09 March 2017 EMA/171110/2017 Human Medicines Evaluation Division

List of nationally authorised medicinal products

Active substance(s): lubiprostone Procedure No.: PSUSA/00010290/201607

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

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© European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged.

Product name (in authorisation country) Amitiza 24 microgramos cápsulas blandas AMITIZA 24 microgram soft capsules AMITIZA 24 microgram soft capsules AMITIZA 24 Mikrogramm Weichkapseln AMITIZA 24 microgram zachte capsules AMITIZA 24 Mikrogramm Weichkapseln AMITIZA 24 microgrammes en capsules molles AMITIZA 24 microgram capsules, zacht AMITIZA 24 Mikrogramm Weichkapseln AMITIZA 24 microgrammes en capsules molles AMITIZA® 24 Mikrogramm Weichkapseln AMITIZA 24 microgrammi capsule molli AMITIZA 24 microgrammi capsule molli

MRP/DCP or CP Authorisation number

National Authorisation Number

MAH of product in the member state

Member State where product is authorised

UK/H/5509/001

79875

ES

not available

PA 1547/011/001

SUCAMPO PHARMA EUROPE LTD TAKEDA UK LTD

not available

PL 16189/0030

TAKEDA UK LTD

UK

UK/H/5509/001

136176

AT

UK/H/5509/001

BE 471502

TAKEDA PHARMA GES.M.B.H. TAKEDA BELGIUM SCA/CVA

UK/H/5509/001

BE 471502

TAKEDA BELGIUM SCA/CVA

BE

UK/H/5509/001

BE 471502

TAKEDA BELGIUM SCA/CVA

BE

UK/H/5509/001

115891

TAKEDA NEDERLAND BV

NL

UK/H/5509/001

2015040035

TAKEDA BELGIUM SCA/CVA

LU

UK/H/5509/001

2015040035

TAKEDA BELGIUM SCA/CVA

LU

UK/H/5509/001

92699.00.00

TAKEDA GMBH (KONSTANZ)

DE

not available

043833021

TAKEDA ITALIA S.P.A.

IT

not available

043833019

TAKEDA ITALIA S.P.A.

IT

List of nationally authorised medicinal products EMA/171110/2017

IE

BE

Page 2/2

Lubiprostone - European Medicines Agency - Europa EU

Mar 9, 2017 - Send a question via our website www.ema.europa.eu/contact. © European Medicines ... Page 2/2. Product name ... not available. PA 1547/011/ ...

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