List of nationally authorised medicinal products - European Medicines ...

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Sep 29, 2016 - List of nationally authorised medicinal products cilostazol. EMA/648833/2016. Page 2/3. Product Name. (in
29 September 2016 EMA/648833/2016 Human Medicines Evaluation Division

List of nationally authorised medicinal products

Active substance: cilostazol

Procedure no.: PSUSA/00010209/201602

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© European Medicines Agency, 2016. Reproduction is authorised provided the source is acknowledged.

Product Name

MRP/DCP Authorisation

National Authorisation

MAH of product in the

Member State where

(in authorisation country)

Number

Number

Member State

product is authorised

Pletal® 50mg Tabletten

UK/H/0292/002

66599.00.00

OTSUKA PHARMACEUTICAL EUROPE LTD.

DE

Pletal® 100mg Tabletten

UK/H/0292/001

66599.01.00

OTSUKA PHARMACEUTICAL EUROPE LTD.

DE

Pletal 50 mg comprimidos

UK/H/0292/002

69.562

OTSUKA PHARMACEUTICAL EUROPE LTD.

ES

Pletal 100 mg tablets

UK/H/0292/001

PL 11515/0001

OTSUKA PHARMACEUTICAL EUROPE LTD.

UK

Pletal 100 mg comprimidos

UK/H/0292/001

69.563

OTSUKA PHARMACEUTICAL EUROPE LTD.

ES

Pletal 50 mg compresse

UK/H/0292/002

034887240/M

OTSUKA PHARMACEUTICAL EUROPE LTD.

IT

Pletal 100 mg compresse

UK/H/0292/001

034887354/M

OTSUKA PHARMACEUTICAL EUROPE LTD.

IT

List of nationally authorised medicinal products cilostazol EMA/648833/2016

Page 2/3

Product Name

MRP/DCP Authorisation

National Authorisation

MAH of product in the

Member State where

(in authorisation country)

Number

Number

Member State

product is authorised

Pletal 50 mg tabletter

UK/H/0292/002

25895

OTSUKA PHARMACEUTICAL EUROPE LTD.

SE

Pletal 100 mg tabletter

UK/H/0292/001

25896

OTSUKA PHARMACEUTICAL EUROPE LTD.

SE

Pletal 50 mg tablets

UK/H/0292/002

PL 11515/0002

OTSUKA PHARMACEUTICAL EUROPE LTD.

UK

EKISTOL 50 mg comprimidos

not available

70.126

LACER S.A.

ES

EKISTOL 100 mg comprimidos

not available

70.125

LACER S.A.

ES

List of nationally authorised medicinal products cilostazol EMA/648833/2016

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