CEFAMEZIN 1000 mg/4 ml polvere e solvente per soluzione iniettabile per uso intramuscolare CEFAMEZIN 500 mg/2 ml polvere e solvente per soluzione iniettabile per uso intramuscolare CEFAMEZIN 250 mg/2 ml polvere e solvente per soluzione iniettabile per uso intramuscolare CEFAMEZIN 1000 mg/10 ml polvere e solvente per soluzione iniettabile per uso endovenoso Kefzol, poeder voor oplossing voor injectie 1 gram Kefzol 1 g, poeder voor oplossing voor injectie Kefzol 1 g, poudre pour solution injectable Kefzol 2 g, poudre pour solution injectable Kefzol 2 g, poeder voor oplossing voor injectie Kefzol 1 g + lidocaïne, poeder en oplosmiddel voor oplossing voor injectie Cefazolin 2 g, powder for solution for injection / infusion Cefazolin-MIP Pharma 2000 mg Pulver zur Herstellung einer Injektions- bzw. Infusionslösung Cefazolin MIP 2 g
not available
022662011
PFIZER ITALIA S.R.L.
IT
not available
022662062
PFIZER ITALIA S.R.L.
IT
not available
022662098
PFIZER ITALIA S.R.L.
IT
not available
022662124
PFIZER ITALIA S.R.L.
IT
not available
RVG 06836
EUROCEPT B.V.
NL
not available
BE092897
EUROCEPT B.V.
BE
not available
2002098654
EUROCEPT B.V.
LU
not available
2000010028
EUROCEPT B.V.
LU
not available
BE106276
EUROCEPT B.V.
BE
not available
BE106267
EUROCEPT B.V.
BE
FI/H/0778/001
PL 26928/0014
MIP PHARMA GMBH
UK
FI/H/0778/001
85486.00.00
MIP PHARMA GMBH
DE
FI/H/0778/001/DC
11-8738
MIP PHARMA GMBH
NO
Cefazolin MIP Pharma 2 g injektio/infuusiokuiva-aine, liuosta varten Cefazolin MIP Pharma 2 g pulver
FI/H/0778/001
29965
MIP PHARMA GMBH
FI
FI/H/0778/001
29965
MIP PHARMA GMBH
FI
List of nationally authorised medicinal products EMA/590591/2017
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Page 2/5
Product Name (in authorisation country) till injektions-/infusionsvätska, lösning Cefazolin MIP 2 g pulbere pentru soluţie injectabilă / perfuzabilă Cefazolin MIP 2 g süste- või infusioonilahuse pulber Cefazolin MIP 2 g pulveris injekciju vai infūziju šķīduma pagatavošanai Cefazolin ”MIP”, pulver til injektions-/infusionsvæske, opløsning Cefazolin MIP 2 g milteliai injekciniam ar infuziniam tirpalui Cefazolin MIP 2 g por oldatos injekcióhoz vagy infúzióhoz Cefazolin MIP 2 g, pulver till injektions-/infusionsvätska, lösning Cefazolin MIP Pharma proszek do sporządzania roztworu do wstrzykiwań / do infuzji Cefazolin MIP 2 g por oldatos injekcióhoz vagy infúzióhoz Cefazolin MIP 2 g por oldatos injekcióhoz vagy infúzióhoz Cefazolin MIP 2 g por oldatos injekcióhoz vagy infúzióhoz Cefazolin MIP 2 g por oldatos injekcióhoz vagy infúzióhoz Cefazolin MIP 2 g por oldatos injekcióhoz vagy infúzióhoz Cefazolin MIP 2 g milteliai injekciniam ar infuziniam tirpalui
List of nationally authorised medicinal products EMA/590591/2017
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
FI/H/0778/001
6314/2014/01
MIP PHARMA GMBH
RO
FI/H/0778/001
834414
MIP PHARMA GMBH
EE
FI/H/0778/001
14-0063
MIP PHARMA GMBH
LV
FI/H/0778/001
49906
MIP PHARMA GMBH
DK
FI/H/0778/001
LT/1/14/3488/001
MIP PHARMA GMBH
LT
FI/H/0778/001
OGYI-T-22616/01
MIP PHARMA GMBH
HU
FI/H/0778/001
47208
MIP PHARMA GMBH
SE
FI/H/0778/001
22150
MIP PHARMA GMBH
PL
FI/H/0778/001
OGYI-T-22616/03
MIP PHARMA GMBH
HU
FI/H/0778/001
OGYI-T-22616/05
MIP PHARMA GMBH
HU
FI/H/0778/001
OGYI-T-22616/02
MIP PHARMA GMBH
HU
FI/H/0778/001
OGYI-T-22616/04
MIP PHARMA GMBH
HU
FI/H/0778/001
OGYI-T-22616/06
MIP PHARMA GMBH
HU
FI/H/0778/001
LT/1/14/3488/002
MIP PHARMA GMBH
LT
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
Cefazolin MIP 2 g milteliai injekciniam ar infuziniam tirpalui Cefazolin MIP 2 g milteliai injekciniam ar infuziniam tirpalui Cefazolin MIP 2 g milteliai injekciniam ar infuziniam tirpalui Cefazolin MIP 2 g milteliai injekciniam ar infuziniam tirpalui Cefazolin MIP 2 g pulbere pentru soluţie injectabilă / perfuzabilă Cefazolin MIP 2 g pulbere pentru soluţie injectabilă / perfuzabilă Cefazolin MIP 2 g pulbere pentru soluţie injectabilă / perfuzabilă Cefazolin MIP 2 g pulbere pentru soluţie injectabilă / perfuzabilă Cefazolin MIP 2 g pulbere pentru soluţie injectabilă / perfuzabilă VIFAZOLIN 1G/VIAL
FI/H/0778/001
LT/1/14/3488/003
MIP PHARMA GMBH
LT
FI/H/0778/001
LT/1/14/3488/004
MIP PHARMA GMBH
LT
FI/H/0778/001
LT/1/14/3488/005
MIP PHARMA GMBH
LT
FI/H/0778/001
LT/1/14/3488/006
MIP PHARMA GMBH
LT
FI/H/0778/001
6314/2014/02
MIP PHARMA GMBH
RO
FI/H/0778/001
6314/2014/03
MIP PHARMA GMBH
RO
FI/H/0778/001
6314/2014/04
MIP PHARMA GMBH
RO
FI/H/0778/001
6314/2014/05
MIP PHARMA GMBH
RO
FI/H/0778/001
6314/2014/06
MIP PHARMA GMBH
RO
not available
14873
VIANEX S.A.
GR
CEFAZIL “1 g/4 ml Polvere e Solvente Per Soluzione Iniettabile Per Uso Intramuscolare” 1 Flacone + 1 Fiala Solvente 4 ml INTRAZOLINA 500 mg polvo y disolvente para solución inyectable y para perfusión Cefazolin Hikma 1 g
List of nationally authorised medicinal products EMA/590591/2017
DE DE ES
Page 4/5
Product Name (in authorisation country) disolvente para solución inyectable y para perfusión Kefzol 1 g – Trockenstechampullen Kefzol 2 g – Trockensubstanz zur Infusionsbereitung
List of nationally authorised medicinal products EMA/590591/2017
MRP/DCP Authorisation number
National Authorisation Number
not available
15.629
not available
15.877
MAH of product in the member state LABORATORIOS TORLAN, S.A. ASTRO-PHARMA GMBH ASTRO-PHARMA GMBH
Mar 11, 2017 - Considering the presented cumulative analysis of cases reporting withdrawal symptoms and drug abuse the ... Package Leaflet. â¢. Section 4 ...
Jan 28, 2017 - The primary analysis examined sudden death within seven days of an outpatient prescription for one of ... Package Leaflet. â¢. Section 2.
Oct 29, 2016 - Taking into account the PRAC Assessment Report on the PSUR(s) for ... 3. Annex II. Amendments to the product information of the nationally ...
Oct 29, 2016 - Taking into account the PRAC Assessment Report on the PSUR(s) for ... 3. Annex II. Amendments to the product information of the nationally ...
Oct 29, 2016 - Taking into account the PRAC Assessment Report on the PSUR(s) for ... 3. Annex II. Amendments to the product information of the nationally ...
Oct 29, 2016 - should be discontinued if there is persistent bleeding and no alternative explanations are identified. Package Leaflet. 2. Warnings and precautions. Cefoperazone - active substance of â may inhibit blood clotting. Serious bleedings,
Sep 2, 2016 - THE WELLCOME FOUNDATION. LTD. GR. Valtrex 250 mg comprimidos revestidos por pelÃcula. SE/H/1041/001. 2966083. LABORATORIOS WELLCOME DE. PORTUGAL LIMITADA. PT. Valtrex 250 mg comprimidos revestidos por pelÃcula. SE/H/1041/001. 3131786.
Oct 29, 2016 - Amendments to be included in the relevant sections of the Product Information (new text underlined and in bold, deleted text strike through). Summary of Product Characteristics. â¢. Section 4.6. Prolonged use of hydromorphone during p
Jan 27, 2018 - EMA/CMDh/766270/2017. 1. Annex I. Scientific conclusions and grounds for the variation to the terms of the Marketing. Authorisation(s) ...
