01 September 2017 EMA/590524/2017 Procedure Management and Committees Support

List of nationally authorised medicinal products

Active substance: brotizolam

Procedure no. PSUSA/00000444/201612

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

LENDORMIN 0,250 MG TABLETTEN

not available

205 IS 97 F3

LENDORMIN 0,250 MG TABLETTEN

not available

0632/06/11/9120

Lendorm® 0,25 mg - Tabletten

not available

1-18220

Lendormin® 0,250 mg comprimés

not available

0632/06/11/9120

Lendormin, tabletten 0,250 mg

not available

RVG 10015

Lendormin 0,25 mg comprimidos

not available

9599621

Lendormin® 0,25 mg Tabletten

not available

5612.00.00

LENDORMIN 0,25 mg compresse

not available

026343018

Lendormin 0,25 mg tabletta

not available

OGYI-T-2276/02

Lendormin® 0,250 mg comprimés

not available

205 IS 97 F3

Lendormin 0,250 mg tabletten

not available

205 IS 97 F3

Lendormin 0,25 mg tabletta

not available

OGYI-T-2276/01

List of nationally authorised medicinal products EMA/590524/2017

MAH of product in the member state

Member State where product is authorised

SCS BOEHRINGER INGELHEIM COMM.V. SCS BOEHRINGER INGELHEIM COMM.V. BOEHRINGER INGELHEIM RCV GMBH & CO KG SCS BOEHRINGER INGELHEIM COMM.V. BOEHRINGER INGELHEIM B.V. UNILFARMA LDA.

BE

BOEHRINGER INGELHEIM PHARMA GMBH & CO. KG BOEHRINGER INGELHEIM ITALIA S.P.A. BOEHRINGER INGELHEIM INTERNATIONAL GMBH SCS BOEHRINGER INGELHEIM COMM.V. SCS BOEHRINGER INGELHEIM COMM.V. BOEHRINGER INGELHEIM INTERNATIONAL GMBH

DE

LU AT LU NL PT

IT HU

BE BE HU

Page 2/3

Product Name (in authorisation country) Sintonal 0,25 mg comprimidos

List of nationally authorised medicinal products EMA/590524/2017

MRP/DCP Authorisation number not available

National Authorisation Number 58.229

MAH of product in the member state BOEHRINGER INGELHEIM ESPANA S.A.

Member State where product is authorised ES

Page 3/3

brotizolam PSUSA 000444-201612, Regulatory outcome: maintenance

Sep 1, 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 ...
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