Sandoz


15 mg


Capsule, hard


oral use




Sweden


Teva Sweden AB
Box 1070
251 10 Helsingborg
Sweden


Sibutramine Teva


10 mg


Capsule, hard


Oral use




Sweden


Teva Sweden AB
Box 1070
251 10 Helsingborg
Sweden


Sibutramine Teva


15 mg


Capsule, hard


Oral use




United Kingdom


Abbott Laboratories Limited
Queenborough
Kent ME11 5EL
United Kingdom


Reductil 10mg


10mg


Capsule, hard


oral use




United Kingdom


Abbott Laboratories Limited
Queenborough
Kent ME11 5EL
United Kingdom


Reductil 15mg


15mg


Capsule, hard


oral use




United Kingdom


Teva UK Limited
Brampton Road
HampdenPark
Eastbourne, East Sussex BN22 9AG
United Kingdom


Sibutramine Hydrochloride 15mg Capsules


10mg


Capsule, hard


oral use




United Kingdom


Teva UK Limited
Brampton Road
HampdenPark
Eastbourne, East Sussex BN22 9AG
United Kingdom


Sibutramine Hydrochloride 15mg Capsules


15mg


Capsule, hard


oral use







ANNEX XVII
LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATIONS AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES










Member State


Marketing Authorisation Holder


Product Name


Strength/dextropropoxyphene/paracetamol/caffeine


Pharmaceutical Form


Route of Administration




Greece


Stargen Ltd
Favierou 48
Athens 10438
Greece


Romidon


75mg/2ml


Solution for injection


Intramuscular, intravenous use




Greece


Norma Hellas S.A.
Menandrou 54
Athens 10431
Greece


Zideron


75mg/2ml


Solution for injection


Intramuscular, intravenous use







ANNEX XVIII
LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATIONS AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES










Member State


Marketing Authorisation Holder


Invented Name


Strength/dextropropoxyphene/paracetamol/caffeine


Pharmaceutical Form


Route of Administration




Belgium


Laboratories SMB s.a.
26-28 Rue de la Pastorale
B–1080 Bruxelles
Belgium


Algophene smb


30 mg/400 mg


Capsule, hard


Oral use




Cyprus


Remedica LTD
PO Box 51706
3508 Lemesos
Cyprus


Destirol


32,5 mg/325 mg


Tablet


Oral use




Cyprus


Interpak LTD
PO Box 51166
3502 Lemesos
Cyprus


Dologesic


32,5 mg/325 mg


Tablet


Oral use




Cyprus


Medochemie LTD
MedochemieBuilding
1-10 Constantinoupoleos Str.,
3011 Limassol,
Cyprus


Medonol


32,5 mg/325 mg


Tablet


Oral use




Cyprus


Phadisco LTD
PO Box 22173
1518 Lefkosia
Cyprus


Distalgesic


32,5 mg/325 mg


Tablet


Oral use




France


Arrow Generiques
26, avenue Tony Garnier
69007 Lyon
France


Dextropropoxyphene Paracetamol almus


30 mg/400 mg


Capsule, hard


Oral use




France


Arrow Generiques
26, avenue Tony Garnier
69007 Lyon
France


Dextropropoxyphene Paracetamol arrow


30 mg/400 mg


Capsule, hard


Oral use




France


Sanofi-aventis France
1-13 Bd Romain Rolland
75014 Paris
France


Dextropropoxyphene Paracetamol Biogalenique


30 mg/400 mg


Capsule, hard


Oral use




France


Sanofi- aventis France
1-13, boulevard Romain Rolland
75014 Paris
France


Di-antalvic


30 mg/400 mg


Suppository


Rectal use




France


Biogaran
15, boulevard Charles de Gaulle
92700 Colombes
France


Dextropropoxyphene Paracetamol biogaran


30 mg/400 mg


Capsule, hard


Oral use




France


Bouchara Recordati
68, rue Marjolin,
BP 67 92302 Levallois-Perret Cedex
France


Dioalgo


30 mg/400 mg


Capsule, hard


Oral use




France


Chemical Farma
3 quai Louis Blériot
75016 PARIS
France


Dextroref


30 mg/400 mg


Capsule, hard


Oral use




France


Dci Pharma
180, rue Eugène Avinée
59120 Loos
France


Dextropropoxyphene Paracetamol dci Pharma


30 mg/400 mg


Capsule, hard


Oral use




France


EG Labo - Laboratoires EuroGenerics
‘Le Quintet’ bâtiment A
12, rue Danjou
92517 Boulogne Billancourt Cedex
France


Dextropropoxyphene Paracetamol eg


30 mg/400 mg


Capsule, hard


Oral use




France


Expanpharm International
6, rue de la Rochefoucauld
16000 Angoulême
France


Dextropropoxyphene Paracetamol Expanpharm


30 mg/400 mg


Capsule, hard


Oral use




France


Substipharm
8 Rue Bellini
75116 Paris
France


Dextropropoxyphene Paracetamol hexal


30 mg/400 mg


Capsule, hard


Oral use




France


Teva Santé
Le Palatin 1
1, cours du Triangle
92936 Paris La Défense Cedex
France


Dextropropoxyphene Paracetamol ivax


30 mg/400 mg


Capsule, hard


Oral use




France


Labo Concept Pharm
26, boulevard Paul Vaillant Couturier
94200 Ivry Sur Seine
France


Dextropropoxyphene Paracetamol isomed


30 mg/400 mg


Capsule, hard


Oral use




France


Qualimed
117 Allée des Parcs
69800 Saint Priest
France


Dextropropoxyphene Paracetamol qualimed


30 mg/400 mg


Capsule, hard


Oral use




France


Ranbaxy Pharmacie Generiques
11-15 Quai de Dion Bouton
92800 Puteaux
France


Dextropropoxyphene Paracetamol rpg


30 mg/400 mg


Capsule, hard


Oral use




France


Laboratoires Alter
3, avenue de la Baltique
ZI de Courtaboeuf
91140 Villebon Sur Yvette
France


Dextropropoxyphene Paracetamol alter


30 mg/400 mg


Capsule, hard


Oral use




France


Sanofi-aventis France
1-13, boulevard Romain Rolland
75014 Paris
France


Di-antalvic


30 mg/400 mg


Capsule, hard


Oral use




France


Laboratoires Therabel Lucien Pharma
19 Rue Alphone de Neuville
75017 Paris
France


Di dolko


30 mg/400 mg


Capsule, hard


Oral use




France


Leurquin Mediolanum
68-88, rue Louis Ampère
93330 Neuilly-sur-Marne
France


Talvidol


30 mg/400 mg


Capsule, hard


Oral use




France


Mylan SAS
117 Allée des Parcs
69800 Saint Priest
France


Dextropropoxyphene Paracetamol Mylan


30 mg/400 mg


Capsule, hard


Oral use




France


Ratiopharm GmbH
Graf Arco Strasse 3 89079 Ulm
Germany


Dextropropoxyphene Paracetamol Ratiopharm


30 mg/400 mg


Capsule, hard


Oral use




France


Sandoz
49, avenue Georges Pompidou
92300 Levallois-Perret
France


Dextropropoxyphene Paracetamol G Gam


30 mg/400 mg


Capsule, hard


Oral use




France


Sandoz
49, avenue Georges Pompidou
92300 Levallois-Perret
France


Dextropropoxyphene Paracetamol Sandoz


30 mg/400 mg


Capsule, hard


Oral use




France


Teva Santé
Le Palatin 1
1, cours du Triangle
92936 Paris la Défense Cedex
France


Dextropropoxyphene Paracetamol Teva


30 mg/400 mg


Capsule, hard


Oral use




France


Sodephar
176, rue de l'Arbrisseau
59000 Lille
France


Dextropropoxyphene Paracetamol Sodephar


30 mg/400 mg


Capsule, hard


Oral use




France


Actavis France
Centre d'Affaires la Boursidière
92357 le Plessis-Robinson
France


Dextropropoxyphene Paracetamol Actavis


30 mg/400 mg


Capsule, hard


Oral use




France


Actavis France
Centre d'Affaires la Boursidière
92357 le Plessis-Robinson
France


Dexap


30 mg/400 mg


Capsule, hard


Oral use




France


Sanofi-aventis France
1-13 Bd Romain Rolland
75014 Paris
France


Dialgirex


30 mg/400 mg


Capsule, hard


Oral use




France


Sanofi-aventis France
1-13 Bd Romain Rolland
75014 Paris
France


Dextropropoxyphene/Paracetamol Theraplix


30 mg/400 mg


Capsule, hard


Oral use




France


Zydus France
25, rue des Peupliers
ZAC Les Hautes Pâtures
Parc d'Activités des Peupliers
92000 Nanterre
France


Dextropropoxyphene Paracetamol Zydus


30 mg/400 mg


Capsule, hard


Oral use




France


Alter
3, avenue de la Baltique
91140 Villebon Sur Yvette
France


Dextropropoxyphene/Paracetamol/Cafeine Alter


27 mg/400 mg/30 mg


Tablet


Oral use




France


Arrow Generiques
26, avenue Tony Garnier
69007 Lyon
France


Dextropropoxyphene/Paracetamol/Cafeine Almus


27 mg/400 mg/30 mg


Tablet


Oral use




France


Arrow Generiques
26, avenue Tony Garnier
69007 Lyon
France


Dextropropoxyphene/Paracetamol/Cafeine Arrow


27 mg/400 mg/30 mg


Tablet


Oral use




France


Arrow Generiques
26, avenue Tony Garnier
69007 Lyon
France


Dextropropoxyphene/Paracetamol/Cafeine Offilink


27 mg/400 mg/30 mg


Tablet


Oral use




France


Plus Pharmacie
26, boulevard Paul Vaillant-Couturier
94200 Ivry-sur-Seine
France


Dextropropoxyphene / Paracetamol / Cafeine Isomed


27 mg/400 mg/30 mg


Tablet


Oral use




France


Biogaran
15, boulevard Charles de Gaulle
92700 Colombes
France


Dextropropoxyphene/Paracetamol/Cafeine Biogaran


27 mg/400 mg/30 mg


Tablet


Oral use




France


Eg Labo - Laboratoires EUROGENERICS
‘Le Quintet’ - bâtiment A
92517 Boulogne Billancourt Cedex
France


Dextropropoxyphene/Paracetamol/Cafeine Eg


27 mg/400 mg/30 mg


Tablet


Oral use




France


Ranbaxy Pharmacie Generiques
1115 Quai de Dion Bouton
Immeuble Avant Seine
92816 Puteaux Cédex
France


Dextropropoxyphene/Paracetamol/Cafeine Rpg


27 mg/400 mg/30 mg


Tablet


Oral use




France


Mylan SAS
117 Allée des Parcs
69800 Saint Priest
France


Dextropropoxyphene/Paracetamol/Cafeine Mylan


27 mg/400 mg/30 mg


Tablet


Oral use




France


Mylan SAS
117 Allée des Parcs
69800 Saint Priest
France


Dextropropoxyphene/Paracetamol/Cafeine Mylan Pharma


27 mg/400 mg/30 mg


Tablet


Oral use




France


Qualimed (Lyon)
117 Allée des Parcs
69800 Saint Priest
France


Dextropropoxyphene/Paracetamol/Cafeine Qualimed


27 mg/400 mg/30 mg


Tablet


Oral use




France


Laboratoire Ratiopharm
19, boulevard Paul Vaillant Couturier
94200 Ivry sur Seine
France


Dextropropoxyphene/Paracetamol/Cafeine Ratiopharm


27 mg/400 mg/30 mg


Tablet


Oral use




France


Sandoz
49, avenue Georges Pompidou
92593 Levallois-Perret
France


Dextropropoxyphene/Paracetamol/Cafeine G Gam


27 mg/400 mg/30 mg


Tablet


Oral use




France


Sandoz
49, avenue Georges Pompidou
92300 Levallois-Perret
France


Dextropropoxyphene/Paracetamol/Cafeine Sandoz


27 mg/400 mg/30 mg


Tablet


Oral use




France


TEVA Santé
Le Palatin 1
1, cours du Triangle
92936 Paris la Défense Cedex
France


Dextropropoxyphene/Paracetamol/Cafeine Teva


27 mg/400 mg/30 mg


Tablet


Oral use




France


Zydus France
25, rue des Peupliers
ZAC Les Hautes Pâtures
Parc d'Activités des Peupliers
92000 Nanterre
France


Dextropropoxyphene/Paracetamol/Cafeine Zydus


27 mg/400 mg/30 mg


Tablet


Oral use




France


Sanofi-aventis France
1-13 Bd Romain Rolland
75014 Paris
France


Propofan


27 mg/400 mg/30 mg


Tablet


Oral use




France


Sanofi-aventis France
1-13 Bd Romain Rolland
75014 Paris
France


Dextropropoxyphene/Paracetamol/Cafeine Winthrop


27 mg/400 mg/30 mg


Tablet


Oral use




Luxembourg


S.M.B
26-28 rue de la Pastorale
B–1080 Bruxelles
Belgium


Algophene


30 mg/400 mg


Capsule


Oral use




Malta


Medochemie LTD
MedochemieBuilding
1-10 Constantinoupoleos Str.,
3011 Limassol,
Cyprus


Medonol


32,5 mg/325 mg


Tablet


Oral use




Malta


Phadisco Ltd
185 Giannou Kranidioti Avenue
CY–2235
Latsia
Cyprus


Distalgesic


32,5 mg/325 mg


Tablet


Oral use




Norway


Actavis group hf
Dalshraun 1
220 Hafnafjordur
Iceland


Aporex


70 mg/400 mg


Tablet


Oral use




Portugal


Ferraz Lynce S.A
Rua Consiglieri Pedroso
123 Queluz de Baixo Apartado 1001
2731901 Barcarena
Portugal


Algifene


25 mg/300 mg


Coated tablet


Oral use

















Member State


Marketing Authorisation Holder


Product Name


Strength/dextropropoxyphene/paracetamol/caffeine


Pharmaceutical Form


Route of Administration




Belgium


Pfizer s-a.
Boulevard de la Plaine 111050 Bruxelles
Belgium


Depronal


150 mg


Prolonged-release capsule, hard


Oral use




Denmark


Dansk Lægemiddelforsyning DLF ApS, Lodshusvej 11, DK–4230 Skælskør
Denmark


Abalgin


65 mg


Capsule, hard


Oral use




Denmark


Dansk Lægemiddelforsyning DLF ApS, Lodshusvej 11, DK–4230 Skælskør
Denmark


Abalgin


65 mg


Film-coated tablet


Oral use




Denmark


Dansk Lægemiddelforsyning DLF ApS, Lodshusvej 11, DK–4230 Skælskør
Denmark


Abalgin retard


150 mg


Prolonged-release capsule


Oral use




Denmark


NordMedica A/S, Bredgade 41, DK–1260 Copenhagen K
Denmark


Doloxene


100 mg


Capsule, hard


Oral use




Finland


Alternova A/S, Lodshusvej 11
4230 Skaelskoer
Denmark


Abalgin


65 mg


Capsule, hard


Oral use




Finland


Alternova A/S, Lodshusvej 11
4230 Skaelskoer
Denmark


Abalgin retard


150 mg


Prolonged-release capsule, hard


Oral use




France


Sanofi Aventis France
1-13 boulevard Romain Rolland
75014 Paris
France


Antalvic adultes


65mg


Tablet


Oral use




Greece


Stargen Ltd
Favierou 48
Athens 10439
Greece


Romidon


65 mg


Capsule, hard


Oral use




Luxembourg


PFIZER s-a.
Boulevard de la Plaine 11
1050 Bruxelles
Belgium


Depronal


150 mg


Prolonged-release capsule


Oral use




Netherlands


Pfizer B.V.
Rivium Westlaan 142
2909 LD Capelle a/d Ijssel
Nederlands


Depronal


150 mg


Modified release capsule


Oral use




Spain


Parke Davis, S.L. Avda. de Europa, 20 B. Parque Empresarial La Moraleja; Alcobendas;
28108 Madrid
España


Deprancol a.s.


150 mg


Prolonged-release capsule, hard


Oral use




Sweden


Meda AB, Box 906
170 09 Solna
Sweden


Doloxene


50 mg


Capsule, hard


Oral use




Sweden


Meda AB, Box 906
170 09 Solna
Sweden


Doloxene


100 mg


Capsule, hard


Oral use




Sweden


BioPhausiaAB, Blasieholmsgatan 2111 48 Stockholm
Sweden


Dexofen


50 mg


Tablet


Oral use




Sweden


BioPhausiaAB, Blasieholmsgatan 2111 48 Stockholm
Sweden


Dexofen


100 mg


Tablet


Oral use







ANNEX XIX
LIST OF THE INVENTED NAMES, PHARMACEUTICAL FORMS, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES (EEA)










Member State (EEA)


Marketing Authorisation Holder


Invented Name


Strength


Pharmaceutical Form


Route of administration




CY - Cyprus


Les Laboratoires Servier
22, rue Garnier
F- 92200 Neuilly-sur-Seine
France


Lipophoral Tablets 150mg


150 mg


tablet


oral




FR - France


Les laboratoires Servier
22 rue Garnier
F-92200 Neuilly-sur-Seine
France


Mediator


150 mg


tablet


oral




FR - France


Mylan SAS
117 allée des Parcs
69800 Saint-Priest
France


Benfluorex Mylan


150 mg


tablet


oral




FR - France


Qualimed
117 allée des Parcs
69800 Saint-Priest
France


Benfluorex Qualimed


150 mg


tablet


oral




LU - Luxembourg


Les Laboratoires Servier
22, rue Garnier
F- 92200 Neuilly-sur-Seine
France


Mediator


150 mg


tablet


oral




PT - Portugal


Servier Portugal - Especialidades Farmacêuticas, Lda.
Av. António Augusto de Aguiar 128, 1069-133 Lisboa
Portugal


Mediator


150 mg


coated tablet


oral