Annex I List of the names, pharmaceutical form, strengths of the

Annex I
List of the names, pharmaceutical form, strengths of the medicinal
products, route of administration, marketing authorisation holders in the
member states
Member State
Marketing Authorisation Holder
(Invented) Name
Strength
Pharmaceutical Form
administration
EU/EEA
Austria
Route of
Teva Pharma B.V.
Cilazapril TEVA 0,5 mg
Computerweg 10
Filmtabletten
Film-coated tablet
Oral use
Film-coated tablet
Oral use
Film-coated tablet
Oral use
Film-coated tablet
Oral use
Film-coated tablet
Oral use
Film-coated tablet
Oral use
0,5 mg
3542 DR Utrecht
The Netherlands
Austria
Teva Pharma B.V.
Cilazapril TEVA 2,5 mg
Computerweg 10
Filmtabletten
2,5 mg
3542 DR Utrecht
The Netherlands
Austria
Teva Pharma B.V.
Cilazapril TEVA 5 mg
Computerweg 10
Filmtabletten
5,0 mg
3542 DR Utrecht
The Netherlands
Teva Pharmaceuticals CR, s.r.o.
Czech Republic
CILAZAPRIL TEVA
5 MG
Radlická 3185/1c
5 mg
150 00 Praha 5,
Czech Republic
Teva Pharmaceuticals CR, s.r.o.
Czech Republic
CILAZAPRIL TEVA 2,5 MG
Radlická 3185/1c
2,5 mg
150 00 Praha 5,
Czech Republic
France
TEVA SANTE
CILAZAPRIL TEVA
110 ESPLANADE DU GENERAL DE
1 mg, comprimé pelliculé
GAULLE
sécable
1 mg
92931 PARIS LA DEFENSE CEDEX
FRANCE
2
Member State
Marketing Authorisation Holder
(Invented) Name
Strength
Pharmaceutical Form
administration
EU/EEA
France
Route of
TEVA SANTE
CILAZAPRIL TEVA 0,5 mg,
110 ESPLANADE DU GENERAL DE
comprimé pelliculé sécable
GAULLE
Film-coated tablet
Oral use
Film-coated tablet
Oral use
Film-coated tablet
Oral use
Film-coated tablet
Oral use
Film-coated tablet
Oral use
0,5 mg
92931 PARIS LA DEFENSE CEDEX
FRANCE
France
TEVA SANTE
CILAZAPRIL TEVA 2,5 mg,
110 ESPLANADE DU GENERAL DE
comprimé pelliculé sécable
GAULLE
2,5 mg
92931 PARIS LA DEFENSE CEDEX
FRANCE
123ratio Sp. z o.o.
Poland
Cilazaprilum 123ratio
ul. Emilii Plater 53
1 mg
00-113 Warsaw
Poland
123ratio Sp. z o.o.
Poland
Cilazaprilum 123ratio
ul. Emilii Plater 53
2,5 mg
00-113 Warsaw
Poland
123ratio Sp. z o.o.
Poland
Cilazaprilum 123ratio
ul. Emilii Plater 53
5 mg
00-113 Warsaw
Poland
3
Member State
Marketing Authorisation Holder
(Invented) Name
Strength
Pharmaceutical Form
administration
EU/EEA
Spain
Route of
TEVA PHARMA, S.L.U.
CILAZAPRIL TEVA
C/ Anabel Segura, 11
comprimidos recubiertos con
1 mg
Edificio Albatros B, 1ª planta
película EFG
Film-coated tablet
Oral use
Film-coated tablet
Oral use
Film-coated tablet
Oral use
Tablet
Oral use
1 mg
28108 Alcobendas (Madrid)
Spain
Spain
TEVA PHARMA, S.L.U.
CILAZAPRIL TEVA
5 mg
C/ Anabel Segura, 11
comprimidos recubiertos con
Edificio Albatros B, 1ª planta
película EFG
5 mg
28108 Alcobendas (Madrid)
Spain
Spain
TEVA PHARMA, S.L.U.
CILAZAPRIL TEVA
C/ Anabel Segura, 11
comprimidos recubiertos con
2,5 mg
Edificio Albatros B, 1ª planta
película EFG
2.5 mg
28108 Alcobendas (Madrid)
Spain
Teva UK Ltd,
Cilazapril 0.5mg tablets
Brampton Road,
United Kingdom
Hampden Park,
0.5mg
Eastbourne,
BN22 9AG,
United Kingdom
4
Member State
Marketing Authorisation Holder
(Invented) Name
Strength
Pharmaceutical Form
Route of
administration
EU/EEA
Teva UK Ltd,
Cilazapril 1mg tablets
Tablet
Oral use
Tablet
Oral use
Tablet
Oral use
Brampton Road,
United Kingdom
Hampden Park,
1mg
Eastbourne,
BN22 9AG,
United Kingdom
United Kingdom
United Kingdom
Teva UK Ltd,
Brampton Road,
Hampden Park,
Eastbourne,
BN22 9AG,
United Kingdom
Teva UK Ltd,
Brampton Road,
Hampden Park,
Eastbourne,
BN22 9AG,
United Kingdom
Cilazapril 2.5mg tablets
2.5mg
Cilazapril 5mg tablets
5mg
5