Pregabalin Mylan

Country: European Union

Language: Slovenian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
13-01-2023
Summary of Product characteristics Summary of Product characteristics (SPC)
13-01-2023
Public Assessment Report Public Assessment Report (PAR)
19-07-2017

Active ingredient:

pregabalin

Available from:

Mylan Pharmaceuticals Limited

ATC code:

N03AX16

INN (International Name):

pregabalin

Therapeutic group:

Antiepileptics,

Therapeutic area:

Anxiety Disorders; Epilepsy

Therapeutic indications:

Nevropatske painPregabalin Mylan je primerna za zdravljenje periferne in centralne nevropatske bolečine pri odraslih. EpilepsyPregabalin Mylan je označen kot adjunctive terapija pri odraslih z delni epileptični napadi z ali brez sekundarne posplošitev. Splošne Anksioznosti DisorderPregabalin Mylan je primerna za zdravljenje Splošne Anksiozne Motnje (GAD) pri odraslih.

Product summary:

Revision: 16

Authorization status:

Pooblaščeni

Authorization date:

2015-06-24

Patient Information leaflet

                                28
9.
POSEBNA NAVODILA ZA SHRANJEVANJE
Shranjujte v originalni ovojnini za zagotovitev zaščite pred vlago.
10.
POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEUPORABLJENIH
ZDRAVIL ALI IZ NJIH NASTALIH ODPADNIH SNOVI, KADAR SO POTREBNI
11.
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM
Mylan Pharmaceuticals Limited
Damastown Industrial Park,
Mulhuddart, Dublin 15,
DUBLIN
Irland
12.
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET
EU/1/15/997/001
EU/1/15/997/002
EU/1/15/997/003
EU/1/15/997/004
EU/1/15/997/005
EU/1/15/997/006
EU/1/15/997/007
EU/1/15/997/008
13.
ŠTEVILKA SERIJE
Lot
14.
NAČIN IZDAJANJA ZDRAVILA
15.
NAVODILA ZA UPORABO
16.
PODATKI V BRAILLOVI PISAVI
Pregabalin Mylan 25 mg
17.
EDINSTVENA OZNAKA – DVODIMENZIONALNA ČRTNA KODA
Vsebuje dvodimenzionalno črtno kodo z edinstveno oznako.
29
18.
EDINSTVENA OZNAKA – V BERLJIVI OBLIKI
PC
SN
NN
30
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI
DVOJNEM TRAKU
PRETISNI OMOT
1.
IME ZDRAVILA
Pregabalin Mylan 25 mg trde kapsule
pregabalin
2.
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM
Mylan Pharmaceuticals Limited
3.
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
EXP
4.
ŠTEVILKA SERIJE
Lot
5.
DRUGI PODATKI
31
PODATKI NA ZUNANJI OVOJNINI
ŠKATLA
1.
IME ZDRAVILA
Pregabalin Mylan 50 mg trde kapsule
pregabalin
2.
NAVEDBA ENE ALI VEČ UČINKOVIN
Ena trda kapsula vsebuje 50 mg pregabalina.
3.
SEZNAM POMOŽNIH SNOVI
4.
FARMACEVTSKA OBLIKA IN VSEBINA
trda kapsula
14 trdih kapsul
21 trdih kapsul
56 trdih kapsul
84 trdih kapsul
100 trdih kapsul
84 x 1 trda kapsula
100 x 1 trda kapsula
5.
POSTOPEK IN POT(I) UPORABE ZDRAVILA
Pred uporabo preberite priloženo navodilo!
peroralna uporaba
6.
POSEBNO OPOZORILO O SHRANJEVANJU ZDRAVILA ZUNAJ DOSEGA IN
POGLEDA OTROK
Zdravilo shranjujte nedosegljivo otrokom!
7.
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA
8.
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
EXP
32
9.
POSEBNA NAVODILA ZA SHRANJEVANJE
Shranjujte v originalni ovojnini za zagotovitev zaščite pred vlago.
10.
POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEUPORABLJENIH
Z
                                
                                Read the complete document

Summary of Product characteristics

                                1
PRILOGA I
POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA
2
1.
IME ZDRAVILA
Pregabalin Mylan 25 mg trde kapsule
Pregabalin Mylan 50 mg trde kapsule
Pregabalin Mylan 75 mg trde kapsule
Pregabalin Mylan 100 mg trde kapsule
Pregabalin Mylan 150 mg trde kapsule
Pregabalin Mylan 200 mg trde kapsule
Pregabalin Mylan 225 mg trde kapsule
Pregabalin Mylan 300 mg trde kapsule
2.
KAKOVOSTNA IN KOLIČINSKA SESTAVA
Pregabalin Mylan 25 mg trde kapsule
Ena trda kapsula vsebuje 25 mg pregabalina.
Pregabalin Mylan 50 mg trde kapsule
Ena trda kapsula vsebuje 50 mg pregabalina.
Pregabalin Mylan 75 mg trde kapsule
Ena trda kapsula vsebuje 75 mg pregabalina.
Pregabalin Mylan 100 mg trde kapsule
Ena trda kapsula vsebuje 100 mg pregabalina.
Pregabalin Mylan 150 mg trde kapsule
Ena trda kapsula vsebuje 150 mg pregabalina.
Pregabalin Mylan 200 mg trde kapsule
Ena trda kapsula vsebuje 200 mg pregabalina.
Pregabalin Mylan 225 mg trde kapsule
Ena trda kapsula vsebuje 225 mg pregabalina.
Pregabalin Mylan 300 mg trde kapsule
Ena trda kapsula vsebuje 300 mg pregabalina.
Za celoten seznam pomožnih snovi glejte poglavje 6.1.
3.
FARMACEVTSKA OBLIKA
trda kapsula
Pregabalin Mylan 25 mg trde kapsule
Trda želatinasta kapsula, velikosti št. 4, z belim neprozornim
telesom kapsule in neprozornim
pokrovčkom kapsule svetlo breskove barve. Kapsula je napolnjena z
belim do belkastim prahom.
3
Kapsula ima na telesu in pokrovčku kapsule s črnilom vzdolžno
odtisnjeno oznako MYLAN preko
PB25.
Pregabalin Mylan 50 mg trde kapsule
Trda želatinasta kapsula, velikosti št. 3, z belim neprozornim
telesom kapsule in neprozornim
pokrovčkom kapsule temno breskove barve. Kapsula je napolnjena z
belim do belkastim prahom.
Kapsula ima na telesu in pokrovčku kapsule s črnilom vzdolžno
odtisnjeno oznako MYLAN preko
PB50.
Pregabalin Mylan 75 mg trde kapsule
Trda želatinasta kapsula, velikosti št. 4, z neprozornim telesom in
pokrovčkom kapsule svetlo breskove
barve. Kapsula je napolnjena z belim do belkastim prahom. Kapsula ima
na telesu in pokrovčku
kapsule s črnilo
                                
                                Read the complete document

Similar products

Active ingredient pregabalin

pregabalin

ATC code N03AX16

N03AX16

Marketed by Mylan Pharmaceuticals Limited

Mylan Pharmaceuticals Limited

INN (International Name) pregabalin

pregabalin

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Patient Information leaflet Patient Information leaflet Bulgarian 13-01-2023
Summary of Product characteristics Summary of Product characteristics Bulgarian 13-01-2023
Public Assessment Report Public Assessment Report Bulgarian 19-07-2017
Patient Information leaflet Patient Information leaflet Spanish 13-01-2023
Summary of Product characteristics Summary of Product characteristics Spanish 13-01-2023
Public Assessment Report Public Assessment Report Spanish 19-07-2017
Patient Information leaflet Patient Information leaflet Czech 13-01-2023
Summary of Product characteristics Summary of Product characteristics Czech 13-01-2023
Public Assessment Report Public Assessment Report Czech 19-07-2017
Patient Information leaflet Patient Information leaflet Danish 13-01-2023
Summary of Product characteristics Summary of Product characteristics Danish 13-01-2023
Public Assessment Report Public Assessment Report Danish 19-07-2017
Patient Information leaflet Patient Information leaflet German 13-01-2023
Summary of Product characteristics Summary of Product characteristics German 13-01-2023
Public Assessment Report Public Assessment Report German 19-07-2017
Patient Information leaflet Patient Information leaflet Estonian 13-01-2023
Summary of Product characteristics Summary of Product characteristics Estonian 13-01-2023
Public Assessment Report Public Assessment Report Estonian 19-07-2017
Patient Information leaflet Patient Information leaflet Greek 13-01-2023
Summary of Product characteristics Summary of Product characteristics Greek 13-01-2023
Public Assessment Report Public Assessment Report Greek 19-07-2017
Patient Information leaflet Patient Information leaflet English 13-01-2023
Summary of Product characteristics Summary of Product characteristics English 13-01-2023
Public Assessment Report Public Assessment Report English 19-07-2017
Patient Information leaflet Patient Information leaflet French 13-01-2023
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Public Assessment Report Public Assessment Report French 19-07-2017
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Public Assessment Report Public Assessment Report Italian 19-07-2017
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Public Assessment Report Public Assessment Report Lithuanian 19-07-2017
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Public Assessment Report Public Assessment Report Hungarian 19-07-2017
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Public Assessment Report Public Assessment Report Slovak 19-07-2017
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Summary of Product characteristics Summary of Product characteristics Finnish 13-01-2023
Public Assessment Report Public Assessment Report Finnish 19-07-2017
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Patient Information leaflet Patient Information leaflet Croatian 13-01-2023
Summary of Product characteristics Summary of Product characteristics Croatian 13-01-2023
Public Assessment Report Public Assessment Report Croatian 19-07-2017

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