28 September 2017 EMA/658671/2017 Procedure Management and Committees Support

List of nationally authorised medicinal products

Active substance: loratadine / pseudoephedrine

Procedure no.: PSUSA/00001908/201702

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

Clarinase 5 mg/120 mg Retardtabletten CLARINASE® Repetabs 5 mg/120 mg comprimés à libération prolongée CLARINASE® Repetabs 5 mg/120 mg tabletten met verlengde afgifte Clarinase Once Daily 10 mg/240 mg comprimés à libération prolongée Clarinase Once Daily 10 mg/240 mg tabletten met verlengde afgifte Clarinase, 10 mg/240 mg toimeainet prolongeeritult vabastavad tabletid Clarinase 10 mg/240 mg pailginto atpalaidavimo tabletės Claritine Active, 5 mg + 120 mg, tabletki o przedłużonym uwalnianiu Clarinase, depottabletter

BE/H/0121/001

1-19913

BE/H/0121/001

Clarinase 10 mg/240 mg forðatafla Claridon 5 mg/120 mg comprimidos de libertação modificada Claridon 5 mg/120 mg comprimidos de libertação modificada Clarinase 10 mg/240 mg ilgstošās darbības tabletes Claridon QD 10 mg/240 mg comprimidos de libertação prolongada List of nationally authorised medicinal products EMA/658671/2017

MAH of product in the member state

Member State where product is authorised AT

2008049754

BAYER AUSTRIA GMBH BAYER SA NV

BE/H/0121/001

BE152826

BAYER SA NV

BE

BE/H/0102/001

2008049753

BAYER SA NV

LU

BE/H/0102/001

BE175375

BAYER SA NV

BE

not available

224598

BAYER UAB

EE

not available

LT/1/98/1717/001

BAYER UAB

LT

not available

R/7061

BAYER SP.Z.O.O

PL

BE/H/0102/001

17154

BAYER AB

DK

BE/H/0102/001

950030

BAYER AB

IS

BE/H/0121/001

9796516

BAYER PORTUGAL LDA

PT

BE/H/0121/001

9796508

BAYER PORTUGAL LDA

PT

not available

01-0213

BAYER UAB

LV

BE/H/0102/001

9796524

BAYER PORTUGAL LDA

PT

LU

Page 2/4

Product Name (in authorisation country) Claridon QD 10 mg/240 mg comprimidos de libertação prolongada CLARITYNE-D 5 mg/120 mg δισκία παρατεταμένης αποδέσμευσης CLARINASE® Repetabs 5 mg/120 mg prolonged-release tablets Clarinase Repetabs 5 mg/120 mg tablety s predĺženým uvoľňovaním Clarinase repetabs tablety s prodlouženým uvolňováním Клариназе 5 mg/120 mg таблетки с удължено освобождаване CLARINASE 5 mg/120 mg comprimate cu eliberare modificată Narine Repetabs 5 mg/120 mg comprimidos de liberación prolongada Clarityne Plus 10 mg/240 mg comprimidos de liberación prolongada Claritine kombo 120 mg/5 mg tablete s podaljšanim sproščanjem CLARINASE 5 mg/120 mg comprimate cu eliberare modificată Clarinase 5 mg/120 mg tablete s produljenim oslobađanjem CLARITYNE-D 10 mg/240 mg List of nationally authorised medicinal products EMA/658671/2017

MRP/DCP Authorisation number

National Authorisation Number

MAH of product in the member state

Member State where product is authorised

BE/H/0102/001

9796532

BAYER PORTUGAL LDA

PT

not available

16294

BAYER HELLAS SA

CY

not available

MA897/00201

BAYER SA NV

MT

not available

24/0163/95-S

BAYER SPOL SRO

SK

not available

24/117/95-C

BAYER SRO

CZ

not available

9800074

BAYER BULGARIA EOOD

BG

not available

2360/2010/01

BAYER SRL

RO

BE/H/0121/001

59.556

BAYER HISPANIA SL

ES

BE/H/0102/001(OTC)

63.423

BAYER HISPANIA SL

ES

not available

H/95/00398/001

BAYER D.O.O

SI

not available

2360/2010/02

BAYER SRL

RO

not available

UP/I-530-09/11-02/603

BAYER DOO

HR

BE/H/0102/001

65452/2-10-2015

BAYER HELLAS

GR

Page 3/4

Product Name (in authorisation country) δισκία παρατεταμένης αποδέσμευσης CLARITYNE-D 5 mg/120 mg Δισκία παρατεταμένης αποδέσμευσης

List of nationally authorised medicinal products EMA/658671/2017

MRP/DCP Authorisation number

National Authorisation Number

MAH of product in the member state

Member State where product is authorised

SA BE/H/0121/001

65451/2-10-2015

BAYER HELLAS SA

GR

Page 4/4

Loratadine / pseudoephedrine - European Medicines Agency - Europa ...

Sep 28, 2017 - Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5525. Send a question via our website www.ema.europa.eu/contact. © European Medicines ... EMA/658671/2017. Procedure Management and Committees Support.

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