Europe 25 mg/ml, koncentrat do sporządzania roztworu do infuzji Normosang 25 mg/ml – infuusiokonsentraatti liuosta varten Normosang 25 mg/ml Konzentrat zur Herstellung einer Infusionslösung Normosang 25 mg/ml Konzentrat zur Herstellung einer Infusionslösung Normosang 25 mg/ml infusioonilahuse kontsentraat NORMOSANG 25 mg/ml infúzny koncentrát Normosang 25 mg/ml innrennslisþykkni, lausn Normosang 25 mg/ml koncentrat za otopinu za infuziju
List of nationally authorised medicinal products EMA/24790/2018
Page 2/5
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Normosang 25 mg/ml
FR/H/0140/001
H/09/01129/001
ORPHAN EUROPE SARL
SI
FR/H/0140/001
LT/1/08/1024/001
ORPHAN EUROPE SARL
LT
FR/H/0140/001
06-0218
ORPHAN EUROPE SARL
LV
FR/H/0140/001
OGYI-T-20408/01
ORPHAN EUROPE SARL
HU
FR/H/0140/001
BE207496
ORPHAN EUROPE SARL
BE
FR/H/0140/001
RVG 33614
ORPHAN EUROPE SARL
NL
FR/H/0140/001
2938082
ORPHAN EUROPE SARL
PT
FR/H/0140/001
63.116
ORPHAN EUROPE SARL
ES
FR/H/140/01
PA928/1/1
ORPHAN EUROPE SARL
IE
koncentrat za raztopino za infundiranje Normosang 25 mg/ml koncentratas infuziniam tirpalui NORMOSANG 25 mg/ml koncentrāts infūziju šķīduma pagatavošanai Normosang 25 mg/ml koncentrátum oldatos infúzióhoz Normosang 25 mg/ml, concentraat voor oplossing voor infusie Normosang 25 mg/ml, concentraat voor oplossing voor infusie Normosang 25 mg/ml, concentrado para solução para perfusão NORMOSANG 25 mg/ml, concentrado para solución para perfusión. NORMOSANG 25 mg/ml, concentrate for solution for infusion
List of nationally authorised medicinal products EMA/24790/2018
Page 3/5
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
NORMOSANG 25 mg/ml,
FR/H/0140/001
PL 15266/0008
ORPHAN EUROPE SARL
UK
FR/H/0140/001
034543013/M
ORPHAN EUROPE SARL
IT
FR/H/0140/001
MA135/00101
ORPHAN EUROPE SARL
MT
FR/H/0140/001
80/271/06-C
ORPHAN EUROPE SARL
CZ
FR/H/0140/001
15349
ORPHAN EUROPE SARL
SE
FR/H/140/01
06-3943
ORPHAN EUROPE SARL
NO
FR/H/0140/001
BE207496
ORPHAN EUROPE SARL
BE
FR/H/0140/001
0084/99/07/0010
ORPHAN EUROPE SARL
LU
concentrate for solution for infusion Normosang 25 mg/mL, concentrato per soluzione per infusione Normosang 25 mg/ml, konċentrat għal soluzzjoni għall-infużjoni. Normosang 25 mg/ml, koncentrát pro infuzní roztok Normosang 25 mg/ml, koncentrat till infusionsvätska, lösning Normosang 25 mg/ml, konsentrat til infusjonsvæske Normosang 25 mg/ml, Konzentrat zur Herstellung einer Infusionslösung Normosang 25 mg/ml, Konzentrat zur Herstellung einer Infusionslösung
List of nationally authorised medicinal products EMA/24790/2018
Page 4/5
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Normosang 25 mg/ml,
FR/H/0140/001
BE207496
ORPHAN EUROPE SARL
BE
FR/H/0140/001
34009 558 611 1 9
ORPHAN EUROPE SARL
FR
FR/H/140/01
18966
ORPHAN EUROPE SARL
CY
FR/H/0140/001
18966/22-10-99
ORPHAN EUROPE SARL
GR
FR/H/0140/001
30617
ORPHAN EUROPE SARL
DK
solution à diluer pour perfusion Normosang 25 mg/ml, solution à diluer pour perfusion Normosang 25 mg/ml, πυκνό διάλυμα για παρασκευή διαλύματος προς έγχυση. Normosang 25 mg/ml, πυκνό διάλυμα για παρασκευή διαλύματος προς έγχυση Normosang, koncentrat til infusionsvæske, opløsning
List of nationally authorised medicinal products EMA/24790/2018
PSUSA/00001629/201705 - European Medicines Agency - Europa EU
Jan 11, 2018 - List of nationally authorised medicinal products. EMA/24790/2018. Page 3/5. Product Name (in authorisation country). MRP/DCP. Authorisation.
Jul 7, 2017 - COMMUNITY MARKETING AUTHORISATIONS AND EXTENSIONS. 2.1. Opinions ... Quality. Rapp: E. Werner .... solutions table with EMA and CVMP responses to the recommendations made by the FishMed Plus. Coalition ...
Jun 22, 2016 - Information Management Division ... This document provides current information related to the volume and evaluation of .... Plasma master file.
Feb 9, 2017 - Notification of discontinuation of a paediatric development which is covered by an agreed ... for the following reason(s): (tick all that apply).
Jul 5, 2017 - Send a question via our website www.ema.europa.eu/contact ... non-proprietary names (INN) and therapeutic areas for all new ... also available in the monthly reports of the Committee for Orphan Medicinal Products (COMP).
Jul 4, 2016 - Send a question via our website www.ema.europa.eu/contact ... non-proprietary names (INN) and therapeutic areas for all new ... also available in the monthly reports of the Committee for Orphan Medicinal Products (COMP).
maximises the chances of a successful marketing authorisation. ... marketing authorisation. ⢠inclusion in the public SME ... E-mail [email protected]. Website ...
Jun 19, 2017 - and may also vary during the course of the review. ...... ViiV Healthcare UK Limited; Treatment of Human Immunodeficiency Virus ..... adjunctive administration of brivaracetam, Treatment of paediatric patients with partial.
5 days ago - Guidelines should include more details on the principles of good information design in which content and layout are ... relevance and importance of the QRD template is also acknowledged in this respect as it is the main tool .... databas
Jun 15, 2016 - Agenda - EMA Human Scientific Committees' Working. Parties with Healthcare Professionals' Organisations. (HCPWP) meeting. 15 June 2016, 08:45hrs to 10:30hrs â meeting room: 3E. Chairs: I. Moulon (EMA) and Gonzalo Calvo (HCPWP). 15 Ju
Feb 7, 2017 - Add an existing Tag to a specific Term . ...... This service creates an email body (text/html) of a user's notification data, a notification is based on.
Feb 9, 2018 - 30 Churchill Place â Canary Wharf â London E14 5EU â United Kingdom. An agency of the European Union ... product information. For information: Summary of opinion. 2.2. Oral explanations and list of outstanding issues. â¢. Product
Oct 23, 2017 - Page 2/61. Table of contents. 1. Introduction. 11. 1.1. Welcome and declarations of interest of members, alternates and experts .......... 11. 1.2. Agenda of the meeting on 23-26 October 2017 . ...... different database to study the ri
Notification of discontinuation of a paediatric development which is covered by an agreed ... for the following reason(s): (tick all that apply). (possible) lack of ...
17 Jan 2018 - Expert meeting on adeno-associated viral vectors, 06 September 2017, EMA, London. CAT: Martina SchüÃler-Lenz. Scope: report of the meeting that took place on 6 September 2017. Action: for adoption. 7.6.3. Environmental assessment of g
Jun 14, 2018 - Page 2/26. Product Name (in authorisation country). MRP/DCP Authorisation number. National Authorisation. Number. MAH of product in the.
Oct 26, 2017 - Injektionssuspension in einer Fertigspritze. Influenza-Impfstoff. (Spaltimpfstoff, inaktiviert, in Zellkulturen hergestellt) not available. BE393556. NANOTHERAPEUTICS. BOHUMIL, S.R.O.. BE. Preflucel injektionsvätska, suspension i för
March 2016 a joint database drug utilisation final study report to the European .... With regards to prescription of CPA/EE for contraceptive management, ...
For a list of RSS readers please refer to our RSS guide and follow the instructions ..... PCWP and HCPWP joint meeting: Workshop on social media - Sep 2016.
Jul 14, 2016 - Stem cell-based products for veterinary use: specific ... potentially delay time to rejection providing a window of therapeutic benefit but limiting ...
