9 February 2017 EMA/89247/2017 Human Medicines Evaluation Division
List of nationally authorised medicinal products
Active substance: ibuprofen / pseudoephedrine Procedure no.: PSUSA/00001711/201607
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
Larofen Plus
not available
119/2007/01
LAROPHARM SRL
RO
not available
480/2007/02
ZENTIVA, K.S.
RO
not available
480/2007/03
ZENTIVA, K.S.
RO
not available
480/2007/04
ZENTIVA, K.S.
RO
not available
480/2007/01
ZENTIVA, K.S.
RO
DE/H/4183/001/DC
93268.00.00
JOHNSON & JOHNSON GMBH
DE
DE/H/4183/001/DC
93268.00.00
JOHNSON & JOHNSON GMBH
DE
DE/H/4183/001/DC
93268.00.00
JOHNSON & JOHNSON GMBH
DE
DE/H/4183/001/DC
93268.00.00
JOHNSON & JOHNSON GMBH
DE
DE/H/4183/001/DC
23235
MCNEIL PRODUCTS LIMITED
PL
DE/H/4183/001/DC
23235
MCNEIL PRODUCTS LIMITED
PL
DE/H/4183/001/DC
23235
MCNEIL PRODUCTS LIMITED
PL
200mg/30mg, comprimate filmate MODAFEN 200 MG/30 MG COMPRIMATE FILMATE MODAFEN 200 MG/30 MG COMPRIMATE FILMATE MODAFEN 200 MG/30 MG COMPRIMATE FILMATE Modafen 200 mg/30 mg comprimate filmate Olytabs 200 mg/30 mg Filmtabletten Olytabs 200 mg/30 mg Filmtabletten Olytabs 200 mg/30 mg Filmtabletten Olytabs 200 mg/30 mg Filmtabletten Sudafed Extra, 200 mg + 30 mg, tabletki powlekane Sudafed Extra, 200 mg + 30 mg, tabletki powlekane Sudafed Extra, 200 mg + 30 mg, tabletki powlekane
List of nationally authorised medicinal products EMA/89247/2017
Page 2/24
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
Sudafed Extra, 200 mg +
DE/H/4183/001/DC
23235
MCNEIL PRODUCTS LIMITED
PL
DE/H/4183/001
20160014
MCNEIL PRODUCTS LIMITED
BG
DE/H/4183/001
8529/2016/03
MCNEIL PRODUCTS LIMITED
RO
DE/H/4183/001
8529/2016/01
MCNEIL PRODUCTS LIMITED
RO
DE/H/4183/001
8529/2016/04
MCNEIL PRODUCTS LIMITED
RO
DE/H/4183/001
8529/2016/02
MCNEIL PRODUCTS LIMITED
RO
DE/H/4183/001
H/16/02163/004
MCNEIL PRODUCTS LIMITED
SI
DE/H/4183/001
HR-H-962261553
JOHNSON & JOHNSON
HR
DE/H/4183/001
HR-H-962261553
JOHNSON & JOHNSON
30 mg, tabletki powlekane Олитабс 200 mg/30 mg филмирани таблетки Olytabs 200 mg/30 mg comprimate filmate Olytabs 200 mg/30 mg comprimate filmate Olytabs 200 mg/30 mg comprimate filmate Olytabs 200 mg/30 mg comprimate filmate Olytabs 200 mg/30 mg filmsko obložene tablete Olytabs 200 mg/30 mg filmom obložene tablete Olytabs 200 mg/30 mg
S.E.D.O.O.
filmom obložene tablete Olytabs 200 mg/30 mg
S.E.D.O.O. DE/H/4183/001
HR-H-962261553
filmom obložene tablete Olytabs 200 mg/30 mg
HR
JOHNSON & JOHNSON
HR
S.E.D.O.O. DE/H/4183/001
H/16/02163/002
MCNEIL PRODUCTS LIMITED
SI
DE/H/4183/001
HR-H-962261553
JOHNSON & JOHNSON
HR
filmsko obložene tablete Olytabs 200 mg/30 mg filmom obložene tablete Olytabs 200 mg/30 mg
S.E.D.O.O. DE/H/4183/001
H/16/02163/001
MCNEIL PRODUCTS LIMITED
SI
filmsko obložene tablete
List of nationally authorised medicinal products EMA/89247/2017
Page 3/24
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
Olytabs 200 mg/30 mg
DE/H/4183/001
H/16/02163/003
MCNEIL PRODUCTS LIMITED
SI
DE/H/4183/001
20160014
MCNEIL PRODUCTS LIMITED
BG
DE/H/4183/001
20160014
MCNEIL PRODUCTS LIMITED
BG
DE/H/4183/001
20160014
MCNEIL PRODUCTS LIMITED
BG
DE/H/4183/001
BE484782
JOHNSON & JOHNSON
BE
filmsko obložene tablete Олитабс 200 mg/30 mg филмирани таблетки Олитабс 200 mg/30 mg филмирани таблетки Олитабс 200 mg/30 mg филмирани таблетки Ibuprofen/Pseudoephedri ne Hydrochloride
CONSUMER N.V./S.A.
Diapharm 200 mg/30 mg filmomhulde tabletten Ibuprofen/Pseudoephedri
DE/H/4183/001
BE484782
ne Hydrochloride
JOHNSON & JOHNSON
BE
CONSUMER N.V./S.A.
Diapharm 200 mg/30 mg Filmtabletten Ibuprofen/Pseudoephedri
DE/H/4183/001
BE484782
ne Hydrochloride
JOHNSON & JOHNSON
BE
CONSUMER N.V./S.A.
Diapharm 200 mg/30 mg comprimés pelliculés Ibuprofen/Pseudoephedri
DE/H/4183/001
BE484782
ne Hydrochloride
JOHNSON & JOHNSON
BE
CONSUMER N.V./S.A.
Diapharm 200 mg/30 mg filmomhulde tabletten Ibuprofen/Pseudoephedri
DE/H/4183/001
ne Hydrochloride
BE484782
JOHNSON & JOHNSON
BE
CONSUMER N.V./S.A.
Diapharm 200 mg/30 mg comprimés pelliculés
List of nationally authorised medicinal products EMA/89247/2017
Page 4/24
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
Ibuprofen/Pseudoephedri
DE/H/4183/001
BE484782
JOHNSON & JOHNSON
BE
ne Hydrochloride
CONSUMER N.V./S.A.
Diapharm 200 mg/30 mg Filmtabletten Ibuprofen/Pseudoephedri
DE/H/4183/001
BE484782
ne Hydrochloride
JOHNSON & JOHNSON
BE
CONSUMER N.V./S.A.
Diapharm 200 mg/30 mg comprimés pelliculés Ibuprofen/Pseudoephedri
DE/H/4183/001
BE484782
ne Hydrochloride
JOHNSON & JOHNSON
BE
CONSUMER N.V./S.A.
Diapharm 200 mg/30 mg filmomhulde tabletten Ibuprofen/Pseudoephedri
DE/H/4183/001
BE484782
ne Hydrochloride
JOHNSON & JOHNSON
BE
CONSUMER N.V./S.A.
Diapharm 200 mg/30 mg Filmtabletten Ibuprofen/Pseudoephedri
DE/H/4183/001
BE484782
ne Hydrochloride
JOHNSON & JOHNSON
BE
CONSUMER N.V./S.A.
Diapharm 200 mg/30 mg Filmtabletten Ibuprofen/Pseudoephedri
DE/H/4183/001
BE484782
ne Hydrochloride
JOHNSON & JOHNSON
BE
CONSUMER N.V./S.A.
Diapharm 200 mg/30 mg comprimés pelliculés Ibuprofen/Pseudoephedri
DE/H/4183/001
ne Hydrochloride
BE484782
JOHNSON & JOHNSON
BE
CONSUMER N.V./S.A.
Diapharm 200 mg/30 mg filmomhulde tabletten
List of nationally authorised medicinal products EMA/89247/2017
Page 5/24
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
Non-Drowsy Sudapro
DE/H/4183/001/DC
PA 823/68/1
MCNEIL HEALTHCARE
IE
Head Cold 200mg / 30mg
(IRELAND) LIMITED
Film-coated Tablets Non-Drowsy Sudapro
DE/H/4183/001/DC
PA 823/68/1
Head Cold 200mg / 30mg
MCNEIL HEALTHCARE
IE
(IRELAND) LIMITED
Film-coated Tablets Non-Drowsy Sudapro
DE/H/4183/001/DC
PA 823/68/1
Head Cold 200mg / 30mg
MCNEIL HEALTHCARE
IE
(IRELAND) LIMITED
Film-coated Tablets Non-Drowsy Sudapro
DE/H/4183/001
PA 823/68/1
Head Cold 200mg/30mg
MCNEIL HEALTHCARE
IE
(IRELAND) LIMITED
Film-coated Tablets Non-Drowsy Sudapro
DE/H/4183/001
PA 823/68/1
Head Cold 200mg/30mg
MCNEIL HEALTHCARE
IE
(IRELAND) LIMITED
Film-coated Tablets Non-Drowsy Sudapro
DE/H/4183/001
PA 823/68/1
Head Cold 200mg / 30mg
MCNEIL HEALTHCARE
IE
(IRELAND) LIMITED
Film-coated Tablets Non-Drowsy Sudapro
DE/H/4183/001
PA 823/68/1
Head Cold 200mg / 30mg
MCNEIL HEALTHCARE
IE
(IRELAND) LIMITED
Film-coated Tablets Metafen ZATOKI, 200 mg
not available
11005
+ 30 mg, tabletki
ZAKLADY FARMACEUTYCZNE
PL
"POLPHARMA" SPOLKA AKCYJNA
MODAFEN filmom obalené
not available
07/0263/01-S
ZENTIVA, K.S.
SK
not available
07/0263/01-S
ZENTIVA, K.S.
SK
tablety MODAFEN filmom obalené tablety
List of nationally authorised medicinal products EMA/89247/2017
Page 6/24
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
MODAFEN
not available
07/0263/01-S
ZENTIVA, K.S.
SK
not available
11339
US PHARMACIA SP. Z O.O.
PL
not available
9650
US PHARMACIA SP. Z O.O.
PL
not available
21816
BIO PROFIL POLSKA SP Z OO
PL
not available
20100639
ZENTIVA, K.S.
BG
not available
20100639
ZENTIVA, K.S.
BG
not available
20100639
ZENTIVA, K.S.
BG
filmom obalené tablety Acatar Zatoki, 200 mg + 30 mg, tabletki powlekane IBUPROM ZATOKI, 200 mg + 30 mg, tabletki powlekane Laboratoria PolfaŁódź ZATOKI, 200 mg + 30 mg, tabletki EXTRALGIN COLD 200 mg/30 mg film-coated tablets Ibuprofen/Pseudoephedri ne hydrochloride EXTRALGIN COLD 200 mg/30 mg film-coated tablets Ibuprofen/Pseudoephedri ne hydrochloride EXTRALGIN COLD 200 mg/30 mg film-coated tablets Ibuprofen/Pseudoephedri ne hydrochloride
List of nationally authorised medicinal products EMA/89247/2017
Page 7/24
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
EXTRALGIN COLD 200
not available
20100639
ZENTIVA, K.S.
BG
not available
20080222
US PHARMACIA SP. Z O.O.
BG
DE/H/4187/001
93272.00.00
DIAPHARM GMBH & CO. KG
DE
DE/H/4186/001
93271.00.00
AZIENDE CHIMICHE RIUNITE
DE
mg/30 mg film-coated tablets Ibuprofen/Pseudoephedri ne hydrochloride Ибупром Синус 200 mg/30 mg обвити таблетки IbuSinex 200 mg/30 mg Filmtabletten Ibuprofen/Pseudoephedri nhydrochlorid Diapharm
ANGELINI FRANCESCO -
200 mg/30 mg
A.C.R.A.F. S.P.A.
Filmtabletten Momenxsin 200 mg/30
DE/H/4186/001
043682018
AZIENDE CHIMICHE RIUNITE
mg compresse rivestite
ANGELINI FRANCESCO -
con film
A.C.R.A.F. S.P.A.
Momenxsin 200 mg/30
DE/H/4186/001
043682020
AZIENDE CHIMICHE RIUNITE
mg compresse rivestite
ANGELINI FRANCESCO -
con film
A.C.R.A.F. S.P.A.
Momenxsin 200 mg/30
DE/H/4186/001
043682032
mg compresse rivestite
IT
IT
ANGELINI FRANCESCO -
con film Momenxsin 200 mg/30
AZIENDE CHIMICHE RIUNITE
IT
A.C.R.A.F. S.P.A. DE/H/4186/001
043682044
AZIENDE CHIMICHE RIUNITE
mg compresse rivestite
ANGELINI FRANCESCO -
con film
A.C.R.A.F. S.P.A.
List of nationally authorised medicinal products EMA/89247/2017
IT
Page 8/24
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
Ибупром Синус 200
not available
20080222
US PHARMACIA SP. Z O.O.
BG
not available
92698.00.00
RATIOPHARM GMBH
DE
not available
UP/I-530-09/11-01/363
FIDIFARM D.O.O.
HR
not available
PL 15513/0126
MCNEIL PRODUCTS LIMITED
UK
not available
PL 15513/0126
MCNEIL PRODUCTS LIMITED
UK
not available
PL 15513/0126
MCNEIL PRODUCTS LIMITED
UK
not available
PL 15513/0126
MCNEIL PRODUCTS LIMITED
UK
not available
07/136/98-C
ZENTIVA, K.S.
CZ
not available
07/136/98-C
ZENTIVA, K.S.
CZ
not available
07/136/98-C
ZENTIVA, K.S.
CZ
not available
07/136/98-C
ZENTIVA, K.S.
CZ
not available
21376
HASCO-LEK
PL
not available
10924
HASCO-LEK
PL
mg/30 mg обвити таблетки ratioGrippal® 200 mg/30 mg Filmtabletten Fidiprofen flu 200 mg+ 30 mg tablete Sudafed Sinus Pressure & Pain Tablets Sudafed Sinus Pressure & Pain Tablets Sudafed Sinus Pressure & Pain Tablets Sudafed Sinus Pressure & Pain Tablets Modafen potahované tablety Modafen potahované tablety Modafen potahované tablety Modafen potahované tablety Ibum Zatoki, 200 mg + 30 mg, tabletki powlekane IBUM GRIP, 200 mg + 30 mg, tabletki powlekane
List of nationally authorised medicinal products EMA/89247/2017
Page 9/24
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
Nurofen Sinus and Pain
not available
PA 979/65/1
RECKITT BENCKISER
IE
Film-Coated Tablets
IRELAND LTD.
Ibuprofen 200mg Pseudoephedrine Hydrochloride 30mg Nurofen Sinus and Pain
not available
PA 979/65/1
Film-Coated Tablets
RECKITT BENCKISER
IE
IRELAND LTD.
Ibuprofen 200mg Pseudoephedrine Hydrochloride 30mg Nurofen Cold and Flu 200
not available
OGYI-T-6797/02
mg/30 mg filmtabletta
RECKITT BENCKISER
HU
HEALTHCARE INTERNATIONAL LIMITED
Nurofen Sinus Pressure &
not available
PL 00063/0718
Headache Relief
RECKITT BENCKISER
UK
HEALTHCARE (UK) LIMITED
200mg/30mg Tablets Nurofen Raceala si Gripa
not available
4144/2011/02
RECKITT BENCKISER
200 mg/30 mg
HEALTHCARE
comprimate filmate
INTERNATIONAL LIMITED
Нурофен Стопколд 200
not available
9800356
RECKITT BENCKISER
mg/30 mg филмирани
HEALTHCARE
таблетки (Nurofen
INTERNATIONAL LIMITED
RO
BG
Stopcold 200 mg/30 mg film-coated tablets) Nurofen Cold and Flu
not available
19671
RECKITT BENCKISER HELLAS
CY
CHEMICALS ABEE
List of nationally authorised medicinal products EMA/89247/2017
Page 10/24
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
Nurofen StopGrip
not available
07/612/96-C
RECKITT BENCKISER
CZ
potahované tablety
HEALTHCARE INTERNATIONAL LIMITED
RHINUREFLEX, comprimé
not available
338 856-5
not available
343 625-8
not available
OGYI-T-6797/01
pelliculé NUROFEN RHUME,
FR
HEALTHCARE FRANCE
comprimé pelliculé Nurofen Cold and Flu 200
RECKITT BENCKISER RECKITT BENCKISER
FR
HEALTHCARE FRANCE
mg/30mg filmtabletta
RECKITT BENCKISER
HU
HEALTHCARE INTERNATIONAL LIMITED
Nurofen Cold & Flu Film-
not available
PA 979/33/1
coated Tablets, Ibuprofen
RECKITT BENCKISER
IE
IRELAND LTD.
200mg, Pseduoephedrine Hydrochloride 30mg NUROFEN INFLUENZA E
not available
034246013
RECKITT BENCKISER
RAFFREDDORE 200 mg +
HEALTHCARE
30 mg Compresse
INTERNATIONAL LIMITED
IT
Rivestite NUROFEN INFLUENZA E
not available
034246025
RECKITT BENCKISER
RAFFREDDORE 200 mg +
HEALTHCARE
30 mg Compresse
INTERNATIONAL LIMITED
IT
Rivestite Nurofen Antigrip 200
not available
04-0197
mg/30 mg apvalkotās
RECKITT BENCKISER
LV
(POLAND) S.A.
tabletes Nurofen Cold & Flu
not available
MA 190/00404
RECKITT BENCKISER
MT
HEALTHCARE INTERNATIONAL LIMITED
List of nationally authorised medicinal products EMA/89247/2017
Page 11/24
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
Nurofen Zatoki, 200 mg
not available
7787
RECKITT BENCKISER
PL
+ 30 mg, tabletki
(POLAND) S.A.
powlekane Nurofen Răceală şi Gripă
not available
4144/2011/01
RECKITT BENCKISER
200 mg/30 mg
HEALTHCARE
comprimate filmate
INTERNATIONAL LIMITED
NUROFEN STOPGRIP
not available
07/0662/96-S
RECKITT BENCKISER
RO
SK
HEALTHCARE INTERNATIONAL LIMITED Nurofen Cold & Flu
not available
PL 00063/0375
RECKITT BENCKISER
UK
HEALTHCARE (UK) LIMITED NUROFEN COLD & FLU
not available
44616/10
RECKITT BENCKISER HELLAS
GR
CHEMICALS ABEE Nurofen Cold and Flu 200
not available
UP/I-530-09/11-02/20
mg + 30 mg filmom
RECKITT BENCKISER
HR
(CROATIA) D.O.O.
obložene tablete Mucocold 200mg/30mg
UK/H/4352/001
91698
επικαλυμμένα με λεπτό
BOEHRINGER INGELHEIM
GR
INTERNATIONAL GMBH
υμένιο δισκία IBUPROFEN/PSEUDOEPH
UK/H/4352/001
EDRINE
2014040030
BOEHRINGER INGELHEIM
LU
INTERNATIONAL GMBH
HYDROCHLORIDE BOEHRINGER INGELHEIM 200 mg/30 mg comprimés pelliculés
List of nationally authorised medicinal products EMA/89247/2017
Page 12/24
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
Ibuprofen/Pseudoephedri
UK/H/4352/001
2014040030
BOEHRINGER INGELHEIM
LU
ne hydrochloride
INTERNATIONAL GMBH
Boehringer Ingelheim 200 mg/30 mg Filmtabletten Ibuprofen/Pseudoephedri
UK/H/4352/001
BE445164
ne hydrochloride
BOEHRINGER INGELHEIM
BE
INTERNATIONAL GMBH
Boehringer Ingelheim 200 mg/30 mg filmomhulde tabletten Ibuprofen/Pseudoephedri
UK/H/4352/001
BE445164
ne hydrochloride
BOEHRINGER INGELHEIM
BE
INTERNATIONAL GMBH
Boehringer Ingelheim 200 mg/30 mg Filmtabletten Ibuprofen/Pseudoephedri
UK/H/4352/001
BE445164
ne hydrochloride
BOEHRINGER INGELHEIM
BE
INTERNATIONAL GMBH
Boehringer Ingelheim 200 mg/30 mg filmomhulde tabletten Bisolpront 200 mg + 30
UK/H/4352/001
5666110
mg comprimidos
BOEHRINGER INGELHEIM
PT
INTERNATIONAL GMBH
revestidos por película Bisolpront 200 mg + 30
UK/H/4352/001
5666102
mg comprimidos
BOEHRINGER INGELHEIM
PT
INTERNATIONAL GMBH
revestidos por película BoxaGrippal 200 mg / 30
UK/H/4352/001
mg Filmtabletten
List of nationally authorised medicinal products EMA/89247/2017
85528.00.00
BOEHRINGER INGELHEIM
DE
INTERNATIONAL GMBH
Page 13/24
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
Мукогрип 200 mg/30 mg
UK/H/4352/001
20120408
BOEHRINGER INGELHEIM
BG
филмирани таблетки Lasynac 200mg/30mg
INTERNATIONAL GMBH UK/H/4352/001/DC
PL 14598/0091
film coated tablets Bisolfren 200 mg/30 mg
BOEHRINGER INGELHEIM
UK
INTERNATIONAL GMBH UK/H/4352/001
76389
comprimidos recubiertos
BOEHRINGER INGELHEIM
ES
INTERNATIONAL GMBH
con película BoxaGrippal™ 200 mg/30
UK/H/4352/001
1-31668
mg - Filmtabletten Mucogrip 200mg/30mg
UK/H/4352/001
OGYI-T-22371/01
BOEHRINGER INGELHEIM
HU
INTERNATIONAL GMBH UK/H/4352/001
OGYI-T-22371/02
filmtabletta Mucocold 200mg/30mg
AT
INTERNATIONAL GMBH
filmtabletta Mucogrip 200mg/30mg
BOEHRINGER INGELHEIM
BOEHRINGER INGELHEIM
HU
INTERNATIONAL GMBH UK/H/4352/001
21691
επικαλυμμένα με λεπτό
BOEHRINGER INGELHEIM
CY
INTERNATIONAL GMBH
υμένιο δισκία IBUPROFENE E
UK/H/4352/001
041218013
PSEUDOEFEDRINA
BOEHRINGER INGELHEIM
IT
INTERNATIONAL GMBH
BOEHRINGER INGELHEIM 200 mg/30 mg compresse rivestite con film IBUPROFENE E
UK/H/4352/001
PSEUDOEFEDRINA
041218025
BOEHRINGER INGELHEIM
IT
INTERNATIONAL GMBH
BOEHRINGER INGELHEIM 200 mg/30 mg compresse rivestite con film
List of nationally authorised medicinal products EMA/89247/2017
Page 14/24
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
IBUPROFEN/PSEUDOEPH
UK/H/4352/001
BE445164
BOEHRINGER INGELHEIM
BE
EDRINE
INTERNATIONAL GMBH
HYDROCHLORIDE BOEHRINGER INGELHEIM 200 mg/30 mg comprimés pelliculés Dolormin Grippal 200
DE/H/4182/001/DC
93267.00.00
JOHNSON & JOHNSON GMBH
DE
DE/H/4182/001/DC
93267.00.00
JOHNSON & JOHNSON GMBH
DE
DE/H/4182/001/DC
93267.00.00
JOHNSON & JOHNSON GMBH
DE
DE/H/4182/001/DC
93267.00.00
JOHNSON & JOHNSON GMBH
DE
DE/H/4182/001
PA823/067/001
MCNEIL HEALTHCARE
IE
mg/30 mg Filmtabletten Dolormin Grippal 200 mg/30 mg Filmtabletten Dolormin Grippal 200 mg/30 mg Filmtabletten Dolormin Grippal 200 mg/30 mg Filmtabletten Ibuprofen/Pseudoephedri ne Hydrochloride
(IRELAND) LIMITED
200mg/30mg film coated tablets Ibuprofen/Pseudoephedri
DE/H/4182/001
PA823/067/001
ne Hydrochloride
MCNEIL HEALTHCARE
IE
(IRELAND) LIMITED
200mg/30mg film coated tablets Ibuprofen/Pseudoephedri
DE/H/4182/001
ne Hydrochloride
PA0823/067/001
MCNEIL HEALTHCARE
IE
(IRELAND) LIMITED
200mg/30mg film coated tablets
List of nationally authorised medicinal products EMA/89247/2017
Page 15/24
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
Ibuprofen/Pseudoephedri
DE/H/4182/001
PA823/067/001
MCNEIL HEALTHCARE
IE
ne Hydrochloride
(IRELAND) LIMITED
200mg/30mg film coated tablets IbuHEXAL Grippal 200
DE/H/4184/001
93269.00.00
HEXAL AG
DE
DE/H/4184/001
HR-H-099217339
SANDOZ D.O.O.
HR
DE/H/4184/001
136793
SANDOZ GMBH
AT
DE/H/4185/001
16-0009
PHARMASWISS ČESKÁ
LV
mg/30 mg Filmtabletten Ibutren Flu 200 mg/30 mg filmom obložene tablete Dolorflu akut 200 mg/30 mg - Filmtabletten ILOXEN 200 mg/30 mg apvalkotās tabletes GRIPOMED 200 mg/30
REPUBLIKA S.R.O. DE/H/4185/001
93270.00.00
mg Filmtabletten Febrilek 200 mg / 30 mg
PHARMASWISS ČESKÁ
DE
REPUBLIKA S.R.O. DE/H/4185/001
899915
õhukese
PHARMASWISS ČESKÁ
EE
REPUBLIKA S.R.O.
polümeerikattega tabletid ILOXEN 200 mg/30 mg
DE/H/4185/001
LT/1/16/3881/001
plėvele dengtos tabletės ILOXEN 200 mg/30 mg
DE/H/4185/001
LT/1/16/3881/002
DE/H/4185/001
LT/1/16/3881/003
DE/H/4185/001
LT/1/16/3881/004
LT
DE/H/4185/001
23302
PHARMASWISS ČESKÁ
LT
REPUBLIKA S.R.O.
plėvele dengtos tabletės Efedoxin, 200 mg + 30
PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
plėvele dengtos tabletės ILOXEN 200 mg/30 mg
LT
REPUBLIKA S.R.O.
plėvele dengtos tabletės ILOXEN 200 mg/30 mg
PHARMASWISS ČESKÁ
PHARMASWISS ČESKÁ
LT
REPUBLIKA S.R.O.
mg, tabletki powlekane
List of nationally authorised medicinal products EMA/89247/2017
PHARMASWISS ČESKÁ
PL
REPUBLIKA S.R.O.
Page 16/24
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
BoxaGrippal®
UK/H/5545/001
90668.00.00
BOEHRINGER INGELHEIM
DE
Erkältungssaft
INTERNATIONAL GMBH
200 mg/10 ml + 30 mg/10 ml Suspension zum Einnehmen Ibuprofen/Pseudoephedri
UK/H/5545/001
PL 14598/0103
ne hydrochloride
BOEHRINGER INGELHEIM
UK
INTERNATIONAL GMBH
100mg/15mg per 5 ml Oral suspension Acatar Zatoki, 200 mg +
not available
11339
US PHARMACIA SP. Z O.O.
PL
not available
9650
US PHARMACIA SP. Z O.O.
PL
IE/H/0420/001
OGYI-T-22705/02
PFIZER CORPORATION
HU
30 mg, tabletki powlekane IBUPROM ZATOKI, 200 mg + 30 mg, tabletki powlekane Advil Cold 200 mg/30 mg bevont tabletta
AUSTRIA GESELLSCHAFT M.B.H.
Advil Cold 200 mg/30 mg
IE/H/0420/001
OGYI-T-22705/01
bevont tabletta
PFIZER CORPORATION
HU
AUSTRIA GESELLSCHAFT M.B.H.
Ibuprofen/Pseudoephedri
IE/H/0420/001
BE463680
PFIZER B.V.
BE
IE/H/0420/001
07/040/15-C
PFIZER CORPORATION
CZ
ne HCl Pfizer 200 mg/30 mg comprimés enrobés Robicold 200 mg/30 mg obalené tablety
AUSTRIA GESELLSCHAFT M.B.H.
List of nationally authorised medicinal products EMA/89247/2017
Page 17/24
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
RobiCold Sinus Relief 200
IE/H/0420/001
PL 00165/0391
PFIZER CONSUMER
UK
mg, 30 mg Tablets Ibuprofen/Pseudoephedri
HEALTHCARE LTD. IE/H/0420/001
BE463680
PFIZER B.V.
BE
IE/H/0420/001
BE463680
PFIZER B.V.
BE
IE/H/0420/001
07/0264/14-S
PFIZER CORPORATION
SK
ne HCl Pfizer 200 mg/30 mg omhulde tabletten Ibuprofen/Pseudoephedri ne HCl Pfizer 200mg/30 mg überzogene Tabletten Robicold 200 mg/30 mg obalené tablety
AUSTRIA GESELLSCHAFT M.B.H.
Advil Zatoki, 200 mg +
IE/H/0420/001
22369
30 mg, tabletki
PL
AUSTRIA GESELLSCHAFT
powlekane RobiCold Cold & Flu Relief
PFIZER CORPORATION M.B.H.
UK/H/5670/001
PL 00165/0388
200 mg / 30 mg Soft
PFIZER CONSUMER
UK
HEALTHCARE LTD.
Capsules Advil Sinus Relief Soft
UK/H/5670/001
PA 0822/164/002
Capsules Ibuprofen 200
PFIZER HEALTHCARE
IE
IRELAND
mg Pseudoephedrine hydrochloride 30 mg Robicold Rapid 200
UK/H/5670/001
07/0235/16-S
PFIZER CORPORATION
mg/30 mg mäkké
AUSTRIA GESELLSCHAFT
kapsuly
M.B.H.
Advil Sinus și Răceală
UK/H/5670/001
8760/2016/01
PFIZER CORPORATION
200 mg/30 mg capsule
AUSTRIA GESELLSCHAFT
moi
M.B.H.
List of nationally authorised medicinal products EMA/89247/2017
SK
RO
Page 18/24
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
Advil Sinus și Răceală
UK/H/5670/001
8760/2016/02
PFIZER CORPORATION
RO
200 mg/30 mg capsule
AUSTRIA GESELLSCHAFT
moi
M.B.H.
Advil Sinus și Răceală
UK/H/5670/001
8760/2016/08
PFIZER CORPORATION
200 mg/30 mg capsule
AUSTRIA GESELLSCHAFT
moi
M.B.H.
Advil Sinus și Răceală
UK/H/5670/001
8760/2016/14
200 mg/30 mg capsule
M.B.H. UK/H/5670/001
8760/2016/12
PFIZER CORPORATION
200 mg/30 mg capsule
AUSTRIA GESELLSCHAFT
moi
M.B.H.
Advil Sinus și Răceală
UK/H/5670/001
8760/2016/03
PFIZER CORPORATION
200 mg/30 mg capsule
AUSTRIA GESELLSCHAFT
moi
M.B.H.
Advil Sinus și Răceală
UK/H/5670/001
8760/2016/10
PFIZER CORPORATION
200 mg/30 mg capsule
AUSTRIA GESELLSCHAFT
moi
M.B.H.
Advil Sinus și Răceală
UK/H/5670/001
8760/2016/06
200 mg/30 mg capsule
PFIZER CORPORATION
RO
RO
RO
M.B.H. UK/H/5670/001
8760/2016/04
PFIZER CORPORATION
200 mg/30 mg capsule
AUSTRIA GESELLSCHAFT
moi
M.B.H.
Advil Sinus și Răceală
RO
AUSTRIA GESELLSCHAFT
moi Advil Sinus și Răceală
RO
AUSTRIA GESELLSCHAFT
moi Advil Sinus și Răceală
PFIZER CORPORATION
RO
UK/H/5670/001
8760/2016/16
PFIZER CORPORATION
200 mg/30 mg capsule
AUSTRIA GESELLSCHAFT
moi
M.B.H.
List of nationally authorised medicinal products EMA/89247/2017
RO
RO
Page 19/24
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
Advil Sinus și Răceală
UK/H/5670/001
8760/2016/05
PFIZER CORPORATION
RO
200 mg/30 mg capsule
AUSTRIA GESELLSCHAFT
moi
M.B.H.
Advil Sinus și Răceală
UK/H/5670/001
8760/2016/13
PFIZER CORPORATION
200 mg/30 mg capsule
AUSTRIA GESELLSCHAFT
moi
M.B.H.
Advil Sinus și Răceală
UK/H/5670/001
8760/2016/07
200 mg/30 mg capsule
M.B.H. UK/H/5670/001
8760/2016/11
PFIZER CORPORATION
200 mg/30 mg capsule
AUSTRIA GESELLSCHAFT
moi
M.B.H.
Advil Sinus Relief Soft
RO
AUSTRIA GESELLSCHAFT
moi Advil Sinus și Răceală
PFIZER CORPORATION
RO
UK/H/5670/001
MA969/00202
PFIZER CORPORATION
Capsules Ibuprofen 200
AUSTRIA GESELLSCHAFT
mg Pseudoephedrine
M.B.H.
RO
MT
hydrochloride 30 mg Advil Sinus și Răceală
UK/H/5670/001
8760/2016/09
PFIZER CORPORATION
200 mg/30 mg capsule
AUSTRIA GESELLSCHAFT
moi
M.B.H.
Advil Sinus și Răceală
UK/H/5670/001
8760/2016/15
PFIZER CORPORATION
200 mg/30 mg capsule
AUSTRIA GESELLSCHAFT
moi
M.B.H.
SpaltGrippal 200 mg/30
UK/H/5671/001
94021.00.00
mg Weichkapseln Ibuprofen/Pseudoephedri
PFIZER CONSUMER
RO
RO
DE
HEALTHCARE GMBH IE/H/0420/001
2015040073
PFIZER B.V.
LU
ne HCl Pfizer 200 mg / 30 mg Comprimés enrobé
List of nationally authorised medicinal products EMA/89247/2017
Page 20/24
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
Spalt Effekt 30mg/200
FR/H/0238/001
62958.00.00
PFIZER CONSUMER
DE
mg überzogene Tabletten RHINADVIL RHUME
HEALTHCARE GMBH FR/H/0238/001
334 084-8
IBUPROFENE/PSEUDOEP
PFIZER SANTE FAMILIALE
FR
SAS
HEDRINE, comprimé enrobé Advil Cold & Flu Coated
IE/H/0420/001
PA 822/164/1
Tablets Ibuprofen 200 mg
PFIZER HEALTHCARE
IE
IRELAND
Pseudoephedrine Hydrochloride 30 mg Advil Cold & Flu Coated
not available
MA 969/00201
Tablets Ibuprofen 200 mg
PFIZER CONSUMER
MT
HEALTHCARE LTD.
Pseudoephedrine Hydrochloride 30 mg Boots Cold & Flu Relief
not available
00014/0600
THE BOOTS COMPANY PLC
UK
DE/H/4188/001
93273.00.00
KREWEL MEUSELBACH GMBH
DE
DE/H/4188/001
07/155/16-C
KREWEL MEUSELBACH GMBH
CZ
DE/H/4188/001
07/0143/16-S
KREWEL MEUSELBACH GMBH
SK
with Ibuprofen Ibuprofen/Pseudoephedri nhydrochlorid Krewel 200 mg/30 mg Filmtabletten Grippecton 200 mg/30 mg potahované tablety Grippecton 200 mg/30 mg filmom obalené tablety
List of nationally authorised medicinal products EMA/89247/2017
Page 21/24
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
Ibuprofene e
IT/H/0331/001
042499032
WICK PHARMA
IT
pseudoefedrina Wick
ZWEIGNIEDERLASSUNG DER
Pharma 200 mg/30 mg
PROCTER & GAMBLE GMBH
compresse rivestite con film Ibuprofene e
IT/H/0331/001
042499044
WICK PHARMA
pseudoefedrina Wick
ZWEIGNIEDERLASSUNG DER
Pharma 200 mg/30 mg
PROCTER & GAMBLE GMBH
IT
compresse rivestite con film WICK DuoGrippal 200
IT/H/0331/001
88707.00.00
mg/30 mg Filmtabletten
WICK PHARMA
DE
ZWEIGNIEDERLASSUNG DER PROCTER & GAMBLE GMBH
Gripaduo 200 mg/30 mg
IT-H-0331-001-DC
78831
LABORATORIOS VICKS, S.L.
ES
IT/H0331/001
OGYI-T-22836/01
WICK PHARMA
HU
comprimidos recubiertos con película Ibuprofen/Pszeudoefedrin Wick 200 mg/30 mg
ZWEIGNIEDERLASSUNG DER
filmtabletta
PROCTER & GAMBLE GMBH
Ibuprofen/Pszeudoefedrin
IT/H0331/001/DC
OGYI-T-22836/02
WICK PHARMA
Wick 200mg/30mg
ZWEIGNIEDERLASSUNG DER
filmtabletta
PROCTER & GAMBLE GMBH
Ibuprofen/Pszeudoefedrin
IT/H0331/001/DC
OGYI-T-22836/03
WICK PHARMA
Wick 200mg/30mg
ZWEIGNIEDERLASSUNG DER
filmtabletta
PROCTER & GAMBLE GMBH
List of nationally authorised medicinal products EMA/89247/2017
HU
HU
Page 22/24
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
Ibuprofene e
IT/H/0331/001
042499057
WICK PHARMA
IT
pseudoefedrina Wick
ZWEIGNIEDERLASSUNG DER
Pharma 200 mg/30 mg
PROCTER & GAMBLE GMBH
compresse rivestite con film Infex Zatoki
IT-H-0331-001-DC
22111
WICK DayMed Duo
IT/H/0331/001
135488
TEVA PHARMACEUTICALS
PL
POLSKA SP. Z O.O. 200mg/30mg
RATIOPHARM ARZNEIMITTEL
AT
VERTRIEBS-GMBH
Filmtabletten TEDOLFEN 200mg/30mg
IT/H/0331/001
6744/2014/01-04
comprimate filmate ALGOFLEX COLD 200
TEVA PHARMACEUTICALS
RO
S.R.L not available
OGYI-T-22831/03
SANOFI-AVENTIS ZRT
HU
not available
OGYI-T-22831/01
SANOFI-AVENTIS ZRT
HU
not available
OGYI-T-22831/02
SANOFI-AVENTIS ZRT
HU
not available
9603
ZENTIVA, K.S.
PL
not available
9603
ZENTIVA, K.S.
PL
not available
9603
ZENTIVA, K.S.
PL
not available
OGYI-T-9161/02
SANOFI-AVENTIS ZRT
HU
mg/30 mg filmtabletta ALGOFLEX COLD 200 mg/30 mg filmtabletta ALGOFLEX COLD 200 mg/30 mg filmtabletta MODAFEN, 200 mg + 30 mg, tabletki powlekane MODAFEN, 200 mg + 30 mg, tabletki powlekane MODAFEN, 200 mg + 30 mg, tabletki powlekane RHINATHIOL COLD 200 MG/30 MG FILMTABLETTA
List of nationally authorised medicinal products EMA/89247/2017
Page 23/24
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
RHINATHIOL COLD 200
not available
OGYI-T-9161/01
SANOFI-AVENTIS ZRT
HU
not available
OGYI-T-9161/03
SANOFI-AVENTIS ZRT
HU
MG/30 MG FILMTABLETTA RHINATHIOL COLD 200 MG/30 MG FILMTABLETTA
List of nationally authorised medicinal products EMA/89247/2017
Page 24/24
