6 July 2017
EMA/434947/2017
Human Medicines Evaluation Division
List of nationally authorised medicinal products
Active substance: calcium salts / colecalciferol
Procedure no.: PSUSA/00010386/201610
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5525
Send a question via our website www.ema.europa.eu/contact
An agency of the European Union
© European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged.
Product Name (in
authorisation country)
MRP/DCP
Authorisation
number
National Authorisation Number
MAH of product in the
member state
Member State where
product is authorised
BONESIL D FLAS 1500
not available
68.620
ITALFARMACO S.A.
ES
not available
68.620
ITALFARMACO S.A.
ES
FR/H/0103/001/MR
PL 10947/0017
WARNER CHILCOTT UK
UK
mg/400 UI comprimidos
bucodispersables
BONESIL D FLAS 1500
mg/400 UI comprimidos
bucodispersables
Cacit D3 effervescent
granules, 500 mg/440 IU
Cacit VITAMINA D3 1000
LIMITED
FR/H/103/001
032033058
mg / 880 U.I., granulato
WARNER CHILCOTT ITALY
IT
S.R.L.
effervescent per
soluzione orale in bustine
CACIT VITAMINA D3
FR/H/103/001
032033019
1000 mg / 880 U.I.,
WARNER CHILCOTT ITALY
IT
S.R.L.
granulato effervescente
per soluzione orale in
bustine
CACIT VITAMINA D3 500
FR/H/103/002
032033033
mg / 440 U.I., granulato
WARNER CHILCOTT ITALY
IT
S.R.L.
effervescente per
soluzione orale in bustine
Cacit VITAMINA D3 500
FR/H/103/002
032033060
mg/440 U.I., granulato
WARNER CHILCOTT ITALY
IT
S.R.L.
effervescente per
soluzione orale in bustine
CACIT VITAMINE D3
FR/H/103/001
372 410-6
WARNER CHILCOTT FRANCE
FR
1000 mg/880 UI,
granules effervescents
pour solution buvable en
List of nationally authorised medicinal products
EMA/434947/2017
Page 2/50
Product Name (in
authorisation country)
MRP/DCP
Authorisation
number
National Authorisation Number
MAH of product in the
member state
Member State where
product is authorised
FR/H/103/002/MR
0643/01/06/6398
WARNER CHILCOTT
LU
sachet
Cacit Vitamine D3
1000/880,
PHARMACEUTICALS BVBA
Brausegranulat für
Trinklösung
Cacit Vitamine D3
FR/H/0103/002
BE179891
1000/880, bruisgranulaat
WARNER CHILCOTT
BE
PHARMACEUTICALS BVBA
voor drank
Cacit Vitamine D3
FR/H/0103/002
0643/01/06/6398
1000/880, granulé
WARNER CHILCOTT
LU
PHARMACEUTICALS BVBA
effervescent pour boisson
CACIT VITAMINE D3 500
FR/H/103/002
19044
WARNER CHILCOTT FRANCE
FR
FR/H/0103/001
BE179882
WARNER CHILCOTT
BE
mg/440 UI, granules
effervescents pour
solution buvable en
sachet
Cacit Vitamine D3
500/440, Brausegranulat
PHARMACEUTICALS BVBA
für Trinklösung
Cacit Vitamine D3
FR/H/103/001/MR
0643/01/06/6397
500/440, Brausegranulat
WARNER CHILCOTT
LU
PHARMACEUTICALS BVBA
für Trinklösung
CACIT VITAMINE D3
not available
364 409-2
WARNER CHILCOTT FRANCE
FR
500/440, comprime a
sucer ou a croquer
List of nationally authorised medicinal products
EMA/434947/2017
Page 3/50
Product Name (in
authorisation country)
MRP/DCP
Authorisation
number
National Authorisation Number
MAH of product in the
member state
Member State where
product is authorised
Cacit Vitamine D3
FR/H/0103/001
0643/01/06/6397
WARNER CHILCOTT
LU
500/440, granulé
PHARMACEUTICALS BVBA
effervescent pour boisson
CALCEOS 500mg/400IU
not available
PL 19152/0001
Chewable Tablets
CALCEOS 500mg/400IU
UK
INTERNATIONAL
not available
PL 19152/0001
Chewable Tablets
Calchichew-D3 Forte,
LABORATOIRE INNOTECH
LABORATOIRE INNOTECH
UK
INTERNATIONAL
SE/H/0126/001
18189
TAKEDA PHARMA A/S
DK
not available
66.064
ESPECIALIDADES
ES
tyggetabletter
CALCIAL D comprimidos
masticables
FARMACEUTICAS CENTRUM,
S.A
Calci-Chew D3 1000
SE/H/0126/002
RVG 101127
TAKEDA NEDERLAND BV
NL
not available
39/546/00-C
TAKEDA AUSTRIA GMBH
CZ
SE/H/0126/001
RVG 25692
TAKEDA NEDERLAND BV
NL
SE/H/0126/004
RVG 105832
TAKEDA NEDERLAND BV
NL
mg/800 I.E.
kauwtabletten
CALCICHEW D3 200 IU
žvýkací tablety
Calci-Chew D3 500
mg/400 I.E.
kauwtabletten
Calci-Chew D3 500
mg/800 I.E.,
kauwtabletten
List of nationally authorised medicinal products
EMA/434947/2017
Page 4/50
Product Name (in
authorisation country)
MRP/DCP
Authorisation
number
National Authorisation Number
MAH of product in the
member state
Member State where
product is authorised
Calcichew D3 Extra
SE/H/0126/005
27854
TAKEDA OY
FI
SE/H/0126/004
27855
TAKEDA OY
FI
SE/H/0126/003
RVG 104844
TAKEDA NEDERLAND BV
NL
SE/H/0126/006
32239
TAKEDA OY
FI
SE/H/0126/006
32239
TAKEDA OY
FI
SE/H/0412/001
20058
TAKEDA OY
FI
SE/H/0126/001
15953
TAKEDA OY
FI
SE/H/0126/003
24110
TAKEDA OY
FI
appelsiini 500 mg/20
mikrog -purutabletti
Calcichew D3 Extra
sitruuna 500 mg/20
mikrog -purutabletti
Calci-Chew D3 FLEX 500
mg/400 I.E. filmomhulde
tabletten
Calcichew D3 Forte
mansikka-meloni 500
mg/10 mikrog purutabletti
Calcichew D3 Forte
mansikka-meloni 500
mg/10 mikrogtuggtablett
Calcichew D3 Forte
minttu 500 mg/10 mikrog
-purutabletti
Calcichew D3 Forte
sitruuna 500 mg/10
mikrog -purutabletti
Calcichew D3 Forte
sitruuna 500 mg/10
mikrog -tabletti,
kalvopäällysteinen
List of nationally authorised medicinal products
EMA/434947/2017
Page 5/50
Product Name (in
authorisation country)
MRP/DCP
Authorisation
number
National Authorisation Number
MAH of product in the
member state
Member State where
product is authorised
Calcichew D3 Jahoda 500
SE/H/0126/008
39/415/15-C
TAKEDA BELGIUM SCA/CVA
CZ
SE/H/0126/006
39/414/15-C
TAKEDA NYCOMED AS
CZ
SE/H/0126/001
39/549/12-C
TAKEDA NYCOMED AS
CZ
SE/H/0126/007
39/413/15-C
TAKEDA NYCOMED AS
CZ
SE/H/0126/002
39/550/12-C
TAKEDA NYCOMED AS
CZ
SE/H/0126/008
32240
TAKEDA OY
FI
SE/H/0126/008
32240
TAKEDA OY
FI
SE/H/0126/005
27854
TAKEDA OY
FI
SE/H/0126/004
27855
TAKEDA OY
FI
mg/1000 IU žvýkací
tablety
Calcichew D3 Jahoda 500
mg/400 IU žvýkací
tablety
CALCICHEW D3 Lemon
400 IU žvýkací tablety
Calcichew D3 Lemon 500
mg/1000 IU žvýkací
tablety
CALCICHEW D3 Lemon
800 IU žvýkací tablety
Calcichew D3 Opti
mansikka-meloni 500
mg/25 mikrog purutabletti
Calcichew D3 Opti
mansikka-meloni 500
mg/25 mikrogtuggtablett
Calcichew® D3 Extra
appelsiini 500 mg/20
mikrog-tuggtabletter
Calcichew® D3 Extra
sitruuna 500 mg/20
mikrog-tuggtabletter
List of nationally authorised medicinal products
EMA/434947/2017
Page 6/50
Product Name (in
authorisation country)
MRP/DCP
Authorisation
number
National Authorisation Number
MAH of product in the
member state
Member State where
product is authorised
Calcichew® D3 Forte
SE/H/0412/001
20058
TAKEDA OY
FI
SE/H/0126/003
24110
TAKEDA OY
FI
SE/H/0126/001
15953
TAKEDA OY
FI
not available
1-25487
TAKEDA PHARMA GES.M.B.H.
AT
SE/H/0126/002
PL 16189/0028
TAKEDA UK LTD
UK
SE/H/0126/002
OGYI-T-22251/20
TAKEDA PHARMA KFT.
HU
SE/H/0126/002
OGYI-T-22251/21
TAKEDA PHARMA KFT.
HU
SE/H/0126/002
OGYI-T-22251/22
TAKEDA PHARMA KFT.
HU
SE/H/0126/002
OGYI-T-22251/23
TAKEDA PHARMA KFT.
HU
minttu 500 mg/10
mikrog-tuggtabletter
Calcichew® D3 Forte
sitruuna 500 mg/10
mikrog-filmdragerade
tabletter
Calcichew® D3 Forte
sitruuna 500 mg/10
mikrog-tuggtabletter
Calcichew®-D3 Kautabletten
Calcichew-D3 1000
mg/800 IU Once Daily
Chewable tablets
Calcichew-D3 1000
mg/800 NE rágótabletta
Calcichew-D3 1000
mg/800 NE rágótabletta
Calcichew-D3 1000
mg/800 NE rágótabletta
Calcichew-D3 1000
mg/800 NE rágótabletta
List of nationally authorised medicinal products
EMA/434947/2017
Page 7/50
Product Name (in
authorisation country)
MRP/DCP
Authorisation
number
National Authorisation Number
MAH of product in the
member state
Member State where
product is authorised
Calcichew-D3 1000
SE/H/0126/002
OGYI-T-22251/24
TAKEDA PHARMA KFT.
HU
SE/H/0126/002
OGYI-T-22251/25
TAKEDA PHARMA KFT.
HU
SE/H/0126/002
OGYI-T-22251/26
TAKEDA PHARMA KFT.
HU
SE/H/0126/002
OGYI-T-22251/27
TAKEDA PHARMA KFT.
HU
SE/H/0126/002
OGYI-T-22251/28
TAKEDA PHARMA KFT.
HU
SE/H/0126/002
OGYI-T-22251/29
TAKEDA PHARMA KFT.
HU
SE/H/0126/002
OGYI-T-22251/30
TAKEDA PHARMA KFT.
HU
SE/H/0126/002
OGYI-T-22251/31
TAKEDA PHARMA KFT.
HU
SE/H/0126/002
OGYI-T-22251/32
TAKEDA PHARMA KFT.
HU
mg/800 NE rágótabletta
Calcichew-D3 1000
mg/800 NE rágótabletta
Calcichew-D3 1000
mg/800 NE rágótabletta
Calcichew-D3 1000
mg/800 NE rágótabletta
Calcichew-D3 1000
mg/800 NE rágótabletta
Calcichew-D3 1000
mg/800 NE rágótabletta
Calcichew-D3 1000
mg/800 NE rágótabletta
Calcichew-D3 1000
mg/800 NE rágótabletta
Calcichew-D3 1000
mg/800 NE rágótabletta
List of nationally authorised medicinal products
EMA/434947/2017
Page 8/50
Product Name (in
authorisation country)
MRP/DCP
Authorisation
number
National Authorisation Number
MAH of product in the
member state
Member State where
product is authorised
Calcichew-D3 1000
SE/H/0126/002
OGYI-T-22251/33
TAKEDA PHARMA KFT.
HU
SE/H/0126/007
OGYI-T-22251/34
TAKEDA PHARMA KFT.
HU
SE/H/0126/007
OGYI-T-22251/35
TAKEDA PHARMA KFT.
HU
SE/H/0126/007
OGYI-T-22251/36
TAKEDA PHARMA KFT.
HU
SE/H/0126/007
OGYI-T-22251/37
TAKEDA PHARMA KFT.
HU
SE/H/0126/007
OGYI-T-22251/38
TAKEDA PHARMA KFT.
HU
SE/H/0126/003
PL 16189/0027
TAKEDA UK LTD
UK
SE/H/0126/001
OGYI-T-22251/02
TAKEDA PHARMA KFT.
HU
SE/H/0126/001
OGYI-T-22251/04
TAKEDA PHARMA KFT.
HU
mg/800 NE rágótabletta
Calcichew-D3 500
mg/1000 NE rágótabletta
Calcichew-D3 500
mg/1000 NE rágótabletta
Calcichew-D3 500
mg/1000 NE rágótabletta
Calcichew-D3 500
mg/1000 NE rágótabletta
Calcichew-D3 500
mg/1000 NE rágótabletta
Calcichew-D3 500
mg/400 IU Caplets
Calcichew-D3 500
mg/400 NE rágótabletta
Calcichew-D3 500
mg/400 NE rágótabletta
List of nationally authorised medicinal products
EMA/434947/2017
Page 9/50
Product Name (in
authorisation country)
MRP/DCP
Authorisation
number
National Authorisation Number
MAH of product in the
member state
Member State where
product is authorised
Calcichew-D3 500
SE/H/0126/001
OGYI-T-22251/07
TAKEDA PHARMA KFT.
HU
SE/H/0126/001
OGYI-T-22251/09
TAKEDA PHARMA KFT.
HU
SE/H/0126/001
OGYI-T-22251/11
TAKEDA PHARMA KFT.
HU
SE/H/0126/001
OGYI-T-22251/13
TAKEDA PHARMA KFT.
HU
SE/H/0126/001
OGYI-T-22251/15
TAKEDA PHARMA KFT.
HU
SE/H/0126/001
OGYI-T-22251/19
TAKEDA PHARMA KFT.
HU
SE/H/0126/001
OGYI-T-22251/01
TAKEDA PHARMA KFT.
HU
SE/H/0126/001
OGYI-T-22251/03
TAKEDA PHARMA KFT.
HU
SE/H/0126/001
OGYI-T-22251/05
TAKEDA PHARMA KFT.
HU
mg/400 NE rágótabletta
Calcichew-D3 500
mg/400 NE rágótabletta
Calcichew-D3 500
mg/400 NE rágótabletta
Calcichew-D3 500
mg/400 NE rágótabletta
Calcichew-D3 500
mg/400 NE rágótabletta
Calcichew-D3 500
mg/400 NE rágótabletta
Calcichew-D3 500
mg/400 NE rágótabletta
Calcichew-D3 500
mg/400 NE rágótabletta
Calcichew-D3 500
mg/400 NE rágótabletta
List of nationally authorised medicinal products
EMA/434947/2017
Page 10/50
Product Name (in
authorisation country)
MRP/DCP
Authorisation
number
National Authorisation Number
MAH of product in the
member state
Member State where
product is authorised
Calcichew-D3 500
SE/H/0126/001
OGYI-T-22251/06
TAKEDA PHARMA KFT.
HU
SE/H/0126/001
OGYI-T-22251/08
TAKEDA PHARMA KFT.
HU
SE/H/0126/001
OGYI-T-22251/10
TAKEDA PHARMA KFT.
HU
SE/H/0126/001
OGYI-T-22251/12
TAKEDA PHARMA KFT.
HU
SE/H/0126/001
OGYI-T-22251/14
TAKEDA PHARMA KFT.
HU
SE/H/0126/001
OGYI-T-22251/16
TAKEDA PHARMA KFT.
HU
SE/H/0126/001
OGYI-T-22251/18
TAKEDA PHARMA KFT.
HU
SE/H/0126/001
OGYI-T-22251/17
TAKEDA PHARMA KFT.
HU
SE/H/0126/002
39/0322/12-S
TAKEDA PHARMACEUTICALS
SK
mg/400 NE rágótabletta
Calcichew-D3 500
mg/400 NE rágótabletta
Calcichew-D3 500
mg/400 NE rágótabletta
Calcichew-D3 500
mg/400 NE rágótabletta
Calcichew-D3 500
mg/400 NE rágótabletta
Calcichew-D3 500
mg/400 NE rágótabletta
Calcichew-D3 500
mg/400 NE rágótabletta
Calcichew-D3 500
mg/400 NE rágótabletta
Calcichew-D3 Citron 1
000 mg/800 IU žuvacie
SLOVAKIA S.R.O.
tablety
List of nationally authorised medicinal products
EMA/434947/2017
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Product Name (in
authorisation country)
MRP/DCP
Authorisation
number
National Authorisation Number
MAH of product in the
member state
Member State where
product is authorised
Calcichew-D3 Citron 1000
SE/H/0126/002
26065
TAKEDA AS
SE
SE/H/0126/001
12634
TAKEDA AS
SE
SE/H/0126/001
39/0321/12-S
TAKEDA PHARMACEUTICALS
SK
mg/800 IE tuggtablett
Calcichew-D3 Citron 500
mg/400 IE tuggtabletter
Calcichew-D3 Citron 500
mg/400 IU žuvacie
SLOVAKIA S.R.O.
tablety
Calcichew-D3 Citron,
SE/H/0126/007
51115
TAKEDA NYCOMED AS
SE
SE/H/0126/007
PA 1547/7/5
TAKEDA UK LTD
IE
SE/H/0126/003
PA1547/007/003
TAKEDA UK LTD
IE
not available
PL 16189/0026
TAKEDA UK LTD
UK
SE/H/0126/005
42960
TAKEDA AS
SE
not available
PA 1547/007/002
TAKEDA UK LTD
IE
500mg/1000IE
tuggtablett
Calcichew-D3 Extra 500
mg/1000 IU chewable
tablets
Calcichew-D3 Forte 500
mg / 400 IU Film-coated
Tablets
Calcichew-D3 Forte 500
mg/400 IU Chewable
Tablets
Calcichew-D3 Forte
Apelsin 500 mg/800 IE
tuggtabletter
Calcichew-D3 Forte
Chewable Tablets,
calcium
carbonate/colecalciferol
equivalent to 500mg
List of nationally authorised medicinal products
EMA/434947/2017
Page 12/50
Product Name (in
authorisation country)
MRP/DCP
Authorisation
number
National Authorisation Number
MAH of product in the
member state
Member State where
product is authorised
SE/H/0126/004
42959
TAKEDA AS
SE
SE/H/0126/002
PA 1547/007/004
TAKEDA UK LTD
IE
SE/H/0126/006
PL 16189/0029
TAKEDA UK LTD
UK
SE/H/0126/008
51116
TAKEDA NYCOMED AS
SE
SE/H/0126/006
51114
TAKEDA NYCOMED AS
SE
SE/H/0411/001
16506
TAKEDA AS
SE
SE/H/0412/001
16924
TAKEDA AS
SE
SE/H/0126/003
26066
TAKEDA AS
SE
Calcium / 400IU
colecalciferol
Calcichew-D3 Forte Citron
500 mg/800 IE
tuggtabletter
Calcichew-D3 Forte
Double Strength 1000 mg
/ 800 IU Chewable
Tablets
Calcichew-D3 Forte
Strawberry and
Watermelon 500 mg/400
IU chewable tablets
Calcichew-D3 Melon,
500mg/1000IE
tuggtablett
Calcichew-D3 Melon,
500mg/400IE tuggtablett
Calcichew-D3 Mite Citron
500 mg/200 IE
tuggtabletter
Calcichew-D3 Spearmint
500 mg/400 IE
tuggtabletter
Calciflex-D3 Citron 500
mg/400 IE filmdragerade
tabletter
List of nationally authorised medicinal products
EMA/434947/2017
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Product Name (in
authorisation country)
MRP/DCP
Authorisation
number
National Authorisation Number
MAH of product in the
member state
Member State where
product is authorised
CALCIGAUROL VITAMINE
not available
NL 22529-3400934880254
LABORATOIRE DES
FR
D3 500mg/400 UI,
REALISATIONS
comprimé à croquer ou à
THERAPEUTIQUES ELERTE
sucer
CALCIGAUROL VITAMINE
not available
NL 22529-3400934880254
LABORATOIRE DES
D3 500mg/400 UI,
REALISATIONS
comprimé à croquer ou à
THERAPEUTIQUES ELERTE
FR
sucer
Calcigran 500 mg/200 TV
not available
LT/1/98/1332/002
TAKEDA AS
LT
not available
LT/1/98/1332/003
TAKEDA AS
LT
SE/H/0126/002
07-5272
TAKEDA AS
NO
SE/H/0126/002
LT/1/05/0177/016
TAKEDA AS
LT
SE/H/0126/002
LT/1/05/0177/009
TAKEDA AS
LT
SE/H/0126/002
LT/1/05/0177/010
TAKEDA AS
LT
SE/H/0126/002
LT/1/05/0177/011
TAKEDA AS
LT
kramtomosios tabletės
Calcigran 500 mg/200 TV
kramtomosios tabletės
Calcigran Forte 1000
mg/800 IE tyggetabletter
Calcigran Forte 1000
mg/800 TV kramtomosios
tabletes
Calcigran Forte 1000
mg/800 TV kramtomosios
tabletės
Calcigran Forte 1000
mg/800 TV kramtomosios
tabletės
Calcigran Forte 1000
mg/800 TV kramtomosios
tabletės
List of nationally authorised medicinal products
EMA/434947/2017
Page 14/50
Product Name (in
authorisation country)
MRP/DCP
Authorisation
number
National Authorisation Number
MAH of product in the
member state
Member State where
product is authorised
Calcigran Forte 1000
SE/H/0126/002
LT/1/05/0177/012
TAKEDA AS
LT
SE/H/0126/002
LT/1/05/0177/013
TAKEDA AS
LT
SE/H/0126/002
LT/1/05/0177/014
TAKEDA AS
LT
SE/H/0126/002
LT/1/05/0177/015
TAKEDA AS
LT
SE/H/0126/002
LT/1/05/0177/017
TAKEDA AS
LT
SE/H/0126/002
LT/1/05/0177/018
TAKEDA AS
LT
SE/H/0126/002
LT/1/05/0177/019
TAKEDA AS
LT
SE/H/0126/002
LT/1/05/0177/020
TAKEDA AS
LT
SE/H/0126/002
LT/1/05/0177/021
TAKEDA AS
LT
mg/800 TV kramtomosios
tabletės
Calcigran Forte 1000
mg/800 TV kramtomosios
tabletės
Calcigran Forte 1000
mg/800 TV kramtomosios
tabletės
Calcigran Forte 1000
mg/800 TV kramtomosios
tabletės
Calcigran Forte 1000
mg/800 TV kramtomosios
tabletės
Calcigran Forte 1000
mg/800 TV kramtomosios
tabletės
Calcigran Forte 1000
mg/800 TV kramtomosios
tabletės
Calcigran Forte 1000
mg/800 TV kramtomosios
tabletės
Calcigran Forte 1000
mg/800 TV kramtomosios
tabletės
List of nationally authorised medicinal products
EMA/434947/2017
Page 15/50
Product Name (in
authorisation country)
MRP/DCP
Authorisation
number
National Authorisation Number
MAH of product in the
member state
Member State where
product is authorised
Calcigran Forte 1000
SE/H/0126/002
LT/1/05/0177/022
TAKEDA AS
LT
SE/H/0126/008
LT/1/05/3786/001
TAKEDA AS
LT
SE/H/0126/008
LT/1/05/3786/002
TAKEDA AS
LT
SE/H/0126/008
LT/1/05/3786/003
TAKEDA AS
LT
SE/H/0126/008
LT/1/05/3786/004
TAKEDA AS
LT
SE/H/0126/008
LT/1/05/3786/005
TAKEDA AS
LT
SE/H/0126/003
07-5268
TAKEDA AS
NO
SE/H/0126/001
97-1657
TAKEDA AS
NO
not available
LT/1/2000/1332/001
TAKEDA AS
LT
mg/800 TV kramtomosios
tabletės
Calcigran Forte 500
mg/1000 TV
kramtomosios tabletės
Calcigran Forte 500
mg/1000 TV
kramtomosios tabletės
Calcigran Forte 500
mg/1000 TV
kramtomosios tabletės
Calcigran Forte 500
mg/1000 TV
kramtomosios tabletės
Calcigran Forte 500
mg/1000 TV
kramtomosios tabletės
Calcigran Forte 500
mg/400 IE tabletter,
filmdrasjerte
Calcigran Forte 500
mg/400 IE tyggetabletter
Calcigran Forte 500
mg/400 TV kramtomosios
tabletės
List of nationally authorised medicinal products
EMA/434947/2017
Page 16/50
Product Name (in
authorisation country)
MRP/DCP
Authorisation
number
National Authorisation Number
MAH of product in the
member state
Member State where
product is authorised
Calcigran Forte 500
SE/H/0126/005
09-6986
TAKEDA AS
NO
SE/H/0126/004
09-6985
TAKEDA AS
NO
SE/H/0126/004
700010
TAKEDA PHARMA AS
EE
SE/H/0126/005
10-0340
TAKEDA AS
LV
SE/H/0126/003
10-0061
TAKEDA AS
LV
SE/H/0126/003
LT/1/05/1837/006
TAKEDA AS
LT
SE/H/0126/003
LT/1/05/1837/009
TAKEDA AS
LT
SE/H/0126/003
LT/1/05/1837/001
TAKEDA AS
LT
SE/H/0126/003
LT/1/05/1837/002
TAKEDA AS
LT
mg/800 IE tyggetabletter
med appelsinsmak
Calcigran Forte 500
mg/800 IE tyggetabletter
med sitronsmak
Calcigran Forte D Lemon,
500 mg/800 RÜ
närimistabletid
Calcigran Forte Extra D
500 mg/800 SV
košļājamās tabletes
Calcigran Forte Flex 500
mg/400 SV apvalkotas
tabletes
Calcigran Forte Flex 500
mg/400 TV plevele
dengtos tabletes
Calcigran Forte Flex 500
mg/400 TV plevele
dengtos tabletes
Calcigran Forte Flex 500
mg/400 TV plėvele
dengtos tabletės
Calcigran Forte Flex 500
mg/400 TV plėvele
dengtos tabletės
List of nationally authorised medicinal products
EMA/434947/2017
Page 17/50
Product Name (in
authorisation country)
MRP/DCP
Authorisation
number
National Authorisation Number
MAH of product in the
member state
Member State where
product is authorised
Calcigran Forte Flex 500
SE/H/0126/003
LT/1/05/1837/003
TAKEDA AS
LT
SE/H/0126/003
LT/1/05/1837/004
TAKEDA AS
LT
SE/H/0126/003
LT/1/05/1837/005
TAKEDA AS
LT
SE/H/0126/003
LT/1/05/1837/007
TAKEDA AS
LT
SE/H/0126/003
LT/1/05/1837/008
TAKEDA AS
LT
SE/H/0126/004
LT/1/05/0177/040
TAKEDA AS
LT
SE/H/0126/004
LT/1/05/0177/023
TAKEDA AS
LT
SE/H/0126/004
LT/1/05/0177/024
TAKEDA AS
LT
SE/H/0126/004
LT/1/05/0177/025
TAKEDA AS
LT
mg/400 TV plėvele
dengtos tabletės
Calcigran Forte Flex 500
mg/400 TV plėvele
dengtos tabletės
Calcigran Forte Flex 500
mg/400 TV plėvele
dengtos tabletės
Calcigran Forte Flex 500
mg/400 TV plėvele
dengtos tabletės
Calcigran Forte Flex 500
mg/400 TV plėvele
dengtos tabletės
Calcigran Forte Lemon
500 mg/800 TV
kramtomosios tabletės
Calcigran Forte Lemon
500 mg/800 TV
kramtomosios tabletės
Calcigran Forte Lemon
500 mg/800 TV
kramtomosios tabletės
Calcigran Forte Lemon
500 mg/800 TV
kramtomosios tabletės
List of nationally authorised medicinal products
EMA/434947/2017
Page 18/50
Product Name (in
authorisation country)
MRP/DCP
Authorisation
number
National Authorisation Number
MAH of product in the
member state
Member State where
product is authorised
Calcigran Forte Lemon
SE/H/0126/004
LT/1/05/0177/026
TAKEDA AS
LT
SE/H/0126/004
LT/1/05/0177/027
TAKEDA AS
LT
SE/H/0126/004
LT/1/05/0177/028
TAKEDA AS
LT
SE/H/0126/004
LT/1/05/0177/029
TAKEDA AS
LT
SE/H/0126/004
LT/1/05/0177/030
TAKEDA AS
LT
SE/H/0126/004
LT/1/05/0177/031
TAKEDA AS
LT
SE/H/0126/004
LT/1/05/0177/032
TAKEDA AS
LT
SE/H/0126/004
LT/1/05/0177/033
TAKEDA AS
LT
SE/H/0126/004
LT/1/05/0177/034
TAKEDA AS
LT
500 mg/800 TV
kramtomosios tabletės
Calcigran Forte Lemon
500 mg/800 TV
kramtomosios tabletės
Calcigran Forte Lemon
500 mg/800 TV
kramtomosios tabletės
Calcigran Forte Lemon
500 mg/800 TV
kramtomosios tabletės
Calcigran Forte Lemon
500 mg/800 TV
kramtomosios tabletės
Calcigran Forte Lemon
500 mg/800 TV
kramtomosios tabletės
Calcigran Forte Lemon
500 mg/800 TV
kramtomosios tabletės
Calcigran Forte Lemon
500 mg/800 TV
kramtomosios tabletės
Calcigran Forte Lemon
500 mg/800 TV
kramtomosios tabletės
List of nationally authorised medicinal products
EMA/434947/2017
Page 19/50
Product Name (in
authorisation country)
MRP/DCP
Authorisation
number
National Authorisation Number
MAH of product in the
member state
Member State where
product is authorised
Calcigran Forte Lemon
SE/H/0126/004
LT/1/05/0177/035
TAKEDA AS
LT
SE/H/0126/004
LT/1/05/0177/036
TAKEDA AS
LT
SE/H/0126/004
LT/1/05/0177/037
TAKEDA AS
LT
SE/H/0126/004
LT/1/05/0177/038
TAKEDA AS
LT
SE/H/0126/004
LT/1/05/0177/039
TAKEDA AS
LT
SE/H/0412/001
LT/1/05/0177/001
TAKEDA AS
LT
SE/H/0412/001
LT/1/05/0177/002
TAKEDA AS
LT
SE/H/0412/001
LT/1/05/0177/003
TAKEDA AS
LT
SE/H/0412/001
LT/1/05/0177/004
TAKEDA AS
LT
500 mg/800 TV
kramtomosios tabletės
Calcigran Forte Lemon
500 mg/800 TV
kramtomosios tabletės
Calcigran Forte Lemon
500 mg/800 TV
kramtomosios tabletės
Calcigran Forte Lemon
500 mg/800 TV
kramtomosios tabletės
Calcigran Forte Lemon
500 mg/800 TV
kramtomosios tabletės
Calcigran Forte Mint 500
mg/400 TV kramtomosios
tabletės
Calcigran Forte Mint 500
mg/400 TV kramtomosios
tabletės
Calcigran Forte Mint 500
mg/400 TV kramtomosios
tabletės
Calcigran Forte Mint 500
mg/400 TV kramtomosios
tabletės
List of nationally authorised medicinal products
EMA/434947/2017
Page 20/50
Product Name (in
authorisation country)
MRP/DCP
Authorisation
number
National Authorisation Number
MAH of product in the
member state
Member State where
product is authorised
Calcigran Forte Mint 500
SE/H/0412/001
LT/1/05/0177/005
TAKEDA AS
LT
SE/H/0412/001
LT/1/05/0177/006
TAKEDA AS
LT
SE/H/0412/001
LT/1/05/0177/007
TAKEDA AS
LT
SE/H/0412/001
LT/1/05/0177/008
TAKEDA AS
LT
SE/H/0412/001
464805
TAKEDA PHARMA AS
EE
SE/H/0126/005
LT/1/05/0177/042
TAKEDA AS
LT
SE/H/0126/005
LT/1/05/0177/041
TAKEDA AS
LT
SE/H/0126/005
LT/1/05/0177/043
TAKEDA AS
LT
SE/H/0126/005
LT/1/05/0177/044
TAKEDA AS
LT
mg/400 TV kramtomosios
tabletės
Calcigran Forte Mint 500
mg/400 TV kramtomosios
tabletės
Calcigran Forte Mint 500
mg/400 TV kramtomosios
tabletės
Calcigran Forte Mint 500
mg/400 TV kramtomosios
tabletės
Calcigran Forte Mint, 500
mg/400 RÜ
närimistabletid
Calcigran Forte Orange
500 mg/800 TV
kramtomosios tabletės
Calcigran Forte Orange
500 mg/800 TV
kramtomosios tabletės
Calcigran Forte Orange
500 mg/800 TV
kramtomosios tabletės
Calcigran Forte Orange
500 mg/800 TV
kramtomosios tabletės
List of nationally authorised medicinal products
EMA/434947/2017
Page 21/50
Product Name (in
authorisation country)
MRP/DCP
Authorisation
number
National Authorisation Number
MAH of product in the
member state
Member State where
product is authorised
Calcigran Forte Orange
SE/H/0126/005
LT/1/05/0177/045
TAKEDA AS
LT
SE/H/0126/005
LT/1/05/0177/046
TAKEDA AS
LT
SE/H/0126/005
LT/1/05/0177/047
TAKEDA AS
LT
SE/H/0126/005
LT/1/05/0177/048
TAKEDA AS
LT
SE/H/0126/005
LT/1/05/0177/049
TAKEDA AS
LT
SE/H/0126/005
LT/1/05/0177/050
TAKEDA AS
LT
SE/H/0126/005
LT/1/05/0177/051
TAKEDA AS
LT
SE/H/0126/005
LT/1/05/0177/052
TAKEDA AS
LT
SE/H/0126/005
LT/1/05/0177/053
TAKEDA AS
LT
500 mg/800 TV
kramtomosios tabletės
Calcigran Forte Orange
500 mg/800 TV
kramtomosios tabletės
Calcigran Forte Orange
500 mg/800 TV
kramtomosios tabletės
Calcigran Forte Orange
500 mg/800 TV
kramtomosios tabletės
Calcigran Forte Orange
500 mg/800 TV
kramtomosios tabletės
Calcigran Forte Orange
500 mg/800 TV
kramtomosios tabletės
Calcigran Forte Orange
500 mg/800 TV
kramtomosios tabletės
Calcigran Forte Orange
500 mg/800 TV
kramtomosios tabletės
Calcigran Forte Orange
500 mg/800 TV
kramtomosios tabletės
List of nationally authorised medicinal products
EMA/434947/2017
Page 22/50
Product Name (in
authorisation country)
MRP/DCP
Authorisation
number
National Authorisation Number
MAH of product in the
member state
Member State where
product is authorised
Calcigran Forte Orange
SE/H/0126/005
LT/1/05/0177/054
TAKEDA AS
LT
SE/H/0126/005
LT/1/05/0177/055
TAKEDA AS
LT
SE/H/0126/005
LT/1/05/0177/056
TAKEDA AS
LT
SE/H/0126/005
LT/1/05/0177/057
TAKEDA AS
LT
SE/H/0126/005
LT/1/05/0177/058
TAKEDA AS
LT
SE/H/0126/008
878015
TAKEDA PHARMA AS
EE
SE/H/0412/001
04-2980
TAKEDA AS
NO
SE/H/0126/004
79553.00.00
TAKEDA GMBH (KONSTANZ)
DE
not available
1-25486
TAKEDA PHARMA GES.M.B.H.
AT
500 mg/800 TV
kramtomosios tabletės
Calcigran Forte Orange
500 mg/800 TV
kramtomosios tabletės
Calcigran Forte Orange
500 mg/800 TV
kramtomosios tabletės
Calcigran Forte Orange
500 mg/800 TV
kramtomosios tabletės
Calcigran Forte Orange
500 mg/800 TV
kramtomosios tabletės
Calcigran Forte Red 500
mg/1000 RÜ
närimistabletid
Calcigran Forte spearmint
500 mg/400 IE
tyggetabletter
Calcimagon® Extra D3,
500 mg / 800 I.E.,
Kautabletten
Calcimagon®-D3 Kautabletten
List of nationally authorised medicinal products
EMA/434947/2017
Page 23/50
Product Name (in
authorisation country)
MRP/DCP
Authorisation
number
National Authorisation Number
MAH of product in the
member state
Member State where
product is authorised
Calcimagon®-D3 UNO,
SE/H/0126/002
78240.00.00
TAKEDA GMBH (KONSTANZ)
DE
DE/H/0843/001
40923.00.00
TAKEDA GMBH (KONSTANZ)
DE
not available
66.063
ISDIN, S.A.
ES
SE/H/0126/002
18468/29-2-2016
TAKEDA HELLAS S.A.
GR
SE/H/0126/003
24147/15/24-05-2016
TAKEDA HELLAS S.A.
GR
SE/H/0126/001
34250
TAKEDA HELLAS S.A.
GR
SE/H/0126/001
37742/13-05-2016
TAKEDA HELLAS S.A.
GR
SE/H/0126/004
37743/13-05-2016
TAKEDA HELLAS S.A.
GR
not available
3400936012431
ALFA WASSERMANN PHARMA
FR
1.000 mg/800 I.E.,
Kautabletten
Calcimagon®-D3, 500
mg / 400 I.E,
Kautabletten
Calcio D Isdin
Comprimidos masticables
Calcioral D3® 1000 mg +
20 μg (800 IU) μασώμενο
δισκίο
Calcioral D3® 500 mg +
10 μg (400 IU)
επικαλυμμένο με λεπτό
υμένιο δισκίο
Calcioral D3® 500 mg +
10 μg (400 IU) μασώμενο
δισκίο
Calcioral D3® 500 mg +
10 μg (400 IU) μασώμενο
δισκίο
Calcioral D3® Forte 500
mg + 20 μg (800 IU)
μασώμενο δισκίο
CALCIPRAT VITAMINE D3
1000 mg/800 UI,
comprimé à sucer
List of nationally authorised medicinal products
EMA/434947/2017
Page 24/50
Product Name (in
authorisation country)
MRP/DCP
Authorisation
number
National Authorisation Number
MAH of product in the
member state
Member State where
product is authorised
CALCIPRAT VITAMINE D3
not available
3400937389532
ALFA WASSERMANN PHARMA
FR
not available
3400934115608
ALFA WASSERMANN PHARMA
FR
not available
1-25573
MEDA PHARMA GMBH
AT
not available
3400935646026
BIOGARAN
FR
not available
NL26675
TEVA SANTÉ
FR
not available
NL25498
TEVA SANTÉ
FR
not available
34009 416 034 4 0
ZYDUS FRANCE
FR
not available
34009 416 031 5 0
ZYDUS FRANCE
FR
1000 mg/800 UI,
comprimé à sucer
CALCIPRAT VITAMINE D3
500 mg/400 UI,
comprimé à sucer
Calcium Vit.D3 "Meda"
500mg/400 I.E.Kautabletten
CALCIUM VITAMINE D3
BIOGARAN® 500 mg/400
UI, comprimé à sucer
CALCIUM VITAMINE D3
RATIOPHARM 500
mg/400 UI, comprimé à
sucer ou à croquer
CALCIUM VITAMINE D3
TEVA 500 mg/400 UI,
comprimé à sucer ou à
croquer
CALCIUM VITAMINE D3
ZYDUS 500 mg/400 U.I.,
comprimé à sucer ou à
croquer
CALCIUM VITAMINE D3
ZYDUS 500 mg/400 U.I.,
comprimé à sucer ou à
croquer
List of nationally authorised medicinal products
EMA/434947/2017
Page 25/50
Product Name (in
authorisation country)
MRP/DCP
Authorisation
number
National Authorisation Number
MAH of product in the
member state
Member State where
product is authorised
CALCIUM VITAMINE D3
not available
34009 416 032 1 1
ZYDUS FRANCE
FR
not available
34009 416 033 8 9
ZYDUS FRANCE
FR
not available
34009 416 035 0 1
ZYDUS FRANCE
FR
not available
34009 416 036 7 9
ZYDUS FRANCE
FR
not available
34009 416 037 3 0
ZYDUS FRANCE
FR
not available
34009 416 039 6 9
ZYDUS FRANCE
FR
not available
34009 416 040 4 1
ZYDUS FRANCE
FR
ZYDUS 500 mg/400 U.I.,
comprimé à sucer ou à
croquer
CALCIUM VITAMINE D3
ZYDUS 500 mg/400 U.I.,
comprimé à sucer ou à
croquer
CALCIUM VITAMINE D3
ZYDUS 500 mg/400 U.I.,
comprimé à sucer ou à
croquer
CALCIUM VITAMINE D3
ZYDUS 500 mg/400 U.I.,
comprimé à sucer ou à
croquer
CALCIUM VITAMINE D3
ZYDUS 500 mg/400 U.I.,
comprimé à sucer ou à
croquer
CALCIUM VITAMINE D3
ZYDUS 500 mg/400 U.I.,
comprimé à sucer ou à
croquer
CALCIUM VITAMINE D3
ZYDUS 500 mg/400 U.I.,
comprimé à sucer ou à
croquer
List of nationally authorised medicinal products
EMA/434947/2017
Page 26/50
Product Name (in
authorisation country)
MRP/DCP
Authorisation
number
National Authorisation Number
MAH of product in the
member state
Member State where
product is authorised
CALCIUM VITAMINE D3
not available
34009 416 041 0 2
ZYDUS FRANCE
FR
not available
34009 416 042 7 0
ZYDUS FRANCE
FR
not available
34009 416 043 3 1
ZYDUS FRANCE
FR
not available
34009 416 045 6 0
ZYDUS FRANCE
FR
not available
34009 416 046 2 1
ZYDUS FRANCE
FR
not available
34009 416 047 9 9
ZYDUS FRANCE
FR
not available
34009 416 048 5 0
ZYDUS FRANCE
FR
ZYDUS 500 mg/400 U.I.,
comprimé à sucer ou à
croquer
CALCIUM VITAMINE D3
ZYDUS 500 mg/400 U.I.,
comprimé à sucer ou à
croquer
CALCIUM VITAMINE D3
ZYDUS 500 mg/400 U.I.,
comprimé à sucer ou à
croquer
CALCIUM VITAMINE D3
ZYDUS 500 mg/400 U.I.,
comprimé à sucer ou à
croquer
CALCIUM VITAMINE D3
ZYDUS 500 mg/400 U.I.,
comprimé à sucer ou à
croquer
CALCIUM VITAMINE D3
ZYDUS 500 mg/400 U.I.,
comprimé à sucer ou à
croquer
CALCIUM VITAMINE D3
ZYDUS 500 mg/400 U.I.,
comprimé à sucer ou à
croquer
List of nationally authorised medicinal products
EMA/434947/2017
Page 27/50
Product Name (in
authorisation country)
MRP/DCP
Authorisation
number
National Authorisation Number
MAH of product in the
member state
Member State where
product is authorised
Calcium Wyeth®
not available
8712836
PFIZER BIOFARMACEUTICA,
PT
comprimido revestido
SOCIEDADE UNIPESSOAL
LDA
Calcium Wyeth®
not available
8712828
comprimido revestido
PFIZER BIOFARMACEUTICA,
PT
SOCIEDADE UNIPESSOAL
LDA
Calcium-DSandoz 600mg
DE/H/0198/001
3211588
+ 400IU, comprimidos
SANDOZ FARMACÊUTICA
PT
LDA.
efervescentes
Calcium-DSandoz 600mg
DE/H/0198/001
3211687
+ 400IU, comprimidos
SANDOZ FARMACÊUTICA
PT
LDA.
efervescentes
Calcium-DSandoz 600mg
DE/H/0198/001
3211885
+ 400IU, comprimidos
SANDOZ FARMACÊUTICA
PT
LDA.
efervescentes
Calcium-DSandoz 600mg
DE/H/0198/001
3211786
+ 400IU, comprimidos
SANDOZ FARMACÊUTICA
PT
LDA.
efervescentes
Calcivit D® forte
not available
46565.00.00
HEXAL AG
DE
not available
1880/2009/01
RECORDATI ROMANIA SRL
RO
Brausetabletten, 1000
mg/880 I.E.|Wirkstoffe:
Calciumcarbonat und
Colecalciferol
CALDEFIX 1000
mg/880UI, comprimate
efervescente
List of nationally authorised medicinal products
EMA/434947/2017
Page 28/50
Product Name (in
authorisation country)
MRP/DCP
Authorisation
number
National Authorisation Number
MAH of product in the
member state
Member State where
product is authorised
CALDEVITA, comprimé
not available
34009 344 137 7 3
BAYER HEALTHCARE
FR
not available
34009 344 138 3 4
BAYER HEALTHCARE
FR
not available
34009 344 140 8 4
BAYER HEALTHCARE
FR
not available
34009 344 136 0 5
BAYER HEALTHCARE
FR
SE/H/0126/002
1-29825
TAKEDA AUSTRIA GMBH
AT
SE/H/0126/003
1-29826
TAKEDA AUSTRIA GMBH
AT
SE/H/0126/001
1-22817
TAKEDA AUSTRIA GMBH
AT
SE/H/0126/004
1-29720
TAKEDA AUSTRIA GMBH
AT
SE/H/0126/005
1-29721
TAKEDA AUSTRIA GMBH
AT
effervescent
CALDEVITA, comprimé
effervescent
CALDEVITA, comprimé
effervescent
CALDEVITA, comprimé
effervescent
Cal-D-or 1000 mg/800
I.E. - Kautabletten
Cal-D-or 500 mg/400 I.E.
- Filmtabletten
Cal-D-or 500 mg/400 I.E.
- Kautabletten
Cal-D-or Lemon 500
mg/800 I.E. Kautabletten
Cal-D-or Orange 500
mg/800 I.E. Kautabletten
List of nationally authorised medicinal products
EMA/434947/2017
Page 29/50
Product Name (in
authorisation country)
MRP/DCP
Authorisation
number
National Authorisation Number
MAH of product in the
member state
Member State where
product is authorised
CAL-D-VITA 600 MG /400
not available
6143/2006/01
BAYER SRL
RO
not available
6143/2006/02
BAYER SRL
RO
SE/H/0134/002
13384
BAYER AB
SE
not available
5200/2005/01
BAYER SRL
RO
not available
5200/2005/02
BAYER SRL
RO
SE/H/0134/001
13383
BAYER AB
SE
SE/H/0134/002
1-22440
BAYER AUSTRIA GMBH
AT
not available
023651058
A. MENARINI - INDUSTRIE
IT
UI, comprimate
masticabile
CAL-D-VITA 600 MG /400
UI, comprimate
masticabile
Cal-D-Vita 600 mg/400
IE tuggtablett
CAL-D-VITA 600 mg/400
UI, comprimate
efervescente
CAL-D-VITA 600 mg/400
UI, comprimate
efervescente
Cal-D-Vita 600mg/400
IE, brustablett
CAL-D-VITA® Kautabletten
Calisvit
FARMACEUTICHE RIUNITE S.R.L.
Calperos D3 1250 mg/
not available
LT/1/99/0526/001
BOUCHARA RECORDATI
LT
400 TV tabletės
List of nationally authorised medicinal products
EMA/434947/2017
Page 30/50
Product Name (in
authorisation country)
MRP/DCP
Authorisation
number
National Authorisation Number
MAH of product in the
member state
Member State where
product is authorised
CALPEROS D3, comprimé
not available
346 298-8
BOUCHARA RECORDATI
FR
not available
34009 346 297 1 6
BOUCHARA RECORDATI
FR
not available
34009 366 749 5 0
BOUCHARA RECORDATI
FR
not available
34009 341 157 7 6
BOUCHARA RECORDATI
FR
not available
34009 372 234 3 0
BOUCHARA RECORDATI
FR
not available
0241648
BOUCHARA RECORDATI
LU
not available
OGYI-T-22788/01
PHARMA PATENT KFT.
HU
not available
OGYI-T-22788/02
PHARMA PATENT KFT.
HU
not available
9937136
MEDA PHARMA – PRODUTOS
PT
à sucer
CALPEROS D3, comprimé
à sucer
CALPEROS D3, comprimé
à sucer
CALPEROS D3, comprimé
à sucer
CALPEROS D3, comprimé
à sucer
CALPEROS D3, comprimé
à sucer
CITROKALCIUMD 300
mg/300 NE tabletta
CitrokalciumD 300
mg/300 NE tabletta
DAGRAVIT D-CALCIUM
250 mg + 250 mg + 100
FARMACÊUTICOS, S.A.
U.I., Comprimido para
mastigar
List of nationally authorised medicinal products
EMA/434947/2017
Page 31/50
Product Name (in
authorisation country)
MRP/DCP
Authorisation
number
National Authorisation Number
MAH of product in the
member state
Member State where
product is authorised
DISNAL comprimidos
not available
62871
ITALFARMACO S.A.
ES
not available
BE184877
WILL-PHARMA S.A.
BE
not available
0489/03077784
WILL-PHARMA LUXEMBOURG
LU
not available
BE184861
WILL-PHARMA S.A.
BE
not available
0489/03077785
WILL-PHARMA LUXEMBOURG
LU
not available
BE474924
WILL-PHARMA S.A.
BE
not available
32840011
AMDIPHARM LIMITED
IT
not available
32840023
AMDIPHARM LIMITED
IT
not available
032840047
AMDIPHARM LIMITED
IT
masticables
D-vital 500/440 Calcium /
Vitamine D3 Granulés
effervescents
D-vital 500/440 Calcium /
Vitamine D3 granulés
effervescents
D-vital Forte 1000/880
Calcium / Vitamine D3
Bruisgranulaat
D-vital Forte 1000/880
Calcium / Vitamine D3
granulés effervescents
D-vital forte citron 1000
mg/880 UI, granulés
effervescents
EUROCAL D3 1000
mg/880 U.I, granulato
effervescente
EUROCAL D3 1000
mg/880 U.I, granulato
effervescente
EUROCAL D3 500 mg /
440 U.I., granulato
effervescente
List of nationally authorised medicinal products
EMA/434947/2017
Page 32/50
Product Name (in
authorisation country)
MRP/DCP
Authorisation
number
National Authorisation Number
MAH of product in the
member state
Member State where
product is authorised
EUROCAL D3 500 mg /
not available
032840050
AMDIPHARM LIMITED
IT
not available
34009 364 247 2 2
LABORATOIRES
FR
440 U.I., granulato
effervescente
FIXICAL VITAMINE D3
1000 mg/800 UI,
EXPANSCIENCE
comprimé à sucer
FIXICAL VITAMINE D3
not available
34009 376 287 4 7
1000 mg/800 UI,
LABORATOIRES
FR
EXPANSCIENCE
comprimé à sucer
Ideos
not available
39/0263/03-S
LABORATOIRE INNOTECH
SK
INTERNATIONAL
Ideos
not available
39/0263/03-S
LABORATOIRE INNOTECH
SK
INTERNATIONAL
Ideos 500 mg / 400 IE
not available
34358.00.00
Kautabletten
Ideos 500 mg / 400 IE
not available
34358.00.00
LABORATOIRE INNOTECH
DE
INTERNATIONAL
not available
OGYI-T- 8315/01
rágótabletta
Ideos 500 mg/400 NE
DE
INTERNATIONAL
Kautabletten
Ideos 500 mg/400 NE
LABORATOIRE INNOTECH
LABORATOIRE INNOTECH
HU
INTERNATIONAL
not available
rágótabletta
List of nationally authorised medicinal products
EMA/434947/2017
OGYI-T- 8315/02
LABORATOIRE INNOTECH
HU
INTERNATIONAL
Page 33/50
Product Name (in
authorisation country)
MRP/DCP
Authorisation
number
National Authorisation Number
MAH of product in the
member state
Member State where
product is authorised
Ideos 500 mg/400 NE
not available
OGYI-T- 8315/01
LABORATOIRE INNOTECH
HU
rágótabletta
Ideos 500 mg/400 NE
INTERNATIONAL
not available
OGYI-T- 8315/02
rágótabletta
IDEOS 500 mg/400 RÜ
not available
458404
not available
458404
not available
8017/2006/01
not available
8017/2006/02
not available
8017/2006/01
LABORATOIRE INNOTECH
RO
LABORATOIRE INNOTECH
RO
LABORATOIRE INNOTECH
RO
INTERNATIONAL
not available
8017/2006/02
Comprimate masticabile
IDEOS 500 mg/400 UI,
EE
INTERNATIONAL
Comprimate masticabile
IDEOS 500 mg/400 UI,
LABORATOIRE INNOTECH
INTERNATIONAL
Comprimate masticabile
IDEOS 500 mg/400 UI,
EE
INTERNATIONAL
Comprimate masticabile
IDEOS 500 mg/400 UI,
LABORATOIRE INNOTECH
INTERNATIONAL
närimistabletid
IDEOS 500 mg/400 UI,
HU
INTERNATIONAL
närimistabletid
IDEOS 500 mg/400 RÜ
LABORATOIRE INNOTECH
LABORATOIRE INNOTECH
RO
INTERNATIONAL
FR/H/0114/001
comprimé à sucer ou à
360 752-4
LABORATOIRE INNOTECH
FR
INTERNATIONAL
croquer
List of nationally authorised medicinal products
EMA/434947/2017
Page 34/50
Product Name (in
authorisation country)
MRP/DCP
Authorisation
number
National Authorisation Number
MAH of product in the
member state
Member State where
product is authorised
IDEOS 500 mg/400 UI,
FR/H/0114/001
342 533-2
LABORATOIRE INNOTECH
FR
comprimé à sucer ou à
INTERNATIONAL
croquer
IDEOS 500 mg/400 UI,
FR/H/0114/001
342 534-9
comprimé à sucer ou à
LABORATOIRE INNOTECH
FR
INTERNATIONAL
croquer
IDEOS 500 mg/400 UI,
FR/H/0114/001
338 097-7
comprimé à sucer ou à
LABORATOIRE INNOTECH
FR
INTERNATIONAL
croquer
IDEOS 500 mg/400 UI,
FR/H/0114/001
347 338-3
comprimé à sucer ou à
LABORATOIRE INNOTECH
FR
INTERNATIONAL
croquer
IDEOS 500 mg/400 UI,
FR/H/0114/001
563 749-8
comprimé à sucer ou à
LABORATOIRE INNOTECH
FR
INTERNATIONAL
croquer
IDEOS 500 mg/400 UI,
FR/H/0114/001
360 752-4
comprimé à sucer ou à
LABORATOIRE INNOTECH
FR
INTERNATIONAL
croquer
IDEOS 500 mg/400 UI,
FR/H/0114/001
342 533-2
comprimé à sucer ou à
LABORATOIRE INNOTECH
FR
INTERNATIONAL
croquer
IDEOS 500 mg/400 UI,
FR/H/0114/001
342 534-9
comprimé à sucer ou à
LABORATOIRE INNOTECH
FR
INTERNATIONAL
croquer
IDEOS 500 mg/400 UI,
FR/H/0114/001
comprimé à sucer ou à
338 097-7
LABORATOIRE INNOTECH
FR
INTERNATIONAL
croquer
List of nationally authorised medicinal products
EMA/434947/2017
Page 35/50
Product Name (in
authorisation country)
MRP/DCP
Authorisation
number
National Authorisation Number
MAH of product in the
member state
Member State where
product is authorised
IDEOS 500 mg/400 UI,
FR/H/0114/001
347 338-3
LABORATOIRE INNOTECH
FR
comprimé à sucer ou à
INTERNATIONAL
croquer
IDEOS 500 mg/400 UI,
FR/H/0114/001
563 749-8
comprimé à sucer ou à
LABORATOIRE INNOTECH
FR
INTERNATIONAL
croquer
IDEOS 500mg/400 IU
not available
PA1033/001/001
Chewable Tablets
IDEOS 500mg/400 IU
not available
PA1033/001/001
not available
97/4704/7
IE
LABORATOIRE INNOTECH
LT
INTERNATIONAL
not available
97/4704/7
tabletės
IDÉOS TYGGETABLETTER
LABORATOIRE INNOTECH
INTERNATIONAL
tabletės
Ideos Kramtomosios
IE
INTERNATIONAL
Chewable Tablets
Ideos Kramtomosios
LABORATOIRE INNOTECH
LABORATOIRE INNOTECH
LT
INTERNATIONAL
not available
97-2598
LABORATOIRE INNOTECH
NO
INTERNATIONAL
IDÉOS TYGGETABLETTER
not available
97-2598
LABORATOIRE INNOTECH
NO
INTERNATIONAL
IDEOS, 500 mg /400 UI
FR/H/0114/001
Comprimido para
2711380
LABORATOIRE INNOTECH
PT
INTERNATIONAL
mastigar
List of nationally authorised medicinal products
EMA/434947/2017
Page 36/50
Product Name (in
authorisation country)
MRP/DCP
Authorisation
number
National Authorisation Number
MAH of product in the
member state
Member State where
product is authorised
IDEOS, 500 mg /400 UI
FR/H/0114/001
2585784
LABORATOIRE INNOTECH
PT
Comprimido para
INTERNATIONAL
mastigar
IDEOS, 500 mg /400 UI
FR/H/0114/001
2585883
Comprimido para
LABORATOIRE INNOTECH
PT
INTERNATIONAL
mastigar
IDEOS, 500 mg /400 UI
FR/H/0114/001
2585982
Comprimido para
LABORATOIRE INNOTECH
PT
INTERNATIONAL
mastigar
IDEOS, 500 mg /400 UI
FR/H/0114/001
2711489
Comprimido para
LABORATOIRE INNOTECH
PT
INTERNATIONAL
mastigar
IDEOS, 500 mg /400 UI
FR/H/0114/001
2586089
Comprimido para
LABORATOIRE INNOTECH
PT
INTERNATIONAL
mastigar
IDEOS, 500 mg /400 UI
FR/H/0114/001
4162384
Comprimido para
LABORATOIRE INNOTECH
PT
INTERNATIONAL
mastigar
IDEOS, 500 mg /400 UI
FR/H/0114/001
2711380
Comprimido para
LABORATOIRE INNOTECH
PT
INTERNATIONAL
mastigar
IDEOS, 500 mg /400 UI
FR/H/0114/001
2585784
Comprimido para
LABORATOIRE INNOTECH
PT
INTERNATIONAL
mastigar
IDEOS, 500 mg /400 UI
FR/H/0114/001
Comprimido para
2585883
LABORATOIRE INNOTECH
PT
INTERNATIONAL
mastigar
List of nationally authorised medicinal products
EMA/434947/2017
Page 37/50
Product Name (in
authorisation country)
MRP/DCP
Authorisation
number
National Authorisation Number
MAH of product in the
member state
Member State where
product is authorised
IDEOS, 500 mg /400 UI
FR/H/0114/001
2585982
LABORATOIRE INNOTECH
PT
Comprimido para
INTERNATIONAL
mastigar
IDEOS, 500 mg /400 UI
FR/H/0114/001
2711489
Comprimido para
LABORATOIRE INNOTECH
PT
INTERNATIONAL
mastigar
IDEOS, 500 mg /400 UI
FR/H/0114/001
2586089
Comprimido para
LABORATOIRE INNOTECH
PT
INTERNATIONAL
mastigar
IDEOS, 500 mg /400 UI
FR/H/0114/001
4162384
Comprimido para
LABORATOIRE INNOTECH
PT
INTERNATIONAL
mastigar
IDEOS, 500 mg/400 IU
FR/H/0114/001
75221/1-11-2011
VIANEX S.A.
GR
FR/H/0114/001
75221/1-11-2011
VIANEX S.A.
GR
FR/H/0114/001
034213013
MEDA PHARMA S.P.A.
IT
FR/H/0114/001
034213025
MEDA PHARMA S.P.A.
IT
FR/H/0114/001
034213037
MEDA PHARMA S.P.A.
IT
Μασώμενα Δισκία
IDEOS, 500 mg/400 IU
Μασώμενα Δισκία
IDEOS, 500 mg/400 UI
Compresse masticabili
IDEOS, 500 mg/400 UI
Compresse masticabili
IDEOS, 500 mg/400 UI
Compresse masticabili
List of nationally authorised medicinal products
EMA/434947/2017
Page 38/50
Product Name (in
authorisation country)
MRP/DCP
Authorisation
number
National Authorisation Number
MAH of product in the
member state
Member State where
product is authorised
IDEOS, 500 mg/400 UI
FR/H/0114/001
034213049
MEDA PHARMA S.P.A.
IT
FR/H/0114/001
034213052
MEDA PHARMA S.P.A.
IT
FR/H/0114/001
034213064
MEDA PHARMA S.P.A.
IT
FR/H/0114/001
034213013
MEDA PHARMA S.P.A.
IT
FR/H/0114/001
034213025
MEDA PHARMA S.P.A.
IT
FR/H/0114/001
034213037
MEDA PHARMA S.P.A.
IT
FR/H/0114/001
034213049
MEDA PHARMA S.P.A.
IT
FR/H/0114/001
034213052
MEDA PHARMA S.P.A.
IT
FR/H/0114/001
034213064
MEDA PHARMA S.P.A.
IT
Compresse masticabili
IDEOS, 500 mg/400 UI
Compresse masticabili
IDEOS, 500 mg/400 UI
Compresse masticabili
IDEOS, 500 mg/400 UI
Compresse masticabili
IDEOS, 500 mg/400 UI
Compresse masticabili
IDEOS, 500 mg/400 UI
Compresse masticabili
IDEOS, 500 mg/400 UI
Compresse masticabili
IDEOS, 500 mg/400 UI
Compresse masticabili
IDEOS, 500 mg/400 UI
Compresse masticabili
List of nationally authorised medicinal products
EMA/434947/2017
Page 39/50
Product Name (in
authorisation country)
MRP/DCP
Authorisation
number
National Authorisation Number
MAH of product in the
member state
Member State where
product is authorised
IDEOS, Chewable tablets
not available
MA093/00201
LABORATOIRE INNOTECH
MT
INTERNATIONAL
IDEOS, Chewable tablets
not available
MA093/00201
LABORATOIRE INNOTECH
MT
INTERNATIONAL
KOMBI-KALZ 1000/880
not available
39/252/00-C
MEDA PHARMA S.R.O.
CZ
Kombi-Kalz 1000/880
not available
39/0172/00-S
MEDA PHARMA GMBH
SK
Kombi-Kalz 500mg/400
not available
1-25151
MEDA PHARMA GMBH
AT
SE/H/0126/008
79937
TAKEDA FARMACÉUTICA
ES
I.E.Vit. D3 - Kautabletten
Mastical D 500 mg/1000
U.I comprimidos
ESPAÑA S.A
masticables sabor fresa
Mastical D 500 mg/1000
SE/H/0126/007
79939
U.I comprimidos
TAKEDA FARMACÉUTICA
ES
ESPAÑA S.A
masticables sabor limón
Mastical D 500 mg/400
SE/H/0126/006
79938
U.I comprimidos
TAKEDA FARMACÉUTICA
ES
ESPAÑA S.A
masticables sabor fresa
Mastical D 500 mg/400
not available
UI comprimidos
65.097
TAKEDA FARMACÉUTICA
ES
ESPAÑA S.A
masticables sabor
naranja
List of nationally authorised medicinal products
EMA/434947/2017
Page 40/50
Product Name (in
authorisation country)
MRP/DCP
Authorisation
number
National Authorisation Number
MAH of product in the
member state
Member State where
product is authorised
Mastical D 500 mg/800
SE/H/0126/004
72.582
TAKEDA FARMACÉUTICA
ES
UI comprimidos
ESPAÑA S.A
masticables
Mastical D sabor limón
SE/H/0126/001
67.800
500 mg/400 UI
TAKEDA FARMACÉUTICA
ES
ESPAÑA S.A
comprimidos masticables
Mastical D Unidia 1000
SE/H/0126/002
71639
mg/800 UI comprimidos
TAKEDA FARMACÉUTICA
ES
ESPAÑA S.A
masticables
Maxi-Kalz Vit. D3 1000
FR/H/0103/002
1-21503
MEDA PHARMA GMBH
AT
not available
1-25150
MEDA PHARMA GMBH
AT
SE/H/0411/001
00-7420
TAKEDA AS
NO
SE/H/0412/001
11390
TAKEDA PHARMA SP.Z.O.O.
PL
SE/H/0554/001
NL 31018
TEVA SANTÉ
FR
not available
NL 20442
TEVA SANTÉ
FR
mg/880 I.E. - Granulat
Maxi-Kalz Vit. D3 500
mg/400 I.E.-Kautabletten
Nycoplus Calcigran 500
mg/200 IE tyggetabletter
Orocal D3, 500 mg + 10
μg (400 j.m.), tabletki do
żucia
Orocal Vitamine D3 500
mg/200 UI, comprimé à
sucer
OROCAL VITAMINE D3
500 mg/400 U.I.,
comprimé à sucer
List of nationally authorised medicinal products
EMA/434947/2017
Page 41/50
Product Name (in
authorisation country)
MRP/DCP
Authorisation
number
National Authorisation Number
MAH of product in the
member state
Member State where
product is authorised
OROTRE 500 mg + 400
not available
033861028
TAKEDA ITALIA S.P.A.
IT
not available
033861016
TAKEDA ITALIA S.P.A.
IT
not available
24509-3400938751536
LABORATOIRES SCIENCEX
FR
DE/H/0372/001
62.474
MERCK, S.L.
ES
DE/H/0372/001
348 810-8
MERCK SANTÉ S.A.S.
FR
DE/H/0372/001
348 807-7
MERCK SANTÉ S.A.S.
FR
DE/H/0372/001
351 546-6
MERCK SANTÉ S.A.S.
FR
DE/H/0372/001
348 805-4
MERCK SANTÉ S.A.S.
FR
UI compresse
OROTRE 500 mg + 400
UI compresse
OSSEANS VITAMINE D3
500 mg/400 UI,
comprimé à sucer ou à
croquer
OSTEOMERCK 1200 mg /
800 UI polvo para
suspensión oral
OSTRAM VITAMINE D3
1200 mg/800 U.I.,
poudre pour suspension
buvable en sachet-dose
OSTRAM VITAMINE D3
1200 mg/800 U.I.,
poudre pour suspension
buvable en sachet-dose
OSTRAM VITAMINE D3
1200 mg/800 U.I.,
poudre pour suspension
buvable en sachet-dose
OSTRAM VITAMINE D3
1200 mg/800 U.I.,
poudre pour suspension
buvable en sachet-dose
List of nationally authorised medicinal products
EMA/434947/2017
Page 42/50
Product Name (in
authorisation country)
MRP/DCP
Authorisation
number
National Authorisation Number
MAH of product in the
member state
Member State where
product is authorised
OSTRAM VITAMINE D3
DE/H/0372/001
348 808-3
MERCK SANTÉ S.A.S.
FR
DE/H/0372/001
348 806-0
MERCK SANTÉ S.A.S.
FR
not available
68428
FARMASIERRA
ES
1200 mg/800 U.I.,
poudre pour suspension
buvable en sachet-dose
OSTRAM VITAMINE D3
1200 mg/800 U.I.,
poudre pour suspension
buvable en sachet-dose
Reliveran 600 mg/400 UI
comprimidos
Sandocal®-D 1000
LABORATORIOS, S.L.
not available
38695.01.00
HEXAL AG
DE
not available
38695.00.00
HEXAL AG
DE
SE/H/0126/003
BE362582
TAKEDA BELGIUM SCA/CVA
BE
SE/H/0126/003
BE362582
TAKEDA BELGIUM SCA/CVA
BE
SE/H/0126/003
2010060035
TAKEDA BELGIUM SCA/CVA
LU
SE/H/0126/003
BE362582
TAKEDA BELGIUM SCA/CVA
BE
mg/880 I.E.
Brausegranulat
Sandocal®-D 500
mg/440 I.E.
Brausegranulat
Steovit D3 500 mg/400
I.E. filmomhulde
tabletten
Steovit D3 500 mg/400
I.E. Filmtabletten
Steovit D3 500 mg/400
I.E. Filmtabletten
Steovit D3 500 mg/400
U.I. comprimés pelliculés
List of nationally authorised medicinal products
EMA/434947/2017
Page 43/50
Product Name (in
authorisation country)
MRP/DCP
Authorisation
number
National Authorisation Number
MAH of product in the
member state
Member State where
product is authorised
Steovit D3 500 mg/400
SE/H/0126/003
2010060035
TAKEDA BELGIUM SCA/CVA
LU
SE/H/0126/008
BE476933
TAKEDA BELGIUM SCA/CVA
BE
SE/H/0126/006
BE476915
TAKEDA BELGIUM SCA/CVA
BE
SE/H/0126/005
BE377535
TAKEDA BELGIUM SCA/CVA
BE
SE/H/0126/005
BE377544
TAKEDA BELGIUM SCA/CVA
BE
SE/H/0126/005
2011040073
TAKEDA BELGIUM SCA/CVA
LU
SE/H/0126/007
BE476924
TAKEDA BELGIUM SCA/CVA
BE
SE/H/0126/001
BE324922
TAKEDA BELGIUM SCA/CVA
BE
SE/H/0126/001
BE221426
TAKEDA BELGIUM SCA/CVA
BE
U.I. comprimés pelliculés
Steovit D3
aardbei/watermeloen 500
mg/1000 I.E.
kauwtabletten
Steovit D3
aardbei/watermeloen 500
mg/400 I.E.
kauwtabletten
Steovit D3 Apfelsine
500mg/800 I.E.
Kautabletten
Steovit D3 Apfelsine
500mg/800 I.E.
Kautabletten
Steovit D3 Apfelsine
500mg/800 I.E.
Kautabletten
Steovit D3 citroen 500
mg/1000 I.E.
kauwtabletten
Steovit D3 citroen 500
mg/400 I.E.
kauwtabletten
Steovit D3 citroen 500
mg/400 I.E.
List of nationally authorised medicinal products
EMA/434947/2017
Page 44/50
Product Name (in
authorisation country)
MRP/DCP
Authorisation
number
National Authorisation Number
MAH of product in the
member state
Member State where
product is authorised
SE/H/0126/007
BE476924
TAKEDA BELGIUM SCA/CVA
BE
SE/H/0126/007
2016110329
TAKEDA BELGIUM SCA/CVA
LU
SE/H/0126/001
BE221426
TAKEDA BELGIUM SCA/CVA
BE
SE/H/0126/001
BE324922
TAKEDA BELGIUM SCA/CVA
BE
SE/H/0126/001
2009010134
TAKEDA BELGIUM SCA/CVA
LU
SE/H/0126/008
BE476933
TAKEDA BELGIUM SCA/CVA
BE
SE/H/0126/008
2016110330
TAKEDA BELGIUM SCA/CVA
LU
SE/H/0126/006
BE476915
TAKEDA BELGIUM SCA/CVA
BE
kauwtabletten
Steovit D3 citron 500
mg/1000 U.I. comprimés
à croquer
Steovit D3 citron 500
mg/1000 U.I. comprimés
à croquer
Steovit D3 citron 500
mg/400 U.I. comprimés à
croquer
Steovit D3 citron 500
mg/400 U.I. comprimés à
croquer
Steovit D3 citron 500
mg/400 U.I. comprimés à
croquer
Steovit D3
Erdbeere/Wassermelone
500mg/1000 I.E.
Kautabletten
Steovit D3
Erdbeere/Wassermelone
500mg/1000 I.E.
Kautabletten
Steovit D3
Erdbeere/Wassermelone
List of nationally authorised medicinal products
EMA/434947/2017
Page 45/50
Product Name (in
authorisation country)
MRP/DCP
Authorisation
number
National Authorisation Number
MAH of product in the
member state
Member State where
product is authorised
SE/H/0126/006
2016110331
TAKEDA BELGIUM SCA/CVA
LU
SE/H/0126/008
BE476933
TAKEDA BELGIUM SCA/CVA
BE
SE/H/0126/008
2016110330
TAKEDA BELGIUM SCA/CVA
LU
SE/H/0126/006
BE476915
TAKEDA BELGIUM SCA/CVA
BE
SE/H/0126/006
2016110331
TAKEDA BELGIUM SCA/CVA
LU
SE/H/0412/001
BE333557
TAKEDA BELGIUM SCA/CVA
BE
SE/H/0412/001
2009110047
TAKEDA BELGIUM SCA/CVA
LU
500mg/400 I.E.
Kautabletten
Steovit D3
Erdbeere/Wassermelone
500mg/400 I.E.
Kautabletten
Steovit D3
fraise/pastèque 500
mg/1000 U.I. comprimés
à croquer
Steovit D3
fraise/pastèque 500
mg/1000 U.I. comprimés
à croquer
Steovit D3
fraise/pastèque 500
mg/400 U.I. comprimés à
croquer
Steovit D3
fraise/pastèque 500
mg/400 U.I. comprimés à
croquer
Steovit D3 goût menthe
500 mg/400 U.I.
comprimés à croquer
Steovit D3 goût menthe
500 mg/400 U.I.
comprimés à croquer
List of nationally authorised medicinal products
EMA/434947/2017
Page 46/50
Product Name (in
authorisation country)
MRP/DCP
Authorisation
number
National Authorisation Number
MAH of product in the
member state
Member State where
product is authorised
Steovit D3
SE/H/0412/001
BE333557
TAKEDA BELGIUM SCA/CVA
BE
SE/H/0412/001
2009110047
TAKEDA BELGIUM SCA/CVA
LU
SE/H/0412/001
BE333557
TAKEDA BELGIUM SCA/CVA
BE
SE/H/0126/005
BE377535
TAKEDA BELGIUM SCA/CVA
BE
SE/H/0126/005
BE377544
TAKEDA BELGIUM SCA/CVA
BE
SE/H/0126/005
2011040073
TAKEDA BELGIUM SCA/CVA
LU
SE/H/0126/005
BE377535
TAKEDA BELGIUM SCA/CVA
BE
SE/H/0126/005
BE377544
TAKEDA BELGIUM SCA/CVA
BE
Minzgeschmack
500mg/400 I.E.
Kautabletten
Steovit D3
Minzgeschmack
500mg/400 I.E.
Kautabletten
Steovit D3 muntsmaak
500 mg/400 I.E.
kauwtabletten
Steovit D3 orange 500
mg/800 U.I. comprimés à
croquer
Steovit D3 orange 500
mg/800 U.I. comprimés à
croquer
Steovit D3 orange 500
mg/800 U.I. comprimés à
croquer
Steovit D3 sinaasappel
500 mg/800 I.E.
kauwtabletten
Steovit D3 sinaasappel
500 mg/800 I.E.
kauwtabletten
List of nationally authorised medicinal products
EMA/434947/2017
Page 47/50
Product Name (in
authorisation country)
MRP/DCP
Authorisation
number
National Authorisation Number
MAH of product in the
member state
Member State where
product is authorised
Steovit D3 Zitrone
SE/H/0126/007
BE476924
TAKEDA BELGIUM SCA/CVA
BE
SE/H/0126/007
2016110329
TAKEDA BELGIUM SCA/CVA
LU
SE/H/0126/001
BE324922
TAKEDA BELGIUM SCA/CVA
BE
SE/H/0126/001
BE221426
TAKEDA BELGIUM SCA/CVA
BE
SE/H/0126/001
2009010134
TAKEDA BELGIUM SCA/CVA
LU
SE/H/0126/002
BE325044
TAKEDA BELGIUM SCA/CVA
BE
SE/H/0126/002
BE324931
TAKEDA BELGIUM SCA/CVA
BE
SE/H/0126/002
BE325044
TAKEDA BELGIUM SCA/CVA
BE
SE/H/0126/002
BE324931
TAKEDA BELGIUM SCA/CVA
BE
500mg/1000 I.E.
Kautabletten
Steovit D3 Zitrone
500mg/1000 I.E.
Kautabletten
Steovit D3 Zitrone
500mg/400 I.E.
Kautabletten
Steovit D3 Zitrone
500mg/400 I.E.
Kautabletten
Steovit D3 Zitrone
500mg/400 I.E.
Kautabletten
Steovit Forte citroen
1000 mg/800 I.E.
kauwtabletten
Steovit Forte citroen
1000 mg/800 I.E.
kauwtabletten
Steovit Forte citron 1000
mg/800 U.I. comprimés à
croquer
Steovit Forte citron 1000
mg/800 U.I. comprimés à
croquer
List of nationally authorised medicinal products
EMA/434947/2017
Page 48/50
Product Name (in
authorisation country)
MRP/DCP
Authorisation
number
National Authorisation Number
MAH of product in the
member state
Member State where
product is authorised
Steovit Forte citron 1000
SE/H/0126/002
2009020026
TAKEDA BELGIUM SCA/CVA
LU
SE/H/0126/002
BE324931
TAKEDA BELGIUM SCA/CVA
BE
SE/H/0126/002
BE325044
TAKEDA BELGIUM SCA/CVA
BE
SE/H/0126/002
2009020026
TAKEDA BELGIUM SCA/CVA
LU
SE/H/0412/001
RVG 31801
TAKEDA NEDERLAND BV
NL
SE/H/0126/005
RVG 105833
TAKEDA NEDERLAND BV
NL
not available
64.998
LABORATORIO STADA, S.L.
ES
not available
62442
LABORATORIOS
ES
mg/800 U.I. comprimés à
croquer
Steovit Forte Zitrone
1000 mg/800 I.E.
Kautabletten
Steovit Forte Zitrone
1000 mg/800 I.E.
Kautabletten
Steovit Forte Zitrone
1000 mg/800 I.E.
Kautabletten
Tacal D3 500 mg/400 I.E.
Munt, kauwtabletten
Tacal D3 500 mg/800 I.E.
sinaasappel,
kauwtabletten
TEPOX-CAL D polvo para
suspensión oral
VERISCAL D
FARMACÉUTICOS VALOMED
S.A.
VERISCAL D
not available
62442
LABORATORIOS
ES
FARMACÉUTICOS VALOMED
S.A.
List of nationally authorised medicinal products
EMA/434947/2017
Page 49/50
Product Name (in
authorisation country)
MRP/DCP
Authorisation
number
National Authorisation Number
MAH of product in the
member state
Member State where
product is authorised
VERISCAL D FLAS 1500
not available
68402
LABORATORIOS
ES
mg/400 UI comprimidos
FARMACÉUTICOS VALOMED
bucodispersables
S.A.
VERISCAL D FLAS 1500
not available
68402
LABORATORIOS
mg/400 UI comprimidos
FARMACÉUTICOS VALOMED
bucodispersables
S.A.
ИДЕОС 500 mg/ 400 IU
not available
20030664
таблетки за дъвчене
ИДЕОС 500 mg/ 400 IU
LABORATOIRE INNOTECH
ES
BG
INTERNATIONAL
not available
таблетки за дъвчене
List of nationally authorised medicinal products
EMA/434947/2017
20030664
LABORATOIRE INNOTECH
BG
INTERNATIONAL
Page 50/50