natgillin/translations-raw huggingface dataset:
In a rat carcinogenicity study at dosages corresponding to 0.2 and 1.3 times the clinical exposure (based on AUC), the incidence of benign liver nodules and liver carcinomas was significantly increased in high dose males, and the incidence of liver carcinomas increased also in the low dose males, but this increase was not statistically significant.
Vid en studie av karcinogenicitet på råttor vid doser som motsvarande 0, 2 respektive 1, 3 gånger den kliniska dosen (utgående från AUC), var förekomsten av godartade levernoduli och leverkarcinom signifikant ökad hos hanråttor med den högre dosen, och förekomsten av leverkarcinom var ökad även hos hanråttor som fick den lägre dosen; men ökningen i denna grupp var dock inte statistiskt säkerställd.
Liver tumours induced by gemfibrozil and other fibrates in small rodents are generally considered to be related to the extensive proliferation of peroxisomes in these species and, consequently, of minor clinical relevance.
Levertumörer som induceras av gemfibrozil och andra fibrater hos smågnagare anses allmänt ha ett samband med den höga bildningen av peroxisomer hos dessa arter, varför den kliniska relevansen är begränsad.
In the male rat, gemfibrozil also induced benign Leydig cell tumors.
Hos hanråttor inducerade gemfibrozil också godartade tumörer i Leydig- cellerna.
The clinical relevance of this finding is minimal.
Den kliniska relevansen av detta är minimal.
In reproductive toxicity studies, administration of gemfibrozil at approximately 2 times the human dose (based on body surface area) to male rats for 10 weeks resulted in decreased fertility.
I reproduktionstoxikologiska studier gav en tillförsel av gemfibrozil till hanråttor under 10 veckor med omkring 2 gånger dosen till människa (utgående från kroppsarea) upphov till sänkt fertilitet.
Fertility was restored after a drug-free period of 8 weeks.
Fertiliteten hade återgått till normal nivå 8 veckor efter utsättning av läkemedlet.
Gemfibrozil was not teratogenic in either rats or rabbits.
Gemfibrozil var inte teratogent hos råttor eller kaniner.
Administration of 1 and 3 times the human dose (based on body surface area) of gemfibrozil to female rabbits during organogenesis caused a dose-related decrease in litter size.
Tillförsel av gemfibrozil med 1 respektive 3 gånger dosen till människa (utgående från kroppsarea) till kaninhonor under organogenesen gav upphov till en dosrelaterad minskning av kullstorleken.
Administration of 0.6 and 2 times the human dose (based on body surface area) of gemfibrozil to female rats from gestation Day 15 through weaning caused dose-related decreases in birth weight and suppression of pup growth during lactation.
Tillförsel av gemfibrozil med 0, 6 respektive 2 gånger dosen till människa (utgående från kroppsyta) till råtthonor från dräktighetsdag 15 fram till avvänjning, gav en dosrelaterad minskning av födelsevikten och en försämrad tillväxt hos ungarna under digivningsperioden.
Maternal toxicity was observed in both species and the clinical relevance of decreases in rabbit litter size and rat pup weight is uncertain.
Toxiska effekter på honorna observerades hos båda arterna, och den kliniska relevansen av minskad kullstorlek hos kaniner respektive minskad vikt hos råttungar är oklar.
[To be implemented nationally]
[Implementeras nationellt]
Not all pack sizes may be marketed [To be implemented nationally]
6. 5 Förpackningstyp och innehåll
CHMP/ 1268/ 04 6.6 Instructions for use and handling
6. 6 Anvisningar för användning och hantering samt destruktion
22/ 22
22 [Implementeras nationellt]
DATE OF FIRST AUTHORIZATION/ RENEWAL OF AUTHORIZATION
9 - DATUM FÖR FÖRSTA GODKÄNANDE/ FÖRNYAT GODKÄNNANDE
LIST OF THE INVENTED NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS/ MARKETING AUTHORISATION HOLDERS, PACKAGING AND PACKAGE SIZES IN THE MEMBER STATES
LÄKEMEDLENS NAMN, INNEHAVARE AV GODKÄNNANDE FÖR FÖRSÄLJNING, STYRKOR, LÄKEMEDELSFORM, ADMINISTRERINGSSÄTT, FÖRPACKNINGAR OCH FÖRPACKNINGSSTORLEKAR I MEDLEMSSTATERNA
PLEASE NOTE THAT APPLICANTS ARE NOT INCLUDED IN THIS ANNEX FOR CONFIDENTIALITY REASONS
MÄRK ATT SÖKANDEN INTE ÄR INKLUDERADE I DENNA BILAGA AV KONFIDENTIELLA SKÄL
1/ 61
1/ 55
 EMEA 2004
Medlemsstat
Strength
Innehavare
Pharmaceutical
av godkännande för försäljning
Route of
Namn
Package
Läkemedelsfor m
State
Administrerings - sätt
Form
Förpackning
Clarityn 10 mg - lösliche Tabletten
Clarityn
Clarityn 10 mg - Lyotabletten
Clarityn 10 mg
Oral lyophilisate
Frystorkad
Clarityn 10 mg Tabletten
Clarityn 10 mg
Loratyn 10 mg - Brausetablette n
10 mg
Effervescent tablet
Aesca chem. pharm.
Oral use
Frystorkad
Tablet container
Oral användning
10
10, 30
2/ 61
2/ 55
Fabrik GmbH., Badner Straße 23, A-2514 Traiskirchen, Austria
Arcana Arzneimittel GmbH.,
Loratyn 10 mg - Lyotabletten
Loratadin
Oral lyophilisate
Filmdragerad
10, 30
5, 7, 10, 14, 15,
Arcana Arzneimittel GmbH., Zimbagasse 5, A-1147 Wien Austria
Zimbagasse 5, A- 1147 Wien Österrike
Blister
tablett
5, 7, 10, 14, 15, 20, 21, 30, 50, 100
20, 21, 30, 50, 100
Lannacher Heilmittelwerke GmbH, Schloßplatz 1, A-8502 Lannach Austria
Lannacher Heilmittelwerke GmbH,
Gran Via Carlos III, 98 ES-08028 Barcelona Spain
Gran Via Carlos III,
Chemotadin 10 mg - Tabletten
Chemotadin 10
Lindopharm GmbH., Neustraße 82, D-40721 Hilden Germany
Lindopharm GmbH.,
Loratadin Lindopharm 10 mg Tabletten
Loratadin
Ratiopharm Arzneimittel Vertriebs- GmbH, Alöbert Schweitzer Gasse 3, A-1147 Wien Austria
Neustraße 82, D- 40721 Hilden Tyskland
Sandoz GmbH., A-6250 Kundl/ Tirol Austria
Sandoz GmbH.,
Lictyn 10 mg - Tabletten
Lictyn 10 mg -
7, 10, 14, 20, 21, 30, 50, 60, 100, 250
7, 10, 14, 20,
Marketing Authorisation Holder
A- 6250 Kundl/ Tirol Österrike
Packaging
Tabletten
administration
21, 30, 50, 60, 100, 250
Loratadine “ Stada” 10 mg Tabletten
Loratadine
1, 5, 7, 10, 14, 15, 20, 21, 30, 50, 60, 90, 100, 250
15, 20, 21, 30, 50, 60, 90, 100, 250
Venecoweg 26 B-9810 Nazareth Belgium
Venecoweg 26 B- 9810 Nazareth Belgien
5, 7, 10, 14, 15, 20, 21, 30, 50, 100
5, 7, 10, 14, 15,
Marketing Authorisation Holder
Brusselsesteenweg 288 B- 3090 Overijse Belgien
Strength
loratadine
Route of
tablett
Packaging
(PVC/ Alu)
administration
20, 21, 30, 50, 100
7, 21 1, 2, 5, 7, 10, 14, 20, 21, 28, 30, 42, 50, 56, 100, 500 - for export
1, 2, 5, 7, 10, 14, 20, 21, 28, 30, 42, 50, 56, 100, 500 - För export
Effervescent tablet
Brustablett
10, 21 10, 14, 15, 21, 30 - for export
10, 14, 15, 21, 30 - För export
100 ml 50, 60, 100, 120, 150 ml – for export
50, 60, 100, 120, 150 ml – För export
Oral Lyophilisate
Frystorkad
A/ S GEA Farmaceutiske Fabrik, Holger Danskes Vej 89, DK-2000 Frederiksberg, Denmark
A/ S GEA Farmaceutiske Fabrik, Holger Danskes Vej 89, DK- 2000 Frederiksberg, Danmark
42a D-13407 Berlin Germany
42a D- 13407 Berlin Tyskland
marketed at the moment
marknadsförda för tillfället
Durascan Medicinal Products A/ S Svendborgvej 243, DK-5260 Odense S, Denmark
Durascan Medicinal Products A/ S Svendborgvej 243, DK- 5260 Odense S, Danmark
Not marketed at the moment
marknadsförda för tillfället
Lichtenstein Pharmazeutica GmbH Industriestrasse 10 D-56218 Mulheim-Karlich Germany
Lichtenstein Pharmazeutica GmbH
Gran Via Carlos III 98, 7 Planta ES-08028 Barcelona Spain
Gran Via Carlos III 98, 7 Planta ES- 08028 Barcelona Spanien
Loratadin "Liconsa"
Loratadin
Form
Ej
administration
Havelse Mølle 14, DK- 3600 Frederikssund Danmark
size
marknadsförda för tillfället
8/ 61
Ej
Marketing Authorisation Holder
Marielund vej 46A DK- 2730 Herlev Danmark
Strength
"PCD"
Route of
marknadsförda för tillfället
Schering Plough Europe Rue de Stalle 73 B-1180 Brussels Belgium
Schering Plough Europe Rue de Stalle 73 B- 1180 Brussels Belgien
9/ 61
Ej
Marketing Authorisation Holder
Stadastrasse 2- 18 D- 61118 Bad Vilbel Tyskland
Loratadin STADA
Loratadin
10, 30, 50, 100
10, 30, 50, 100
Loradis
Loradis
Not marked at the moment
marknadsförda för tillfället
Lorapharm
Lorapharm
DuraScan Medical Products AS, Svendborgvej 243, DK-5260 Odense S, Denmark
Holger Danskes Vej 89, DK- 2000 Frederiksberg, Danmark
Tablet
30, 100
10/ 61
9/ 55
Member
Styrka
Marketing Authorisation Holder
Läkemedelsfor m
Invented
Administrerings - sätt
Pharmaceutical
Förpacknings - storlek
Route of
FI
Packaging
DuraScan Medical Products AS,
Package
Loratadin
State
10 mg
Name
Tablett
Form
Blister
administration
5, 7, 10, 14, 20,
size
Durascan
Laboratoires SMB S. A., Rue de la Pastorale 26-28, B-1080 Brussels, Belgium
Laboratoires SMB S. A., Rue de la Pastorale 26- 28, B- 1080 Brussels, Belgien
2, 7, 10, 20, 30, 50, 100
2, 7, 10, 20, 30,
Blister and tablet container
Blister och
Schering-Plough Europe, 73, Rue De Stalle, B-1180 Brussels, Belgium
Schering- Plough Europe, 73, Rue De Stalle, B- 1180 Brussels, Belgien
11/ 61
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Pharmaceutical
Innehavare av godkännande för försäljning
Verman Oy Ab, Vanhankyläntie 44 B, FIN-04401 Järvenpää, Finland
Verman Oy Ab, Vanhankyläntie 44 B, FIN- 04401 Järvenpää, Finland
LORATADIN E ENDWELL
LORATADIN
LORATADIN E
LORATADIN
Marketing Authorisation Holder
28 Station Close Potters Bar EN6 1TL Hertfordshire, Storbritannien
Invented
E
LORATADIN
LORATADIN
Immeuble Mercure III 55 bis, Quai de Grenelle F-75015 Paris, France
Immeuble Mercure III 55 bis, Quai de Grenelle F- 75015 Paris, Frankrike
E MADAUS
E MADAUS
(PVC/ Alu)
(PVC/ Alu)
Glass (brown)
Glas
Blister (Alu/ Alu)
(Alu/ Alu)
LORATADIN E SCHERING PLOUGH
LORATADIN
Marketing Authorisation Holder
92, rue Baudin F- 92307 Levallois Perret Cedex, Frankrike
1 A Pharma GmbH Keltenring 1+3 D-82041 Oberaching Germany
1 A Pharma GmbH
Loratad
Loratad 10 mg
Loratadin Acis 10 mg
Loratadin Acis
Blister (PVC/ PVD C/ Alu)
Blister
Chemotadin 10 mg Tabletten
Chemotadin 10
7, 10, 20, 30, 50, 100
50, 100
Alfred E. Tiefenbacher GmbH &
Alfred E. Tiefenbacher GmbH & Co.
Lorat
Lorat 10 mg
Van-der-Schmissen-Str 1 D-22767 Hamburg Germany
Van- der- Schmissen- Str 1 D- 22767 Hamburg Tyskland
Marketing Authorisation Holder
Gottlieb- Daimler Str 19 D- 89150 Laichingen Tyskland
Pharmaceutical
10 mg Tabletten
Loratadin AL 1 1 mg/ ml saft
Loratadin AL 1
Bottle (PE)
Flaska
Alpharma-ISIS GmbH & Co KG Elisabeth-Selbert-Str.
Gottlieb- Daimler Str 19 D- 89150 Laichingen Tyskland
1 D-40764 Langenfeld Germany
1 mg/ ml saft
LORA- PUREN
120, 150 ml
7, 10, 20, 50, 100, 500
100, 500
10, 20, 50, 100
10, 20, 50, 100
7, 20, 50, 100, 500
7, 20, 50, 100,
Blister (PVC/ AL, PVC/ AL/ P VDC, PVC/ PE, PVDC/ AL)
Blister
Marketing Authorisation Holder
Kobelweg 95 D- 86156 Augsburg Tyskland
administration
50, 100
42a D-13407 Berlin Germany
ct- Arzneimittel GmbH
Blister 7,
Blister
(PVC/ PVD 100 C/ Alu)
(PVC/ PVDC / Alu)
Lora Rhinol 10 mg Tabletten
Lora Rhinol 10
Dr. Gerhard Mann Chem. - pharm. Fabrik GmbH Brunsbuetteler Damm 165-173, D-13581 Berlin Germany
Dr. Gerhard Mann Chem. -
Vividrin Tabletten Wirkstoff Loratadin
Vividrin
Blister 7, 14, 28, (Alu) 56
7, 14, 28, 56
Marketing Authorisation Holder
pharm. Fabrik GmbH Brunsbuetteler Damm 165- 173, D- 13581 Berlin Tyskland
Pharmaceutical
Tabletten Wirkstoff Loratadin
Packaging
(Alu)
Essex Pharma GmbH Thomas-Dehler-Str.
Essex Pharma GmbH Thomas- Dehler- Str.
27 D-81737 Muenchen Germany
27 D- 81737 Muenchen Tyskland
LORAGALE N
LORAGALEN
Marketing Authorisation Holder
Wittland 13 D- 24109 Kiel Tyskland
size
500
Hermal Kurt Herrmann GmbH & Co.
Hermal Kurt Herrmann GmbH &
Loratadindura 10 mg Filmtabletten
Loratadindura
Blister strips (PVC/ Alu)
Blister strips
25 D-83607 Holzkirchen Germany
25 D- 83607 Holzkirchen Tyskland
Lorano akut
Lorano
7, 14, 20, 50, 100
7, 10, 20, 30,
Krewel Meuselbach GmbH Krewelstr.
Industriestr.
25 D-3783 Eitorf Germany
25 D- 83607 Holzkirchen Tyskland
7, 20, 50, 100, 500
50, 100
KSK – Pharma Vertriebs AG Roggenbackstr.
HEXAL AG
18/ 61
16/ 55
Industriestr.
Krewel Meuselbach GmbH
Lora-Lich 10 mg Tabletten
Loraclar
7, 20, 50, 100
7, 20, 50, 100,
82 D-40721 Hilden Germany
KSK – Pharma Vertriebs AG
7, 20, 50, 100
100
Medis Danmark A/ S Havelse Mølle 14 DK-3600 Fredrikssund Denmark
Lichtenstein Pharmazeutica GmbH
Alerisa
Lora- Lich 10
PROMEDIPHARM GmbH Berliner Ring 89 D-64625 Bensheim Germany
Lindopharm GmbH
Lorasan
Loravis 10 mg
PROMEDIPHARM GmbH Berliner Ring 89 D-64625 Bensheim Germany
Medis Danmark A/ S
3 D-89079 Ulm Germany
PROMEDIPHARM GmbH
20, 50, 100
7, 20, 50, 100,
Loratadin- ratiopharm 10 mg Tabletten
Loratadura
19/ 61
17/ 55
Name
Förpackning
Form
GE
administration
Ratiopharm GmbH
size
Lora -
GE
10 mg
3 D-89079 Ulm Germany
3 D- 89079 Ulm Tyskland
Loratadin- ratiopharm (10 mg Tabletten) bei Allergien
ratiopharm 10 mg Tabletten
Loratadinum von ratio 10 mg Tabletten
ratiopharm 10 mg Tabletten
Sandoz Pharmaceutical GmbH Carl-Zeiss-Ring D-85737 Ismaning Germany
Ratiopharm GmbH
Loratadin Sandoz 10mg Tabletten
Loratadinum
Sandoz Pharmaceutical GmbH Carl-Zeiss-Ring D-85737 Ismaning Germany
3 D- 89079 Ulm Tyskland
Loratadin Sandoz 10 mg Tabletten
von ratio 10 mg Tabletten
Stadapharm GmbH Stadastr.
Sandoz Pharmaceutical GmbH
2-18 D-61118 Bad Vilbel Germany
Loratadin
Loratadin STADA allerg 10 mg Tabletten
10 mg
Blister (PVC/ Alu)
(PVC/ AL, PV C/ AL/ PVDC, PVC/ PE, PV DC/ AL)
Rhoendorfer Str.
Stadapharm GmbH
Livotab direkt Tabletten
Loratadin
7, 10, 14, 28
7, 20, 50, 100
Calwer Str.
Stadastr.
7 D-71034 Boeblingen Germany
2- 18 D- 61118 Bad Vilbel Tyskland
Loragamma 10 mg Tabletten
STADA allerg 10 mg Tabletten
20/ 61
18/ 55
Route of
GE
Packaging
Woerwag Pharma GmbH & Co.
Package
Loragamma 10
administration
7, 10, 20, 50,
442 Acharnon Str GR-11143 Athens Greece
442 Acharnon Str GR- 11143 Athens Grekland
Liolios-Parodos G.
Liolios- Parodos G.
Lyra 25-K.
Lyra 25- K.
Kifisia, Greece
Kifisia, Grekland
39, Favierou str.
BIOSPRAY S. A 39, Favierou str.
GR-104 38 Athens Greece
GR- 104 38 Athens Grekland
Barbaras 53, GR-172 35 Dafni Greece
Barbaras 53, GR- 172 35 Dafni Grekland
GR-115 21 Athens Greece
GR- 115 21 Athens Grekland
Polyxronis Anabrytis 11 Athens, Greece
Polyxronis Anabrytis 11 Athens, Grekland
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HELP ABEE 4 Valaoritou Str GR-14452 Metamorphosi Greece
HELP ABEE 4 Valaoritou Str GR- 14452 Metamorphosi Grekland
189 Parnithos Ave GR-13671 Acharnai Greece
189 Parnithos Ave GR- 13671 Acharnai Grekland
5 mg/ 5 ml
5 mg / 5 ml
152 33 Chalandri Athens Greece
152 33 Chalandri Athens Grekland
LEOVAN Pharmaceuticals 22 Argonafton Argyroupoli T. K.
LEOVAN Pharmaceuticals 22 Argonafton Argyrollpoli T. K.
16452 Athens Greece
16452 Athens Grekland
ΕΛΛΑΣ 211 Parnithos Ave GR-13671 Acharnal Athens Greece
ΕΛΛΑΣ 211 Parnithos Ave GR- 13671 Acharnal Athens Grekland
22/ 61
20/ 55
Allerdrug
Loratadine/ Bio
Novartis (Hellas) A. E. B. E 120 xlm Ethnikis Odou Athinon- Lamias GR-14410 Metamorfosi Greece
120 xlm Ethnikis Odou Athinon - Lamias GR- 14410 Metamorfosi Grekland
Tablet
chemie
Blister (PVC/ AL, PVC/ PE, PVC)
(PVC/ AL, PVC/ PE, PVC)
Novexal Hellas 25 AgDimitriou Str 174 55 Kalamaki, Athens Greece
25 AgDimitriou Str 174 55 Kalamaki, Athens Grekland
administration
25 AgDimitriou Str 174 55 Kalamaki, Athens Grekland
size
Novexal
Kabbadas Fabicrou 48 Athens, Greece
Kabbadas Fabicrou 48 Athens, Grekland
63 Agiou Dimitriou GR-17456 Alimos Greece
63 Agiou Dimitriou GR- 17456 Alimos Grekland
154 51 Psychiko Athens Greece
154 51 Psychiko Athens Grekland
VIOFAR EPE Terma Evaggelistrias GR-136 71 Acharnai Athens Greece
VIOFAR EPE Terma Evaggelistrias GR- 136 71 Acharnai Athens Grekland
ΦΑΡΜΑΤΕΝ Ε .Π .Ε 68 Menandrou Str GR-10432 Athens Greece
ΦΑΡΜΑΤΕΝ Ε. Π. Ε 68 Menandrou Str GR- 10432 Athens Grekland
156 Aylonos Str Sepolia GR-1044 Greece
156 Aylonos Str Sepolia GR- 1044 Grekland
Reykjavíkurvegi 78 IS-220 Hafnarfjörður Ísland
Reykjavíkurvegi 78 IS- 220 Hafnarfjörður Island
Loratadine NM Pharma
Loratadine NM
Schering-Plough Europe, Rue de Stalle, B-1180 Brussels Belgium
Schering- Plough Europe, Rue de Stalle, B- 1180 Brussels Belgien
Schering-Plough Ltd Schering-Plough House Shire Park Welwyn Garden City Hertfordshire, AL7 1TW, United Kingdom
Schering- Plough Ltd Schering- Plough House Shire Park Welwyn Garden City Hertfordshire, AL7 1TW, Storbritannien
Essex Italia SPA Via Serio, 1 I-20139 Milano, Italy
Essex Italia SPA Via Serio, 1 I- 20139 Milano, Italien
SPA Via Dio Scandicci, 37 I-50143 Firenze, Italy
SPA Via Dio Scandicci, 37 I- 50143 Firenze, Italien
Schering Plough SPA Via Ripamonti, 89 I-20141 Milano, Italy
Schering Plough SPA Via Ripamonti, 89 I- 20141 Milano, Italien
Blister (PVC/ AL)
(PVC/ AL)
Blister (PVC/ Al)
Blister
73, Rue de Stalle B-1180 Brussels, Belgium
73, Rue de Stalle B- 1180 Brussels, Belgien
Loratadine CF 1 mg/ ml
Loratadine CF
Loratadine CF 10 mg
Loratadine CF
1, 5, 7, 10, 14, 15, 20, 21, 30, 50, 60, 90, 100, 250
1, 5, 7, 10, 14,
Postbus 100 NL-7255 ZK Hengelo (Gld), Netherlands
Postbus 289 NL- 4870 AG Etten- Leur Nederländerna
Loratadine Disphar 10
10 mg
Box 2062 NL-1500 GB Zaandam Netherlands
Postbus 100 NL- 7255 ZK Hengelo (Gld), Nederländerna
administration
Postbus 408 NL- 2300 AK Leiden, Nederländerna
size
mg Katwijk
Postbus 1364 NL-3600 BJ Maarssen, Netherlands
Postbus 1364 NL- 3600 BJ Maarssen, Nederländerna
Claritine
EMEA 2004
31/ 61
28/ 55
Route of
NL
Packaging
Schering- Plough B. V.
Package
Claritine
Name
Brustablett
administration
7, 10, 30
Sandoz GmbH, Biochemiestrasse 10, A-6250 Kundl, Austria
10 mg
Loraratidin Biochemie
Biochemie
7, 10, 14, 20, 21, 30, 50, 60, 100, 100x1, 250
5, 7, 10, 14, 20,
Duranor AS, Hoffsv.
NM Pharma AS,
5, 7, 10, 14, 20, 30, 40, 100, 105
5, 7, 10, 14, 15,
32/ 61
29/ 55
2 B, N-0283 Oslo, Norway
Ratiopharm GmbH,
5, 7, 10, 14, 15, 20, 21, 30, 50, 100
2, 7, 10, 20,
Ratiopharm GmbH, Graf-Arco-Str 3, DE-89079 Ulm, Germany
Graf- Arco- Str 3, DE- 89079 Ulm, Tyskland
Blister
Ratiopharm
Schering-Plough AS, Ankerveien 209, N-1359 Eiksmarka, Norway
Schering- Plough AS, Ankerveien 209, N- 1359 Eiksmarka, Norge
Schering-Plough Europe, 73, Rue de Stalle, B-1180 Brussels, Belgium
Schering- Plough Europe, 73, Rue de Stalle, B- 1180 Brussels, Belgien
Marketing Authorisation Holder
D- 61118 Bad Vilbel, Tyskland
State
Stada
administration
120, 150 ml
10, 20,
10, 20, 28, 30,
D-61118 Bad Vilbel, Germany
D- 61118 Bad Vilbel, Tyskland
28, 30, 50, 56, 60, 90, 100
50, 56, 60, 90, 100
Rua Sebastião e Silva, 56 P-2745-838 Massamá Portugal
Rua Sebastião e Silva, 56 P- 2745- 838 Massamá Portugal
Euro-Labor, Laboratórios de Síntese Química e Especialidades Farmacêuticas, S. A.
Euro- Labor, Laboratórios de Síntese Química e Especialidades Farmacêuticas, S. A.
Rua Alfredo da Silva, 16 P. º Box 60270 P-2720-028 Amadora Portugal
Rua Alfredo da Silva, 16 P. º Box 60270 P- 2720- 028 Amadora Portugal
Henrique de Barros, Edifício Sagres, 3ºA P-2685-338 Prior Velho Portugal
Henrique de Barros, Edifício Sagres, 3ºA P- 2685- 338 Prior Velho Portugal
Rua José Galhardo, n. º 3 P-1750-131 Lisboa Portugal
Rua
Irex - Promoção e Comercialização de Produtos Farmacêuticos, Lda Praça Duque de Saldanha n° 1-4°E P-1050-094 Lisboa Portugal
José Galhardo, n. º 3 P- 1750- 131 Lisboa Portugal
Labesfal - Laboratórios Almiro, S. A., Avenida Dr Afonso Costa P-3465-051 Campo de Besteiros Portugal
de Produtos Farmacêuticos, Lda Praça Duque de Saldanha n° 1- 4°E P- 1050- 094 Lisboa Portugal
Loratadina Labesfal 10 mg Comprimidos
10 mg comprimidos
Avenida Dr Afonso Costa Apartado 7 P-3465-051 Campo de Besteiros Portugal
Avenida Dr Afonso Costa Apartado 7 P- 3465- 051 Campo de Besteiros Portugal
CPMP/ 1333/ 03
Farmacêuticos, Lda.
Marketing Authorisation Holder
Rua Alfredo da Silva, 3 - C - 4º P- 1300- 040 Lisboa Portugal
Pharmaceutical
Merck Genéricos 10 mg Comprimidos Revestidos
Pentafarma - Sociedade Técnico- Medicinal, S. A.
Pentafarma - Sociedade Técnico - Medicinal, S. A.
Sagres, 5ºA P-2685-338 Prior Velho Portugal
Sagres, 5ºA P- 2685- 338 Prior Velho Portugal
Rua Agualva dos Açores no 16 P-2735-557 Agualva - Cacém Portugal
Rua Agualva dos Açores no 16 P- 2735- 557 Agualva - Cacém Portugal
36/ 61
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(Laboratório Scientia) Estrada de Benfica, 403- B P-1500-077 Lisboa Portugal
(Laboratório Scientia) Estrada de Benfica, 403 - B P- 1500- 077 Lisboa Portugal
Loratadina Ratiopharm 10 mg Comprimidos
Loratadina
PT
Edifício Tejo - 6º Piso Rua Quinta do Pinheiro P- 2790- 145 Carnaxide Portugal
Sandoz, GmbH Biochemiestraße 10 A-6250 Kundl Austria
Ratiopharm 10 mg Comprimidos
Loratadina Sandoz 10 mg Comprimidos
Loratadina
Marketing Authorisation Holder
Biochemiestraße 10 A- 6250 Kundl Österrike
Pharmaceutical
Sandoz 10 mg Comprimidos
Rua Agualva dos Açores 16 P-2735-557 Agualva- Cacém Portugal
Rua Agualva dos Açores 16 P- 2735- 557 Agualva - Cacém Portugal
Loratadina Stada 10 mg Comprimidos
Loratadina
Tecnimede - Sociedade Técnico- Medicinal, S. A.
Tecnimede - Sociedade Técnico - Medicinal, S. A.
Sagres, 3º A P-2685-338 Prior Velho Portugal
Sagres, 3º A P- 2685- 338 Prior Velho Portugal
Loratadina Bexal
Loratadina
Combino Pharma Fructuoso Gelabert 6-8 ES-08970 San Juan Despi Barcelona, Spain
Combino Pharma
Loratadine Combino Pharm
Loratadine
Industrial Farmacéutica Cantabria Carretera Cazoña-Ardazo s/ n ES-39011 Santander, Spain
Industrial Farmacéutica Cantabria Carretera Cazoña- Ardazo s/ n ES- 39011 Santander, Spanien
Industrial Farmacéutica Cantabria Carretera Cazoña-Ardazo s/ n – ES-39011 Santander, Spain
Industrial Farmacéutica Cantabria Carretera Cazoña- Ardazo s/ n – ES- 39011 Santander, Spanien
Laureà Miró 395 ES-08980 Sant Feliu de Llobregat Barcelona, Spain
Laureà Miró 395 ES- 08980 Sant Feliu de Llobregat Barcelona, Spanien
39/ 61
35/ 55
Tablet
Dragerad tablett
Laboratorio Bayvit Av.
Av.
Frederic Mompou 5 ES-08960 Sant Just Desvern Barcelona, Spain
Frederic Mompou 5 ES- 08960 Sant Just Desvern Barcelona, Spanien
Loratadina Bayvit
Bayvit
Laboratorios Cinfa C/ Olaz-Chipi 10 ES-31620 Huarte, Pamplona, Spain
Laboratorios Cinfa
Loratadina Geminis
Loratadina
administration
Gran Via de Les Cortes Catalanes 7674 ES- 08013 Barcelona, Spanien
size
Geminis
Loratadine Genpril
Loratadine
Blister (PVC/ AL)
Blister
Avda Barcelona 69 Sant Joan Despi ES-08970 Barcelona, Spain
Avda Barcelona 69 Sant Joan Despi ES- 08970 Barcelona, Spanien
Avda Barcelona 69 Sant Joan Despi, ES-08970 Barcelona, Spain
Avda Barcelona 69 Sant Joan Despi, ES- 08970 Barcelona, Spanien
Ind., Urtinsa II, ES-28923 Alcorcón, Spain
Ind., Urtinsa II, ES- 28923 Alcorcón, Spanien
Km 36 Carret Nacional 1 ES-28750 San Agustin de Guadalix Madrid, Spain
Km 36 Carret Nacional 1 ES- 28750 San Agustin de Guadalix Madrid, Spanien
Oral use use
Oral användning
administration
Balmes 84, 4º 2ª ES- 08008 Barcelona, Spanien
size
Tamarang
Astra Zeneca AB S-151 85 Södertälje Sweden
Astra Zeneca AB
Loratadin Astra Zeneca
Loratadin Astra
5, 7, 10, 14, 20, 30, 40, 100, 105
5, 7, 10, 14, 20,
Generics (UK) Ltd 12 Station Close Potters Bar Herts EN6 1TL United Kingdom
Generics (UK) Ltd
Loratadin NM Pharma
Loratadin NM
Pro Medica AB Box 271 90 S-10252 Stockholm, Sweden
Pro Medica AB Box 271 90 S- 10252 Stockholm, Sverige
60, 100, 250 7, 10, 14, 20, 21, 30, 50, 60, 100, 250
7, 10, 14, 20, 21, 30, 50, 60, 100, 250
Schering-Plough Europe Rue de Stalle 73 B-1180 Brussels, Belgium
Schering- Plough Europe Rue de Stalle 73 B- 1180 Brussels, Belgien
Stada Arzneimittel AG Stadastraße 2-18 D-61118 Bad Vibel Germany
Rue de Stalle 73 B- 1180 Brussels, Belgien
Oral use
tablett
45/ 61
40/ 55
Route of
SW
Packaging
Stada Arzneimittel AG
administration
1, 5, 7, 10, 14,
size
Stada
Blister Strip
Blister
Approved Prescription Services Ltd 41 Brampton Road Hampden Park, Eastbourne East Sussex, BN22 9AG, UK
Approved Prescription Services Ltd
5, 7, 10, 15, 20, 28, 30, 50, 100
5, 7, 10, 15, 20,
50, 60, 100, 120, 150, 200ml
120, 150, 200ml
Egis Pharmaceuticals UK Limited 127 Shirland Road London W9 2EP, UK
Egis Pharmaceuticals UK Limited
46/ 61
41/ 55
Film-coated Tablets
Filmdragerad
Norton Healthcare Limited Ivax Quays, Albert Basin Armada Way, Royal Docks London, E16 2QJ UK
Norton Healthcare Limited Ivax Quays, Albert Basin Armada Way, Royal Docks London, E16 2QJ Storbritannien
47/ 61
42/ 55
Loratadine 10 mg Tablets
Förpacknings - storlek
Rockspring Healthcare Ltd Nerin House 26 Bridgeway Street Douglas IM1 1EL – Isle of Man UK
Nerin House 26 Bridgeway Street Douglas IM1 1EL – Isle of Man Storbritannien
Marketing Authorisation Holder
Shire Park Welwyn Garden City AL7 1TW Storbritannien
State
200 ml
Clarityn Tablets
Clarityn
2, 5, 7, 10, 14, 20, 21, 30
2, 5, 7, 10, 14,
50, 60, 100, 120, 150, 200 ml
120, 150, 200 ml