ISSN 1977-1088
doi:10.3000/19771088.C_2013.250.hrv
Službeni list
Europske unije
C 250
Hrvatsko izdanje
Informacije i objave
56
30. kolovoza 2013.
|
ISSN 1977-1088 doi:10.3000/19771088.C_2013.250.hrv |
||
|
Službeni list Europske unije |
C 250 |
|
|
|
||
|
Hrvatsko izdanje |
Informacije i objave |
56 |
|
Obavijest br. |
Sadržaj |
Stranica |
|
|
IV. Obavijesti |
|
|
|
OBAVIJESTI INSTITUCIJA, TIJELA, UREDA I AGENCIJA EUROPSKE UNIJE |
|
|
|
Europska komisija |
|
|
2013/C 250/01 |
||
|
2013/C 250/02 |
||
|
2013/C 250/03 |
||
|
HR |
|
IV. Obavijesti
OBAVIJESTI INSTITUCIJA, TIJELA, UREDA I AGENCIJA EUROPSKE UNIJE
Europska komisija
|
30.8.2013 |
HR EN |
Službeni list Europske unije |
C 250/1 |
Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. veljače 2013. do 28. veljače 2013.
(Odluke donesene u skladu s člankom 34. Direktive 2001/83/EZ (1) ili člankom 38. Direktive 2001/82/EZ (2) ) (3)
2013/C 250/01
— Issuing, maintenance or modification of a national marketing authorization
|
Date of the decision |
Name(s) of the medicinal product |
Holder(s) of the marketing authorization |
Member State concerned |
Date of notification |
|
28.2.2013 |
Monovalent and multivalent measles, mumps, rubella and varicella vaccines (live) |
See Annex I |
See Annex I |
1.3.2013 |
(1) SL L 311, 28.11.2001., str. 67.
(2) SL L 311, 28.11.2001., str. 1.
(3) Hrvatski prijevod ovog dokumenta nije dostupan, dokument je objavljen na engleskom jeziku.
ANNEX I
LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Measles vaccines (live) with Marketing Authorisation in the European Union
|
Member State (EU/EEA) |
Marketing authorisaton holder |
Invented name |
Strength |
Pharmaceutical form |
Route of administration |
||||
|
France |
|
ROUVAX, poudre et solvant pour suspension injectable en flacon multidose, vaccin vivant hyperatténué contre la rougeole |
one dose (0,5 ml) contains: Measles virus Schwartz strain (live, attenuated) - not less than 1 000 CCID50 |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
||||
|
France |
|
ROUVAX, poudre et solvant pour suspension injectable, vaccin vivant hyperatténué contre la rougeole |
one dose (0,5 ml) contains: Measles virus Schwartz strain (live, attenuated) - not less than 1 000 CCID50 |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
||||
|
Germany |
|
Masern-Impfstoff Merieux |
one dose (0,5 ml) contains: Measles virus Schwartz strain (live, attenuated) - not less than 1 000 CCID50 |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
||||
|
Germany |
|
Masern-Impfstoff Merieux |
one dose (0,5 ml) contains: Measles virus Schwartz strain (live, attenuated) - not less than 1 000 CCID50 |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
||||
|
Spain |
|
AMUNOVAX VIAL |
Measles virus (live, attenuated) - not less than 1 000 TCID50 |
Powder and solvent for solution for injection |
Subcutaneous use |
Mumps vaccines (live) with Marketing Authorisation in the European Union
|
Member State (EU/EEA) |
Marketing authorisation holder |
Invented name |
Strength |
Pharmaceutical form |
Route of administration |
||||
|
France |
|
VACCIN OREILLONS AVENTIS PASTEUR MSD, poudre et solvant pour suspension injectable en seringue préremplie vaccin des oreillons, atténué |
one dose (0,5 ml) contains: Mumps virus Jeryl Lynn strain (live, attenuated) - 5 000 CCID50 |
Powder and solvent for solution for injection |
Subcutaneous use |
||||
|
France |
|
IMOVAX OREILLONS, poudre et solvant pour préparation injectable. vaccin à virus vivants atténués contre les oreillons |
one dose (0,5 ml) contains: Mumps virus URABE AM-9 strain (live, attenuated) - not less than 5 000 CCID50 |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
||||
|
Spain |
|
VACUNA MSD ANTI-PAROTIDITIS |
Mumps virus (Strain Jeryl Lynn - B level) - not less than 20 000 TCID50 |
Powder and solvent for solution for injection |
Subcutaneous use |
Rubella vaccines (live) with Marketing Authorisation in the European Union
|
Member State (EU/EEA) |
Marketing authorisation holder |
Invented name |
Strength |
Pharmaceutical form |
Route of administration |
|||||
|
Bulgaria |
|
Rudixax |
live, attenuated rubella virus (strain Wistar RA 27/3) - at least 1 000 CCID50 |
Powder and solvent for suspension for injection |
Intramuscular use, subcutaneous use |
|||||
|
France |
|
RUDIVAX, poudre et solvant pour suspension injectable. Vaccin rubéoleux atténué. |
one dose (0,5 ml) contains: Rubella virus Wistar RA 27/3 strain (live, attenuated) - 1 000 CCID50 |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
|||||
|
Germany |
|
Röteln-Impfstoff HDC Merieux |
one dose (0,5 ml) contains: Rubella virus Wistar RA 27/3 strain (live, attenuated) - 1 000 CCID50 |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
|||||
|
Germany |
|
Röteln-Impfstoff HDC Merieux |
one dose (0,5 ml) contains: Rubella virus Wistar RA 27/3 strain (live, attenuated) - 1 000 CCID50 |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
|||||
|
Spain |
|
VACUNA ANTIRRUBEOLA MERIEUX |
Rubella virus live attenuated (Strain Wistar RA 27/3M) - not less than 1 000 TCID50 |
Powder and solvent for solution for injection |
Subcutaneous use |
|||||
|
Spain |
|
VACUNA ANTIRRUBEOLA GSK |
Rubella virus live attenuated (Strain RA 27/3) - not less than 1 000 TCID50 |
Powder and solvent for solution for injection |
Subcutaneous use |
|||||
|
Spain |
|
RUBEATEN BERNA |
Rubella virus live (Strain Wistar RA 27/3) - not less than 1 000 TCID50 |
Powder and solvent for solution for injection |
Subcutaneous use |
Varicella vaccines (live) with Marketing Authorisation in the European Union
|
Member State (EU/EEA) |
Marketing authorisation holder |
Invented name |
Strength |
Pharmaceutical form |
Route of administration |
||||||
|
Austria |
|
Varilrix Pulver und Lösungsmittel zur Herstellung einer Injektionssuspension |
After resuspension, one dose (0,5 ml) contains attenuated varicella zoster virus (OKA strain) - not less than 103,3 PFU (Plaque forming units) |
Powder and solvent for suspension for injection |
Subcutaneous use |
||||||
|
Austria |
|
VARIVAX Pulver und Lösungsmittel zur Herstellung einer Injektionssuspension |
After reconstitution, one dose (0,5 ml) contains: Varicella virus** strain Oka/Merck (live, attenuated) ≥ 1.350 PFU*** ** produced in MRC-5 human diploid cells. *** PFU = Plaque forming units |
Powder and solvent for suspension for injection |
Intramuscular use, subcutaneous use |
||||||
|
Belgium |
|
Varilrix |
Each 0,5 ml dose of the reconstituted vaccine contains: Varicella virus - not less than 103,3 UFP |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Belgium |
|
Provarivax |
After reconstitution, one dose (0,5 mL) contains: Varicella virus** Oka/Merck strain (live, attenuated) 31 350 PFU*** * Produced in human diploid cells (MRC-5) ***PFU = Plaque-forming units |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Cyprus |
|
Varivax powder and solvent for suspension for injection 1 350 PFU |
After reconstitution, one dose (0,5 ml) contains: Varicella virus** Oka/Merck strain (live, attenuated)1 350 PFU*** |
Powder and solvent for suspension for injection |
Subcutaneous use |
||||||
|
Cyprus |
|
VARILRIX powder and solvent for solution for injection |
One dose (0,5 ml) contains: Live attenuated varicella-zoster (Oka strain) virus* 103,3 plaque forming units (PFU) |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Czech Republic |
|
VARILRIX |
One dose (0,5 ml) contains: Live, attenuated varicella virus - not less than 103,3 PFU |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Estonia |
|
VARILRIX |
After reconstitution, one dose (0,5 ml) contains: minimum 103,3 PFU Varicella zoster-virus |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Estonia |
|
VARIVAX |
After reconstitution, one dose (0,5 ml) contains: Varicella virus Oka/Merck strain (live, attenuated) ≥ 1 350 PFU |
Powder and solvent for suspension for injection |
Subcutaneous use |
||||||
|
Finland |
|
VARIVAX |
per 0,5 ml: Varicella virus (Oka/Merck): not less than: 1 350 PFU |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
||||||
|
Finland |
|
VARILRIX |
per 0,5 ml: Varicella virus (Oka): not less than: 103,3 PFU |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
||||||
|
France |
|
VARILRIX, poudre et solvant pour solution injectable en seringue préremplie. Vaccin varicelleux vivant |
one dose (0,5 ml) contains: Varicella virus** Oka/Merck strain (live, attenuated) 103,7 PFU*** ** Produced in human diploid cells (MRC-5) ***PFU = Plaque-forming units |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
France |
|
VARIVAX, poudre et solvant pour suspension injectable. Vaccin varicelleux vivant |
one dose (0.5 ml) contains: Varicella virus** Oka/Merck strain (live, attenuated) ≥ 1 350 PFU*** ** Produced in human diploid cells (MRC-5) ***PFU = Plaque-forming units |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
||||||
|
Germany |
|
Varivax |
one dose (0,5 ml) contains: Varicella virus** Oka/Merck strain (live, attenuated) ≥ 1 350 PFU*** ** Produced in human diploid cells (MRC-5) ***PFU = Plaque-forming units |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Germany |
|
Varilrix |
one dose (0,5 ml) contains: Varicella virus** OKA strain (live, attenuated) 103,7 PFU*** ***Produced in human diploid cells (MRC-5) ***PFU = Plaque-forming units |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
||||||
|
Germany |
|
Varivax |
one dose (0,5 ml) contains: Varicella virus** Oka/Merck strain (live, attenuated) ≥ 1 350 PFU*** ** Produced in human diploid cells (MRC-5) ***PFU = Plaque-forming units |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Germany |
|
Varilrix |
one dose (0,5 ml) contains: Varicella virus** OKA strain (live, attenuated)103,7 PFU*** ** Produced in human diploid cells (MRC-5) ***PFU = Plaque-forming units |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
||||||
|
Greece |
|
VARILRIX |
per 0,5 ml dose: Live Attenuated Varicella Virus OKA Strain not less than 103,3 PFU |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Greece |
|
VARIVAX |
per 0,5 ml dose: Varicella Virus OKA/Merck Strain - not less than 1 350 PFU |
Powder and solution for injection |
Intramuscular use, subcutaneous use |
||||||
|
Hungary |
|
Varilrix |
After reconstitution, 1 dose (0,5 ml) contains:Varicella virus OKA strain (live, attenuated) not less than 103,3 PFU |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Hungary |
|
Varivax |
After reconstitution, 1 dose (0,5 ml) contains:Varicella virus OKA/Merck strain (live, attenuated) not less than 1 350 PFU |
Powder and solution for injection |
Intramuscular use, subcutaneous use |
||||||
|
Iceland |
|
Varilrix |
1 dose (0,5 ml) contains: ≥ 103.3 PFU (Plaque forming units) of Varicella-Zoster Virus OKA strain |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Ireland |
|
VARIVAX powder and solvent for suspension for injection. |
Each 0.5 ml dose of reconstituted vaccine contains:Live attenuated varicella virus (Oka/Merck strain) not less than 1 350 PFU |
Powder and solvent for suspension for injection |
Subcutaneous use |
||||||
|
Italy |
|
VARILRIX |
After reconstitution, 1 dose (0,5 ml) contains: Live, attenuated Varicella virus (OKA strain) not less than 2 000 PFU |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Italy |
|
VARIVAX |
After reconstitution, 1 dose (0,5 ml) contains: Live, attenuated Varicella virus (OKA/Merck strain) not less than 1 350 PFU |
Powder and solvent for suspension for injection |
Intramuscular use, subcutaneous use |
||||||
|
Latvia |
|
Varivax powder and solvent for suspension for injection |
After reconstitution, one dose (0,5 ml) contains: Varicella virus Oka/Merck strain (live, attenuated) ≥ 1 350 PFU |
Powder and solvent for suspension for injection |
Intramuscular use, subcutaneous use |
||||||
|
Latvia |
|
Varilrix powder and solvent for solution for injection |
One dose (0,5 ml) contains: Live attenuated varicella-zoster (Oka strain) virus 103,3 plaque forming units (PFU) |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Lithuania |
|
Varilrix |
After reconstitution, 1 dose (0,5 ml) contains: Live attenuated varicella zoster virus (Oka strain) - not less than 103,3 PFU |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Lithuania |
|
VARIVAX |
per dose (0,5 ml): Varicella, live attenuated (Oka/Merck strain) - 1 350 PFU |
Powder and solvent for suspension for injection |
Intramuscular use, subcutaneous use |
||||||
|
Luxembourg |
|
VARILRIX |
1 dose (0,5 ml) contains: Live attenuated Varicella virus - not less than 103,3 PFU |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Luxembourg |
|
PROVARIVAX |
1 dose (0,5 ml) contains: Live attenuated varicella-zoster (Oka/Merck strain) virus not less than 1 350 PFU |
Powder for suspension for injection |
Subcutaneous use |
||||||
|
Malta |
|
Varilrix |
Each 0,5 ml dose of the reconstituted vaccine contains: NLT 103,3 PFU of the live attenuated varicella-zoster virus (OKA strain) |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Malta |
Merck Sharp & Dohme Ltd. Hertford Road Hoddesdon Hertfordshire EN 11 9BU United Kingdom |
Varivax |
Each 0,5 ml dose of the reconstituted vaccine contains: NLT 1 350 PFU of the live attenuated varicella virus (produced in human diploid (MRC-5) cells (OKA.Merck strain) |
Powder and solvent for suspension for injection |
Intramuscular use, subcutaneous use |
||||||
|
Norway |
|
Varilrix |
After reconstitution, 1 dose (0,5 ml) contains: Live attenuated varicella zoster virus (Oka strain) - not less than 103,3 PFU |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Norway |
|
Varivax |
After reconstitution, one dose (0,5 ml) contains: Varicella virus, live attenuated, Oka/Merck strain ≥ 1 350 PFU |
Powder and solvent for suspension for injection |
Intramuscular use, subcutaneous use |
||||||
|
Poland |
|
Varilrix |
per 0,5 ml of reconstituted vaccine: Not less than 2 000 PFU of the varicella-zoster virus (oka strain) |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Portugal |
|
Varilrix |
varicella virus (zoster vivo) - 3,3 log10 PFU/0,5 ml |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Portugal |
|
Varivax |
varicella virus (zoster vivo) - 1 350 FPU/0,5 ml |
Powder and solvent for suspension for injection |
Subcutaneous use |
||||||
|
Romania |
|
VARILRIX |
Varicella virus (Oka strain): ≥ 103,3 PFU |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Slovak Republic |
|
Varivax |
Varicella virus** (Oka/Merck strain) 31 350 PFU*** ** Produced on human diploid cells (MRC-5) ***PFU = Plaque-forming units |
Powder and solvent for suspension for injection |
Intramuscular use, subcutaneous use |
||||||
|
Slovenia |
|
Varivax prasek in vehikel za suspenzijo za injiciranje |
per dose (0,5 ml): Varicella virus (strain Oka/Merck) (live, attenuated) - not less than 1 350,00 PFU |
Powder and solvent for suspension for injection |
Intramuscular use, subcutaneous use |
||||||
|
Spain |
|
VARILRIX |
Live atenuated varicella-zoster virus (Strain OKA) - not less than 103,3 UFP |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Spain |
|
VARIVAX POLVO Y DISOLVENTE PARA SUSPENSIÓN INYECTABLE |
Live atenuated varicella virus (Strain OKA/Merk) - 31 350 UFP |
Powder and solvent for suspension for injection |
Intramuscular use, subcutaneous use |
||||||
|
Sweden |
|
Varilrix® |
Varicella virus, strain Oka/Merck live attenuated - 103,3 pfu |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Sweden |
|
Varivax® |
Varicella virus, strain Oka/Merck live attenuated - 1 350 pfu |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
||||||
|
The Netherlands |
|
Provarivax, poeder en oplosmiddel voor suspensie voor injectie |
per 0,5 ml Varicella virus Oka/Merck strain (live, attenuated) > 1 350 PFU |
Powder and solvent for solution for injection |
Parenteral use |
||||||
|
United Kingdom |
|
VARILRIX |
Live Attenuated Varicella Virus OKA Strain - 10 000 PFU/0,5 ml |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
United Kingdom |
|
VARIVAX Powder for Suspension |
Varicella Virus OKA/Merck Strain - 1 350 PFU |
Powder for suspension for injection |
Subcutaneous use |
Measles and rubella vaccines (live) with Marketing Authorisation in the European Union
|
Member State (EU/EEA) |
Marketing Authorisation Holder |
Invented name |
Strength |
Pharmaceutical form |
Route of administration |
||||||||
|
France |
|
RUDI ROUVAX, poudre et solvant pour solution injectable. vaccin à virus vivants atténués contre la rougeole et la rubéole |
one dose (0,5 ml) contains:
|
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
Measles, mumps and rubella vaccines (live) with Marketing Authorisation in the European Union
|
Member State (EU/EEA) |
Marketing authorisation holder |
Invented name |
Strength |
Pharmaceutical form |
Route of administration |
||||||||||||||||
|
Austria |
|
Priorix Pulver in Durchstechflaschen und Lösungsmittel in Fertigspritzen zur Herstellung einer Injektionslösung |
After reconstitution, one dose (0,5 ml) contains:
|
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
||||||||||||||||
|
Austria |
|
Priorix Pulver und Lösungsmittel zur Herstellung einer Injektionslösung |
After reconstitution, one dose (0,5 ml) contains: Measles virus, strain Schwarz1 (live, attenuated) not less than 103,0 CCID503 Mumps virus, strain RIT 43851, derived from strain Jeryl Lynn (live, attenuated) not less than 103,7 CCID503 Rubella virus, strain Wistar RA 27/32 (live, attenuated) not less than 103,0 CCID503
|
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
||||||||||||||||
|
Belgium |
|
Priorix |
Each 0,5 ml dose of the reconstituted vaccine contains:
*CCID50 – Cell Culture Infective Dose 50
|
Powder and solvent for solution for injection |
Subcutaneous use Intramuscular use, subcutaneous use |
||||||||||||||||
|
Bulgaria |
|
Priorix |
live attenuated measles virus (Schwarz strain) ≥ 103,0 CCID50 live attenuated mumps virus (RIT 4385 strain) ≥ 103,7 CCID50 live attenuated rubella virus (strain Wistar RA 27/3) ≥ 103,0 CCID50 |
Powder and solvent for suspension for injection |
Intramuscular use, subcutaneous use |
||||||||||||||||
|
Cyprus |
|
Priorix injection |
Each 0,5 ml dose of the reconstituted vaccine contains: not less than 103,0 CCID50* of the Schwarz measles1 not less than 103,7 CCID50 of the RIT 4385 mumps1 not less than 103,0 CCID50 of the Wistar RA 27/3 rubella2 virus strains. |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
||||||||||||||||
|
Czech Republic |
|
PRIORIX |
per 0,5 ml/dose: Live, attenuated measles virus (Schwarz strain) - not less than 103,0 CCID503 Live, attenuated mumps virus (RIT 4385 strain, derived from Jeryl Lynn strain) - not less than 103,7 CCID503 Live, attenuated rubella virus (Wistar RA 27/3 strain) - not less than 103,0 CCID503 |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
||||||||||||||||
|
Denmark |
|
Priorix |
per 0,5 ml dose: Not less than:103,0 CCID50 of the Schwarz measles; Not less than:103,7 CCID50 of the RIT 4385 mumps; Not less than:103,0 CCID50 of the Wistar RA 27/3 rubella |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
||||||||||||||||
|
Denmark |
|
Varilrix |
One dose (0,5 ml) contains: Live attenuated varicella-zoster (Oka strain) virus* 103.3 plaque forming units (PFU) |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||||||||||||
|
Denmark |
|
Provarivax |
One dose (0,5 ml) contains: Live attenuated varicella-zoster (Oka strain) virus* 103.3 plaque forming units (PFU) |
Powder and solvent for solution for injection, suspension |
Subcutaneous use |
||||||||||||||||
|
Estonia |
|
PRIORIX |
Measles virus (live, attenuated) NLT 103,0 CCID50; Mumps virus (live, attenuated) NLT 103,7 CCID50; Rubella virus (live, attenuated) NLT 103,0 CCID50 |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||||||||||||
|
Finland |
|
PRIORIX |
per 0,5 ml: Measles virus (Schwarz) - not less than 103,0 CCID50 Mumps virus (RIT 4385) - not less than 103,7 CCID50 Rubella virus (Wistar RA27/3) - not less than: 103,0 CCID50 |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
||||||||||||||||
|
France |
|
PRIORIX, poudre et solvant pour solution injectable en seringue préremplie. vaccin rougeoleux, des oreillons et rubéoleux vivant |
1 dose (0,5 ml) contains: Live attenuated measles virus (Schwarz strain) - not less than 103,0 CCID50 Live attenuated mumps virus (RIT 4385 strain, derived from Jeryl Lynn strain) - not less than 103,7 CCID50 Live attenuated rubella virus (Wistar RA 27/3 strain) - not less than 103,0 CCID50 |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
||||||||||||||||
|
France |
|
R.O.R., poudre et solvant pour solution injectable. vaccin à virus vivants atténués contre la rougeole, les oreillons et la rubéole |
one dose (0,5 ml) contains: Measles virus Schwartz strain (live, attenuated) not less than 1 000 CCID50 Mumps virus URABE AM-9 strain (live, attenuated) not less than 5 000 CCID50 Rubella virus Wistar RA 27/3 strain (live, attenuated) not less than 1 000 CCID50 |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
||||||||||||||||
|
France |
|
R.O.R. VAX, poudre et solvant pour suspension injectable. Vaccin rougeoleux, des oreillons et rubéoleux atténué. |
one dose (0,5 ml) contains: Measles virus Edmonston 749D strain (live, attenuated) - 1 000 CCID50 Mumps virus Jeryl Lynn strain (live, attenuated) - 5 000 CCID50 Rubella virus Wistar RA 27/3 strain (live, attenuated) - 1 000 CCID50 |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
||||||||||||||||
|
Germany |
|
Priorix |
per 0,5 ml dose: Measles virus - not less than 3,0 log10 CCID50 mumps virus - not less than 3,7 log10 CCID50 rubella virus - not less than 3,0 log10 CCID50 |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
||||||||||||||||
|
Germany |
|
Priorix |
per 0,5 ml dose: Measles virus - not less than 3,0 log10 CCID50 mumps virus - not less than 3,7 log10 CCID50 rubella virus - not less than 3,0 log10 CCID50 |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
||||||||||||||||
|
Greece |
|
PRIORIX |
Live attenuated measles virus (Schwarz strain) – 1 000,000 CC Live attenuated mumps virus (RIT 4385 strain) – 1 000,000 CC Live attenuated rubella virus (Wistar RA 27/3 strain) – 1 000,000 CC |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
||||||||||||||||
|
Hungary |
|
Priorix por ésoldószer oldatos injekcióhoz |
After reconstitution, 1 dose (0,5 ml) contains: Live attenuated measles virus (Schwarz strain) not less than 103,0 CCID50 Live attenuated mumps virus (RIT 4385 strain, derived from Jeryl Lynn strain) not less than 103,7 CCID50 Live attenuated rubella virus (Wistar RA 27/3 strain) not less than 103,0 CCID50 |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
||||||||||||||||
|
Iceland |
|
Priorix |
per 0,5 ml Rubella virus >= 103 CCID50 Measles virus >= 103 CCID50 Mumps virus >= 103,7 CCID50 |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
||||||||||||||||
|
Italy |
|
PRIORIX |
Live attenuated measles virus1 (Schwarz strain) - not less than 103,0 CCID503 Live attenuated mumps virus1 (RIT 4385 strain, derived from Jeryl Lynn strain) - not less than 103,7 CCID503 Live attenuated rubella virus2 (Wistar RA 27/3 strain) - not less than 103,0 CCID503 |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
||||||||||||||||
|
Latvia |
|
Priorix powder and solvent for solution for injection |
After reconstitution, 1 dose (0,5 ml) contains: Live attenuated measles virus (Schwarz strain) not less than 103,0 CCID50 Live attenuated mumps virus (RIT 4385 strain, derived from Jeryl Lynn strain) not less than 103,7 CCID50 Live attenuated rubella virus (Wistar RA 27/3 strain) not less than 103,0 CCID50 |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
||||||||||||||||
|
Latvia |
|
Priorix powder and solvent for solution for injection in pre-filled syringe |
After reconstitution, 1 dose (0,5 ml) contains: Live attenuated measles virus (Schwarz strain) not less than 103,0 CCID50 Live attenuated mumps virus (RIT 4385 strain, derived from Jeryl Lynn strain) not less than 103,7 CCID50 Live attenuated rubella virus (Wistar RA 27/3 strain) not less than 103,0 CCID50 |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
||||||||||||||||
|
Lithuania |
|
Priorix |
After reconstitution, 1 dose (0,5 ml) contains: Live attenuated measles virus (Schwarz strain) - not less than 103,0 CCID50 Live attenuated mumps virus (RIT 4385 strain, derived from Jeryl Lynn strain) - not less than 103,7 CCID50 Live attenuated rubella virus (Wistar RA 27/3 strain) - not less than 103,0 CCID50 |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
||||||||||||||||
|
Luxembourg |
|
PRIORIX |
1 dose (0,5 ml) contains: Live attenuated measles virus (Schwarz strain) - not less than 103 CCID50 Live attenuated mumps virus (RIT 4385 strain, derived from Jeryl Lynn strain) - not less than 103,7 CCID50 Live attenuated rubella virus (Wistar RA 27/3 strain) - not less than 103 CCID50 |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
||||||||||||||||
|
Malta |
|
Priorix |
Each 0,5 ml dose of the reconstituted vaccine contains; NLT 103,0 CCID50 of the Schwarz measles (produced in chick embryo cells) NLT 103,7 CCID50 of the RIT 4385 mumps (produced in chick embryo cells) NTL 103,0 CCID50 of the Wistar RA 27/3 rubella (produced in human diploid MRC-5 cells) virus strains |
Powder and solvent for solution for injection |
Subcutaneous use, Intramascular use |
||||||||||||||||
|
Norway |
|
Priorix |
Each 0,5 ml dose of the reconstitured vaccine contains: Live attenuated Schwarz measles virus strain: not less than 103 CCID50 Live attenuated RIT 4385 mumps virus strain: not less than 103.7 CCID50 Live attenuated Wistar RA 27/3 rubella virus strain: not less than 103 CCID50. |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
||||||||||||||||
|
Poland |
|
M-M-R II |
per 0,5 ml dose: not less than 1 000 CCID50 of the measlec virus Enders-Edmonston strain, not less than 12 500 CCID50 of the mumps virus (Jeryl Lynn strain); and not less than 1 000 CCID50 of the Wistar RA 27/3 rubella virus strains |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||||||||||||
|
Poland |
|
Priorix |
per 0,5 ml dose: Not less than: 103,0 CCID50 of the Schwarz measles virus; Not less than:103.7 CCID50 of the RIT 4385 mumps virus; Not less than:103,0 CCID50 of the Wistar RA 27/3 rubella virus strains |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
||||||||||||||||
|
Portugal |
|
Priorix |
per 0,5 ml dose: Measles virus (Schwarz strain) - not less than 3,0 log10 CCID50 mumps virus (RIT 4385 strain) - not less than 3,7 log10 CCID50 rubella virus (Wistar RA 27/3 starin) - not less than 3,0 log10 CCID50 |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
||||||||||||||||
|
Portugal |
|
Priorix |
per 0,5 ml dose: Measles virus (Schwarz strain) - not less than 3,0 log10 CCID50 mumps virus (RIT 4385 strain) - not less than 3,7 log10 CCID50 rubella virus (Wistar RA 27/3 starin) - not less than 3,0 log10 CCID50 |
Powder and solvent for solution for injection in pre-filled syringe |
Intramuscular use, subcutaneous use |
||||||||||||||||
|
Romania |
|
PRIORIX |
Measles virus (Schwarz strain): ≥ 103,0 CCID50 Mumps virus (RIT 4385 strain): ≥ 103,7 CCID50 Rubella virus (Wistar RA 27/3 strain): ≥ 103,0 CCID50 |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
||||||||||||||||
|
Slovak Republic |
|
Proirix |
Measles virus Schwarz strain (live, attenuated) not less than 103,0 CCID503 Mumps virus RIT 4385 strain, derived from Jeryl Lynn strain (live, attenuated) not less than 103,7 CCID503 Rubella virus (Wistar RA 27/3 strain) (live, attenuated) - not less than 103,0 CCID503 |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
||||||||||||||||
|
Slovenia |
|
Priorix prašek in vehikel za raztopino za injiciranje |
per dose (0,5 ml): Measles virus (strain Schwarz) (live, atenuated) - not less than 103,0 CCID50 Mumps virus (strain RIT 4385 - derived from strain Jeryl Lynn) (live, atenuated) - not less than 103,7 CCID50 Rubella virus (strain Wistar RA 27/3) (live, atenuated) - not less than 103,0 CCID50 |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
||||||||||||||||
|
Spain |
|
PRIORIX, POLVO Y DISOLVENTE EN JERINGA PRECARGADA PARA SOLUCIÓN INYECTABLE |
Live atenuated rubella (Strain Wistar RA 27/3) - not less than 103,0 CCID50, measles (Cepa Schwarz) - 103,0 CCID50 mumps (Cepa RIT 4385, derivated from Cepa Jeryl Lynn) - 103,7 CCID50 |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
||||||||||||||||
|
Sweden |
|
Priorix® |
After reconstitution, 1 dose (0,5 ml) contains: Live attenuated measles virus (Schwarz strain) not less than 103,0 CCID50 Live attenuated mumps virus (RIT 4385 strain, derived from Jeryl Lynn strain) not less than 103,7 CCID50 Live attenuated rubella virus (Wistar RA 27/3 strain) not less than 103,0 CCID50 |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
||||||||||||||||
|
The Netherlands |
|
Priorix, poeder en oplosmiddel voor suspensie voor injectie |
per 0,5 ml: Measles virus Schwarz strain (live, attenuated) not less than 10 CCID50 Mumps virus RIT 4385 strain, derived from Jeryl Lynn strain (live, attenuated) not less than 10 CCID50 Rubella virus Wistar RA 27/3 strain (live, attenuated) not less than 100 CCID50 |
Powder and solvent for solution for injection |
Parenteral use |
||||||||||||||||
|
United Kingdom |
SmithKline Beecham plc 980 Great West Road Brentford Middlesex TW8 9GS United Kingdom |
PRIORIX powder and solvent for solution for injection |
Mumps (RIT 4385 Derived from Jeryl Lynn): 5 011 CID50 Measles (Schwarz Strain): 1 000 CID50 Rubella (Wistar RA 27/3 Strain): 1 000 CID50 |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
Measles, mumps, rubella and varicella vaccines (live) with Marketing Authorisation in the European Union
|
Member State (EU/EEA) |
Marketing authorisation holder |
Invented name |
Strength |
Pharmaceutical form |
Route of administration |
||||||||||||
|
Austria |
|
Priorix - Tetra Pulver in Durchstechflaschen und Lösungsmittel in Fertigspritzen zur Herstellung einer Injektionslösung |
One dose (0,5 ml) of the solved vaccine contains: Measles virus, strain Schwarz1 (live, attenuated) - not less than 103,0 CCID503 Mumps virus, strain RIT 43851, derived from strain Jeryl Lynn (live, attenuated) - not less than 104,4 CCID503 Rubella virus, strain Wistar RA 27/32 (live, attenuated) - not less than 103,0 CCID503 Varicella Virus, strain OKA2 (live, attenuated) - not less than 103,3 PFU4
|
Powder and solvent for solution for injection |
Subcutaneous use |
||||||||||||
|
Austria |
|
Priorix - Tetra Pulver und Lösungsmittel zur Herstellung einer Injektionslösung |
One dose (0,5 ml) of the solved vaccine contains: Measles virus, strain Schwarz1 (live, attenuated) - not less than 103,0 CCID503 Mumps virus, strain RIT 43851, derived from strain Jeryl Lynn (live, attenuated) - not less than 104,4 CCID503 Rubella virus, strain Wistar RA 27/32 (live, attenuated) - not less than 103,0 CCID503 Varicella virus, strain OKA2 (live, attenuated) - not less than 103,3 PFU4
|
Powder and solvent for solution for injection |
Subcutaneous use |
||||||||||||
|
Belgium |
|
Priorix-Tetra |
After reconstitution, 1 dose (0,5 ml) contains: Measles virus Schwarz strain (live, attenuated) not less than 103,0 CCID50 Mumps virus RIT 4385 strain, derived from Jeryl Lynn strain (live, attenuated) not less than 104,4 CCID50 Rubella virus (Wistar RA 27/3 strain) (live, attenuated) not less than 103,0 CCID50 Varicella virus OKA strain (live, attenuated) not less than 103,3 PFU |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||||||||
|
Cyprus |
|
Priorix Tetra powder and solvent for solution for injection |
Each 0,5 ml dose of the reconstituted vaccine contains:- not less than 103,0 CCID50* of the Schwarz measles1 - not less than 104,4 CCID50 of the RIT 4385 mumps1, - not less than 103,0 CCID50 of the Wistar RA 27/3 rubella2 virus strains and - not less than 103,3 plaque forming units (PFU) of live attenuated varicella-zoster (Oka strain) virus |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||||||||
|
Cyprus |
|
PRIORIX TETRA POWDER IN VIAL + SOLVENT IN AMPOULE |
Each 0,5 ml dose of the reconstituted vaccine contains:- not less than 103,0 CCID50* of the Schwarz measles1 - not less than 104,4 CCID50 of the RIT 4385 mumps1, - not less than 103,0 CCID50 of the Wistar RA 27/3 rubella2 virus strains and - not less than 103,3 plaque forming units (PFU) of live attenuated varicella-zoster (Oka strain) virus |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||||||||
|
Czech Republic |
|
PRIORIX-TETRA INJ. STŘÍKAČKA |
per 0,5 ml/dose: Live, attenuated measles virus (Schwarz strain) - not less than 103,0 CCID50 Live, attenuated mumps virus (RIT 4385 strain, derived from Jeryl Lynn strain) - not less than 104,4 CCID50 Live, attenuated rubella virus (Wistar RA 27/3 strain) - not less than 103,0 CCID50 Live, attenuated varicella virus (Oka strain) - not less than 103.3 PFU |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||||||||
|
Czech Republic |
|
PRIORIX-TETRA LAHVIČKA/AMPULE |
per 0,5 ml/dose: Live, attenuated measles virus (Schwarz strain) - not less than 103,0 CCID50 Live, attenuated mumps virus (RIT 4385 strain, derived from Jeryl Lynn strain) - not less than 104,4 CCID50 Live, attenuated rubella virus (Wistar RA 27/3 strain) - not less than 103,0 CCID50 Live, attenuated varicella virus (Oka strain) - not less than 103.3 PFU |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||||||||
|
Denmark |
|
Priorix-Tetra |
Live, attenuated measles virus (Schwarz strain) - not less than 103,0 CCID50 Live, attenuated mumps virus (RIT 4385 strain, derived from Jeyl Lynn strain) - not less than 104.0 CCID50 Live attenuated rubella virus (Wistar RA 27/3 strain) - not less than 103,0 CCID50. Live, attenuated varicella virus (Oka strain) - not less than 103.3 PFU |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||||||||
|
Denmark |
|
Priorix-Tetra |
Live, attenuated measles virus (Schwarz strain) - not less than 103,0 CCID50 Live, attenuated mumps virus (RIT 4385 strain, derived from Jeyl Lynn strain) - not less than 104.4 CCID50 Live attenuated rubella virus (Wistar RA 27/3 strain) - not less than 103,0 CCID50. Live, attenuated varicella virus (Oka strain) - not less than 103.3 PFU |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||||||||
|
Estonia |
|
PRIORIX-TETRA |
Measles virus (live, attenuated) NLT 103,0 CCID50; Mumps virus (live, attenuated) NLT 104,4 CCID50; Rubella virus (live, attenuated) NLT 103,0 CCID50; Varicella virus (live, attenuated) NLT 103,3 PFU |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||||||||
|
Estonia |
|
PRIORIX-TETRA |
Measles virus (live, attenuated) NLT 103,0 CCID50; Mumps virus (live, attenuated) NLT 104,4 CCID50; Rubella virus (live, attenuated) NLT 103,0 CCID50; Varicella virus (live, attenuated) NLT 103,3 PFU |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||||||||
|
Finland |
|
PRIORIX TETRA |
per 0,5 ml: Measles virus (Schwarz) - not less than 103,0 CCID50 Mumps virus (RIT 4385) - not less than 104,4 CCID50 Rubella virus (Wistar RA27/3) - not less than: 103,0 CCID50 Varicella virus (Oka) - not less than: 103,3 PFU |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
||||||||||||
|
France |
|
PRIORIX-TETRA, poudre et solvant pour solution injectable en seringue préremplie. Vaccin rougeoleux, des oreillons, rubéoleux et varicelleux (vivant) |
1 dose (0,5 ml) contains: Measles virus1 Schwarz strain (live, attenuated) not less than 103,0 CCID503 Mumps virus1 RIT 4385 strain, derived from Jeryl Lynn strain (live, attenuated) not less than 104,4 CCID503 Rubella virus2 Wistar RA 27/3 strain (live, attenuated) not less than 103,0 CCID503 Varicella virus2 OKA strain (live, attenuated) not less than 103,3 PFU4 |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||||||||
|
France |
|
PRIORIX-TETRA, poudre et solvant pour solution injectable. Vaccin rougeoleux, des oreillons, rubéoleux et varicelleux (vivant) |
1 dose (0,5 ml) contains: Measles virus1 Schwarz strain (live, attenuated) - not less than 103,0 CCID503 Mumps virus1 RIT 4385 strain, derived from Jeryl Lynn strain (live, attenuated) - not less than 104,4 CCID503 Rubella virus2 Wistar RA 27/3 strain (live, attenuated) - not less than 103,0 CCID503 Varicella virus2 OKA strain (live, attenuated) - not less than 103,3 PFU4 |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||||||||
|
Germany |
|
Priorix-Tetra |
per 0,5 ml dose: Measles virus - not less than 3,0 log10 CCID50 mumps virus - not less than 4.4 log10 CCID50; rubella virus - not less than 3,0 log10 CCID50; varicella virus - not less than 3,3 log10 PFU |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||||||||
|
Germany |
|
Priorix-Tetra |
per 0,5 ml dose: Measles virus - not less than 3,0 log10 CCID50; mumps virus - not less than 4.4 log10 CCID50; rubella virus - not less than 3,0 log10 CCID50; varicella virus - not less than 3,3log10 PFU |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||||||||
|
Greece |
|
PRIORIX-TETRA |
Measles virus live attenuated (Schwarz strain) – 1 000,000 CC Mumps virus live attenuated (RIT 4385 strain) – 1 000,000 CC Rubella virus live attenuated (WISTAR RA 27/3 strain) – 1 000,000 CC |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
||||||||||||
|
Greece |
|
R.O.R.VAX, |
per 0,5 ml dose: not less than 1 000 CCID50 of the measles virus Enders-Edmonston strain not less than 5 000 CCID50 of the mumps virus (Jeryl Lynn strain) not less than 1 000 CCID50 of the rubella virus strain |
Powder and solvent for solution for injection |
Intramuscular use |
||||||||||||
|
Hungary |
|
Priorix Tetra por és oldószer oldatos injekcióhoz |
After reconstitution, 1 dose (0,5 ml) contains: Live attenuated measles virus (Schwarz strain) - not less than 103,0 CCID50 Live attenuated mumps virus (RIT 4385 strain, derived from Jeryl Lynn strain) not less than 103,7 104,4 CCID50 Live attenuated rubella virus (Wistar RA 27/3 strain) not less than 103,0 CCID50 Varicella virus OKA strain (live, attenuated) not less than 103,3 PFU |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||||||||
|
Hungary |
|
Priorix Tetra por és oldószer oldatos injekcióhoz előretöltött fecskendőben |
After reconstitution, 1 dose (0,5 ml) contains: Live attenuated measles virus (Schwarz strain) - not less than 103,0 CCID50 Live attenuated mumps virus (RIT 4385 strain, derived from Jeryl Lynn strain) not less than 104,4 CCID50 Live attenuated rubella virus (Wistar RA 27/3 strain) not less than 103,0 CCID50 Varicella virus OKA strain (live, attenuated) not less than 103,3 PFU |
Powder and solvent for solution for injection in pre-filled syringe |
Subcutaneous use |
||||||||||||
|
Iceland |
|
Priorix Tetra |
per 0,5 ml Live attenuated measles virus >= 103 CCID50 - Live attenuated mumps virus >= 104,4 CCID50 - Live attenuated rubella virus >= 103 CCID50 - Live attenuated varicella virus >= 103,3 CCID50 |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||||||||
|
Iceland |
|
Priorix Tetra |
per 0,5 ml Live attenuated measles virus >= 103 CCID50 - Live attenuated mumps virus >= 104,4 CCID50 - Live attenuated rubella virus >= 103 CCID50 - Live attenuated varicella virus >= 103,3 CCID50 |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||||||||
|
Ireland |
|
Priorix-Tetra – powder and solvent for solution for injection in a pre-filled syringe Measles, mumps, rubella and varicella vaccine (live) |
per 0.5 mg: Live attenuated measles virus (Schwarz strain) not less than 103,0 CCID50 Live attenuated mumps virus (RIT 4385 strain) not less than 104,4 CCID50 Live attenuated rubella virus (Wistar RA 27/3 strain) not less than 103,0 CCID50 Live attenuated varicella virus (OKA strain) not less than 103,3 PFU |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||||||||
|
Ireland |
|
Priorix-Tetra – powder and solvent for solution for injection Measles, mumps, rubella and varicella vaccine (live) |
per 0,5 ml: Live attenuated measles virus (Schwarz strain) -not less than 103,0 CCID50 Live attenuated mumps virus (RIT 4385 strain) - not less than 104,4 CCID50 Live attenuated rubella virus (Wistar RA 27/3 strain) - not less than 103,0 CCID50 Live attenuated varicella virus (OKA strain) - not less than 103,3 PFU |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||||||||
|
Ireland |
|
Priorix-Tetra – powder and solvent for solution for injection Measles, mumps, rubella and varicella vaccine (live) |
per 0,5 ml: Live attenuated measles virus (Schwarz strain) - not less than 103,0 CCID50 Live attenuated mumps virus (RIT 4385 in) - not less than 104,4 CCID50 Live attenuated rubella virus (Wistar RA 27/3 strain) - not less than 103,0 CCID50 Live attenuated varicella virus (OKA strain) - not less than 103,3 PFU |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||||||||
|
Italy |
|
PRIRIX TETRA |
Measles virus1 Schwarz strain (live, attenuated) - not less than 103,0 CCID503 Mumps virus1 RIT 4385 strain, derived from Jeryl Lynn strain (live, attenuated) - not less than 104,4CCID503 Rubella virus2 Wistar RA 27/3 strain (live, attenuated) - not less than 103,0 CCID503 Varicella virus2 OKA strain (live, attenuated) - not less than 103,3 PFU4 |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||||||||
|
Latvia |
|
Priorix-Tetra powder and solvent for solution for injection |
After reconstitution, 1 dose (0,5 ml) contains: Measles virus1 Schwarz strain (live, attenuated) not less than 103,0 CCID503 Mumps virus1 RIT 4385 strain, derived from Jeryl Lynn strain (live, attenuated) not less than 104,4 CCID503 Rubella virus2 Wistar RA 27/3 strain (live, attenuated) not less than 103,0 CCID503 Varicella virus2 OKA strain (live, attenuated) not less than 103,3 PFU4 |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||||||||
|
Latvia |
|
Priorix-Tetra powder and solvent for solution for injection in pre-filled syringe |
After reconstitution, 1 dose (0,5 ml) contains: Measles virus1 Schwarz strain (live, attenuated) not less than 103,0 CCID503 Mumps virus1 RIT 4385 strain, derived from Jeryl Lynn strain (live, attenuated) - not less than 104,4 CCID503 Rubella virus2 Wistar RA 27/3 strain (live, attenuated) - not less than 103,0 CCID503 Varicella virus2 OKA strain (live, attenuated) - not less than 103,3 PFU4 |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||||||||
|
Lithuania |
|
Priorix-Tetra |
After reconstitution, 1 dose (0,5 ml) contains: Live attenuated measles virus (Schwarz strain) - not less than 103,0 CCID50 Live attenuated mumps virus (RIT 4385 strain, derived from Jeryl Lynn strain) - not less than 104,4 CCID50 Live attenuated rubella virus (Wistar RA 27/3 strain) - not less than 103,0 CCID50 Live, attenuated varicella virus - not less than 103,3 PFU 4 |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||||||||
|
Luxembourg |
|
PRIORIX TETRA |
1 dose (0,5 ml) contains: Live attenuated Measles virus (Schwarz strain) - not less than 103 CCID503 Live attenuated Mumps virus (RIT 4385 strain derived from Jeryl Lynn strain) -not less than 104.4 CCID503 Live attenuated Rubella virus (Wistar RA 27/3 strain) - not less than 103 CCID503 Live attenuated Varicella virus (OKA strain) - not less than 103.3 PFU |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||||||||
|
Poland |
|
Priorix-Tetra |
per 0,5 ml dose: Not less than 103,0 CCID50 of the live, attenuated measles virus (Schwarz strain), not less than 104.4 CCID50 of the live, attenuated mumps virus (RIT 4385 strain, derived from Jeryl Lynn strain), not less than 103,0 CCID50 of the live, attenuated rubella virus (Wistar RA 27/3 strain), not less than 103.3 PFU of the live, attenuated varicella virus (Oka strain) |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||||||||
|
Poland |
|
Priorix-Tetra |
Not less than 103,0 CCID50 of the live, attenuated measles virus (Schwarz strain) not less than 104.4 CCID50 of the live, attenuated mumps virus (RIT 4385 strain, derived from Jeryl Lynn strain) not less than 103,0 CCID50 of the live, attenuated rubella virus (Wistar RA 27/3 strain) not less than 103.3 PFU of the live, attenuated varicella virus (Oka strain) per 0,5 ml dose |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||||||||
|
Portugal |
|
Priorix-Tetra |
per 0,5 ml dose: Measles virus (Schwarz strain) - not less than 3,0 log10 CCID50 mumps virus (RIT 4385 strain) - not less than 3,7 log10 CCID50 rubella virus (Wistar RA 27/3 starin) - not less than 3,0 log10 CCID50 varicella virus (zoster vivo - OKA strain) - not less than 3,3log10 PFU |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||||||||
|
Portugal |
|
Priorix-Tetra |
per 0,5 ml dose: Measles virus (Schwarz strain) - not less than 3,0 log10 CCID50 mumps virus (RIT 4385 strain) - not less than 3,7 log10 CCID50 rubella virus (Wistar RA 27/3 starin) - not less than 3,0 log10 CCID50 varicella virus (zoster vivo - OKA strain) - not less than 3,3 log10 PFU |
Powder and solvent for solution for injection in pre-filled syringe |
Subcutaneous use |
||||||||||||
|
Romania |
|
PRIORIX-TETRA |
Measles virus (Schwarz strain): ≥ 103,0 CCID50 Mumps virus (RIT 4385 strain): ≥ 104,4 CCID50 Rubella virus (Wistar RA 27/3 strain): ≥ 103,0 CCID50 Varicella virus (Oka strain): ≥ 103,3 PFU |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||||||||
|
Romania |
|
PRIORIX-TETRA |
Measles virus (Schwarz strain): ≥ 103,0 CCID50 Mumps virus (RIT4385 strain): ≥ 104,4 CCID50 Rubella virus (Wistar RA 27/3 strain): ≥ 103,0 CCID50 Varicella virus (Oka strain): ≥ 103,3 PFU |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||||||||
|
Slovak Republic |
|
Priorix Tetra |
Measles virus Schwarz strain (live, attenuated) not less than 103,0 CCID503 Mumps virus RIT 4385 strain, derived from Jeryl Lynn strain (live, attenuated) not less than 104,4 CCID503 Varicella virus OKA strain (live, attenuated) not less than 103,3 PFU4 |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||||||||
|
Slovak Republic |
|
Priorix-Tetra lag |
Measles virus Schwarz strain (live, attenuated) not less than 103,0 CCID503 Mumps virus RIT 4385 strain, derived from Jeryl Lynn strain (live, attenuated) not less than 104,4 CCID503 Rubella virus (Wistar RA 27/3 strain) (live, attenuated) not less than 103,0 CCID503 Varicella virus OKA strain (live, attenuated) not less than 103,3 PFU4 |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||||||||
|
Slovenia |
|
Priorix-Tetra prašek in vehikel za raztopino za injiciranje v napolnjeni injekcijski brizgi |
per dose (0,5 ml): Measles virus (strain Schwarz) (live, atenuated) - not less than 103,0 CCID50 Mumps virus (strain RIT 4385 - derived from strain Jeryl Lynn) (live, atenuated) - not less than 104,4 CCID50 Rubella virus (strain Wistar RA 27/3) (live, atenuated) - not less than 103,0 CCID50 Varicella virus (strain OKA) (live, atenuated) - not less than 103,3 PFU |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||||||||
|
Sweden |
|
Priorix Tetra |
Measles virus, live attenuated strain Schwarz 103,0 CCID50; Mumps virus, live attenuated strain RIT 4385104,4 CCID50 Rubella virus, live attenuated strain Wistar RA 27/3 - 103,0 CCID50 Varicella virus, strain OKA, live attenuated 103.3 pfu |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||||||||
|
Sweden |
|
Priorix Tetra |
Measles virus, live attenuated strain Schwarz 103,0 CCID50; Mumps virus, live attenuated strain RIT 4385104,4 CCID50 Rubella virus, live attenuated strain Wistar RA 27/3 103,0 CCID50 Varicella virus, strain OKA, live attenuated 103.3 pfu |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||||||||
|
The Netherlands |
|
Priorix-Tetra injectieflacon/ampul, poeder en oplosmiddel voor oplossing voor injectie |
per 0,5 ml: Measles virus Schwarz strain (live, attenuated) not less than 10 CCID50 Mumps virus RIT 4385 strain, derived from Jeryl Lynn strain (live, attenuated) not less than 10 CCID50 Rubella virus Wistar RA 27/3 strain (live, attenuated) not less than 100 CCID50 Varicella virus OKA strain (live, attenuated) not less than 10 PFU |
Powder and solvent for solution for injection |
Parenteral use |
||||||||||||
|
The Netherlands |
|
Priorix-Tetra, poeder en oplosmiddel in voorgevulde spuit voor oplossing voor injectie |
per 0,5 ml: Measles virus Schwarz strain (live, attenuated) not less than 10 CCID50 Mumps virus RIT 4385 strain, derived from Jeryl Lynn strain (live, attenuated) not less than 10 CCID50 Rubella virus Wistar RA 27/3 strain (live, attenuated) not less than 100 CCID50 Varicella virus OKA strain (live, attenuated) not less than 10 PFU |
Powder and solvent for solution for injection |
Parenteral use |
||||||||||||
|
United Kingdom |
|
PRIORIX-TETRA powder for solution for injection |
Live Attenuated Mumps Virus RT 4385: 4,4 CID50 Live Attenuated Measles Virus (Schwarz Strain): 3 CID50 Live Attenuated Rubella (Wistar RA 27/3 Strain): 3 CID50 Varicella Virus OKA Strain: 3,3 CID50 |
Powder and solution for injection |
Subcutaneous use |
|
30.8.2013 |
HR |
Službeni list Europske unije |
C 250/30 |
Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. lipnja 2013. do 31. srpnja 2013.
(Objavljeno u skladu s člankom 13. ili člankom 38. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća (1) )
2013/C 250/02
— Izdavanje odobrenja za stavljanje u promet (članak 13. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća): Prihvaćeno
|
Datum odluke |
Naziv lijeka |
INN (medunarodni nezašticeni naziv lijeka) |
Nositelj odobrenja za stavljanje u promet |
Broj upisa u registar Zajednice |
Farmaceutski oblik |
Oznaka ATC (Anatomsko-terapijsko-kemijska klasifikacija lijekova) |
Datum obavijesti |
||
|
13.6.2013 |
Memantine ratiopharm |
memantin |
|
EU/1/13/836 |
Filmom obložena tableta |
N06DX01 |
17.6.2013 |
||
|
14.6.2013 |
Votrient |
Pazopanibklorida |
|
EU/1/10/628 |
Filmom obložena tableta |
L01XE11 |
18.6.2013 |
||
|
21.6.2013 |
Capecitabine SUN |
Kapecitabin |
|
EU/1/13/831 |
Filmom obložena tableta |
L01BC06 |
25.6.2013 |
||
|
21.6.2013 |
Spedra |
avanafil |
|
EU/1/13/841 |
Tableta |
G04BE |
25.6.2013 |
||
|
21.6.2013 |
Xtandi |
enzalutamid |
|
EU/1/13/846 |
Kapsula, meka |
Pending |
25.6.2013 |
||
|
24.6.2013 |
Nuedexta |
dekstrometorfan/kinidin |
|
EU/1/13/833 |
Kapsula, tvrda |
N07XX |
26.6.2013 |
||
|
24.6.2013 |
Stayveer |
|
|
EU/1/13/832 |
Filmom obložena tableta |
C02KX01 |
25.6.2013 |
||
|
27.6.2013 |
MACI |
kultivirani karakterizirani autologni hondrociti aplicirani na matriks |
|
EU/1/13/847 |
Matrica za implantaciju |
M09AX02 |
1.7.2013 |
||
|
1.7.2013 |
Iclusig |
ponatiniba |
|
EU/1/13/839 |
Filmom obložena tableta |
L01XE24 |
3.7.2013 |
||
|
1.7.2013 |
Imatinib Accord |
Imatinib |
|
EU/1/13/845 |
Filmom obložena tableta |
L01XE01 |
3.7.2013 |
||
|
12.7.2013 |
Erivedge |
vismodegib |
|
EU/1/13/848 |
Kapsula, tvrda |
L01XX43 |
17.7.2013 |
||
|
25.7.2013 |
Lonquex |
lipegfilgrastim |
|
EU/1/13/856 |
Otopina za injekciju |
L03AA14 |
29.7.2013 |
||
|
31.7.2013 |
Atosiban SUN |
atosiban |
|
EU/1/13/852 |
Koncentrat za otopinu za infuziju Otopina za injekciju |
G02CX01 |
2.8.2013 |
||
|
31.7.2013 |
Imvanex |
modificirani virus vakcinije ankara |
|
EU/1/13/855 |
Suspenzija za injekciju |
J07BX |
5.8.2013 |
||
|
31.7.2013 |
Lojuxta |
Lomitapid |
|
EU/1/13/851 |
Kapsula, tvrda |
C10AX12 |
5.8.2013 |
||
|
31.7.2013 |
PHEBURANE |
natrijev fenilbutirat |
|
EU/1/13/822/ |
Zrnce |
A16AX03 |
5.8.2013 |
— Izmjena odobrenja za stavljanje u promet (članak 13. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća): Prihvaćeno
|
Datum odluke |
Naziv lijeka |
Nositelj odobrenja za stavljanje u promet |
Broj upisa u registar Zajednice |
Datum obavijesti |
||
|
11.6.2013 |
IOA |
|
EU/1/11/689 |
13.6.2013 |
||
|
11.6.2013 |
Rienso |
|
EU/1/12/774 |
13.6.2013 |
||
|
11.6.2013 |
Zoely |
|
EU/1/11/690 |
18.6.2013 |
||
|
13.6.2013 |
Abilify |
|
EU/1/04/276 |
17.6.2013 |
||
|
13.6.2013 |
Atripla |
|
EU/1/07/430 |
17.6.2013 |
||
|
13.6.2013 |
Revlimid |
|
EU/1/07/391 |
17.6.2013 |
||
|
13.6.2013 |
Tysabri |
|
EU/1/06/346 |
17.6.2013 |
||
|
21.6.2013 |
Bridion |
|
EU/1/08/466 |
25.6.2013 |
||
|
21.6.2013 |
Brinavess |
|
EU/1/10/645 |
25.6.2013 |
||
|
21.6.2013 |
EDURANT |
|
EU/1/11/736 |
25.6.2013 |
||
|
21.6.2013 |
Eviplera |
|
EU/1/11/737 |
25.6.2013 |
||
|
21.6.2013 |
Intelence |
|
EU/1/08/468 |
25.6.2013 |
||
|
21.6.2013 |
Javlor |
|
EU/1/09/550 |
25.6.2013 |
||
|
21.6.2013 |
Osseor |
|
EU/1/04/287 |
25.6.2013 |
||
|
21.6.2013 |
Protelos |
|
EU/1/04/288 |
25.6.2013 |
||
|
21.6.2013 |
Reyataz |
|
EU/1/03/267 |
25.6.2013 |
||
|
21.6.2013 |
Xenical |
|
EU/1/98/071 |
25.6.2013 |
||
|
21.6.2013 |
Zerit |
|
EU/1/96/009 |
25.6.2013 |
||
|
27.6.2013 |
Glivec |
|
EU/1/01/198 |
1.7.2013 |
||
|
27.6.2013 |
Levodopa/Carbidopa/Entacapone Orion |
|
EU/1/11/706 |
1.7.2013 |
||
|
27.6.2013 |
Rasilamlo |
|
EU/1/11/686 |
1.7.2013 |
||
|
27.6.2013 |
Rasilez |
|
EU/1/07/405 |
1.7.2013 |
||
|
27.6.2013 |
Vivanza |
|
EU/1/03/249 |
1.7.2013 |
||
|
1.7.2013 |
Ariclaim |
|
EU/1/04/283 |
3.7.2013 |
||
|
1.7.2013 |
Emtriva |
|
EU/1/03/261 |
3.7.2013 |
||
|
1.7.2013 |
Fampyra |
|
EU/1/11/699 |
3.7.2013 |
||
|
1.7.2013 |
Intelence |
|
EU/1/08/468 |
3.7.2013 |
||
|
1.7.2013 |
PREZISTA |
|
EU/1/06/380 |
3.7.2013 |
||
|
1.7.2013 |
Rasilez HCT |
|
EU/1/08/491 |
3.7.2013 |
||
|
1.7.2013 |
Replagal |
|
EU/1/01/189 |
3.7.2013 |
||
|
1.7.2013 |
Stocrin |
|
EU/1/99/111 |
3.7.2013 |
||
|
1.7.2013 |
Sustiva |
|
EU/1/99/110 |
3.7.2013 |
||
|
1.7.2013 |
Trobalt |
|
EU/1/11/681 |
3.7.2013 |
||
|
1.7.2013 |
Truvada |
|
EU/1/04/305 |
3.7.2013 |
||
|
1.7.2013 |
Viread |
|
EU/1/01/200 |
3.7.2013 |
||
|
1.7.2013 |
Votrient |
|
EU/1/10/628 |
3.7.2013 |
||
|
1.7.2013 |
Yentreve |
|
EU/1/04/280 |
3.7.2013 |
||
|
4.7.2013 |
Cymbalta |
|
EU/1/04/296 |
8.7.2013 |
||
|
4.7.2013 |
Lucentis |
|
EU/1/06/374 |
8.7.2013 |
||
|
4.7.2013 |
Rasitrio |
|
EU/1/11/730 |
8.7.2013 |
||
|
4.7.2013 |
Xeristar |
|
EU/1/04/297 |
8.7.2013 |
||
|
9.7.2013 |
Prevenar 13 |
|
EU/1/09/590 |
11.7.2013 |
||
|
9.7.2013 |
Tysabri |
|
EU/1/06/346 |
11.7.2013 |
||
|
15.7.2013 |
Benlysta |
|
EU/1/11/700 |
17.7.2013 |
||
|
15.7.2013 |
Onduarp |
|
EU/1/11/729 |
17.7.2013 |
||
|
15.7.2013 |
Pradaxa |
|
EU/1/08/442 |
17.7.2013 |
||
|
15.7.2013 |
Votubia |
|
EU/1/11/710 |
17.7.2013 |
||
|
17.7.2013 |
Iscover |
|
EU/1/98/070 |
19.7.2013 |
||
|
17.7.2013 |
Plavix |
|
EU/1/98/069 |
19.7.2013 |
||
|
17.7.2013 |
Votubia |
|
EU/1/11/710 |
19.7.2013 |
||
|
19.7.2013 |
Clopidogrel Zentiva |
|
EU/1/08/465 |
23.7.2013 |
||
|
19.7.2013 |
DuoPlavin |
|
EU/1/10/619 |
23.7.2013 |
||
|
19.7.2013 |
Ratiograstim |
|
EU/1/08/444 |
23.7.2013 |
||
|
19.7.2013 |
Tevagrastim |
|
EU/1/08/445 |
23.7.2013 |
||
|
19.7.2013 |
Thalidomide Celgene |
|
EU/1/08/443 |
23.7.2013 |
||
|
25.7.2013 |
Aranesp |
|
EU/1/01/185 |
29.7.2013 |
||
|
25.7.2013 |
Biograstim |
|
EU/1/08/450 |
29.7.2013 |
||
|
25.7.2013 |
Leflunomide medac |
|
EU/1/10/637 |
29.7.2013 |
||
|
25.7.2013 |
Remicade |
|
EU/1/99/116 |
29.7.2013 |
||
|
25.7.2013 |
Tyverb |
|
EU/1/07/440 |
29.7.2013 |
||
|
25.7.2013 |
Vectibix |
|
EU/1/07/423 |
29.7.2013 |
||
|
25.7.2013 |
Zytiga |
|
EU/1/11/714 |
29.7.2013 |
||
|
26.7.2013 |
BYDUREON |
|
EU/1/11/696 |
31.7.2013 |
||
|
26.7.2013 |
DuoCover |
|
EU/1/10/623 |
31.7.2013 |
||
|
26.7.2013 |
Eucreas |
|
EU/1/07/425 |
30.7.2013 |
||
|
26.7.2013 |
Evicel |
|
EU/1/08/473 |
30.7.2013 |
||
|
26.7.2013 |
Iscover |
|
EU/1/98/070 |
31.7.2013 |
||
|
26.7.2013 |
Onglyza |
|
EU/1/09/545 |
30.7.2013 |
||
|
26.7.2013 |
Plavix |
|
EU/1/98/069 |
30.7.2013 |
||
|
26.7.2013 |
Rasilez |
|
EU/1/07/405 |
31.7.2013 |
||
|
26.7.2013 |
Rasitrio |
|
EU/1/11/730 |
30.7.2013 |
||
|
26.7.2013 |
Teysuno |
|
EU/1/11/669 |
31.7.2013 |
||
|
31.7.2013 |
Aprovel |
|
EU/1/97/046 |
5.8.2013 |
||
|
31.7.2013 |
CoAprovel |
|
EU/1/98/086 |
5.8.2013 |
||
|
31.7.2013 |
Copalia |
|
EU/1/06/372 |
2.8.2013 |
||
|
31.7.2013 |
Copalia HCT |
|
EU/1/09/575 |
5.8.2013 |
||
|
31.7.2013 |
Dafiro |
|
EU/1/06/371 |
5.8.2013 |
||
|
31.7.2013 |
Dafiro HCT |
|
EU/1/09/574 |
2.8.2013 |
||
|
31.7.2013 |
Exforge |
|
EU/1/06/370 |
5.8.2013 |
||
|
31.7.2013 |
Exforge HCT |
|
EU/1/09/569 |
2.8.2013 |
||
|
31.7.2013 |
Galvus |
|
EU/1/07/414 |
5.8.2013 |
||
|
31.7.2013 |
Icandra |
|
EU/1/08/484 |
5.8.2013 |
||
|
31.7.2013 |
Imprida |
|
EU/1/06/373 |
5.8.2013 |
||
|
31.7.2013 |
Irbesartan HCT Zentiva |
|
EU/1/06/377 |
2.8.2013 |
||
|
31.7.2013 |
Irbesartan Zentiva |
|
EU/1/06/376 |
5.8.2013 |
||
|
31.7.2013 |
Jalra |
|
EU/1/08/485 |
5.8.2013 |
||
|
31.7.2013 |
Karvea |
|
EU/1/97/049 |
2.8.2013 |
||
|
31.7.2013 |
Karvezide |
|
EU/1/98/085 |
2.8.2013 |
||
|
31.7.2013 |
Leganto |
|
EU/1/11/695 |
2.8.2013 |
||
|
31.7.2013 |
Neupro |
|
EU/1/05/331 |
2.8.2013 |
||
|
31.7.2013 |
ProQuad |
|
EU/1/05/323 |
2.8.2013 |
||
|
31.7.2013 |
VELCADE |
|
EU/1/04/274 |
5.8.2013 |
||
|
31.7.2013 |
Vimpat |
|
EU/1/08/470 |
5.8.2013 |
||
|
31.7.2013 |
Xiliarx |
|
EU/1/08/486 |
5.8.2013 |
||
|
31.7.2013 |
Zomarist |
|
EU/1/08/483 |
2.8.2013 |
— Povlačenje odobrenja za stavljanje u promet (članak 13. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća)
|
Datum odluke |
Naziv lijeka |
Nositelj odobrenja za stavljanje u promet |
Broj upisa u registar Zajednice |
Datum obavijesti |
||
|
6.6.2013 |
Sepioglin |
|
EU/1/12/754 |
10.6.2013 |
— Prekid obustave odobrenja za stavljanje u promet (članak 20. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća)
|
Datum odluke |
Naziv lijeka |
Nositelj odobrenja za stavljanje u promet |
Broj upisa u registar Zajednice |
Datum obavijesti |
||
|
17.7.2013 |
Ribavirin Teva |
|
EU/1/09/509 |
19.7.2013 |
||
|
17.7.2013 |
Ribavirin Teva Pharma BV |
|
EU/1/09/527 |
19.7.2013 |
— Izdavanje odobrenja za stavljanje u promet (članak 38. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća (2) ): Prihvaćeno
|
Datum odluke |
Naziv lijeka |
INN (medunarodni nezašticeni naziv lijeka) |
Nositelj odobrenja za stavljanje u promet |
Broj upisa u registar Zajednice |
Farmaceutski oblik |
Oznaka ATC (Anatomsko-terapijsko-kemijska klasifikacija lijekova) |
Datum obavijesti |
||
|
6.6.2013 |
Equilis West Nile |
Inaktivirani kimerni flavivirus soj YF-WN |
|
EU/2/13/151 |
Suspenzija za injekciju |
QI05AA10 |
10.6.2013 |
||
|
12.7.2013 |
ProZinc |
Ljudski inzulin |
|
EU/2/13/152 |
Suspenzija za injekciju |
QA10AC01 |
16.7.2013 |
||
|
15.7.2013 |
Aftovaxpur Doe |
pročišćeni, inaktivirani sojeva virusa koji uzrokuje bolest slinavke i šapa O1 Manisa, O1 BFS, O Taiwan 3/97, A22 Iraq, A24 Cruzeiro, A Turkey 14/98, Asia 1 Shamir |
|
EU/2/13/153 |
Emulzija za injekciju |
QI02AA04 |
17.7.2013 |
— Izmjena odobrenja za stavljanje u promet (članak 38. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća): Prihvaćeno
|
Datum odluke |
Naziv lijeka |
Nositelj odobrenja za stavljanje u promet |
Broj upisa u registar Zajednice |
Datum obavijesti |
||
|
6.6.2013 |
Equioxx |
|
EU/2/08/083 |
11.6.2013 |
||
|
13.6.2013 |
Contacera |
|
EU/2/12/144 |
17.6.2013 |
||
|
9.7.2013 |
Suvaxyn Aujeszky 783 +O/W |
|
EU/2/98/009 |
11.7.2013 |
||
|
15.7.2013 |
Reconcile |
|
EU/2/08/080 |
19.7.2013 |
||
|
15.7.2013 |
Zactran |
|
EU/2/08/082 |
17.7.2013 |
||
|
26.7.2013 |
Zulvac 1+8 Ovis |
|
EU/2/11/120 |
30.7.2013 |
— Povlačenje odobrenja za stavljanje u promet (članak 38. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća)
|
Datum odluke |
Naziv lijeka |
Nositelj odobrenja za stavljanje u promet |
Broj upisa u registar Zajednice |
Datum obavijesti |
||
|
21.6.2013 |
Ibaflin |
|
EU/2/00/022 |
25.6.2013 |
Zainteresirane osobe koje žele na uvid dobiti javno izvješće o procjeni predmetnih lijekova i odluka koje se na njih odnose trebale bi se obratiti:
|
The European Medicines Agency |
|
7, Westferry Circus, Canary Wharf |
|
UK-LONDON E14 4H |
(1) SL L 136, 30.4.2004., str. 1.
(2) SL L 136, 30.4.2004., str. 1.
|
30.8.2013 |
HR |
Službeni list Europske unije |
C 250/44 |
Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. lipnja 2013. do 31. srpnja 2013.
(Odluke donesene u skladu s člankom 34. Direktive 2001/83/EZ (1) ili člankom 38. Direktive 2001/82/EZ (2) )
2013/C 250/03
— Izdavanje, zadržavanje ili izmjena nacionalnog odobrenja za stavljanje u promet
|
Datum odluke |
Naziv(i) lijeka |
Nositelj(i) odobrenja za stavljanje u promet |
Država članica na koju se odnosi |
Datum obavijesti |
|
24.6.2013. |
Cilostazol |
Vidi Prilog I. (3) |
Vidi Prilog I. (3) |
25.6.2013. |
|
25.7.2013. |
Cyproterone acetate/ethinylestradiol |
Vidi Prilog II. |
Vidi Prilog II. |
29.7.2013. |
|
27.6.2013. |
Monovalent and multivalent measles, mumps, rubella and varicella vaccines |
Vidi Prilog III. (3) |
Vidi Prilog III. (3) |
1.7.2013. |
(1) SL L 311, 28.11.2001., str. 67.
(2) SL L 311, 28.11.2001., str. 1.
(3) Hrvatski prijevod ovog dokumenta nije dostupan, dokument je objavljen na engleskom jeziku.
PRILOG I.
POPIS NAZIVA, FARMACEUTSKIH OBLIKA, JAČINA LIJEKOVA, PUTEVA PRIMJENE, NOSITELJA ODOBRENJA ZA STAVLJANJE U PROMET U DRŽAVAMA ČLANICAMA
|
Member State (in EEA) |
Marketing Authorisation Holder |
Invented name |
Strength |
Pharmaceutical Form |
Route of administration |
||||||
|
France |
|
PLETAL 100 mg, comprimé |
100 mg |
tablet |
oral use |
||||||
|
France |
|
PLETAL 50 mg, comprimé |
50 mg |
tablet |
oral use |
||||||
|
Germany |
|
Pletal 50 mg, Tabletten |
50 mg |
tablet |
oral use |
||||||
|
Germany |
|
Pletal 100 mg, Tabletten |
100 mg |
tablet |
oral use |
||||||
|
Italy |
|
PLETAL |
50 MG |
tablet |
oral use |
||||||
|
Italy |
|
PLETAL |
100 MG |
tablet |
oral use |
||||||
|
Spain |
|
PLETAL 50 mg comprimidos |
50 mg |
tablet |
oral use |
||||||
|
Spain |
|
PLETAL 100 mg comprimidos |
100 mg |
tablet |
oral use |
||||||
|
Spain |
|
EKISTOL 50 mg comprimidos |
50 mg |
tablet |
oral use |
||||||
|
Spain |
|
EKISTOL 100 mg comprimidos |
100 mg |
tablet |
oral use |
||||||
|
Sweden |
|
PLETAL |
50 mg |
tablet |
oral use |
||||||
|
Sweden |
|
PLETAL |
100 mg |
tablet |
oral use |
||||||
|
United Kingdom |
|
Pletal 50 mg Tablets |
50 mg |
tablet |
oral use |
||||||
|
United Kingdom |
|
Pletal 100 mg Tablets |
100 mg |
tablet |
oral use |
PRILOG II.
POPIS NAZIVA, FARMACEUTSKIH OBLIKA, JAČINA LIJEKOVA, PUTEVA PRIMJENE, NOSITELJA ODOBRENJA ZA STAVLJANJE U PROMET U DRŽAVAMA ČLANICAMA
|
Zemlja članica (u EEA) |
Nositelj odobrenja |
Naziv lijeka |
Jačina |
Farmaceutski oblik |
Put primjene |
|||||||
|
Austrija |
|
Alisma 2 mg/35 μg Filmtablette |
2,00 mg 0,035 mg |
Filmom obložena tableta |
Kroz usta |
|||||||
|
Austrija |
|
Bellgyn „ratiopharm” 2 mg/0,035 mg - überzogene Tabletten |
2,00 mg 0,035 mg |
Obložena tableta |
Kroz usta |
|||||||
|
Austrija |
|
Cyprotomin 2 mg/0,035 mg Filmtabletten |
2,00 mg 0,035 mg |
Filmom obložena tableta |
Kroz usta |
|||||||
|
Austrija |
|
Diane mite - Dragees |
2,00 mg 0,035 mg |
Obložena tableta |
Kroz usta |
|||||||
|
Austrija |
|
Femogyn 2 mg/0,035 mg überzogene Tabletten |
2,00 mg 0,035 mg |
Obložena tableta |
Kroz usta |
|||||||
|
Austrija |
|
Midane - Dragees |
2,00 mg 0,035 mg |
Obložena tableta |
Kroz usta |
|||||||
|
Austrija |
|
Minerva - Dragees |
2,00 mg 0,035 mg |
Obložena tableta |
Kroz usta |
|||||||
|
Austrija |
|
Xylia - Dragées |
2,00 mg 0,035 mg |
Obložena tableta |
Kroz usta |
|||||||
|
Belgija |
|
Chloe |
2,00 mg 0,035 mg |
Filmom obložena tableta |
Kroz usta |
|||||||
|
Belgija |
|
Claudia-35 |
2,00 mg 0,035 mg |
Obložena tableta |
Kroz usta |
|||||||
|
Belgija |
|
Daphne |
2,00 mg 0,035 mg |
Obložena tableta |
Kroz usta |
|||||||
|
Belgija |
|
Diane-35 |
2,00 mg 0,035 mg |
Obložena tableta |
Kroz usta |
|||||||
|
Belgija |
|
Elisamylan |
2,00 mg 0,035 mg |
Obložena tableta |
Kroz usta |
|||||||
|
Belgija |
|
Gratiella 35 |
2,00 mg 0,035 mg |
Obložena tableta |
Kroz usta |
|||||||
|
Bugarska |
|
Diane 35 |
0,035 mg 2,00 mg |
Obložena tableta |
Kroz usta |
|||||||
|
Bugarska |
|
Melleva |
0,035 mg 2,00 mg |
Filmom obložena tableta |
Kroz usta |
|||||||
|
Bugarska |
|
Chloe |
0,035 mg 2,00 mg |
Filmom obložena tableta |
Kroz usta |
|||||||
|
Češka Republika |
|
CHLOE |
2,00 mg 0,035 mg |
Filmom obložena tableta |
Kroz usta |
|||||||
|
Češka Republika |
|
VREYA |
2,00 mg 0,035 mg |
Filmom obložena tableta |
Kroz usta |
|||||||
|
Češka Republika |
|
MINERVA |
2,00 mg 0,035 mg |
Obložena tableta |
Kroz usta |
|||||||
|
Češka Republika |
|
DIANE-35 |
2,00 mg 0,035 mg |
Obložena tableta |
Kroz usta |
|||||||
|
Danska |
|
Chloe |
2,00 mg 0,035 mg |
Filmom obložena tableta |
Kroz usta |
|||||||
|
Danska |
|
Cypretyl |
2,00 mg 0,035 mg |
Filmom obložena tableta |
Kroz usta |
|||||||
|
Danska |
|
Diane Mite |
2,00 mg 0,035 mg |
Filmom obložena tableta |
Kroz usta |
|||||||
|
Danska |
|
Dianova Mite |
2,00 mg 0,035 mg |
Filmom obložena tableta |
Kroz usta |
|||||||
|
Danska |
|
Feminil mite |
2,00 mg 0,035 mg |
Filmom obložena tableta |
Kroz usta |
|||||||
|
Danska |
|
Vreya |
2,00 mg 0,035 mg |
Filmom obložena tableta |
Kroz usta |
|||||||
|
Danska |
|
Zyrona |
2,00 mg 0,035 mg |
Filmom obložena tableta |
Kroz usta |
|||||||
|
Estonija |
|
Diane |
2,00 mg 0,035 mg |
Obložena tableta |
Kroz usta |
|||||||
|
Estonija |
|
Femina |
2,00 mg 0,035 mg |
Obložena tableta |
Kroz usta |
|||||||
|
Estonija |
|
Cypretil |
2,00 mg 0,035 mg |
Obložena tableta |
Kroz usta |
|||||||
|
Finska |
|
DIANE NOVA |
2,00 mg 0,035 mg |
Tableta |
Kroz usta |
|||||||
|
Finska |
|
CYPRETYL |
2,00 mg 0,035 mg |
Tableta |
Kroz usta |
|||||||
|
Finska |
|
FEMINIL |
2,00 mg 0,035 mg |
Tableta |
Kroz usta |
|||||||
|
Finska |
|
VREYA |
2,00 mg 0,035 mg |
Tableta |
Kroz usta |
|||||||
|
Francuska |
|
DIANE 35 μg, coated tablet |
2,00 mg 0,035 mg |
Obložena tableta |
Kroz usta |
|||||||
|
Francuska |
|
MINERVA 35 μg |
2,00 mg 0,035 mg |
Obložena tableta |
Kroz usta |
|||||||
|
Francuska |
|
CYPROTERONE/ETHINYLESTRADIOL BAYER 35 μg |
2,00 mg 0,035 mg |
Obložena tableta |
Kroz usta |
|||||||
|
Francuska |
|
CYPROPHARM 2 mg/0,035 mg |
2,00 mg 0,035 mg |
Obložena tableta |
Kroz usta |
|||||||
|
Francuska |
|
CYPROTERONE/ETHINYLESTRADIOL DCI PHARMA 2 mg/0,035 mg |
2,00 mg 0,035 mg |
Obložena tableta |
Kroz usta |
|||||||
|
Francuska |
|
CYPROTERONE/ETHINYLESTRADIOL EG 2 mg/0,035 mg |
2,00 mg 0,035 mg |
Obložena tableta |
Kroz usta |
|||||||
|
Francuska |
|
CYPROTERONE/ETHINYLESTRADIOL RANBAXY 2 mg/0,035 mg |
2,00 mg 0,035 mg |
Obložena tableta |
Kroz usta |
|||||||
|
Francuska |
|
CYPROTERONE/ETHINYLESTRADIOL RATIOPHARM 2 mg/0,035 mg |
2,00 mg 0,035 mg |
Obložena tableta |
Kroz usta |
|||||||
|
Francuska |
|
CYPROTERONE/ETHINYLESTRADIOL SANDOZ 2 mg/0,035 mg |
2,00 mg 0,035 mg |
Obložena tableta |
Kroz usta |
|||||||
|
Francuska |
|
CYPROTERONE/ETHINYLESTRADIOL TEVA 2 mg/0,035 mg |
2,00 mg 0,035 mg |
Obložena tableta |
Kroz usta |
|||||||
|
Francuska |
|
CYPROTERONE/ETHINYLESTRADIOL ZENTIVA 2 mg/0,035 mg |
2,00 mg 0,035 mg |
Obložena tableta |
Kroz usta |
|||||||
|
Francuska |
|
CYPROTERONE/ETHINYLESTRADIOL ZYDUS 2 mg/0,035 mg |
2,00 mg 0,035 mg |
Obložena tableta |
Kroz usta |
|||||||
|
Francuska |
|
ELLEACNELLE 2 mg/0,035 mg |
2,00 mg 0,035 mg |
Obložena tableta |
Kroz usta |
|||||||
|
Francuska |
|
EVEPAR 2 mg/0,035 mg |
2,00 mg 0,035 mg |
Obložena tableta |
Kroz usta |
|||||||
|
Francuska |
|
HOLGYEME 2 mg/0,035 mg |
2,00 mg 0,035 mg |
Obložena tableta |
Kroz usta |
|||||||
|
Francuska |
|
LUMALIA 2 mg/0,035 mg |
2,00 mg 0,035 mg |
Obložena tableta |
Kroz usta |
|||||||
|
Njemačka |
|
Cyproethinyl acis |
0,035 mg 2,00 mg |
Filmom obložena tableta |
Kroz usta |
|||||||
|
Njemačka |
|
Jennifer 35 2 mg/0,035 mg Filmtabletten |
0,035 mg 2,00 mg |
Filmom obložena tableta |
Kroz usta |
|||||||
|
Njemačka |
|
Diane-35 0,035 mg/2 mg überzogene Tablette |
0,035 mg 2,00 mg |
Obložena tableta |
Kroz usta |
|||||||
|
Njemačka |
|
Cyproteronacetat/Ethinylestradiol Dermapharm 2 mg/0,035 mg überzogene Tablette |
0,035 mg 2,00 mg |
Obložena tableta |
Kroz usta |
|||||||
|
Njemačka |
|
Bella HEXAL 35 2 mg/0,035 mg überzogene Tablette |
0,035 mg 2,00 mg |
Obložena tableta |
Kroz usta |
|||||||
|
Njemačka |
|
Juliette |
0,035 mg 2,00 mg |
Obložena tableta |
Kroz usta |
|||||||
|
Njemačka |
|
Attempta-ratiopharm 35 2 mg/0,035 mg überzogene Tablette |
0,035 mg 2,00 mg |
Obložena tableta |
Kroz usta |
|||||||
|
Njemačka |
|
Ergalea 2,00/0,035 mg Filmtabletten |
0,035 mg 2,00 mg |
Filmom obložena tableta |
Kroz usta |
|||||||
|
Njemačka |
|
Moea Sanol 2 mg/0,035 mg überzogene Tabletten |
0,035 mg 2,00 mg |
Obložena tableta |
Kroz usta |
|||||||
|
Grčka |
|
GYNOFEN 35 |
2,00 mg 0,035 mg |
Obložena tableta |
Kroz usta |
|||||||
|
Mađarska |
|
Bellune Pliva |
2,00 mg 0,035 mg |
Obložena tableta |
Kroz usta |
|||||||
|
Mađarska |
|
Diane |
2,00 mg 0,035 mg |
Obložena tableta |
Kroz usta |
|||||||
|
Mađarska |
|
Minerva |
2,00 mg 0,035 mg |
Obložena tableta |
Kroz usta |
|||||||
|
Island |
|
Diane mite |
2,00 mg 0,035 mg |
Tableta |
Kroz usta |
|||||||
|
Island |
|
Cypretyl |
2,00 mg 0,035 mg |
Obložena tableta |
Kroz usta |
|||||||
|
Irska |
|
Cyproterone Acetate/Ethinylestradiol Tablets 2 mg/0.035 mg |
2,00 mg 0,035 mg |
Tableta |
Kroz usta |
|||||||
|
Irska |
|
Dianette 2 mg/35 microgram coated tablets. |
2,00 mg 0,035 mg |
Obložena tableta |
Kroz usta |
|||||||
|
Italija |
|
DIANE |
2,00 mg 0,035 mg |
Obložena tableta |
Kroz usta |
|||||||
|
Italija |
|
VISOFID |
2,00 mg 0,035 mg |
Obložena tableta |
Kroz usta |
|||||||
|
Latvija |
|
Chloe 35 micrograms/2 mg film-coated tablets |
0,035 mg 2,00 mg |
Filmom obložena tableta |
Kroz usta |
|||||||
|
Latvija |
|
Femina 2 mg/35 micrograms coated tablets |
2,00 mg 0,035 mg |
Obložena tableta |
Kroz usta |
|||||||
|
Latvija |
|
Diane 2 000 micrograms/35 micrograms film-coated tablets |
2,00 mg 0,035 mg |
Filmom obložena tableta |
Kroz usta |
|||||||
|
Litva |
|
Diane |
2,00 mg 0,035 mg |
Obložena tableta |
Kroz usta |
|||||||
|
Litva |
|
Femina |
2,00 mg 0,035 mg |
Obložena tableta |
Kroz usta |
|||||||
|
Litva |
|
CHLOE |
2,00 mg 0,035 mg |
Filmom obložena tableta |
Kroz usta |
|||||||
|
Litva |
|
Cypretil |
2,00 mg 0,035 mg |
Obložena tableta |
Kroz usta |
|||||||
|
Luksemburg |
|
Diane-35 |
2,00 mg 0,035 mg |
Obložena tableta |
Kroz usta |
|||||||
|
Luksemburg |
|
Chloe |
2,00 mg 0,035 mg |
Obložena tableta |
Kroz usta |
|||||||
|
Luksemburg |
|
Daphne |
2,00 mg 0,035 mg |
Obložena tableta |
Kroz usta |
|||||||
|
Luksemburg |
|
Lumalia |
2,00 mg 0,035 mg |
Obložena tableta |
Kroz usta |
|||||||
|
Malta |
|
Clairette 2000/35 Tablets |
2,00 mg 0,035 mg |
Obložena tableta |
Kroz usta |
|||||||
|
Malta |
|
Acnocin 2000/35 Tablets |
2,00 mg 0,035 mg |
Obložena tableta |
Kroz usta |
|||||||
|
Norveška |
|
Diane |
2,00 mg 0,035 mg |
Obložena tableta |
Kroz usta |
|||||||
|
Norveška |
|
Feminil |
2,00 mg 0,035 mg |
Obložena tableta |
Kroz usta |
|||||||
|
Norveška |
|
Zyrona |
2,00 mg 0,035 mg |
Obložena tableta |
Kroz usta |
|||||||
|
Poljska |
|
Acnemine |
2,00 mg 0,035 mg |
Filmom obložena tableta |
Kroz usta |
|||||||
|
Poljska |
|
Diane-35 |
2,00 mg 0,035 mg |
Filmom obložena tableta |
Kroz usta |
|||||||
|
Poljska |
|
Chloe |
2,00 mg 0,035 mg |
Filmom obložena tableta |
Kroz usta |
|||||||
|
Poljska |
|
Cyprest |
0,035 mg 2,00 mg |
Obložena tableta |
Kroz usta |
|||||||
|
Poljska |
|
OC-35 |
0,035 mg 2,00 mg |
Filmom obložena tableta |
Kroz usta |
|||||||
|
Poljska |
|
Syndi-35 |
2,00 mg 0,035 mg |
Obložena tableta |
Kroz usta |
|||||||
|
Poljska |
|
Cyprodiol |
2,00 mg 0,035 mg |
Obložena tableta |
Kroz usta |
|||||||
|
Portugal |
|
Diane 35 |
2,00 mg 0,035 mg |
Obložena tableta |
Kroz usta |
|||||||
|
Portugal |
|
Acetato Ciproterona/Etinilestradiol 2 mg/0,035 mg Comprimidos |
2,00 mg 0,035 mg |
Obložena tableta |
Kroz usta |
|||||||
|
Portugal |
|
Ciproterona + Etinilestradiol Generis |
2,00 mg 0,035 mg |
Obložena tableta |
Kroz usta |
|||||||
|
Portugal |
|
Ciproterona + Etinilestradiol Inventis |
2,00 mg 0,035 mg |
Obložena tableta |
Kroz usta |
|||||||
|
Rumunjska |
|
DIANE- 35 |
2,00 mg 0,035 mg |
Obložena tableta |
Kroz usta |
|||||||
|
Rumunjska |
|
MELLEVA 2 mg/0,035 mg |
2,00 mg 0,035 mg |
Filmom obložena tableta |
Kroz usta |
|||||||
|
Slovačka Republika |
|
Vreya |
2,00 mg 0,035 mg |
Obložena tableta |
Kroz usta |
|||||||
|
Slovačka Republika |
|
Minerva |
2,00 mg 0,035 mg |
Obložena tableta |
Kroz usta |
|||||||
|
Slovačka Republika |
|
CHLOE |
2,00 mg 0,035 mg |
Obložena tableta |
Kroz usta |
|||||||
|
Slovačka Republika |
|
Diane-35 |
2,00 mg 0,035 mg |
Obložena tableta |
Kroz usta |
|||||||
|
Slovenija |
|
Diane 0,035 mg/2 mg obložene tablete |
0,035 mg 2,00 mg |
Obložena tableta |
Kroz usta |
|||||||
|
Španjolska |
|
DIANE 35 |
2,00 mg 0,035 mg |
Obložena tableta |
Kroz usta |
|||||||
|
Španjolska |
|
DIANE 35 DIARIO |
2,00 mg 0,035 mg |
Obložena tableta |
Kroz usta |
|||||||
|
Španjolska |
|
ETINILESTRADIOL/CIPROTERONA GINESERVICE 0,035 mg/2 mg comprimidos EFG |
2,00 mg 0,035 mg |
Obložena tableta |
Kroz usta |
|||||||
|
Španjolska |
|
ACETATO DE CIPROTERONA/ETINILESTRADIOL SANDOZ 2 mg/0,035 mg comprimidos recubiertos EFG |
2,00 mg 0,035 mg |
Filmom obložena tableta |
Kroz usta |
|||||||
|
Španjolska |
|
GYNEPLEN 0,035 mg/2 mg comprimidos recubiertos |
2,00 mg 0,035 mg |
Obložena tableta |
Kroz usta |
|||||||
|
Španjolska |
|
DIALIDER 2/0,035 mg comprimidos recubiertos con película |
2,00 mg 0,035 mg |
Filmom obložena tableta |
Kroz usta |
|||||||
|
Španjolska |
|
CYPRINETTE DIARIO 0,035 mg/2 mg comprimidos recubiertos EFG |
2,00 mg 0,035 mg |
Obložena tableta |
Kroz usta |
|||||||
|
Švedska |
|
Diane® |
2,00 mg 0,035 mg |
Tableta |
Kroz usta |
|||||||
|
Švedska |
|
Zyrona |
2,00 mg 0,035 mg |
Obložena tableta |
Kroz usta |
|||||||
|
Nizozemska |
|
Cyproteronacetaat/ethinylestradiol Actavis 2/0,035 mg, filmomhulde tabletten 2 mg/0,035 mg |
2,00 mg 0,035 mg |
Filmom obložena tableta |
Kroz usta |
|||||||
|
Nizozemska |
|
Cyproteronacetaat/ethinylestradiol Apotex 2/0,035 mg, omhulde tabletten |
2,00 mg 0,035 mg |
Filmom obložena tableta |
Kroz usta |
|||||||
|
Nizozemska |
|
Cyproteronacetaat/Ethinylestradiol CF 2/0,035 mg, omhulde tablet |
2,00 mg 0,035 mg |
Filmom obložena tableta |
Kroz usta |
|||||||
|
Nizozemska |
|
Cyproteronacetaat/Ethinylestradiol Mylan 2 mg/0,035 mg, omhulde tabletten |
2,00 mg 0,035 mg |
Filmom obložena tableta |
Kroz usta |
|||||||
|
Nizozemska |
|
Cyproteronacetaat/Ethinylestradiol Mylan 2 mg/0,035 mg, omhulde tabletten |
2,00 mg 0,035 mg |
Filmom obložena tableta |
Kroz usta |
|||||||
|
Nizozemska |
|
Cyproteronacetaat/ethinylestradiol ratiopharm 2 mg/0,035 mg, omhulde tabletten |
2,00 mg 0,035 mg |
Filmom obložena tableta |
Kroz usta |
|||||||
|
Nizozemska |
|
Cyproteronacetaat/Ethinylestradiol Sandoz 2/0,035, omhulde tabletten |
2,00 mg 0,035 mg |
Filmom obložena tableta |
Kroz usta |
|||||||
|
Nizozemska |
|
Cyproteronacetaat/Ethinylestradiol 2 mg/0,035 mg, omhulde tabletten |
2,00 mg 0,035 mg |
Filmom obložena tableta |
Kroz usta |
|||||||
|
Nizozemska |
|
Cyproteronacetaat/Ethinylestradiol 2/0,035 PCH, omhulde tabletten 2 mg/0,035 mg |
2,00 mg 0,035 mg |
Filmom obložena tableta |
Kroz usta |
|||||||
|
Nizozemska |
|
Ethinylestradiol 0,035 mg/Cyproteronacetaat 2 mg, omhulde tabletten |
2,00 mg 0,035 mg |
Filmom obložena tableta |
Kroz usta |
|||||||
|
Nizozemska |
|
Diane-35, omhulde tabletten |
2,00 mg 0,035 mg |
Filmom obložena tableta |
Kroz usta |
|||||||
|
Ujedinjeno Kraljevstvo |
|
Dianette Tablets |
0,035 mg 2,00 mg |
Obložena tableta |
Kroz usta |
|||||||
|
Ujedinjeno Kraljevstvo |
|
Co-Cyprindiol Tablets 2000/35 |
0,035 mg 2,00 mg |
Obložena tableta |
Kroz usta |
|||||||
|
Ujedinjeno Kraljevstvo |
|
Clairette Tablets 2000/35 |
0,035 mg 2,00 mg |
Obložena tableta |
Kroz usta |
|||||||
|
Ujedinjeno Kraljevstvo |
|
Camilette Co-Cyprindiol 2000/35 Tablets |
0,035 mg 2,00 mg |
Tableta |
Kroz usta |
|||||||
|
Ujedinjeno Kraljevstvo |
|
Acnocin 2000/35 Tablets |
0,035 mg 2,00 mg |
Obložena tableta |
Kroz usta |
|||||||
|
Ujedinjeno Kraljevstvo |
|
Cyproterone Acetate 2.0 mg Ethinylestradiol 0.035 mg Tablets |
0,035 mg 2,00 mg |
Obložena tableta |
Kroz usta |
|||||||
|
Ujedinjeno Kraljevstvo |
|
Co-Cyprindiol Tablets 2 mg/0.035 mg |
0,035 mg 2,00 mg |
Obložena tableta |
Kroz usta |
|||||||
|
Ujedinjeno Kraljevstvo |
|
Generics UK Cyproterone Acetate and Ethinylestradiol Tablets |
0,035 mg 2,00 mg |
Obložena tableta |
Kroz usta |
|||||||
|
Ujedinjeno Kraljevstvo |
|
Strandhaven Co-Cyprindiol 2000/35 Tablets |
0,035 mg 2,00 mg |
Obložena tableta |
Kroz usta |
|||||||
|
Ujedinjeno Kraljevstvo |
|
Fannin UK Co-Cyprindiol 2000/35 Tablets |
0,035 mg 2,00 mg |
Filmom obložena tableta |
Kroz usta |
|||||||
|
Ujedinjeno Kraljevstvo |
|
Dialider Tablets |
0,035 mg 2,00 mg |
Filmom obložena tableta |
Kroz usta |
|||||||
|
Ujedinjeno Kraljevstvo |
|
Co-Cyprindiol 2000/35 Tablets |
0,035 mg 2,00 mg |
Filmom obložena tableta |
Kroz usta |
PRILOG III.
POPIS NAZIVA, FARMACEUTSKIH OBLIKA, JAČINA LIJEKOVA, PUTEVA PRIMJENE, NOSITELJA ODOBRENJA ZA STAVLJANJE U PROMET U DRŽAVAMA ČLANICAMA
Measles vaccines (live) with Marketing Authorisation in the European Union
|
Member State (EU/EEA) |
Marketing authorisaton holder |
Invented name |
Strength |
Pharmaceutical form |
Route of administration |
||||
|
France |
|
ROUVAX, poudre et solvant pour suspension injectable en flacon multidose, vaccin vivant hyperatténué contre la rougeole |
one dose (0,5 ml) contains: Measles virus Schwartz strain (live, attenuated) - not less than 103,0 CCID50 |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
||||
|
France |
|
ROUVAX, poudre et solvant pour suspension injectable, vaccin vivant hyperatténué contre la rougeole |
one dose (0,5 ml) contains: Measles virus Schwartz strain (live, attenuated) - not less than 103,0 CCID50 |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
||||
|
Germany |
|
Masern-Impfstoff Merieux |
one dose (0,5 ml) contains: Measles virus Schwartz strain (live, attenuated) - not less than 103,0 CCID50 |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
||||
|
Germany |
|
Masern-Impfstoff Merieux |
one dose (0,5 ml) contains: Measles virus Schwartz strain (live, attenuated) - not less than 103,0 CCID50 |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
||||
|
Spain |
|
AMUNOVAX VIAL |
one dose (0,5 ml) contains: Measles virus (live, attenuated) - not less than 103,0 TCID50 |
Powder and solvent for solution for injection |
Subcutaneous use |
Mumps vaccines (live) with Marketing Authorisation in the European Union
|
Member State (EU/EEA) |
Marketing authorisation holder |
Invented name |
Strength |
Pharmaceutical form |
Route of administration |
||||
|
France |
|
VACCIN OREILLONS AVENTIS PASTEUR MSD, poudre et solvant pour suspension injectable en seringue préremplie vaccin des oreillons, atténué |
one dose (0,5 ml) contains: Mumps virus Jeryl Lynn strain (live, attenuated) – 5 × 103,0 CCID50 |
Powder and solvent for solution for injection |
Subcutaneous use |
||||
|
France |
|
IMOVAX OREILLONS, poudre et solvant pour préparation injectable. vaccin à virus vivants atténués contre les oreillons |
one dose (0,5 ml) contains: Mumps virus URABE AM-9 strain (live, attenuated) - not less than 5 × 103,0 CCID50 |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
||||
|
Spain |
|
VACUNA MSD ANTI-PAROTIDITIS |
one dose (0,5 ml) contains: Mumps virus (Strain Jeryl Lynn - B level) - not less than 20 × 103,0 TCID50 |
Powder and solvent for solution for injection |
Subcutaneous use |
Rubella vaccines (live) with Marketing Authorisation in the European Union
|
Member State (EU/EEA) |
Marketing authorisation holder |
Invented name |
Strength |
Pharmaceutical form |
Route of administration |
|||||
|
Bulgaria |
|
Rudixax |
one dose (0,5 ml) contains: live, attenuated rubella virus (strain Wistar RA 27/3) - at least 103,0 CCID50 |
Powder and solvent for suspension for injection |
Intramuscular use, subcutaneous use |
|||||
|
France |
|
RUDIVAX, poudre et solvant pour suspension injectable. Vaccin rubéoleux atténué. |
one dose (0,5 ml) contains: Rubella virus Wistar RA 27/3 strain (live, attenuated) - 103,0 CCID50 |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
|||||
|
Germany |
|
Röteln-Impfstoff HDC Merieux |
one dose (0,5 ml) contains: Rubella virus Wistar RA 27/3 strain (live, attenuated) - 103,0 CCID50 |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
|||||
|
Germany |
|
Röteln-Impfstoff HDC Merieux |
one dose (0,5 ml) contains: Rubella virus Wistar RA 27/3 strain (live, attenuated) - 103,0 CCID50 |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
|||||
|
Spain |
|
VACUNA ANTIRRUBEOLA MERIEUX |
one dose (0,5 ml) contains: Rubella virus live attenuated (Strain Wistar RA 27/3M) - not less than 103,0 TCID50 |
Powder and solvent for solution for injection |
Subcutaneous use |
|||||
|
Spain |
|
VACUNA ANTIRRUBEOLA GSK |
one dose (0,5 ml) contains: Live attenuated rubella virus (Strain RA 27/3) - not less than 103,0 TCID50 |
Powder and solvent for solution for injection |
Subcutaneous use |
|||||
|
Spain |
|
RUBEATEN BERNA |
Rubella virus live (Strain Wistar RA 27/3) - not less than 103,0 TCID50 |
Powder and solvent for solution for injection |
Subcutaneous use |
Varicella vaccines (live) with Marketing Authorisation in the European Union
|
Member State (EU/EEA) |
Marketing authorisation holder |
Invented name |
Strength |
Pharmaceutical form |
Route of administration |
||||||
|
Austria |
|
Varilrix Pulver und Lösungsmittel zur Herstellung einer Injektionssuspension |
one dose (0,5 ml) contains: Live attenuated varicella-zoster virus (Oka strain) - not less than 103,3 PFU (1) |
Powder and solvent for suspension for injection |
Subcutaneous use |
||||||
|
Austria |
|
VARIVAX Pulver und Lösungsmittel zur Herstellung einer Injektionssuspension |
one dose (0,5 ml) contains: Varicella virus strain Oka/Merck (live, attenuated) ≥ 1 350 PFU (1) |
Powder and solvent for suspension for injection |
Intramuscular use, subcutaneous use |
||||||
|
Belgium |
|
Varilrix |
one dose (0,5 ml) contains: Live attenuated varicella-zoster virus (Oka strain) - not less than 103,3 PFU (1) |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Belgium |
|
Provarivax |
one dose (0,5 ml) contains: Varicella virus Oka/Merck strain (live, attenuated) ≥ 1 350 PFU (1) |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Cyprus |
|
Varivax powder and solvent for suspension for injection 1 350 PFU |
one dose (0,5 ml) contains: Varicella virus Oka/Merck strain (live, attenuated) 1 350 PFU (1) |
Powder and solvent for suspension for injection |
Subcutaneous use |
||||||
|
Cyprus |
|
VARILRIX powder and solvent for solution for injection |
one dose (0,5 ml) contains: Live attenuated varicella-zoster virus (Oka strain) 103,3 PFU (1) |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Czech Republic |
|
VARILRIX |
one dose (0,5 ml) contains: Live attenuated varicella-zoster virus (Oka strain) - not less than 103,3 PFU (1) |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Estonia |
|
VARILRIX |
one dose (0,5 ml) contains: Live attenuated varicella-zoster virus (Oka strain) - not less than 103,3 PFU (1) |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Denmark |
|
Varilrix |
one dose (0,5 ml) contains: Live attenuated varicella-zoster virus (Oka strain) – not less than 103,3 PFU (1) |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Denmark |
|
Provarivax |
one dose (0,5 ml) contains: Varicella virus Oka/Merck strain (live, attenuated) ≥ 1 350 PFU (1) |
Powder and solvent for solution for injection, suspension |
Subcutaneous use |
||||||
|
Estonia |
|
VARIVAX |
one dose (0,5 ml) contains: Varicella virus Oka/Merck strain (live, attenuated) ≥ 1 350 PFU (1) |
Powder and solvent for suspension for injection |
Subcutaneous use |
||||||
|
Finland |
|
VARIVAX |
one dose (0,5 ml) contains: Varicella virus (Oka/Merck): not less than 1 350 PFU (1) |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
||||||
|
Finland |
|
VARILRIX |
one dose (0,5 ml) contains: Live attenuated varicella-zoster virus (OKa strain) - not less than 103,3 PFU (1) |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
||||||
|
France |
|
VARILRIX, poudre et solvant pour solution injectable en seringue préremplie. Vaccin varicelleux vivant |
one dose (0,5 ml) contains: Live attenuated varicella-zoster virus (Oka strain) – not less than 103,7 PFU (1) |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
France |
|
VARIVAX, poudre et solvant pour suspension injectable. Vaccin varicelleux vivant |
one dose (0,5 ml) contains: Varicella virus Oka/Merck strain (live, attenuated) ≥ 1 350 PFU (1) |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
||||||
|
Germany |
|
Varivax |
one dose (0,5 ml) contains: Varicella virus Oka/Merck strain (live, attenuated) ≥ 1 350 PFU (1) |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Germany |
|
Varilrix |
one dose (0,5 ml) contains: Live attenuated varicella-zoster virus (Oka strain) – not less than 103,3 PFU (1) |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
||||||
|
Germany |
|
Varivax |
one dose (0,5 ml) contains: Varicella virus Oka/Merck strain (live, attenuated) ≥ 1 350 PFU (1) |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Greece |
|
VARILRIX |
one dose (0,5 ml) contains: Live attenuated varicella-zoster virus (Oka strain) - not less than 103,3 PFU (1) |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Greece |
|
VARIVAX |
one dose (0,5 ml) contains: Varicella Virus OKA/Merck Strain - not less than 1 350 PFU (1) |
Powder and solution for injection |
Intramuscular use, subcutaneous use |
||||||
|
Hungary |
|
Varilrix |
one dose (0,5 ml) contains: Live attenuated varicella-zoster virus (Oka strain) - not less than 103,3 PFU (1) |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Hungary |
|
Varivax |
one dose (0,5 ml) contains: Varicella virus OKA/Merck strain (live, attenuated) not less than 1 350 PFU (1) |
Powder and solution for injection |
Intramuscular use, subcutaneous use |
||||||
|
Iceland |
|
Varilrix |
one dose (0,5 ml) contains: Live attenuated varicella-zoster virus (Oka strain) - not less than 103,3 PFU (1) |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Ireland |
|
VARIVAX powder and solvent for suspension for injection. |
one dose (0,5 ml) contains: Live attenuated varicella virus (Oka/Merck strain) not less than 1 350 PFU (1) |
Powder and solvent for suspension for injection |
Subcutaneous use |
||||||
|
Italy |
|
VARILRIX |
one dose (0,5 ml) contains: Live attenuated varicella-zoster virus (Oka strain) - not less than 103,3 PFU (1) |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Italy |
|
VARIVAX |
one dose (0,5 ml) contains: Live, attenuated Varicella virus (OKA/Merck strain) not less than 1 350 PFU (1) |
Powder and solvent for suspension for injection |
Intramuscular use, subcutaneous use |
||||||
|
Latvia |
|
Varivax powder and solvent for suspension for injection |
one dose (0,5 ml) contains: Varicella virus Oka/Merck strain (live, attenuated) ≥ 1 350 PFU (1) |
Powder and solvent for suspension for injection |
Intramuscular use, subcutaneous use |
||||||
|
Latvia |
|
Varilrix powder and solvent for solution for injection |
one dose (0,5 ml) contains: Live attenuated varicella-zoster virus (Oka strain) - not less than 103,3 PFU (1) |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Lithuania |
|
Varilrix |
one dose (0,5 ml) contains: Live attenuated varicella-zoster virus (Oka strain) - not less than 103,3 PFU (1) |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Lithuania |
|
VARIVAX |
one dose (0,5 ml) contains: Varicella, live attenuated (Oka/Merck strain) - 1 350 PFU (1) |
Powder and solvent for suspension for injection |
Intramuscular use, subcutaneous use |
||||||
|
Luxembourg |
|
VARILRIX |
one dose (0,5 ml) contains: Live attenuated varicella-zoster virus (Oka strain) - not less than 103,3 PFU (1) |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Luxembourg |
|
PROVARIVAX |
one dose (0,5 ml) contains: Varicella virus Oka/Merck strain (live, attenuated) ≥ 1 350 PFU (1) |
Powder for suspension for injection |
Subcutaneous use |
||||||
|
Malta |
|
Varilrix |
one dose (0,5 ml) contains: Live attenuated varicella-zoster virus (Oka strain) - not less than 103,3 PFU (1) |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Malta |
|
Varivax |
one dose (0,5 ml) contains: not less than 1 350 PFU (1) of the live attenuated varicella virus (OKA.Merck strain) |
Powder and solvent for suspension for injection |
Intramuscular use, subcutaneous use |
||||||
|
Norway |
|
Varilrix |
one dose (0,5 ml) contains: Live attenuated varicella-zoster virus (Oka strain) - not less than 103,3 PFU (1) |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Norway |
|
Varivax |
one dose (0,5 ml) contains: Varicella virus, live attenuated, Oka/Merck strain ≥ 1 350 PFU (1) |
Powder and solvent for suspension for injection |
Intramuscular use, subcutaneous use |
||||||
|
Poland |
|
Varilrix |
one dose (0,5 ml) contains: Live attenuated varicella-zoster virus (Oka strain) - not less than 103,3PFU (1) |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Portugal |
|
Varilrix |
one dose (0,5 ml) contains: Live attenuated varicella-zoster virus (Oka strain) - not less than 103,3 PFU (1) |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Portugal |
|
Varivax |
one dose (0,5 ml) contains: varicella virus (zoster vivo) – 1 350 PFU (1) |
Powder and solvent for suspension for injection |
Subcutaneous use |
||||||
|
Romania |
|
VARILRIX |
one dose (0,5 ml) contains: Live attenuated varicella-zoster virus (Oka strain) - not less than 103,3 PFU (1) |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Slovak Republic |
|
Varivax |
one dose (0,5 ml) contains: Varicella virus (Oka/Merck strain) ≥ 1 350 PFU (1) |
Powder and solvent for suspension for injection |
Intramuscular use, subcutaneous use |
||||||
|
Slovenia |
|
Varivax prasek in vehikel za suspenzijo za injiciranje |
one dose (0,5 ml) contains: Varicella virus (strain Oka/Merck) (live, attenuated) - not less than 1 350,00 PFU (1) |
Powder and solvent for suspension for injection |
Intramuscular use, subcutaneous use |
||||||
|
Spain |
|
VARILRIX |
one dose (0,5 ml) contains: Live attenuated varicella-zoster virus (Oka strain) - not less than 103,3 PFU (1) |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Spain |
|
VARIVAX POLVO Y DISOLVENTE PARA SUSPENSIÓN INYECTABLE |
one dose (0,5 ml) contains: Live atenuated varicella virus (Strain OKA/Merk) - ≥ 1 350 PFU (1) |
Powder and solvent for suspension for injection |
Intramuscular use, subcutaneous use |
||||||
|
Sweden |
|
Varilrix® |
one dose (0,5 ml) contains: Live attenuated varicella-zoster virus (Oka strain) - not less than 103,3 PFU (1) |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Sweden |
|
Varivax® |
one dose (0,5 ml) contains: Varicella virus, strain Oka/Merck live attenuated - 1 350 PFU (1) |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
||||||
|
The Netherlands |
|
Provarivax, poeder en oplosmiddel voor suspensie voor injectie |
one dose (0,5 ml) contains: Varicella virus Oka/Merck strain (live, attenuated) > 1 350 PFU (1) |
Powder and solvent for solution for injection |
Parenteral use |
||||||
|
United Kingdom |
|
VARILRIX |
one dose (0,5 ml) contains: Live attenuated varicella-zoster virus (Oka strain) - not less than 103,3 PFU (1) |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
United Kingdom |
|
VARIVAX Powder for Suspension |
one dose (0,5 ml) contains: Varicella Virus OKA/Merck Strain - 1 350 PFU (1) |
Powder for suspension for injection |
Subcutaneous use |
Measles and rubella vaccines (live) with Marketing Authorisation in the European Union
|
Member State (EU/EEA) |
Marketing Authorisation Holder |
Invented name |
Strength |
Pharmaceutical form |
Route of administration |
||||||||
|
France |
|
RUDI ROUVAX, poudre et solvant pour solution injectable. vaccin à virus vivants atténués contre la rougeole et la rubéole |
one dose (0,5 ml) contains:
|
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
Measles, mumps and rubella vaccines (live) with Marketing Authorisation in the European Union
|
Member State (EU/EEA) |
Marketing authorisation holder |
Invented name |
Strength |
Pharmaceutical form |
Route of administration |
||||||
|
Austria |
|
Priorix Pulver in Durchstechflaschen und Lösungsmittel in Fertigspritzen zur Herstellung einer Injektionslösung |
one dose (0,5 ml) contains: Live attenuated measles virus (Schwarz strain) - not less than 103,0 CCID50 Live attenuated mumps virus (RIT 4385, derived from Jeryl Lynn strain) - not less than 103,7 CCID50 Live attenuated rubella virus (Wistar RA 27/3 strain) - not less than 103,0 CCID50 |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
||||||
|
Austria |
|
Priorix Pulver und Lösungsmittel zur Herstellung einer Injektionslösung |
one dose (0,5 ml) contains: Live attenuated measles virus (Schwarz strain) - not less than 103,0 CCID50 Live attenuated mumps virus (RIT 4385, derived from Jeryl Lynn strain) - not less than 103,7 CCID50 Live attenuated rubella virus (Wistar RA 27/3 strain) - not less than 103,0 CCID50 |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
||||||
|
Belgium |
|
Priorix |
one dose (0,5 ml) contains: Live attenuated measles virus (Schwarz strain) - not less than 103,0 CCID50 Live attenuated mumps virus (RIT 4385, derived from Jeryl Lynn strain) - not less than 103,7 CCID50 Live attenuated rubella virus (Wistar RA 27/3 strain) - not less than 103,0 CCID50 |
Powder and solvent for solution for injection |
Subcutaneous use Intramuscular use, subcutaneous use |
||||||
|
Bulgaria |
|
Priorix |
one dose (0,5 ml) contains: Live attenuated measles virus (Schwarz strain) - not less than 103,0 CCID50 Live attenuated mumps virus (RIT 4385, derived from Jeryl Lynn strain) - not less than 103,7 CCID50 Live attenuated rubella virus (Wistar RA 27/3 strain) - not less than 103,0 CCID50 |
Powder and solvent for suspension for injection |
Intramuscular use, subcutaneous use |
||||||
|
Cyprus |
|
Priorix injection |
one dose (0,5 ml) contains: Live attenuated measles virus (Schwarz strain) - not less than 103,0 CCID50 Live attenuated mumps virus (RIT 4385, derived from Jeryl Lynn strain) - not less than 103,7 CCID50 Live attenuated rubella virus (Wistar RA 27/3 strain) - not less than 103,0 CCID50 |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
||||||
|
Czech Republic |
|
PRIORIX |
one dose (0,5 ml) contains: Live attenuated measles virus (Schwarz strain) - not less than 103,0 CCID50 Live attenuated mumps virus (RIT 4385, derived from Jeryl Lynn strain) - not less than 103,7 CCID50 Live attenuated rubella virus (Wistar RA 27/3 strain) - not less than 103,0 CCID50 |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
||||||
|
Denmark |
|
Priorix |
one dose (0,5 ml) contains: Live attenuated measles virus (Schwarz strain) - not less than 103,0 CCID50 Live attenuated mumps virus (RIT 4385, derived from Jeryl Lynn strain) - not less than 103,7 CCID50 Live attenuated rubella virus (Wistar RA 27/3 strain) - not less than 103,0 CCID50 |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
||||||
|
Estonia |
|
PRIORIX |
one dose (0,5 ml) contains: Live attenuated measles virus (Schwarz strain) - not less than 103,0 CCID50 Live attenuated mumps virus (RIT 4385, derived from Jeryl Lynn strain) - not less than 103,7 CCID50 Live attenuated rubella virus (Wistar RA 27/3 strain) - not less than 103,0 CCID50 |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Finland |
|
PRIORIX |
one dose (0,5 ml) contains: Live attenuated measles virus (Schwarz strain) - not less than 103,0 CCID50 Live attenuated mumps virus (RIT 4385, derived from Jeryl Lynn strain) - not less than 103,7 CCID50 Live attenuated rubella virus (Wistar RA 27/3 strain) - not less than 103,0 CCID50 |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
||||||
|
France |
|
PRIORIX, poudre et solvant pour solution injectable en seringue préremplie. vaccin rougeoleux, des oreillons et rubéoleux vivant |
one dose (0,5 ml) contains: Live attenuated measles virus (Schwarz strain) - not less than 103,0 CCID50 Live attenuated mumps virus (RIT 4385 strain, derived from Jeryl Lynn strain) - not less than 103,7 CCID50 Live attenuated rubella virus (Wistar RA 27/3 strain) - not less than 103,0 CCID50 |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
||||||
|
France |
|
R.O.R., poudre et solvant pour solution injectable. vaccin à virus vivants atténués contre la rougeole, les oreillons et la rubéole |
one dose (0,5 ml) contains: Measles virus Schwartz strain (live, attenuated) not less than 103,0 CCID50 Mumps virus URABE AM-9 strain (live, attenuated) not less than 5 × 103,0 CCID50 Rubella virus Wistar RA 27/3 strain (live, attenuated) not less than 103,0 CCID50 |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
||||||
|
France |
|
R.O.R. VAX, poudre et solvant pour suspension injectable. Vaccin rougeoleux, des oreillons et rubéoleux atténué. |
one dose (0,5 ml) contains: Measles virus Edmonston 749D strain (live, attenuated) - 103,0 CCID50 Mumps virus Jeryl Lynn strain (live, attenuated) – 5 × 103,0 CCID50 Rubella virus Wistar RA 27/3 strain (live, attenuated) - 103,0 CCID50 |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
||||||
|
Germany |
|
Priorix |
one dose (0,5 ml) contains: Live attenuated measles virus (Schwarz strain) - not less than 103,0 CCID50 Live attenuated mumps virus (RIT 4385, derived from Jeryl Lynn strain) - not less than 103,7 CCID50 Live attenuated rubella virus (Wistar RA 27/3 strain) - not less than 103,0 CCID50 |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
||||||
|
Greece |
|
PRIORIX |
one dose (0,5 ml) contains: Live attenuated measles virus (Schwarz strain) - not less than 103,0 CCID50 Live attenuated mumps virus (RIT 4385 strain, derived from Jeryl Lynn strain) - not less than 103,7 CCID50 Live attenuated rubella virus (Wistar RA 27/3 strain) - not less than 103,0 CCID50 |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
||||||
|
Greece |
|
R.O.R.VAX |
one dose (0,5 ml) contains: not less than 103,0 CCID50 of the measles virus Enders-Edmonston strain not less than 5 × 103,0 CCID50 of the mumps virus (Jeryl Lynn strain) not less than 103,0 CCID50 of the rubella virus strain |
Powder and solvent for solution for injection |
Intramuscular use |
||||||
|
Hungary |
|
Priorix por ésoldószer oldatos injekcióhoz |
one dose (0,5 ml) contains: Live attenuated measles virus (Schwarz strain) - not less than 103,0 CCID50 Live attenuated mumps virus (RIT 4385 strain, derived from Jeryl Lynn strain) - not less than 103,7 CCID50 Live attenuated rubella virus (Wistar RA 27/3 strain) - not less than 103,0 CCID50 |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
||||||
|
Iceland |
|
Priorix |
one dose (0,5 ml) contains: Live attenuated measles virus (Schwarz strain) - not less than 103,0 CCID50 Live attenuated mumps virus (RIT 4385, derived from Jeryl Lynn strain) - not less than 103,7 CCID50 Live attenuated rubella virus (Wistar RA 27/3 strain) - not less than 103,0 CCID50 |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
||||||
|
Italy |
|
PRIORIX |
one dose (0,5 ml) contains: Live attenuated measles virus (Schwarz strain) - not less than 103,0 CCID50 Live attenuated mumps virus (RIT 4385 strain, derived from Jeryl Lynn strain) - not less than 103,7 CCID50 Live attenuated rubella virus (Wistar RA 27/3 strain) - not less than 103,0 CCID50 |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
||||||
|
Latvia |
|
Priorix powder and solvent for solution for injection |
one dose (0,5 ml) contains: Live attenuated measles virus (Schwarz strain) - not less than 103,0 CCID50 Live attenuated mumps virus (RIT 4385 strain, derived from Jeryl Lynn strain) - not less than 103,7 CCID50 Live attenuated rubella virus (Wistar RA 27/3 strain) - not less than 103,0 CCID50 |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
||||||
|
Latvia |
|
Priorix powder and solvent for solution for injection in pre-filled syringe |
one dose (0,5 ml) contains: Live attenuated measles virus (Schwarz strain) - not less than 103,0 CCID50 Live attenuated mumps virus (RIT 4385 strain, derived from Jeryl Lynn strain) - not less than 103,7 CCID50 Live attenuated rubella virus (Wistar RA 27/3 strain) - not less than 103,0 CCID50 |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
||||||
|
Lithuania |
|
Priorix |
one dose (0,5 ml) contains: Live attenuated measles virus (Schwarz strain) - not less than 103,0 CCID50 Live attenuated mumps virus (RIT 4385 strain, derived from Jeryl Lynn strain) - not less than 103,7 CCID50 Live attenuated rubella virus (Wistar RA 27/3 strain) - not less than 103,0 CCID50 |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
||||||
|
Luxembourg |
|
PRIORIX |
one dose (0,5 ml) contains: Live attenuated measles virus (Schwarz strain) - not less than 103,0 CCID50 Live attenuated mumps virus (RIT 4385 strain, derived from Jeryl Lynn strain) - not less than 103,7 CCID50 Live attenuated rubella virus (Wistar RA 27/3 strain) - not less than 103,0 CCID50 |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
||||||
|
Malta |
|
Priorix |
one dose (0,5 ml) contains: Live attenuated measles virus (Schwarz strain) - not less than 103,0 CCID50 Live attenuated mumps virus (RIT 4385, derived from strain Jeryl Lynn strain) - not less than 103,7 CCID50 Live attenuated rubella virus (Wistar RA 27/3 strain) - not less than 103,0 CCID50 |
Powder and solvent for solution for injection |
Subcutaneous use, Intramascular use |
||||||
|
Norway |
|
Priorix |
one dose (0,5 ml) contains: Live attenuated measles virus (Schwarz strain) - not less than 103,0 CCID50 Live attenuated mumps virus (RIT 4385, derived from Jeryl Lynn strain) - not less than 103,7 CCID50 Live attenuated rubella virus (Wistar RA 27/3 strain) - not less than 103,0 CCID50 |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
||||||
|
Poland |
|
M-M-R II |
one dose (0,5 ml) contains: not less than 103,0 CCID50 of the measles virus Enders-Edmonston strain, not less than 12 500 CCID50 of the mumps virus (Jeryl Lynn strain); and not less than 103,0 CCID50 of the Wistar RA 27/3 rubella virus strains |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Poland |
|
Priorix |
one dose (0,5 ml) contains: Live attenuated measles virus (Schwarz strain) - not less than 103,0 CCID50 Live attenuated mumps virus (RIT 4385, derived from Jeryl Lynn strain) - not less than 103,7 CCID50 Live attenuated rubella virus (Wistar RA 27/3 strain) - not less than 103,0 CCID50 |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
||||||
|
Portugal |
|
Priorix |
one dose (0,5 ml) contains: Live attenuated measles virus (Schwarz strain) - not less than 103,0 CCID50 Live attenuated mumps virus (RIT 4385, derived from Jeryl Lynn strain) - not less than 103,7 CCID50 Live attenuated rubella virus (Wistar RA 27/3 strain) - not less than 103,0 CCID50 |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
||||||
|
Portugal |
|
Priorix |
one dose (0,5 ml) contains: Live attenuated measles virus (Schwarz strain) - not less than 103,0 CCID50 Live attenuated mumps virus (RIT 4385, derived from Jeryl Lynn strain) - not less than 103,7 CCID50 Live attenuated rubella virus (Wistar RA 27/3 strain) - not less than 103,0 CCID50 |
Powder and solvent for solution for injection in pre-filled syringe |
Intramuscular use, subcutaneous use |
||||||
|
Romania |
|
PRIORIX |
one dose (0,5 ml) contains: Live attenuated measles virus (Schwarz strain) - not less than 103,0 CCID50 Live attenuated mumps virus (RIT 4385, derived from Jeryl Lynn strain) - not less than 103,7 CCID50 Live attenuated rubella virus (Wistar RA 27/3 strain) - not less than 103,0 CCID50 |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
||||||
|
Slovak Republic |
|
Priorix |
one dose (0,5 ml) contains: Live attenuated measles virus (Schwarz strain) - not less than 103,0 CCID50 Live attenuated mumps virus (RIT 4385, derived from Jeryl Lynn strain) - not less than 103,7 CCID50 Live attenuated rubella virus (Wistar RA 27/3 strain) - not less than 103,0 CCID50 |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
||||||
|
Slovenia |
|
Priorix prašek in vehikel za raztopino za injiciranje |
one dose (0,5 ml) contains: Live attenuated measles virus (Schwarz strain) - not less than 103,0 CCID50 Live attenuated mumps virus (RIT 4385, derived from Jeryl Lynn strain) - not less than 103,7 CCID50 Live attenuated rubella virus (Wistar RA 27/3 strain) - not less than 103,0 CCID50 |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
||||||
|
Spain |
|
PRIORIX, POLVO Y DISOLVENTE EN JERINGA PRECARGADA PARA SOLUCIÓN INYECTABLE |
one dose (0,5 ml) contains: Live attenuated measles virus (Schwarz strain) - not less than 103,0 CCID50 Live attenuated mumps virus (RIT 4385, derived from Jeryl Lynn strain) - not less than 103,7 CCID50 Live attenuated rubella virus (Wistar RA 27/3 strain) - not less than 103,0 CCID50 |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
||||||
|
Sweden |
|
Priorix |
one dose (0,5 ml) contains: Live attenuated measles virus (Schwarz strain) - not less than 103,0 CCID50 Live attenuated mumps virus (RIT 4385 strain, derived from Jeryl Lynn strain) - not less than 103,7 CCID50 Live attenuated rubella virus (Wistar RA 27/3 strain) - not less than 103,0 CCID50 |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
||||||
|
The Netherlands |
|
Priorix, poeder en oplosmiddel voor suspensie voor injectie |
one dose (0,5 ml) contains: Live attenuated measles virus (Schwarz strain) - not less than 103,0 CCID50 Live attenuated mumps virus (RIT 4385, derived from Jeryl Lynn strain) - not less than 103,7 CCID50 Live attenuated rubella virus (Wistar RA 27/3 strain) - not less than 103,0 CCID50 |
Powder and solvent for solution for injection |
Parenteral use |
||||||
|
United Kingdom |
|
PRIORIX powder and solvent for solution for injection |
one dose (0,5 ml) contains: Live attenuated measles virus (Schwarz strain) - not less than 103,0 CCID50 Live attenuated mumps virus (RIT 4385, derived from Jeryl Lynn strain) - not less than 103,7 CCID50 Live attenuated rubella virus (Wistar RA 27/3 strain) - not less than 103,0 CCID50 |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
Measles, mumps, rubella and varicella vaccines (live) with Marketing Authorisation in the European Union
|
Member State (EU/EEA) |
Marketing authorisation holder |
Invented name |
Strength |
Pharmaceutical form |
Route of administration |
||||||
|
Austria |
|
Priorix - Tetra Pulver in Durchstechflaschen und Lösungsmittel in Fertigspritzen zur Herstellung einer Injektionslösung |
one dose (0,5 ml) contains: Live attenuated measles virus (Schwarz strain) - not less than 103,0 CCID50 Live attenuated mumps virus (RIT 4385, derived from Jeryl Lynn strain) - not less than 104,4 CCID50 Live attenuated rubella virus (Wistar RA 27/3 strain ) - not less than 103,0 CCID50 Live attenuated varicella virus (Oka strain) - not less than 103,3 PFU (2) |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Austria |
|
Priorix - Tetra Pulver und Lösungsmittel zur Herstellung einer Injektionslösung |
One dose (0,5 ml) contains: Live attenuated measles virus (Schwarz strain ) - not less than 103,0 CCID50 Live attenuated mumps virus (RIT 4385, derived from Jeryl Lynn strain) - not less than 104,4 CCID50 Live attenuated rubella virus (Wistar RA 27/3 strain ) - not less than 103,0 CCID50 Live attenuated varicella virus (Oka strain) - not less than 103,3 PFU (2) |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Belgium |
|
Priorix-Tetra |
one dose (0,5 ml) contains: Live attenuated measles virus (Schwarz strain) - not less than 103,0 CCID50 Live attenuated mumps virus (RIT 4385, derived from Jeryl Lynn strain) - not less than 104,4 CCID50 Live attenuated rubella virus (Wistar RA 27/3 strain ) - not less than 103,0 CCID50 Live attenuated varicella virus (Oka strain) - not less than 103,3 PFU (2) |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Cyprus |
|
Priorix Tetra powder and solvent for solution for injection |
one dose (0,5 ml) contains: Live attenuated measles virus (Schwarz strain) - not less than 103,0 CCID50 Live attenuated mumps virus (RIT 4385, derived from Jeryl Lynn strain) - not less than 104,4 CCID50 Live attenuated rubella virus (Wistar RA 27/3 strain) - not less than 103,0 CCID50 Live attenuated varicella virus (Oka strain) - not less than 103,3 PFU (2) |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Cyprus |
|
PRIORIX TETRA POWDER IN VIAL + SOLVENT IN AMPOULE |
one dose (0,5 ml) contains: Live attenuated measles virus (Schwarz strain) - not less than 103,0 CCID50 Live attenuated mumps virus (RIT 4385, derived from Jeryl Lynn strain) - not less than 104,4 CCID50 Live attenuated rubella virus (Wistar RA 27/3 strain) - not less than 103,0 CCID50 Live attenuated varicella virus (Oka strain) - not less than 103,3 PFU (2) |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Czech Republic |
|
PRIORIX-TETRA INJ. STŘÍKAČKA |
one dose (0,5 ml) contains: Live attenuated measles virus (Schwarz strain) - not less than 103,0 CCID50Live attenuated mumps virus (RIT 4385 strain, derived from Jeryl Lynn strain) - not less than 104,4 CCID50 Live attenuated rubella virus (Wistar RA 27/3 strain) - not less than 103,0 CCID50 Live attenuated varicella virus (Oka strain) - not less than 103,3 PFU (2) |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Czech Republic |
|
PRIORIX-TETRA LAHVIČKA/AMPULE |
one dose (0,5 ml) contains: Live attenuated measles virus (Schwarz strain) - not less than 103,0 CCID50 Live attenuated mumps virus (RIT 4385 strain, derived from Jeryl Lynn strain) - not less than 104,4 CCID50 Live attenuated rubella virus (Wistar RA 27/3 strain) - not less than 103,0 CCID50 Live attenuated varicella virus (Oka strain) - not less than 103,3 PFU (2) |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Denmark |
|
Priorix-Tetra |
one dose (0,5 ml) contains: Live attenuated measles virus (Schwarz strain) - not less than 103,0 CCID50 Live attenuated mumps virus (RIT 4385 strain, derived from Jeryl Lynn strain) - not less than 104,4 CCID50 Live attenuated rubella virus (Wistar RA 27/3 strain) - not less than 103,0 CCID50. Live attenuated varicella virus (Oka strain) - not less than 103,3 PFU (2) |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Denmark |
|
Priorix-Tetra |
one dose (0,5 ml) contains: Live attenuated measles virus (Schwarz strain) - not less than 103,0 CCID50 Live attenuated mumps virus (RIT 4385 strain, derived from Jeryl Lynn strain) - not less than 104,4 CCID50 Live attenuated rubella virus (Wistar RA 27/3 strain) - not less than 103,0 CCID50. Live attenuated varicella virus (Oka strain) - not less than 103,3 PFU (2) |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Estonia |
|
PRIORIX-TETRA |
one dose (0,5 ml) contains: Live attenuated measles virus (Schwarz strain) - not less than 103,0 CCID50 Live attenuated mumps virus (RIT 4385, derived from Jeryl Lynn strain) - not less than 104,4 CCID50 Live attenuated rubella virus (Wistar RA 27/3 strain) - not less than 103,0 CCID50 Live attenuated varicella virus (Oka strain) - not less than 103,3 PFU (2) |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Estonia |
|
PRIORIX-TETRA |
one dose (0,5 ml) contains: Live attenuated measles virus (Schwarz strain) - not less than 103,0 CCID50 Live attenuated mumps virus (RIT 4385, derived from Jeryl Lynn strain) - not less than 104,4 CCID50 Live attenuated rubella virus (Wistar RA 27/3 strain) - not less than 103,0 CCID50 Live attenuated varicella virus (Oka strain) - not less than 103,3 PFU (2) |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Finland |
|
PRIORIX TETRA |
one dose (0,5 ml) contains: Live attenuated measles virus (Schwarz strain) - not less than 103,0 CCID50 Live attenuated mumps virus (RIT 4385, derived from Jeryl Lynn strain) - not less than 104,4 CCID50 Live attenuated rubella virus (Wistar RA 27/3 strain) - not less than 103,0 CCID50 Live attenuated varicella virus (Oka strain) - not less than 103,3 PFU (2) |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
||||||
|
France |
|
PRIORIX-TETRA, poudre et solvant pour solution injectable en seringue préremplie. Vaccin rougeoleux, des oreillons, rubéoleux et varicelleux (vivant) |
one dose (0,5 ml) contains: Live attenuated measles virus (Schwarz strain) - not less than 103,0 CCID50 Live attenuated mumps virus (RIT 4385, derived from Jeryl Lynn strain) - not less than 104,4 CCID50 Live attenuated rubella virus (Wistar RA 27/3 strain) - not less than 103,0 CCID50 Live attenuated varicella virus (Oka strain) - not less than 103,3 PFU (2) |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
France |
|
PRIORIX-TETRA, poudre et solvant pour solution injectable. Vaccin rougeoleux, des oreillons, rubéoleux et varicelleux (vivant) |
one dose (0,5 ml) contains: Live attenuated measles virus (Schwarz strain) - not less than 103,0 CCID50 Live attenuated mumps virus (RIT 4385, derived from Jeryl Lynn strain) - not less than 104,4 CCID50 Live attenuated rubella virus (Wistar RA 27/3 strain) - not less than 103,0 CCID50 Live attenuated varicella virus (Oka strain) - not less than 103,3 PFU (2) |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Germany |
|
Priorix-Tetra |
one dose (0,5 ml) contains: Live attenuated measles virus (Schwarz strain) - not less than 103,0 CCID50 Live attenuated mumps virus (RIT 4385, derived from Jeryl Lynn strain) - not less than 104,4 CCID50 Live attenuated rubella virus (Wistar RA 27/3 strain) - not less than 103,0 CCID50 Live attenuated varicella virus (Oka strain) - not less than 103,3 PFU (2) |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Germany |
|
Priorix-Tetra |
one dose (0,5 ml) contains: Live attenuated measles virus (Schwarz strain) - not less than 103,0 CCID50 Live attenuated mumps virus (RIT 4385, derived from Jeryl Lynn strain) - not less than 104,4 CCID50 Live attenuated rubella virus (Wistar RA 27/3 strain) - not less than 103,0 CCID50 Live attenuated varicella virus (Oka strain) - not less than 103,3 PFU (2) |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Greece |
|
PRIORIX-TETRA |
one dose (0,5 ml) contains: Live attenuated measles virus (Schwarz strain) - not less than 103,0 CCID50 Live attenuated mumps virus (RIT 4385, derived from Jeryl Lynn strain) - not less than 104,4 CCID50 Live attenuated rubella virus (Wistar RA 27/3 strain) - not less than 103,0 CCID50 Live attenuated varicella virus (Oka strain) - not less than 103,3 PFU (2) |
Powder and solvent for solution for injection |
Intramuscular use, subcutaneous use |
||||||
|
Hungary |
|
Priorix Tetra por és oldószer oldatos injekcióhoz |
one dose (0,5 ml) contains: Live attenuated measles virus (Schwarz strain) - not less than 103,0 CCID50 Live attenuated mumps virus (RIT 4385 strain, derived from Jeryl Lynn strain) - not less than 104,4 CCID50 Live attenuated rubella virus (Wistar RA 27/3 strain) - not less than 103,0 CCID50 Live attenuated varicella virus (Oka strain) - not less than 103,3 PFU (2) |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Hungary |
|
Priorix Tetra por és oldószer oldatos injekcióhoz előretöltött fecskendőben |
one dose (0,5 ml) contains: Live attenuated measles virus (Schwarz strain) - not less than 103,0 CCID50 Live attenuated mumps virus (RIT 4385 strain, derived from Jeryl Lynn strain) - not less than 104,4 CCID50 Live attenuated rubella virus (Wistar RA 27/3 strain) - not less than 103,0 CCID50 Live attenuated varicella virus (Oka strain) - not less than 103,3 PFU (2) |
Powder and solvent for solution for injection in pre-filled syringe |
Subcutaneous use |
||||||
|
Iceland |
|
Priorix Tetra |
one dose (0,5 ml) contains: Live attenuated measles virus (Schwarz strain) - not less than 103,0 CCID50 Live attenuated mumps virus (RIT 4385, derived from Jeryl Lynn strain) - not less than 104,4 CCID50 Live attenuated rubella virus (Wistar RA 27/3 strain) - not less than 103,0 CCID50 Live attenuated varicella virus (Oka strain) - not less than 103,3 PFU (2) |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Iceland |
|
Priorix Tetra |
one dose (0,5 ml) contains: Live attenuated measles virus (Schwarz strain) - not less than 103,0 CCID50 Live attenuated mumps virus (RIT 4385, derived from Jeryl Lynn strain) - not less than 104,4 CCID50 Live attenuated rubella virus (Wistar RA 27/3 strain) - not less than 103,0 CCID50 Live attenuated varicella virus (Oka strain) - not less than 103,3 PFU (2) |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Ireland |
|
Priorix-Tetra – powder and solvent for solution for injection in a pre-filled syringe Measles, mumps, rubella and varicella vaccine (live) |
one dose (0,5 ml) contains: Live attenuated measles virus (Schwarz strain) - not less than 103,0 CCID50 Live attenuated mumps virus (RIT 4385, derived from Jeryl Lynn strain) - not less than 104,4 CCID50 Live attenuated rubella virus (Wistar RA 27/3 strain) - not less than 103,0 CCID50 Live attenuated varicella virus (Oka strain) - not less than 103,3 PFU (2) |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Ireland |
|
Priorix-Tetra – powder and solvent for solution for injection Measles, mumps, rubella and varicella vaccine (live) |
one dose (0,5 ml) contains: Live attenuated measles virus (Schwarz strain) -not less than 103,0 CCID50 Live attenuated mumps virus (RIT 4385, derived from Jeryl Lynn strain) - not less than 104,4 CCID50 Live attenuated rubella virus (Wistar RA 27/3 strain) - not less than 103,0 CCID50 Live attenuated varicella virus (Oka strain) - not less than 103,3 PFU (2) |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Ireland |
|
Priorix-Tetra – powder and solvent for solution for injection Measles, mumps, rubella and varicella vaccine (live) |
one dose (0,5 ml) contains: Live attenuated measles virus (Schwarz strain) - not less than 103,0 CCID50 Live attenuated mumps virus (RIT 4385, derived from Jeryl Lynn strain) - not less than 104,4 CCID50 Live attenuated rubella virus (Wistar RA 27/3 strain) - not less than 103,0 CCID50 Live attenuated varicella virus (Oka strain) - not less than 103,3 PFU (2) |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Italy |
|
PRIRIX TETRA |
one dose (0,5 ml) contains: Live attenuated measles virus (Schwarz strain ) - not less than 103,0 CCID50 Live attenuated mumps virus (RIT 4385, derived from Jeryl Lynn strain) - not less than 104,4 CCID50 Live attenuated rubella virus (Wistar RA 27/3 strain ) - not less than 103,0 CCID50 Live attenuated varicella virus (Oka strain) - not less than 103,3 PFU (2) |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Latvia |
|
Priorix-Tetra powder and solvent for solution for injection |
one dose (0,5 ml) contains: Live attenuated measles virus (Schwarz strain) - not less than 103,0 CCID50 Live attenuated mumps virus (RIT 4385, derived from Jeryl Lynn strain) - not less than 104,4 CCID50 Live attenuated rubella virus (Wistar RA 27/3 strain) - not less than 103,0 CCID50 Live attenuated varicella virus (Oka strain) - not less than 103,3 PFU (2) |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Latvia |
|
Priorix-Tetra powder and solvent for solution for injection in pre-filled syringe |
one dose (0,5 ml) contains: Live attenuated measles virus (Schwarz strain) - not less than 103,0 CCID50 Live attenuated mumps virus (RIT 4385, derived from Jeryl Lynn strain) - not less than 104,4 CCID50 Live attenuated rubella virus (Wistar RA 27/3 strain) - not less than 103,0 CCID50 Live attenuated varicella virus (Oka strain) - not less than 103,3 PFU (2) |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Lithuania |
|
Priorix-Tetra |
one dose (0,5 ml) contains: Live attenuated measles virus (Schwarz strain) - not less than 103,0 CCID50 Live attenuated mumps virus (RIT 4385, derived from Jeryl Lynn strain) - not less than 104,4 CCID50 Live attenuated rubella virus (Wistar RA 27/3 strain) - not less than 103,0 CCID50 Live attenuated varicella virus (Oka strain) - not less than 103,3 PFU (2) |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Luxembourg |
|
PRIORIX TETRA |
one dose (0,5 ml) contains: Live attenuated measles virus (Schwarz strain) - not less than 103,0 CCID50 Live attenuated mumps virus (RIT 4385 strain derived from Jeryl Lynn strain) - not less than 104,4 CCID50 Live attenuated rubella virus (Wistar RA 27/3 strain) - not less than 103,0 CCID50 Live attenuated varicella virus (OKA strain) - not less than 103,3 PFU (2) |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Poland |
|
Priorix-Tetra |
one dose (0,5 ml) contains dose: Live attenuated measles virus (Schwarz strain) - not less than 103,0 CCID50 Live attenuated mumps virus (RIT 4385, derived from Jeryl Lynn strain) - not less than 104,4 CCID50 Live attenuated rubella virus (Wistar RA 27/3 strain) - not less than 103,0 CCID50 Live attenuated varicella virus (Oka strain) - not less than 103,3 PFU (2) |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Portugal |
|
Priorix-Tetra |
one dose (0,5 ml) contains: Live attenuated measles virus (Schwarz strain) - not less than 103,0 CCID50 Live attenuated mumps virus (RIT 4385, derived from Jeryl Lynn strain) - not less than 104,4 CCID50 Live attenuated rubella virus (Wistar RA 27/3 strain) - not less than 103,0 CCID50 Live attenuated varicella virus (Oka strain) - not less than 103,3 PFU (2) |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Portugal |
|
Priorix-Tetra |
one dose (0,5 ml) contains: Live attenuated measles virus (Schwarz strain) - not less than 103,0 CCID50 Live attenuated mumps virus (RIT 4385, derived from Jeryl Lynn strain) - not less than 104,4 CCID50 Live attenuated rubella virus (Wistar RA 27/3 strain) - not less than 103,0 CCID50 Live attenuated varicella virus (Oka strain) - not less than 103,3 PFU (2) |
Powder and solvent for solution for injection in pre-filled syringe |
Subcutaneous use |
||||||
|
Romania |
|
PRIORIX-TETRA |
one dose (0,5 ml) contains: Live attenuated measles virus (Schwarz strain) - not less than 103,0 CCID50 Live attenuated mumps virus (RIT 4385, derived from Jeryl Lynn strain) - not less than 104,4 CCID50 Live attenuated rubella virus (Wistar RA 27/3 strain) - not less than 103,0 CCID50 Live attenuated varicella virus (Oka strain) - not less than 103,3 PFU (2) |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Slovak Republic |
|
Priorix Tetra |
one dose (0,5 ml) contains: Live attenuated measles virus (Schwarz strain) - not less than 103,0 CCID50 Live attenuated mumps virus (RIT 4385, derived from Jeryl Lynn strain) - not less than 104,4 CCID50 Live attenuated rubella virus (Wistar RA 27/3 strain ) - not less than 103,0 CCID50 Live attenuated varicella virus (Oka strain) - not less than 103,3 PFU (2) |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Slovak Republic |
|
Priorix-Tetra lag |
one dose (0,5 ml) contains: Live attenuated measles virus (Schwarz strain) - not less than 103,0 CCID50 Live attenuated mumps virus (RIT 4385, derived from Jeryl Lynn strain) - not less than 104,4 CCID50 Live attenuated rubella virus (Wistar RA 27/3 strain) - not less than 103,0 CCID50 Live attenuated varicella virus (Oka strain) - not less than 103,3 PFU (2) |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Slovenia |
|
Priorix-Tetra prašek in vehikel za raztopino za injiciranje v napolnjeni injekcijski brizgi |
one dose (0,5 ml) contains: Live attenuated measles virus (Schwarz strain) - not less than 103,0 CCID50 Live attenuated mumps virus (RIT 4385, derived from Jeryl Lynn strain) - not less than 104,4 CCID50 Live attenuated rubella virus (Wistar RA 27/3 strain) - not less than 103,0 CCID50 Live attenuated varicella virus (Oka strain) - not less than 103,3 PFU (2) |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Sweden |
|
Priorix Tetra |
one dose (0,5 ml) contains: Live attenuated measles virus (Schwarz strain) - not less than 103,0 CCID50 Live attenuated mumps virus (RIT 4385, derived from Jeryl Lynn strain) - not less than 104,4 CCID50 Live attenuated rubella virus (Wistar RA 27/3 strain) - not less than 103,0 CCID50 Live attenuated varicella virus (Oka strain) - not less than 103,3 PFU (2) |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
Sweden |
|
Priorix Tetra |
one dose (0,5 ml) contains: Live attenuated measles virus (Schwarz strain) - not less than 103,0 CCID50 Live attenuated mumps virus (RIT 4385, derived from Jeryl Lynn strain) - not less than 104,4 CCID50 Live attenuated rubella virus (Wistar RA 27/3 strain) - not less than 103,0 CCID50 Live attenuated varicella virus (Oka strain) - not less than 103,3 PFU (2) |
Powder and solvent for solution for injection |
Subcutaneous use |
||||||
|
The Netherlands |
|
Priorix-Tetra injectieflacon/ampul, poeder en oplosmiddel voor oplossing voor injectie |
one dose (0,5 ml) contains: Live attenuated measles virus (Schwarz strain) - not less than 103,0 CCID50 Live attenuated mumps virus (RIT 4385, derived from Jeryl Lynn strain) - not less than 104,4 CCID50 Live attenuated rubella virus (Wistar RA 27/3 strain) - not less than 103,0 CCID50 Live attenuated varicella virus (Oka strain) - not less than 103,3 PFU (2) |
Powder and solvent for solution for injection |
Parenteral use |
||||||
|
The Netherlands |
|
Priorix-Tetra, poeder en oplosmiddel in voorgevulde spuit voor oplossing voor injectie |
one dose (0,5 ml) contains: Live attenuated measles virus (Schwarz strain) - not less than 103,0 CCID50 Live attenuated mumps virus (RIT 4385, derived from Jeryl Lynn strain) - not less than 104,4 CCID50 Live attenuated rubella virus (Wistar RA 27/3 strain) - not less than 103,0 CCID50 Live attenuated varicella virus (Oka strain) - not less than 103,3 PFU (2) |
Powder and solvent for solution for injection |
Parenteral use |
||||||
|
United Kingdom |
|
PRIORIX-TETRA powder for solution for injection |
one dose (0,5 ml) contains: Live attenuated measles virus (Schwarz strain) - not less than 103,0 CCID50 Live attenuated mumps virus (RIT 4385, derived from Jeryl Lynn strain) - not less than 104,4 CCID50 Live attenuated rubella virus (Wistar RA 27/3 strain) - not less than 103,0 CCID50 Live attenuated varicella virus (Oka strain) - not less than 103,3 PFU (2) |
Powder and solution for injection |
Subcutaneous use |
(1) PFU: plaque forming units.
(2) PFU: plaque forming units.