May 30, 2018 - SE. Pepcidtwo chewable tablet not available. PL 15513/0348. MCNEIL PRODUCTS LIMITED UK. Pepcidtwo chewabl
30 May 2018 EMA/471694/2018 Human Medicines Evaluation Division
List of nationally authorised medicinal products
Active substance: calcium carbonate / famotidine / magnesium hydroxide
Procedure no.: PSUSA/00001351/201709
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© European Medicines Agency, 2018. Reproduction is authorised provided the source is acknowledged.
Product Name (in authorisation country)
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Pepcid Duo purutabletti
MRP/DCP Authorisation number FR/H/169/001
15777
OF
FI
Pepcid Duo purutabletti
FR/H/169/001
15777
OF
FI
Pepcid Duo purutabletti
FR/H/169/001
15777
OF
FI
Pepcid Duo purutabletti
FR/H/169/001
15777
OF
FI
Pepcid Duo purutabletti
FR/H/169/001
15777
OF
FI
Pepcid Duo purutabletti
FR/H/0169/001
15777
OF
FI
Pepcid Duo purutabletti
FR/H/169/001
15777
OF
FI
Pepcid Duo purutabletti
FR/H/169/001
15777
OF
FI
Pepcid Duo purutabletti
FR/H/169/001
15777
OF
FI
Pepcid Duo purutabletti
FR/H/169/001
15777
OF
FI
Pepcid Duo tuggtablett
FR/H/169/001
15777
OF
FI
Pepcid Duo tuggtablett
FR/H/169/001
15777
OF
FI
Pepcid Duo tuggtablett
FR/H/0169/001
15777
OF
FI
Pepcid Duo tuggtablett
FR/H/0169/001
15777
OF
FI
Pepcid Duo tuggtablett
FR/H/169/001
15777
OF
FI
Pepcid Duo tuggtablett
FR/H/169/001
15777
OF
FI
Pepcid Duo tuggtablett
FR/H/0169/001
15777
OF
FI
Pepcid Duo tuggtablett
FR/H/169/001
15777
OF
FI
Pepcid Duo tuggtablett
FR/H/0169/001
15777
MCNEIL, A DIVISION JANSSEN-CILAG OY MCNEIL, A DIVISION JANSSEN-CILAG OY MCNEIL, A DIVISION JANSSEN-CILAG OY MCNEIL, A DIVISION JANSSEN-CILAG OY MCNEIL, A DIVISION JANSSEN-CILAG OY MCNEIL, A DIVISION JANSSEN-CILAG OY MCNEIL, A DIVISION JANSSEN-CILAG OY MCNEIL, A DIVISION JANSSEN-CILAG OY MCNEIL, A DIVISION JANSSEN-CILAG OY MCNEIL, A DIVISION JANSSEN-CILAG OY MCNEIL, A DIVISION JANSSEN-CILAG OY MCNEIL, A DIVISION JANSSEN-CILAG OY MCNEIL, A DIVISION JANSSEN-CILAG OY MCNEIL, A DIVISION JANSSEN-CILAG OY MCNEIL, A DIVISION JANSSEN-CILAG OY MCNEIL, A DIVISION JANSSEN-CILAG OY MCNEIL, A DIVISION JANSSEN-CILAG OY MCNEIL, A DIVISION JANSSEN-CILAG OY MCNEIL, A DIVISION JANSSEN-CILAG OY
OF
FI
List of nationally authorised medicinal products EMA/471694/2018
Page 2/6
Product Name (in authorisation country) Pepcid Duo tuggtablett PEPCIDDUO, comprimé à croquer PEPCIDDUO, comprimé à croquer PEPCIDDUO, comprimé à croquer PEPCIDDUO, comprimé à croquer PEPCIDDUO, comprimé à croquer PEPCIDDUO, comprimé à croquer PEPCIDDUO, comprimé à croquer PEPCIDDUO, comprimé à croquer PEPCIDDUO, comprimé à croquer PEPCIDDUO, comprimé à croquer Pepcidtwo Chewable Tablets Famotidine 10mg Magnesium Hydroxide 165mg Calcium Carbonate 800mg Pepcidtwo Chewable Tablets Famotidine 10mg Magnesium Hydroxide 165mg Calcium Carbonate 800mg
MRP/DCP Authorisation number FR/H/0169/001
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
15777
FI
FR/H/0169/001
3400935335821
FR/H/0169/001
3400935635020
FR/H/0169/001
3400935628336
FR/H/0169/001
3400935628626
FR/H/0169/001
3400935628565
FR/H/0169/001
3400935628794
FR/H/0169/001
3400935635198
FR/H/0169/001
3400935335999
FR/H/0169/001
3400935336071
FR/H/0169/001
3400935336132
FR/H/0169/001
PA 823/58/1
MCNEIL, A DIVISION OF JANSSEN-CILAG OY JOHNSON & JOHNSON SANTÉ BEAUTÉ FRANCE JOHNSON & JOHNSON SANTÉ BEAUTÉ FRANCE JOHNSON & JOHNSON SANTÉ BEAUTÉ FRANCE JOHNSON & JOHNSON SANTÉ BEAUTÉ FRANCE JOHNSON & JOHNSON SANTÉ BEAUTÉ FRANCE JOHNSON & JOHNSON SANTÉ BEAUTÉ FRANCE JOHNSON & JOHNSON SANTÉ BEAUTÉ FRANCE JOHNSON & JOHNSON SANTÉ BEAUTÉ FRANCE JOHNSON & JOHNSON SANTÉ BEAUTÉ FRANCE JOHNSON & JOHNSON SANTÉ BEAUTÉ FRANCE MCNEIL HEALTHCARE (IRELAND) LIMITED
FR/H/0169/001
PA 823/58/1
MCNEIL HEALTHCARE (IRELAND) LIMITED
IE
List of nationally authorised medicinal products EMA/471694/2018
FR FR FR FR FR FR FR FR FR FR IE
Page 3/6
Product Name (in authorisation country) Pepcidtwo Chewable Tablets Famotidine 10mg Magnesium Hydroxide 165mg Calcium Carbonate 800mg Pepcidtwo Chewable Tablets Famotidine 10mg Magnesium Hydroxide 165mg Calcium Carbonate 800mg Pepcidtwo Chewable Tablets Famotidine 10mg Magnesium Hydroxide 165mg Calcium Carbonate 800mg Pepcidtwo Chewable Tablets Famotidine 10mg Magnesium Hydroxide 165mg Calcium Carbonate 800mg Pepcidtwo Chewable Tablets Famotidine 10mg Magnesium Hydroxide 165mg Calcium Carbonate 800mg Pepcidtwo Chewable Tablets Famotidine 10mg Magnesium Hydroxide 165mg Calcium Carbonate 800mg Pepcidtwo Chewable Tablets Famotidine 10mg Magnesium Hydroxide 165mg Calcium Carbonate 800mg
MRP/DCP Authorisation number FR/H/0169/001
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
PA 823/58/1
MCNEIL HEALTHCARE (IRELAND) LIMITED
IE
FR/H/0169/001
PA 823/58/1
MCNEIL HEALTHCARE (IRELAND) LIMITED
IE
FR/H/0169/001
PA 823/58/1
MCNEIL HEALTHCARE (IRELAND) LIMITED
IE
FR/H/0169/001
PA 823/58/1
MCNEIL HEALTHCARE (IRELAND) LIMITED
IE
FR/H/0169/001
PA 823/58/1
MCNEIL HEALTHCARE (IRELAND) LIMITED
IE
FR/H/0169/001
PA 823/58/1
MCNEIL HEALTHCARE (IRELAND) LIMITED
IE
FR/H/0169/001
PA 823/58/1
MCNEIL HEALTHCARE (IRELAND) LIMITED
IE
List of nationally authorised medicinal products EMA/471694/2018
Page 4/6
Product Name (in authorisation country) Pepcidtwo Chewable Tablets Famotidine 10mg Magnesium Hydroxide 165mg Calcium Carbonate 800mg Pepcidduo, tyggetablett Pepcidduo, tyggetablett Pepcidduo, tyggetablett Pepcidduo, tyggetablett Pepcidduo, tyggetablett Pepcidduo, tyggetablett Pepcidduo, tyggetablett Pepcidduo, tyggetablett Pepcidduo, tyggetablett Pepcidduo, tyggetablett Pepcid Duo tuggtablett Pepcid Duo tuggtablett Pepcid Duo tuggtablett Pepcid Duo tuggtablett Pepcid Duo tuggtablett Pepcid Duo tuggtablett Pepcid Duo tuggtablett Pepcid Duo tuggtablett Pepcid Duo tuggtablett Pepcid Duo tuggtablett Pepcidtwo chewable tablet Pepcidtwo chewable tablet Pepcidtwo chewable tablet Pepcidtwo chewable tablet Pepcidtwo chewable tablet
MRP/DCP Authorisation number FR/H/0169/001
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
PA 823/58/1
MCNEIL HEALTHCARE (IRELAND) LIMITED
IE
FR/H/169/001 FR/H/169/001 FR/H/169/001 FR/H/169/001 FR/H/169/001 FR/H/169/001 FR/H/169/001 FR/H/169/001 FR/H/169/001 FR/H/169/001 FR/H/0169/001 FR/H/0169/001 FR/H/0169/001 FR/H/0169/001 FR/H/0169/001 FR/H/0169/001 FR/H/0169/001 FR/H/0169/001 FR/H/0169/001 FR/H/0169/001 not available
00-2960 00-2960 00-2960 00-2960 00-2960 00-2960 00-2960 00-2960 00-2960 00-2960 16331 16331 16331 16331 16331 16331 16331 16331 16331 16331 PL 15513/0348
MCNEIL MCNEIL MCNEIL MCNEIL MCNEIL MCNEIL MCNEIL MCNEIL MCNEIL MCNEIL MCNEIL MCNEIL MCNEIL MCNEIL MCNEIL MCNEIL MCNEIL MCNEIL MCNEIL MCNEIL MCNEIL
SWEDEN AB SWEDEN AB SWEDEN AB SWEDEN AB SWEDEN AB SWEDEN AB SWEDEN AB SWEDEN AB SWEDEN AB SWEDEN AB SWEDEN AB SWEDEN AB SWEDEN AB SWEDEN AB SWEDEN AB SWEDEN AB SWEDEN AB SWEDEN AB SWEDEN AB SWEDEN AB PRODUCTS LIMITED
NO NO NO NO NO NO NO NO NO NO SE SE SE SE SE SE SE SE SE SE UK
not available
PL 15513/0348
MCNEIL PRODUCTS LIMITED
UK
not available
PL 15513/0348
MCNEIL PRODUCTS LIMITED
UK
not available
PL 15513/0348
MCNEIL PRODUCTS LIMITED
UK
not available
PL 15513/0348
MCNEIL PRODUCTS LIMITED
UK
List of nationally authorised medicinal products EMA/471694/2018
Page 5/6
Product Name (in authorisation country) Pepcidtwo tablet Pepcidtwo tablet Pepcidtwo tablet Pepcidtwo tablet Pepcidtwo tablet Pepcidtwo tablet Pepcidtwo tablet
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
chewable
MRP/DCP Authorisation number not available
PL 15513/0348
MCNEIL PRODUCTS LIMITED
UK
chewable
not available
PL 15513/0348
MCNEIL PRODUCTS LIMITED
UK
chewable
not available
PL 15513/0348
MCNEIL PRODUCTS LIMITED
UK
chewable
not available
PL 15513/0348
MCNEIL PRODUCTS LIMITED
UK
chewable
not available
PL 15513/0348
MCNEIL PRODUCTS LIMITED
UK
chewable
not available
PL 15513/0348
MCNEIL PRODUCTS LIMITED
UK
chewable
not available
PL 15513/0348
MCNEIL PRODUCTS LIMITED
UK
List of nationally authorised medicinal products EMA/471694/2018
Page 6/6
