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
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
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