14 February 2019
EMA/128842/2019
Human Medicines Evaluation Division
List of nationally authorised medicinal products
Active substance: nimesulide (systemic formulations)
Procedure no.: PSUSA/00009236/201806
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5525
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© European Medicines Agency, 2019. Reproduction is authorised provided the source is acknowledged.
Product Name (in MRP/DCP Authorisation National Authorisation MAH of product in the Member State where
authorisation country) number Number member state product is authorised
Aulin 200 mg supposte IT/H/0151/003 025940065 HELSINN BIREX IT
PHARMACEUTICALS LTD.
НИМЕД 100 mg таблетки IT/H/0150/001 20060230 ANGELINI PHARMA BG
BULGARIA EOOD
Mesulid 100 mg compresse IT/H/0150/001 025971173 HELSINN BIREX IT
PHARMACEUTICALS LTD.
Mesulid 100 mg compresse IT/H/0150/001 025971185 HELSINN BIREX IT
PHARMACEUTICALS LTD.
Mesulid 100 mg compresse IT/H/0150/001 025971197 HELSINN BIREX IT
PHARMACEUTICALS LTD.
Mesulid 100 mg compresse IT/H/0150/001 025971209 HELSINN BIREX IT
PHARMACEUTICALS LTD.
Mesulid 100 mg compresse IT/H/0150/001 025971211 HELSINN BIREX IT
PHARMACEUTICALS LTD.
NIMED 100 mg tablety IT/H/0150/001 29/0098/98-S HELSINN BIREX SK
PHARMACEUTICALS LTD.
Mesulid® 100mg Δισκία not available 36240 BOEHRINGER INGELHEIM GR
ELLAS AE
Mesulid 100 mg compresse IT/H/0150/001 025971021 HELSINN BIREX IT
PHARMACEUTICALS LTD.
Mesulid 100 mg tabletes IT/H/0150/001 97-0248 HELSINN BIREX LV
PHARMACEUTICALS LTD.
Mesulid 100 mg tabletta CZ/H/902/01 OGYI-T-6459/01 ANGELINI PHARMA HU
ÖSTERREICH GMBH
MESULID 100 mg tablety CZ/H/902/01 29/125/01-C ANGELINI PHARMA CZ
ÖSTERREICH GMBH
Aулин 100 mg таблетки IT/H/0151/001 9600168 ANGELINI PHARMA BG
BULGARIA EOOD
List of nationally authorised medicinal products
EMA/128842/2019 Page 2/7
Product Name (in MRP/DCP Authorisation National Authorisation MAH of product in the Member State where
authorisation country) number Number member state product is authorised
AULIN 100 mg comprimate IT/H/0151/001 6646/2014/05 ANGELINI PHARMA RO
ÖSTERREICH GMBH
AULIN 100 mg comprimate IT/H/0151/001 6646/2014/06 ANGELINI PHARMA RO
ÖSTERREICH GMBH
Aulin 100 mg compresse IT/H/0151/001 025940166 HELSINN BIREX IT
PHARMACEUTICALS LTD.
Aulin 100 mg compresse IT/H/0151/001 025940178 HELSINN BIREX IT
PHARMACEUTICALS LTD.
Aulin 100 mg compresse IT/H/0151/001 025940180 HELSINN BIREX IT
PHARMACEUTICALS LTD.
Aulin 100 mg compresse IT/H/0151/001 025940192 HELSINN BIREX IT
PHARMACEUTICALS LTD.
Aulin 100 mg compresse IT/H/0151/001 025940204 HELSINN BIREX IT
PHARMACEUTICALS LTD.
Aulin 100 mg compresse IT/H/0151/001 025940026 HELSINN BIREX IT
PHARMACEUTICALS LTD.
AULIN 100 mg tablety IT/H/0151/001 29/179/97-C ANGELINI PHARMA ČESKÁ CZ
REPUBLIKA S.R.O.
AULIN 100 mg tablety IT/H/0151/001 29/0282/97-S ANGELINI PHARMA ČESKÁ SK
REPUBLIKA S.R.O.
Aulin, 100 mg, tabletki IT/H/0151/001 4113 ANGELINI PHARMA ČESKÁ PL
REPUBLIKA S.R.O.
Aulin, 100 mg, comprimido IT/H/0151/001 5809181 ANGELINI FARMACÊUTICA, PT
LDA
AULIN 100 mg comprimate IT/H/0151/001 6646/2014/01 ANGELINI PHARMA RO
ÖSTERREICH GMBH
AULIN 100 mg comprimate IT/H/0151/001 6646/2014/02 ANGELINI PHARMA RO
ÖSTERREICH GMBH
List of nationally authorised medicinal products
EMA/128842/2019 Page 3/7
Product Name (in MRP/DCP Authorisation National Authorisation MAH of product in the Member State where
authorisation country) number Number member state product is authorised
AULIN 100 mg comprimate IT/H/0151/001 6646/2014/03 ANGELINI PHARMA RO
ÖSTERREICH GMBH
AULIN 100 mg comprimate IT/H/0151/001 6646/2014/04 ANGELINI PHARMA RO
ÖSTERREICH GMBH
NIMEDEX 400 mg granulato not available 029120021 ITALFARMACO S.P.A IT
per sospensione orale
NIMEDEX 400 mg granulato not available 029120033 ITALFARMACO S.P.A IT
per sospensione orale
Nimesil 100 mg granulės not available LT/1/99/0503/003 LABORATORI GUIDOTTI LT
geriamajai suspensijai S.P.A.
Nimesil 100 mg granulės not available LT/1/99/0503/001 LABORATORI GUIDOTTI LT
geriamajai suspensijai S.P.A.
Nimesil 100 mg granulės not available LT/1/99/0503/002 LABORATORI GUIDOTTI LT
geriamajai suspensijai S.P.A.
Xilox 50 mg/g granulátum not available OGYI-T-9791/02 LABORATORI GUIDOTTI HU
belsőleges szuszpenzióhoz S.P.A.
Xilox 50 mg/g granulátum not available OGYI-T-9791/01 LABORATORI GUIDOTTI HU
belsőleges szuszpenzióhoz S.P.A.
Xilox 50 mg/g granulátum not available OGYI-T-9791/03 LABORATORI GUIDOTTI HU
belsőleges szuszpenzióhoz S.P.A.
Aулин 100 mg гранули за IT/H/0151/002 9700287 ANGELINI PHARMA BG
перорална суспензия BULGARIA EOOD
AULIN 100 mg granule IT/H/0151/002 6647/2014/05 ANGELINI PHARMA RO
pentru suspensie orală ÖSTERREICH GMBH
AULIN 100 mg granule IT/H/0151/002 6647/2014/06 ANGELINI PHARMA RO
pentru suspensie orală ÖSTERREICH GMBH
Aulin 100 mg granulato per IT/H/0151/002 025940115 HELSINN BIREX IT
sospensione orale PHARMACEUTICALS LTD.
List of nationally authorised medicinal products
EMA/128842/2019 Page 4/7
Product Name (in MRP/DCP Authorisation National Authorisation MAH of product in the Member State where
authorisation country) number Number member state product is authorised
Aulin 100 mg granulato per IT/H/0151/002 025940154 HELSINN BIREX IT
sospensione orale PHARMACEUTICALS LTD.
Aulin 100 mg granulato per IT/H/0151/002 025940127 HELSINN BIREX IT
sospensione orale PHARMACEUTICALS LTD.
Aulin 100 mg granulato per IT/H/0151/002 025940139 HELSINN BIREX IT
sospensione orale PHARMACEUTICALS LTD.
Aulin 100 mg granulato per IT/H/0151/002 025940141 HELSINN BIREX IT
sospensione orale PHARMACEUTICALS LTD.
Aulin 100 mg granulato per IT/H/0151/002 025940053 HELSINN BIREX IT
sospensione orale PHARMACEUTICALS LTD.
AULIN 100 mg granule pro IT/H/0151/002 29/180/97-C ANGELINI PHARMA ČESKÁ CZ
perorální suspenzi REPUBLIKA S.R.O.
AULIN 100 mg granulát IT/H/0151/002 29/0311/03-S ANGELINI PHARMA ČESKÁ SK
REPUBLIKA S.R.O.
Aulin, 100 mg, granulat do IT/H/0151/002 4114 ANGELINI PHARMA ČESKÁ PL
sporzadzania zawiesiny REPUBLIKA S.R.O.
doustnej
Aulin, 100 mg, granulado IT/H/0151/001 5810882 ANGELINI FARMACÊUTICA, PT
para suspensão oral LDA
AULIN 100 mg granule IT/H/0151/002 6647/2014/01 ANGELINI PHARMA RO
pentru suspensie orală ÖSTERREICH GMBH
AULIN 100 mg granule IT/H/0151/002 6647/2014/02 ANGELINI PHARMA RO
pentru suspensie orală ÖSTERREICH GMBH
AULIN 100 mg granule IT/H/0151/002 6647/2014/03 ANGELINI PHARMA RO
pentru suspensie orală ÖSTERREICH GMBH
AULIN 100 mg granule IT/H/0151/002 6647/2014/04 ANGELINI PHARMA RO
pentru suspensie orală ÖSTERREICH GMBH
Nimed 100 mg comprimido not available 4567392 LABORATÓRIOS AZEVEDOS - PT
List of nationally authorised medicinal products
EMA/128842/2019 Page 5/7
Product Name (in MRP/DCP Authorisation National Authorisation MAH of product in the Member State where
authorisation country) number Number member state product is authorised
revestido por película INDÚSTRIA FARMACÊUTICA,
S.A.
Nimed 100 mg comprimido not available 9599258 LABORATÓRIOS AZEVEDOS - PT
revestido por película INDÚSTRIA FARMACÊUTICA,
S.A.
Nimed 100 mg comprimido not available 4567491 LABORATÓRIOS AZEVEDOS - PT
revestido por película INDÚSTRIA FARMACÊUTICA,
S.A.
NIMEDEX 400 mg compresse not available 029120019 ITALFARMACO S.P.A IT
Mesulid 200 mg supposte IT/H/0150/003 025971060 HELSINN BIREX IT
PHARMACEUTICALS LTD.
Mesulid 100 mg granulato IT/H/0150/002 025971110 HELSINN BIREX IT
per sospensione orale PHARMACEUTICALS LTD.
Mesulid 100 mg granulato IT/H/0150/002 025971159 HELSINN BIREX IT
per sospensione orale PHARMACEUTICALS LTD.
Mesulid 100 mg granulato IT/H/0150/002 025971122 HELSINN BIREX IT
per sospensione orale PHARMACEUTICALS LTD.
Mesulid 100 mg granulato IT/H/0150/002 025971134 HELSINN BIREX IT
per sospensione orale PHARMACEUTICALS LTD.
Mesulid 100 mg granulato IT/H/0150/002 025971146 HELSINN BIREX IT
per sospensione orale PHARMACEUTICALS LTD.
Mesulid 100 mg granulato IT/H/0150/002 025971058 HELSINN BIREX IT
per sospensione orale PHARMACEUTICALS LTD.
MESULID 100 mg granule CZ/H/902/02 29/124/01-C ANGELINI PHARMA CZ
pro perorální suspenzi ÖSTERREICH GMBH
Mesulid 50 mg/g granulátum CZ/H/902/02 OGYI-T-6459/02 ANGELINI PHARMA HU
ÖSTERREICH GMBH
Nimed 100 mg granulado not available 4567095 LABORATÓRIOS AZEVEDOS - PT
List of nationally authorised medicinal products
EMA/128842/2019 Page 6/7
Product Name (in MRP/DCP Authorisation National Authorisation MAH of product in the Member State where
authorisation country) number Number member state product is authorised
para solução oral INDÚSTRIA FARMACÊUTICA,
S.A.
Nimed 100 mg granulado not available 9692137 LABORATÓRIOS AZEVEDOS - PT
para solução oral INDÚSTRIA FARMACÊUTICA,
S.A.
Nimed 100 mg granulado not available 4567194 LABORATÓRIOS AZEVEDOS - PT
para solução oral INDÚSTRIA FARMACÊUTICA,
S.A.
NIMED 100 mg tablety not available 29/415/99-C HELSINN BIREX CZ
PHARMACEUTICALS LTD.
List of nationally authorised medicinal products
EMA/128842/2019 Page 7/7
