12 January 2017 EMA/77705/2017 Pharmacovigilance Risk Assessment Committee (PRAC)

List of nationally authorised medicinal products Active substance(s): macrogol 3350 Procedure No.: PSUSA/00001924/201605

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

Product Name (in

MRP/DCP

authorisation country)

Authorisation

National Authorisation Number

MAH of product in the

Member State where

member state

product is authorised

number

TRANSIPEGLIB 5,9g, poudre pour solution buvable en sachet TRANSIPEGLIB 5,9g, poudre pour solution buvable en sachet TRANSIPEGLIB 5,9g, poudre pour solution buvable en sachet TRANSIPEG 2,95 g, poudre pour solution buvable en sachet TRANSIPEG 2,95 g, poudre pour solution buvable en sachet TRANSIPEG 5,9g, poudre pour solution buvable en sachet TRANSIPEG 5,9g, poudre pour solution buvable en sachet TRANSIPEG 5,9g, poudre pour solution buvable en sachet TRANSIPEG 5,9g, poudre pour solution buvable en sachet TRANSIPEG 5,9g, poudre

not available

34009 375 323 7 2

BAYER HEALTHCARE

FR

not available

34009 375 320 8 2

BAYER HEALTHCARE

FR

not available

34009 375 321 4 3

BAYER HEALTHCARE

FR

FR/H/0117/001

34009 558 262 7 9

BAYER HEALTHCARE

FR

FR/H/0117/001

34009 558 261 0 1

BAYER HEALTHCARE

FR

FR/H/0117/002

34009 393 656 4 0

BAYER HEALTHCARE

FR

FR/H/0117/002

34009 393 655 8 9

BAYER HEALTHCARE

FR

FR/H/0117/002

34009 344 242 5 0

BAYER HEALTHCARE

FR

FR/H/0117/002 FR/H/0117/002

34009 560 641 1 3 34009 344 241 9 9

BAYER HEALTHCARE BAYER HEALTHCARE

FR FR

List of nationally authorised medicinal products EMA/PRAC/4047/2017 Page 2/3

Product Name (in

MRP/DCP

authorisation country)

Authorisation

National Authorisation Number

MAH of product in the

Member State where

member state

product is authorised

number

pour solution buvable en sachet Transipeg 2,95 g® not available TRANSIPEG 5,9g, poudre pour solution buvable en sachet FR/H/0117/002 TRANSIPEG 2,95 g, poudre pour solution buvable en sachet FR/H/0117/001 TRANSIPEGLIB 5,9g, poudre pour solution buvable en sachet not available Lefax Activolax FR/H/0117/002 Transipeg 5,9 g polvere per soluzione orale in bustine FR/H/0117/002 Transipeg 5,9 g polvere per soluzione orale in bustine FR/H/0117/002 Transipeg 5,9 g polvere per soluzione orale in bustine FR/H/0117/002 Transipeg 5,9 g polvere per soluzione orale in bustine FR/H/0117/002

RVG 17247

BAYER BV

NL

34009 344 240 2 1

BAYER HEALTHCARE

FR

34009 336 866 3 5

BAYER HEALTHCARE

FR

34009 415 377 5 2 41540.00.01

BAYER HEALTHCARE BAYER VITAL GMBH

FR DE

033098031

BAYER SPA

IT

033098056

BAYER SPA

IT

033098068

BAYER SPA

IT

033098043

BAYER SPA

IT

macrogol 3350 - European Medicines Agency - Europa EU

Jan 12, 2017 - Send a question via our website www.ema.europa.eu/contact. © European ... Product Name (in authorisation ... not available. 34009 375 323 7 ...

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