31 March 2016 EMA/333388/2016 Procedure Management and Committees Support
List of nationally authorised medicinal products
Active substance: everolimus (indicated for rejection of transplanted organs)
Procedure no.: PSUSA/00010269/201507
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, 2016. Reproduction is authorised provided the source is acknowledged.
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
Certican
SE/H/0356/001
35644
Certican
SE/H/0356/002
35665
Certican
SE/H/0356/003
35666
Certican
SE/H/0356/004
35667
Certican
SE/H/0356/005
35668
Certican
SE/H/0356/006
35669
Certican
SE/H/0356/004
088/04704
Certican
SE/H/0356/001
088/04701
Certican
SE/H/0356/002
088/04702
Certican
SE/H/0356/003
088/04703
Certican
SE/H/0356/005
088/04705
SE/H/0356/006
088/04706
SE/H/0356/003
3400936410244
SE/H/0356/003
3400936410305
SE/H/0356/003
3400936410473
SE/H/0356/003
3400956550425
Certican CERTICAN comprimé CERTICAN comprimé CERTICAN comprimé CERTICAN comprimé
0,75 mg 0,75 mg 0,75 mg 0,75 mg
List of nationally authorised medicinal products EMA/333388/2016
MAH of product in the member state NOVARTIS HEALTHCARE A/S (ART57) NOVARTIS HEALTHCARE A/S (ART57) NOVARTIS HEALTHCARE A/S (ART57) NOVARTIS HEALTHCARE A/S (ART57) NOVARTIS HEALTHCARE A/S (ART57) NOVARTIS HEALTHCARE A/S (ART57) NOVARTIS PHARMACEUTICALS UK LIMITED (ART57) NOVARTIS PHARMACEUTICALS UK LIMITED (ART57) NOVARTIS PHARMACEUTICALS UK LIMITED (ART57) NOVARTIS PHARMACEUTICALS UK LIMITED (ART57) NOVARTIS PHARMACEUTICALS UK LIMITED (ART57) NOVARTIS PHARMACEUTICALS UK LIMITED (ART57) NOVARTIS PHARMA S.A.S. (ART57) NOVARTIS PHARMA S.A.S. (ART57) NOVARTIS PHARMA S.A.S. (ART57) NOVARTIS PHARMA S.A.S. (ART57)
Member State where product is authorised DK DK DK DK DK DK MT MT MT MT MT MT FR FR FR FR
Page 2/22
Product Name (in authorisation country) CERTICAN 0,1 mg compresse dispersibili CERTICAN 0,1 mg compresse dispersibili CERTICAN 0,1 mg compresse dispersibili CERTICAN 0,1 mg compresse dispersibili Certican 0,1 mg comprimate pentru dispersie orala Certican 0,1 mg comprimate pentru dispersie orala Certican 0,1 mg comprimate pentru dispersie orala Certican 0,1 mg comprimate pentru dispersie orala Certican 0,1 mg comprimate pentru dispersie orala Certican 0,1 mg comprimate pentru dispersie orala Certican 0,1 mg comprimate pentru dispersie orala Certican 0,1 mg comprimate pentru dispersie orala Certican 0,1 mg Comprimidos dispersíveis
List of nationally authorised medicinal products EMA/333388/2016
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
SE/H/0356/005
036373177
SE/H/0356/005
036373189
SE/H/0356/005
036373191
SE/H/0356/005
036373203
NOVARTIS (ART57) NOVARTIS (ART57) NOVARTIS (ART57) NOVARTIS (ART57)
SE/H/0356/005
7242/2014/01
NOVARTIS PHARMA GMBH (ART57)
RO
SE/H/0356/005
7242/2014/02
NOVARTIS PHARMA GMBH (ART57)
RO
SE/H/0356/005
7242/2014/03
NOVARTIS PHARMA GMBH (ART57)
RO
SE/H/0356/005
7242/2014/04
NOVARTIS PHARMA GMBH (ART57)
RO
not available
6072/2005/01
NOVARTIS PHARMA GMBH (ART57)
RO
not available
6072/2005/02
NOVARTIS PHARMA GMBH (ART57)
RO
not available
6072/2005/03
NOVARTIS PHARMA GMBH (ART57)
RO
not available
6072/2005/04
SE/H/0356/005
5021688
FARMA S.P.A. FARMA S.P.A. FARMA S.P.A. FARMA S.P.A.
NOVARTIS PHARMA GMBH (ART57) NOVARTIS FARMA PRODUTOS FARMACÊUTICOS S.A. ART57
Member State where product is authorised IT IT IT IT
RO
PT
Page 3/22
Product Name (in authorisation country) Certican 0,1 mg dispergeeruvad tabletid Certican 0,1 mg disperģējamās tabletes Certican 0,1 mg dispergerbara tabletter Certican 0,1 mg dispergerbara tabletter Certican 0,1 mg dispergerbare tabletter Certican 0,1 mg dispergovatelne tablety CERTICAN 0,1 mg dispergovatelné tablety Certican 0,1 mg disperguojamosios tabletės Certican 0,1 mg disperguojamosios tabletės Certican 0,1 mg disperguojamosios tabletės Certican 0,1 mg disperguojamosios tabletės Certican 0,1 mg diszpergálódó tabletta Certican 0,1 mg dreifitöflur Certican 0,1 mg tabletki do sporządzania zawiesiny doustnej Certican 0,1 mg Tabletten zur Herstellung einer
List of nationally authorised medicinal products EMA/333388/2016
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
SE/H/0356/005
464305
SE/H/0356/005
05-0030
SE/H/0356/005
18705
SE/H/0356/005
18694
SE/H/0356/005
03-2079
SE/H/0356/005
59/0296/04-S
SE/H/0356/005
59/429/14-C
NOVARTIS FINLAND OY (ART57) NOVARTIS FINLAND OY (ART57) NOVARTIS FINLAND OY (ART57) NOVARTIS SVERIGE AB (ART57) NOVARTIS NORGE AS (ART57) NOVARTIS, S.R.O. (ART57) NOVARTIS, S.R.O. (ART57)
SE/H/0356/005
LT/1/05/0321/017
NOVARTIS FINLAND OY (ART57)
LT
SE/H/0356/005
LT/1/05/0321/018
NOVARTIS FINLAND OY (ART57)
LT
SE/H/0356/005
LT/1/05/0321/019
NOVARTIS FINLAND OY (ART57)
LT
SE/H/0356/005
LT/1/05/0321/020
SE/H/0356/005
OGYI-T-9961/05
SE/H/0356/005
IS/1/03/040/05
NOVARTIS FINLAND OY (ART57) NOVARTIS HUNGÁRIA KFT. PHARMA (ART57) NOVARTIS HEALTHCARE A/S (ART57)
SE/H/0356/005
R/22336
NOVARTIS POLAND SP. Z O. O. (ART57)
PL
SE/H/0356/005
BE266454
NOVARTIS PHARMA N.V. (ART57)
BE
EE LV FI SE NO SK CZ
LT HU IS
Page 4/22
Product Name (in authorisation country) Suspension zum Einnehmen Certican 0,1 mg Tabletten zur Herstellung einer Suspension zum Einnehmen Certican 0,1 mg Tabletten zur Herstellung einer Suspension zum Einnehmen CERTICAN 0,1 mg, comprimé dispersible CERTICAN 0,1 mg, comprimé dispersible CERTICAN 0,1 mg, comprimé dispersible CERTICAN 0,1 mg, comprimé dispersible Certican 0,1 mg, comprimés dipsersibles Certican 0,10 mg comprimés dispersibles Certican 0,10 mg dispergeerbare tabletten Certican 0,1mg Tabletten zur Herstellung einer Suspension CERTICAN 0,25 mg compresse CERTICAN 0,25 mg compresse CERTICAN 0,25 mg compresse
List of nationally authorised medicinal products EMA/333388/2016
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
SE/H/0356/005
58387.00.01
NOVARTIS PHARMA GMBH (ART57)
SE/H/0378/005
0010/04030109
SE/H/0356/005
3400936411425
SE/H/0356/005
3400936411593
SE/H/0356/005
3400936411654
SE/H/0356/005
3400956550715
SE/H/0356/005
BE266454
SE/H/0378/005
0010/04030109
SE/H/0356/005
BE266454
SE/H/0356/005
1-25275
SE/H/0356/001
036373013
SE/H/0356/001
036373025
SE/H/0356/001
036373037
NOVARTIS PHARMA (ART57) NOVARTIS PHARMA S.A.S. (ART57) NOVARTIS PHARMA S.A.S. (ART57) NOVARTIS PHARMA S.A.S. (ART57) NOVARTIS PHARMA S.A.S. (ART57) NOVARTIS PHARMA (ART57) NOVARTIS PHARMA (ART57) NOVARTIS PHARMA (ART57)
Member State where product is authorised
DE
N.V.
LU FR FR FR
N.V. N.V. N.V.
NOVARTIS PHARMA GMBH (ART57) NOVARTIS FARMA S.P.A. (ART57) NOVARTIS FARMA S.P.A. (ART57) NOVARTIS FARMA S.P.A. (ART57)
FR BE LU BE
AT IT IT IT
Page 5/22
Product Name (in authorisation country) CERTICAN 0,25 mg compresse CERTICAN 0,25 mg compresse dispersibili CERTICAN 0,25 mg compresse dispersibili CERTICAN 0,25 mg compresse dispersibili CERTICAN 0,25 mg compresse dispersibili Certican 0,25 mg comprimate Certican 0,25 mg comprimate Certican 0,25 mg comprimate Certican 0,25 mg comprimate Certican 0,25 mg comprimate pentru dispersie orală Certican 0,25 mg comprimate pentru dispersie orală Certican 0,25 mg comprimate pentru dispersie orală Certican 0,25 mg comprimate pentru dispersie orală Certican 0,25 mg comprimate/Certican 0,25 mg tablets Certican 0,25 mg comprimate/Certican 0,25 mg tablets
List of nationally authorised medicinal products EMA/333388/2016
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
SE/H/0356/001
036373049
SE/H/0356/006
036373215
SE/H/0356/006
036373227
SE/H/0356/006
036373239
SE/H/0356/006
036373241
not available
6068/2005/01
not available
6068/2005/02
not available
6068/2005/03
not available
6068/2005/04
NOVARTIS FARMA S.P.A. (ART57) NOVARTIS FARMA S.P.A. (ART57) NOVARTIS FARMA S.P.A. (ART57) NOVARTIS FARMA S.P.A. (ART57) NOVARTIS FARMA S.P.A. (ART57) NOVARTIS PHARMA GMBH (ART57) NOVARTIS PHARMA GMBH (ART57) NOVARTIS PHARMA GMBH (ART57) NOVARTIS PHARMA GMBH (ART57)
not available
6073/2005/01
NOVARTIS PHARMA GMBH (ART57)
RO
not available
6073/2005/02
NOVARTIS PHARMA GMBH (ART57)
RO
not available
6073/2005/03
NOVARTIS PHARMA GMBH (ART57)
RO
not available
6073/2005/04
NOVARTIS PHARMA GMBH (ART57)
RO
SE/H/0356/001
7238/2014/01
NOVARTIS PHARMA GMBH (ART57)
RO
SE/H/0356/001
7238/2014/02
NOVARTIS PHARMA GMBH (ART57)
RO
IT IT IT IT IT RO RO RO RO
Page 6/22
Product Name (in authorisation country) Certican 0,25 mg comprimate/Certican 0,25 mg tablets Certican 0,25 mg comprimate/Certican 0,25 mg tablets Certican 0,25 mg comprimés Certican 0,25 mg comprimés dispersibles Certican 0,25 mg comprimidos dispersíveis Certican 0,25 mg dispergeerbare tabletten Certican 0,25 mg dispergeeruvad tabletid Certican 0,25 mg disperģējamās tabletes Certican 0,25 mg dispergerbara tabletter Certican 0,25 mg dispergerbara tabletter Certican 0,25 mg dispergerbare tabletter Certican 0,25 mg dispergovatelne tablety CERTICAN 0,25 mg dispergovatelné tablety Certican 0,25 mg disperguojamosios tabletės Certican 0,25 mg disperguojamosios tabletės
List of nationally authorised medicinal products EMA/333388/2016
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
SE/H/0356/001
7238/2014/03
NOVARTIS PHARMA GMBH (ART57)
SE/H/0356/001
7238/2014/04
SE/H/0378/001
0010/04030105
SE/H/0356/006
0010/04030110
SE/H/0356/006
5021787
SE/H/0356/006
BE266497
SE/H/0356/006
464205
SE/H/0356/006
05-0031
SE/H/0356/006
18704
SE/H/0356/006
18695
SE/H/0356/006
03-2080
SE/H/0356/006
59/0297/04-S
SE/H/0356/006
59/430/14-C
NOVARTIS PHARMA GMBH (ART57) NOVARTIS PHARMA N.V. (ART57) NOVARTIS PHARMA N.V. (ART57) NOVARTIS FARMA PRODUTOS FARMACÊUTICOS S.A. ART57 NOVARTIS PHARMA N.V. (ART57) NOVARTIS FINLAND OY (ART57) NOVARTIS FINLAND OY (ART57) NOVARTIS FINLAND OY (ART57) NOVARTIS SVERIGE AB (ART57) NOVARTIS NORGE AS (ART57) NOVARTIS, S.R.O. (ART57) NOVARTIS, S.R.O. (ART57)
SE/H/0356/006
LT/1/05/0321/021
NOVARTIS FINLAND OY (ART57)
LT
SE/H/0356/006
LT/1/05/0321/022
NOVARTIS FINLAND OY (ART57)
LT
RO RO LU LU
PT BE EE LV FI SE NO SK CZ
Page 7/22
Product Name (in authorisation country) Certican 0,25 mg disperguojamosios tabletės Certican 0,25 mg disperguojamosios tabletės Certican 0,25 mg diszpergálódó tabletta Certican 0,25 mg dreifitöflur Certican 0,25 mg tablete za oralnu suspenziju Certican 0,25 mg tabletes Certican 0,25 mg tabletid CERTICAN 0,25 MG TABLETKI Certican 0,25 mg tabletki do sporządzania zawiesiny doustnej Certican 0,25 mg tabletta Certican 0,25 mg Tabletten Certican 0,25 mg tabletten Certican 0,25 mg Tabletten Certican 0,25 mg Tabletten Certican 0,25 mg Tabletten zur Herstellung einer Suspension
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
SE/H/0356/006
LT/1/05/0321/023
NOVARTIS FINLAND OY (ART57)
SE/H/0356/006
LT/1/05/0321/024
SE/H/0356/006
OGYI-T-9961/06
SE/H/0356/006
IS/1/03/040/06
SE/H/0356/006
HR-H-996683373
SE/H/0356/001
05-0026
SE/H/0356/001
464705
SE/H/0356/001
R/11215
SE/H/0356/006
R/22337
SE/H/0356/001
OGYI-T-9961/02
SE/H/0356/001
BE266445
SE/H/0356/001
BE266445
SE/H/0356/001
58387.00.00
SE/H/0378/001
0010/04030105
NOVARTIS POLAND SP. Z O. O. (ART57) NOVARTIS HUNGÁRIA KFT. PHARMA (ART57) NOVARTIS PHARMA N.V. (ART57) NOVARTIS PHARMA N.V. (ART57) NOVARTIS PHARMA GMBH (ART57) NOVARTIS PHARMA N.V. (ART57)
SE/H/0356/006
1-25276
NOVARTIS PHARMA GMBH (ART57)
AT
Certican 0,25 mg
SE/H/0356/006
BE266497
NOVARTIS PHARMA N.V.
BE
List of nationally authorised medicinal products EMA/333388/2016
NOVARTIS FINLAND OY (ART57) NOVARTIS HUNGÁRIA KFT. PHARMA (ART57) NOVARTIS HEALTHCARE A/S (ART57) NOVARTIS HRVATSKA D.O.O. (ART57) NOVARTIS FINLAND OY (ART57) NOVARTIS FINLAND OY (ART57) NOVARTIS POLAND SP. Z O. O. (ART57)
Member State where product is authorised LT LT HU IS HR LV EE PL PL HU BE BE DE LU
Page 8/22
Product Name (in authorisation country) Tabletten zur Herstellung einer Suspension zum Einnehmen Certican 0,25 mg Tabletten zur Herstellung einer Suspension zum Einnehmen Certican 0,25 mg Tabletten zur Herstellung einer Suspension zum Einnehmen Certican 0,25 mg tabletter Certican 0,25 mg tabletter Certican 0,25 mg tabletter CERTICAN 0,25 mg TABLETY
MRP/DCP Authorisation number
National Authorisation Number
SE/H/0356/006
58387.01.01
SE/H/0356/006
0010/04030110
SE/H/0356/001
18698
SE/H/0356/001
03-2075
SE/H/0356/001
18690
SE/H/0356/001
59/014/05-C
Certican 0,25 mg tablety
SE/H/0356/001
59/0294/04-S
Certican 0,25 mg töflur Certican 0,25 mg, comprimé Certican 0,25 mg, comprimé Certican 0,25 mg, comprimé Certican 0,25 mg, comprimé CERTICAN 0,25 mg, comprimé dispersible
SE/H/0356/001
IS/1/03/040/01
SE/H/0356/001
3400936411074
SE/H/0356/001
3400936411135
SE/H/0356/001
3400936411364
SE/H/0356/001
3400956550654
SE/H/0356/006
3400936411715
List of nationally authorised medicinal products EMA/333388/2016
MAH of product in the member state (ART57)
NOVARTIS PHARMA GMBH (ART57)
NOVARTIS PHARMA N.V. (ART57) NOVARTIS FINLAND OY (ART57) NOVARTIS NORGE AS (ART57) NOVARTIS SVERIGE AB (ART57) NOVARTIS, S.R.O. (ART57) NOVARTIS, S.R.O. (ART57) NOVARTIS HEALTHCARE A/S (ART57) NOVARTIS PHARMA S.A.S. (ART57) NOVARTIS PHARMA S.A.S. (ART57) NOVARTIS PHARMA S.A.S. (ART57) NOVARTIS PHARMA S.A.S. (ART57) NOVARTIS PHARMA S.A.S. (ART57)
Member State where product is authorised
DE
LU FI NO SE CZ SK IS FR FR FR FR FR
Page 9/22
Product Name (in authorisation country) CERTICAN 0,25 mg, comprimé dispersible CERTICAN 0,25 mg, comprimé dispersible CERTICAN 0,25 mg, comprimé dispersible Certican 0,25 mg, comprimés Certican 0,25 mg, comprimés dipsersibles
MRP/DCP Authorisation number
National Authorisation Number
SE/H/0356/006
3400936411883
SE/H/0356/006
3400936411944
SE/H/0356/006
3400956550883
SE/H/0356/001
BE266445
SE/H/0356/006
BE266497
Certican 0,25 tabletės
SE/H/0356/001
LT/1/05/0321/001
Certican 0,25 tabletės
SE/H/0356/001
LT/1/05/0321/002
Certican 0,25 tabletės
SE/H/0356/001
LT/1/05/0321/003
Certican 0,25 tabletės Certican 0,25 tabletten 0,25 mg Certican 0,25mg comprimate pentru dispersie orala Certican 0,25mg comprimate pentru dispersie orala Certican 0,25mg comprimate pentru dispersie orala Certican 0,25mg comprimate pentru dispersie orala
SE/H/0356/001
LT/1/05/0321/004
SE/H/0356/001
RVG 30041
NOVARTIS PHARMA S.A.S. (ART57) NOVARTIS PHARMA S.A.S. (ART57) NOVARTIS PHARMA S.A.S. (ART57) NOVARTIS PHARMA N.V. (ART57) NOVARTIS PHARMA N.V. (ART57) NOVARTIS FINLAND OY (ART57) NOVARTIS FINLAND OY (ART57) NOVARTIS FINLAND OY (ART57) NOVARTIS FINLAND OY (ART57) NOVARTIS PHARMA B.V. (ART57)
SE/H/0356/006
7243/2014/01
NOVARTIS PHARMA GMBH (ART57)
RO
SE/H/0356/006
7243/2014/02
NOVARTIS PHARMA GMBH (ART57)
RO
SE/H/0356/006
7243/2014/03
NOVARTIS PHARMA GMBH (ART57)
RO
SE/H/0356/006
7243/2014/04
SE/H/0356/001
5021282
Certican 0,25mg comprimidos
List of nationally authorised medicinal products EMA/333388/2016
MAH of product in the member state
NOVARTIS PHARMA GMBH (ART57) NOVARTIS FARMA PRODUTOS FARMACÊUTICOS S.A. ART57
Member State where product is authorised FR FR FR BE BE LT LT LT LT NL
RO
PT
Page 10/22
Product Name (in authorisation country) Certican 0,25mg Tabletten Certican 0,5 mg compresse CERTICAN 0,5 mg compresse CERTICAN 0,5 mg compresse CERTICAN 0,5 mg compresse Certican 0,5 mg comprimate Certican 0,5 mg comprimate Certican 0,5 mg comprimate Certican 0,5 mg comprimate Certican 0,5 mg comprimate/certican tablets Certican 0,5 mg comprimate/certican tablets Certican 0,5 mg comprimate/certican tablets Certican 0,5 mg comprimate/certican tablets Certican 0,5 mg comprimés
0,5 0,5 0,5 0,5
Certican 0,5 mg Comprimidos
List of nationally authorised medicinal products EMA/333388/2016
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
SE/H/0356/001
1-25271
SE/H/0356/002
036373052
SE/H/0356/002
036373064
SE/H/0356/002
036373076
SE/H/0356/002
036373088
not available
6069/2005/01
not available
6069/2005/02
not available
6069/2005/03
not available
6069/2005/04
NOVARTIS PHARMA GMBH (ART57) NOVARTIS FARMA S.P.A. (ART57) NOVARTIS FARMA S.P.A. (ART57) NOVARTIS FARMA S.P.A. (ART57) NOVARTIS FARMA S.P.A. (ART57) NOVARTIS PHARMA GMBH (ART57) NOVARTIS PHARMA GMBH (ART57) NOVARTIS PHARMA GMBH (ART57) NOVARTIS PHARMA GMBH (ART57)
SE/H/0356/002
7239/2014/01
NOVARTIS PHARMA GMBH (ART57)
RO
SE/H/0356/002
7239/2014/02
NOVARTIS PHARMA GMBH (ART57)
RO
SE/H/0356/002
7239/2014/03
NOVARTIS PHARMA GMBH (ART57)
RO
SE/H/0356/002
7239/2014/04
SE/H/0378/002
0010/04030106
SE/H/0356/002
5021381
NOVARTIS PHARMA GMBH (ART57) NOVARTIS PHARMA N.V. (ART57) NOVARTIS FARMA PRODUTOS FARMACÊUTICOS S.A. ART57
Member State where product is authorised AT IT IT IT IT RO RO RO RO
RO LU
PT
Page 11/22
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
Certican 0,5 mg tablete
not available
UP/I-530-09/11-02/196
Certican 0,5 mg tabletes
SE/H/0356/002
05-0027
Certican 0,5 mg tabletės
SE/H/0356/002
LT/1/05/0321/005
Certican 0,5 mg tabletės
SE/H/0356/002
LT/1/05/0321/006
Certican 0,5 mg tabletės
SE/H/0356/002
LT/1/05/0321/007
Certican 0,5 mg tabletės
SE/H/0356/002
LT/1/05/0321/008
Certican 0,5 mg tabletid CERTICAN 0,5 MG TABLETKI
SE/H/0356/002
464605
SE/H/0356/002
R/11214
Certican 0,5 Certican 0,5 Tabletten Certican 0,5 Tabletten Certican 0,5 Tabletten Certican 0,5 tabletter Certican 0,5 tabletter Certican 0,5 tabletter
SE/H/0356/002
OGYI-T-9961/01
SE/H/0356/002
BE266481
SE/H/0356/002
58387.01.00
SE/H/0378/002
0010/04030106
SE/H/0356/002
18699
SE/H/0356/002
03-2076
SE/H/0356/002
18691
Certican 0,5 mg tablety
SE/H/0356/002
59/428/14-C
Certican 0,5 mg tablety
SE/H/0356/002
59/0295/04-S
Certican 0,5 mg töflur
SE/H/0356/002
IS/1/03/040/02
mg tabletta mg mg mg mg mg mg
List of nationally authorised medicinal products EMA/333388/2016
MAH of product in the member state NOVARTIS HRVATSKA D.O.O. (ART57) NOVARTIS FINLAND OY (ART57) NOVARTIS FINLAND OY (ART57) NOVARTIS FINLAND OY (ART57) NOVARTIS FINLAND OY (ART57) NOVARTIS FINLAND OY (ART57) NOVARTIS FINLAND OY (ART57) NOVARTIS POLAND SP. Z O. O. (ART57) NOVARTIS HUNGÁRIA KFT. PHARMA (ART57) NOVARTIS PHARMA N.V. (ART57) NOVARTIS PHARMA GMBH (ART57) NOVARTIS PHARMA N.V. (ART57) NOVARTIS FINLAND OY (ART57) NOVARTIS NORGE AS (ART57) NOVARTIS SVERIGE AB (ART57) NOVARTIS, S.R.O. (ART57) NOVARTIS, S.R.O. (ART57) NOVARTIS HEALTHCARE A/S (ART57)
Member State where product is authorised HR LV LT LT LT LT EE PL HU BE DE LU FI NO SE CZ SK IS
Page 12/22
Product Name (in authorisation country) CERTICAN 0,5 mg, comprimé CERTICAN 0,5 mg, comprimé CERTICAN 0,5 mg, comprimé CERTICAN 0,5 mg, comprimé Certican 0,5 mg, comprimés Certican 0,5 tabletten 0,5 mg Certican 0,50 mg Tabletten Certican 0,50 mg tabletten Certican 0,75 mg Tabletten Certican 0,75 mg compresse Certican 0,75 mg compresse Certican 0,75 mg compresse Certican 0,75 mg compresse Certican 0,75 mg comprimate Certican 0,75 mg comprimate Certican 0,75 mg comprimate Certican 0,75 mg comprimate Certican 0,75 mg comprimate/Certican
List of nationally authorised medicinal products EMA/333388/2016
MRP/DCP Authorisation number
National Authorisation Number
SE/H/0356/002
3400936410763
SE/H/0356/002
3400936410824
SE/H/0356/002
3400936410992
SE/H/0356/002
3400956550593
SE/H/0356/002
BE266481
SE/H/0356/002
RVG 30042
SE/H/0356/002
1-25272
SE/H/0356/002
BE266481
SE/H/0356/003
1-25273
SE/H/0356/003
036373090
SE/H/0356/003
036373102
SE/H/0356/003
036373114
SE/H/0356/003
036373126
not available
6070/2005/01
not available
6070/2005/02
not available
6070/2005/03
not available
6070/2005/04
SE/H/0356/003
7240/2014/01
MAH of product in the member state NOVARTIS PHARMA S.A.S. (ART57) NOVARTIS PHARMA S.A.S. (ART57) NOVARTIS PHARMA S.A.S. (ART57) NOVARTIS PHARMA S.A.S. (ART57) NOVARTIS PHARMA N.V. (ART57) NOVARTIS PHARMA B.V. (ART57) NOVARTIS PHARMA GMBH (ART57) NOVARTIS PHARMA N.V. (ART57) NOVARTIS PHARMA GMBH (ART57) NOVARTIS FARMA S.P.A. (ART57) NOVARTIS FARMA S.P.A. (ART57) NOVARTIS FARMA S.P.A. (ART57) NOVARTIS FARMA S.P.A. (ART57) NOVARTIS PHARMA GMBH (ART57) NOVARTIS PHARMA GMBH (ART57) NOVARTIS PHARMA GMBH (ART57) NOVARTIS PHARMA GMBH (ART57) NOVARTIS PHARMA GMBH (ART57)
Member State where product is authorised FR FR FR FR BE NL AT BE AT IT IT IT IT RO RO RO RO RO
Page 13/22
Product Name (in authorisation country) 0,75 mg tablets Certican 0,75 mg comprimate/Certican 0,75 mg tablets Certican 0,75 mg comprimate/Certican 0,75 mg tablets Certican 0,75 mg comprimate/Certican 0,75 mg tablets Certican 0,75 mg Comprimidos Certican 0,75 mg tabletes Certican 0,75 mg tabletid CERTICAN 0,75 MG TABLETKI Certican 0,75 mg tabletta Certican 0,75 mg Tabletten Certican 0,75 mg tabletten Certican 0,75 mg Tabletten Certican 0,75 mg Tabletten Certican 0,75 mg tabletten 0,75 mg Certican 0,75 mg tabletter Certican 0,75 mg tabletter List of nationally authorised medicinal products EMA/333388/2016
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
SE/H/0356/003
7240/2014/02
NOVARTIS PHARMA GMBH (ART57)
RO
SE/H/0356/003
7240/2014/03
NOVARTIS PHARMA GMBH (ART57)
RO
SE/H/0356/003
7240/2014/04
SE/H/0356/003
5021480
SE/H/0356/003
05-0028
SE/H/0356/003
464505
SE/H/0356/003
R/11226
SE/H/0356/003
OGYI-T-9961/03
SE/H/0356/003
BE266472
SE/H/0356/003
BE266472
SE/H/0356/003
58387.02.00
SE/H/0378/003
0010/04030107
SE/H/0356/003
RVG 30043
SE/H/0356/003
18702
SE/H/0356/003
03-2077
NOVARTIS PHARMA GMBH (ART57) NOVARTIS FARMA PRODUTOS FARMACÊUTICOS S.A. ART57 NOVARTIS FINLAND OY (ART57) NOVARTIS FINLAND OY (ART57) NOVARTIS POLAND SP. Z O. O. (ART57) NOVARTIS HUNGÁRIA KFT. PHARMA (ART57) NOVARTIS PHARMA N.V. (ART57) NOVARTIS PHARMA N.V. (ART57) NOVARTIS PHARMA GMBH (ART57) NOVARTIS PHARMA N.V. (ART57) NOVARTIS PHARMA B.V. (ART57) NOVARTIS FINLAND OY (ART57) NOVARTIS NORGE AS (ART57)
Member State where product is authorised
RO
PT LV EE PL HU BE BE DE LU NL FI NO
Page 14/22
Product Name (in authorisation country) Certican 0,75 mg tabletter CERTICAN 0,75 mg TABLETY
MRP/DCP Authorisation number
National Authorisation Number
SE/H/0356/003
18692
SE/H/0356/003
59/016/05-C
Certican 0,75 mg töflur Certican 0,75 mg, comprimés
SE/H/0356/003
IS/1/03/040/03
SE/H/0356/003
BE266472
Certican 0,75 tabletės
SE/H/0356/003
LT/1/05/0321/009
Certican 0,75 tabletės
SE/H/0356/003
LT/1/05/0321/010
Certican 0,75 tabletės
SE/H/0356/003
LT/1/05/0321/011
Certican 0,75 tabletės Certican 0,75mg comprimés CERTICAN 0.1 mg comprimidos dispersables Certican 0.1 mg dispergoituva tabletti
SE/H/0356/003
LT/1/05/0321/012
SE/H/0378/003
0010/04030107
SE/H/0356/005
66009
SE/H/0356/005
18705
SE/H/0378/005
PA 13/124/005
SE/H/0356/005
PL 00101/0965
SE/H/0356/005
H/05/00370/001
SE/H/0356/005
H/05/00370/002
SE/H/0356/005
HR-H-542458362
NOVARTIS SVERIGE AB (ART57) NOVARTIS, S.R.O. (ART57) NOVARTIS HEALTHCARE A/S (ART57) NOVARTIS PHARMA N.V. (ART57) NOVARTIS FINLAND OY (ART57) NOVARTIS FINLAND OY (ART57) NOVARTIS FINLAND OY (ART57) NOVARTIS FINLAND OY (ART57) NOVARTIS PHARMA N.V. (ART57) NOVARTIS FARMACÉUTICA S.A. (ART57) NOVARTIS FINLAND OY (ART57) NOVARTIS PHARMACEUTICALS UK LIMITED (ART57) NOVARTIS PHARMACEUTICALS UK LIMITED (ART57) NOVARTIS PHARMA GMBH (ART57) NOVARTIS PHARMA GMBH (ART57) NOVARTIS HRVATSKA D.O.O. (ART57)
SE/H/0356/001
66001
NOVARTIS
Certican 0.1 mg dispersible tablets Certican 0.1 mg dispersible tablets Certican 0.1 mg disperzibilne tablete Certican 0.1 mg disperzibilne tablete Certican 0.1 mg tablete za oralnu suspenziju CERTICAN 0.25 mg List of nationally authorised medicinal products EMA/333388/2016
MAH of product in the member state
Member State where product is authorised SE CZ IS BE LT LT LT LT LU ES FI IE UK SI SI HR ES
Page 15/22
Product Name (in authorisation country) comprimidos
MRP/DCP Authorisation number
National Authorisation Number
SE/H/0356/006
66002
SE/H/0356/006
18704
SE/H/0356/006
PA 13/124/006
SE/H/0356/006
PL 00101/0966
SE/H/0356/006 SE/H/0356/006
H/05/00370/005 5363-I-1011/09 H/05/00370/006
Certican 0.25 mg tablete
SE/H/0356/001
HR-H-809985014
Certican 0.25 mg tablete
SE/H/0356/001
H/05/00370/009
Certican 0.25 mg tablete
SE/H/0356/001
H/05/00370/010
Certican 0.25 mg tablets
SE/H/0378/001
PA 13/124/001
Certican 0.25 mg tablets
SE/H/0356/001
PL 00101/0961
Certican 0.25 mg tabletti
SE/H/0356/001
18698
Certican 0.5 mg tablete
SE/H/0356/002
HR-H-592546271
Certican 0.5 mg tablete
SE/H/0356/002
H/05/00370/013
FARMACÉUTICA S.A. (ART57) NOVARTIS FARMACÉUTICA S.A. (ART57) NOVARTIS FINLAND OY (ART57) NOVARTIS PHARMACEUTICALS UK LIMITED (ART57) NOVARTIS PHARMACEUTICALS UK LIMITED (ART57) NOVARTIS PHARMA GMBH (ART57) NOVARTIS PHARMA GMBH (ART57) NOVARTIS HRVATSKA D.O.O. (ART57) NOVARTIS PHARMA GMBH (ART57) NOVARTIS PHARMA GMBH (ART57) NOVARTIS PHARMACEUTICALS UK LIMITED (ART57) NOVARTIS PHARMACEUTICALS UK LIMITED (ART57) NOVARTIS FINLAND OY (ART57) NOVARTIS HRVATSKA D.O.O. (ART57) NOVARTIS PHARMA GMBH (ART57)
Certican 0.5 mg tablete
SE/H/0356/002
H/05/00370/014
NOVARTIS PHARMA
CERTICAN 0.25 mg comprimidos dispersables Certican 0.25 mg dispergoituva tabletti Certican 0.25 mg dispersible tablets Certican 0.25 mg dispersible tablets Certican 0.25 mg disperzibilne tablete Certican 0.25 mg disperzibilne tablete
List of nationally authorised medicinal products EMA/333388/2016
MAH of product in the member state
Member State where product is authorised
ES FI IE UK SI SI HR SI SI IE UK FI HR SI SI
Page 16/22
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state GMBH (ART57)
Certican 0.5 mg tablets
SE/H/0378/002
PA 13/124/002
Certican 0.5 mg tablets
SE/H/0356/002
PL 00101/0962
Certican 0.5 mg tabletti
SE/H/0356/002
18699
CERTICAN 0.50 mg comprimidos
SE/H/0356/002
66006
CERTICAN 0.75 mg comprimidos
SE/H/0356/003
66007
Certican 0.75 mg tablete
SE/H/0356/003
HR-H-941540378
Certican 0.75 mg tablete
SE/H/0356/003
H/05/00370/017
Certican 0.75 mg tablete
SE/H/0356/003
H/05/00370/018
Certican 0.75 mg tablets
SE/H/0378/003
PA 13/124/003
Certican 0.75 mg tablets
SE/H/0356/003
PL 00101/0963
Certican 0.75 mg tabletti Certican 1 mg comprimate Certican 1 mg comprimate Certican 1 mg comprimate
SE/H/0356/003
18702
not available
6071/2005/01
not available
6071/2005/02
not available
6071/2005/03
NOVARTIS PHARMACEUTICALS UK LIMITED (ART57) NOVARTIS PHARMACEUTICALS UK LIMITED (ART57) NOVARTIS FINLAND OY (ART57) NOVARTIS FARMACÉUTICA S.A. (ART57) NOVARTIS FARMACÉUTICA S.A. (ART57) NOVARTIS HRVATSKA D.O.O. (ART57) NOVARTIS PHARMA GMBH (ART57) NOVARTIS PHARMA GMBH (ART57) NOVARTIS PHARMACEUTICALS UK LIMITED (ART57) NOVARTIS PHARMACEUTICALS UK LIMITED (ART57) NOVARTIS FINLAND OY (ART57) NOVARTIS PHARMA GMBH (ART57) NOVARTIS PHARMA GMBH (ART57) NOVARTIS PHARMA GMBH (ART57)
Certican 1 mg
not available
6071/2005/04
NOVARTIS PHARMA
List of nationally authorised medicinal products EMA/333388/2016
Member State where product is authorised
IE UK FI ES ES HR SI SI IE UK FI RO RO RO RO
Page 17/22
Product Name (in authorisation country) comprimate
MRP/DCP Authorisation number
National Authorisation Number
SE/H/0356/004
7241/2014/01
NOVARTIS PHARMA GMBH (ART57)
RO
SE/H/0356/004
7241/2014/02
NOVARTIS PHARMA GMBH (ART57)
RO
SE/H/0356/004
7241/2014/03
NOVARTIS PHARMA GMBH (ART57)
RO
SE/H/0356/004
7241/2014/04
SE/H/0378/004
0010/04030108
Certican 1 mg Comprimidos
SE/H/0356/004
5021589
Certican 1 mg tabletes
SE/H/0356/004
05-0029
Certican 1 mg tabletės
SE/H/0356/004
LT/1/05/0321/013
Certican 1 mg tabletės
SE/H/0356/004
LT/1/05/0321/014
Certican 1 mg tabletės
SE/H/0356/004
LT/1/05/0321/015
Certican 1 mg tabletės
SE/H/0356/004
LT/1/05/0321/016
Certican 1 mg tabletten
SE/H/0356/004
BE266463
Certican 1 mg tabletter CERTICAN 1 mg TABLETY
SE/H/0356/004
18693
SE/H/0356/004
59/017/05-C
NOVARTIS PHARMA GMBH (ART57) NOVARTIS PHARMA N.V. (ART57) NOVARTIS FARMA PRODUTOS FARMACÊUTICOS S.A. ART57 NOVARTIS FINLAND OY (ART57) NOVARTIS FINLAND OY (ART57) NOVARTIS FINLAND OY (ART57) NOVARTIS FINLAND OY (ART57) NOVARTIS FINLAND OY (ART57) NOVARTIS PHARMA N.V. (ART57) NOVARTIS SVERIGE AB (ART57) NOVARTIS, S.R.O. (ART57)
Certican 1,0 mg
SE/H/0356/004
036373138
NOVARTIS FARMA S.P.A.
Certican 1 mg comprimate/certican mg tablets Certican 1 mg comprimate/certican mg tablets Certican 1 mg comprimate/certican mg tablets Certican 1 mg comprimate/certican mg tablets Certican 1 mg comprimés
1 1 1 1
List of nationally authorised medicinal products EMA/333388/2016
MAH of product in the member state GMBH (ART57)
Member State where product is authorised
RO LU
PT LV LT LT LT LT BE SE CZ IT
Page 18/22
Product Name (in authorisation country) compresse
MRP/DCP Authorisation number
National Authorisation Number
SE/H/0356/004
036373140
SE/H/0356/004
036373153
SE/H/0356/004
036373165
Certican 1,0 mg tabletid
SE/H/0356/004
464405
Certican 1,0 Certican 1,0 Tabletten Certican 1,0 Tabletten Certican 1,0 Tabletten Certican 1,0 tabletter Certican 1,0 tabletter
SE/H/0356/004
OGYI-T-9961/04
SE/H/0356/004
BE266463
SE/H/0356/004
58387.03.00
SE/H/0378/004
0010/04030108
SE/H/0356/004
18703
SE/H/0356/004
03-2078
Certican 1,0 mg tablety
SE/H/0356/004
59/0299/04-S
Certican 1,0 mg töflur. Certican 1,0 mg, comprimés
SE/H/0356/004
IS/1/03/040/04
SE/H/0356/004
BE266463
Certican 1,0 mg, tabletki Certican 1,0 tabletten 1,0 mg
SE/H/0356/004
R/22335
SE/H/0356/004
RVG 30044
Certican 1.0 mg tabletti
SE/H/0356/004
18703
CERTICAN 1.0 mg comprimidos
SE/H/0356/004
66008
Certican 1,0 mg compresse Certican 1,0 mg compresse Certican 1,0 mg compresse
mg tabletta mg mg mg mg mg
List of nationally authorised medicinal products EMA/333388/2016
MAH of product in the member state (ART57) NOVARTIS FARMA S.P.A. (ART57) NOVARTIS FARMA S.P.A. (ART57) NOVARTIS FARMA S.P.A. (ART57) NOVARTIS FINLAND OY (ART57) NOVARTIS HUNGÁRIA KFT. PHARMA (ART57) NOVARTIS PHARMA N.V. (ART57) NOVARTIS PHARMA GMBH (ART57) NOVARTIS PHARMA N.V. (ART57) NOVARTIS FINLAND OY (ART57) NOVARTIS NORGE AS (ART57) NOVARTIS, S.R.O. (ART57) NOVARTIS HEALTHCARE A/S (ART57) NOVARTIS PHARMA N.V. (ART57) NOVARTIS POLAND SP. Z O. O. (ART57) NOVARTIS PHARMA B.V. (ART57) NOVARTIS FINLAND OY (ART57) NOVARTIS FARMACÉUTICA S.A. (ART57)
Member State where product is authorised
IT IT IT EE HU BE DE LU FI NO SK IS BE PL NL FI ES
Page 19/22
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
Certican 1.0 mg tablete
SE/H/0356/004
HR-H-694937531
Certican 1.0 mg tablete
SE/H/0356/004
H/05/00370/021
Certican 1.0 mg tablete
SE/H/0356/004
H/05/00370/022
Certican 1.0 mg tablets
SE/H/0356/004
PA 13/124/004
Certican 1.0mg tablets
SE/H/0356/004
PL 00101/0964
Certican 1mg - Tabletten Certican Dispers 0,1, dispergeerbare tabletten 0,1 mg Certican Dispers 0,25, dispergeerbare tabletten 0,25 mg
SE/H/0356/004
1-25274
NOVARTIS HRVATSKA D.O.O. (ART57) NOVARTIS PHARMA GMBH (ART57) NOVARTIS PHARMA GMBH (ART57) NOVARTIS PHARMACEUTICALS UK LIMITED (ART57) NOVARTIS PHARMACEUTICALS UK LIMITED (ART57) NOVARTIS PHARMA GMBH (ART57)
SE/H/0356/005
RVG 30045
NOVARTIS PHARMA B.V. (ART57)
SE/H/0356/006
RVG 30046
Certican διασπειρόμενα δισκία 0.1mg
SE/H/0356/005
19646
Certican διασπειρόμενα δισκία 0.25mg
SE/H/0356/006
19647
Certican δισκία 0.75mg
SE/H/0356/003
19644
Certican δισκία 0,25mg
SE/H/0356/001
19642
Certican δισκία 0.5mg
SE/H/0356/002
19643
NOVARTIS PHARMA (ART57) NOVARTIS PHARMACEUTICALS LIMITED (ART57) NOVARTIS PHARMACEUTICALS LIMITED (ART57) NOVARTIS PHARMACEUTICALS LIMITED (ART57) NOVARTIS PHARMACEUTICALS LIMITED (ART57) NOVARTIS PHARMACEUTICALS LIMITED (ART57)
Certican δισκία 1mg
SE/H/0356/004
19645
NOVARTIS
List of nationally authorised medicinal products EMA/333388/2016
MAH of product in the member state
B.V. UK UK UK UK UK
Member State where product is authorised HR SI SI IE UK AT NL NL CY CY CY CY CY CY
Page 20/22
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
SE/H/0378/005
261570501
SE/H/0378/005
261570502
SE/H/0378/005
261570503
SE/H/0378/005
261570504
SE/H/0356/006
261570601
SE/H/0356/006
261570602
SE/H/0356/006
261570603
SE/H/0356/006
261570604
Certican, δισκίο 0.25mg
SE/H/0378/001
261570101
Certican, δισκίο 0.25mg
SE/H/0378/001
261570102
Certican, δισκίο 0.25mg
SE/H/0378/001
261570103
Certican, δισκίο 0.25mg
SE/H/0378/001
261570104
Certican, δισκίο 0.5mg
SE/H/0378/002
261570201
Certican, δισκίο 0.5mg
SE/H/0378/002
261570202
Certican, δισκίο 0.5mg
SE/H/0378/002
261570203
Certican, δισκίο 0.5mg
SE/H/0378/002
261570204
Certican, δισκίο 0.75mg
SE/H/0378/003
261570301
Certican, διασπειρόμενο δισκίο 0.1mg Certican, διασπειρόμενο δισκίο 0.1mg Certican, διασπειρόμενο δισκίο 0.1mg Certican, διασπειρόμενο δισκίο 0.1mg Certican, διασπειρόμενο δισκίο 0.25mg Certican, διασπειρόμενο δισκίο 0.25mg Certican, διασπειρόμενο δισκίο 0.25mg Certican, διασπειρόμενο δισκίο 0.25mg
List of nationally authorised medicinal products EMA/333388/2016
MAH of product in the member state PHARMACEUTICALS UK LIMITED (ART57) NOVARTIS (HELLAS) S.A.C.I. (ART57) NOVARTIS (HELLAS) S.A.C.I. (ART57) NOVARTIS (HELLAS) S.A.C.I. (ART57) NOVARTIS (HELLAS) S.A.C.I. (ART57) NOVARTIS (HELLAS) S.A.C.I. (ART57) NOVARTIS (HELLAS) S.A.C.I. (ART57) NOVARTIS (HELLAS) S.A.C.I. (ART57) NOVARTIS (HELLAS) S.A.C.I. (ART57) NOVARTIS (HELLAS) S.A.C.I. (ART57) NOVARTIS (HELLAS) S.A.C.I. (ART57) NOVARTIS (HELLAS) S.A.C.I. (ART57) NOVARTIS (HELLAS) S.A.C.I. (ART57) NOVARTIS (HELLAS) S.A.C.I. (ART57) NOVARTIS (HELLAS) S.A.C.I. (ART57) NOVARTIS (HELLAS) S.A.C.I. (ART57) NOVARTIS (HELLAS) S.A.C.I. (ART57) NOVARTIS (HELLAS) S.A.C.I. (ART57)
Member State where product is authorised
GR GR GR GR GR GR GR GR GR GR GR GR GR GR GR GR GR
Page 21/22
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
Certican, δισκίο 0.75mg
SE/H/0378/003
261570302
Certican, δισκίο 0.75mg
SE/H/0378/003
261570303
Certican, δισκίο 0.75mg
SE/H/0378/003
261570304
Certican, δισκίο 1mg
SE/H/0378/004
261570401
Certican, δισκίο 1mg
SE/H/0378/004
261570402
Certican, δισκίο 1mg
SE/H/0378/004
261570403
Certican, δισκίο 1mg
SE/H/0378/004
261570404
Certican0,75 mg tbl Everolimus Novartis mg dispergerbara tabletter Everolimus Novartis mg dispergerbara tabletter Everolimus Novartis mg tabletter Everolimus Novartis mg tabletter Everolimus Novartis mg tabletter Everolimus Novartis mg tabletter
0,1
SE/H/0356/003 SE/H/378/005
59/0298/04-S
0,25
SE/H/378/006
0,25
NOVARTIS (HELLAS) S.A.C.I. (ART57) NOVARTIS (HELLAS) S.A.C.I. (ART57) NOVARTIS (HELLAS) S.A.C.I. (ART57) NOVARTIS (HELLAS) S.A.C.I. (ART57) NOVARTIS (HELLAS) S.A.C.I. (ART57) NOVARTIS (HELLAS) S.A.C.I. (ART57) NOVARTIS (HELLAS) S.A.C.I. (ART57) NOVARTIS, S.R.O. (ART57) NOVARTIS SVERIGE AB
Member State where product is authorised GR GR GR GR GR GR GR SK SE
NOVARTIS SVERIGE AB
SE
19842
NOVARTIS SVERIGE AB
19843
NOVARTIS SVERIGE AB NOVARTIS SVERIGE AB
SE SE
19847
0,5
SE/H/378/001 SE/H/378/002
0,75
SE/H/378/003
1
SE/H/378/004
List of nationally authorised medicinal products EMA/333388/2016
19846
MAH of product in the member state
19844 19845
NOVARTIS SVERIGE AB
SE SE
Page 22/22
