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Slovenská verzia

Notice of first launch, interruption or termination of supply of a human drug

Date	Holder	Code	Drug	Date from	Subject ▼

6.5.2019	Viatris Healthcare Limited (VIM-1)	86087	Thioctacid 600 HR (tbl flm 100x600 mg (liek.skl.hnedá))	6.5.2019	O
15.4.2019	medac Gesellschaft für klinische Spezialpräparate m.b.H. (MED-2)	8910A	Metoject PEN 15 mg injekčný roztok naplnený v injekčnom pere (sol ira 6x0,30 ml/15 mg (pero napl.))	15.4.2019	O
26.4.2019	KRKA, d.d., Novo mesto (KRK-2)	08791	Amlessa 4 mg/5 mg tablety (tbl 30x4 mg/5 mg (blis.OPA/Al/PVC/Al))	29.4.2019	O
13.5.2019	GlaxoSmithKline Biologicals S.A. (GAG)	25980	HAVRIX 1440 Dosis adulta (sus inj 1x1 ml/1440 E.U. (striek.inj.skl.napln.s ihlou))	13.5.2019	O
18.6.2019	Laboratories THEA (LTH)	76499	Spersadex comp. (int opo 1x5 ml (fľ.LDPE))	21.6.2019	O
4.6.2019	KRKA, d.d., Novo mesto (KRK-2)	3023B	Kventiax SR 200 mg tablety s predĺženým uvoľňovaním (tbl plg 60x200 mg (blis.OPA/Al/PVC/Al))	10.6.2019	O
13.5.2019	GlaxoSmithKline Biologicals S.A. (GAG)	45237	Cervarix injekčná suspenzia v naplnenej injekčnej striekačke (sus inj 1x0,5 ml (striek.inj.napl.+1ihla))	13.5.2019	O
9.5.2019	Actavis Group PTC ehf. (ACT-10)	12118	Levetiracetam Actavis 1000 mg filmom obalené tablety (tbl flm 100x1000 mg (blis.Al/PVC))	17.5.2019	O
9.5.2019	Berlin-Chemie AG (BCE)	34059	ZOVUDEX 125 mg (tbl 7x125 mg (blis.PVC/Al))	15.5.2019	O
9.5.2019	Berlin-Chemie AG (BCE)	32575	Priligy 30 mg filmom obalené tablety (tbl flm 3x30 mg (blis.PVC/PE/PVDC/Al))	15.5.2019	O
2.5.2019	Mylan Pharmaceuticals Limited (MLB-IE-1)	5435B	Pregabalin Mylan 300 mg tvrdé kapsuly (cps dur 56x300 mg (blis.PVC/PVDC/Al))	3.5.2019	O
10.5.2019	Menarini International Operations Luxembourg S.A. (MNR)	6359A	Spedra 200 mg tablety (tbl 4x200 mg (PVC/PCTFE/Al))	10.5.2019	O
2.5.2019	Mylan Pharmaceuticals Limited (MLB-IE-1)	5406B	Pregabalin Mylan 75 mg tvrdé kapsuly (cps dur 56x75 mg (blis.PVC/PVDC/Al))	3.5.2019	O
16.4.2019	B.Braun Melsungen AG (BME)	05641	NuTRIflex Omega special (emu inf 5x1875 ml (vak PA/PP -viackomor.))	16.4.2019	O
7.5.2019	TEVA Pharmaceuticals Slovakia s.r.o. (TEV-SK)	30221	Solifenacin Teva 10 mg (tbl flm 30x10 mg (blis.PVC/PVDC/Al))	17.5.2019	O

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Subject means:
U-Placement of medicine to Slovakian market, R-Discontinuation of medicine supply to Slovakian market,
O-Resumption of medicine supply to Slovakian market, Z-Cancelation of medicine supply to Slovakian market

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