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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 ▼

3.6.2019	Bayer AG (BYE-4)	03134	Gadovist 1,0 mmol/ ml (sol iru 5x7,5 ml (striek.inj.napl.skl.))	3.6.2019	O
30.4.2019	Pfizer Europe MA EEIG (PFI-BE-3)	25313	DIFLUCAN P.O.S. 10 mg/ml (plu por 1x24,4 g (fľ.HDPE+odm.lyžička alebo striekačka))	30.4.2019	O
29.4.2019	MERCK spol. s r.o. (MRS)	02048	Euthyrox 88 mikrogramov (tbl 100x88 µg (blis.PP/Al))	29.4.2019	O
27.5.2019	Pfizer Europe MA EEIG (PFI-BE-3)	83458	DALACIN C 300 mg (cps dur 16x300 mg (blis.PVC/Al))	30.5.2019	O
6.5.2019	B.Braun Melsungen AG (BME)	8133A	Amiped (sol inf 12x250 ml (vak.PP/styrén-etylén-butylén-styrén (SEBS)/polyéter-ester))	6.5.2019	O
29.4.2019	Mylan IRE Healthcare Limited (MYR)	95021	LIPANTHYL SUPRA 215 mg (tbl flm 30x215 mg (blis.PVC/PE/PVDC/Al))	29.4.2019	O
30.4.2019	Pfizer Europe MA EEIG (PFI-BE-3)	25314	DIFLUCAN P.O.S. 40 mg/ml (plu por 1x24,4 g (fľ.HDPE+odm.lyžička alebo striekačka))	30.4.2019	O
29.5.2019	Farmaceutyczna Spółdzielnia Pracy "GALENA" (FRA-2)	0860C	Cyclonamine 500 mg (cps dur 30(3x10)x500 mg (blis.PVC/PVDC/Al))	29.5.2019	O
24.5.2019	Glenmark Pharmaceuticals s.r.o. (GLM-CZ)	6406B	Bendamustine Glenmark 2,5 mg/ml (plc ifo 5x100 mg (liek.inj.skl.jantárová))	23.5.2019	O
30.4.2019	Pfizer Europe MA EEIG (PFI-BE-3)	03365	DALACIN C 150 mg (cps dur 16x150 mg (blis.PVC/Al))	30.4.2019	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
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
2.5.2019	Mylan Ireland Limited (MNY)	95320	Tamsulosin HCL Mylan 0,4 mg (cps mdd 100x0,4 mg (blis.PVC/PE/PVDC/Al))	6.5.2019	O
3.5.2019	Haleon Czech Republic s.r.o. (HLE)	26253	Fenistil 1 mg/g gél (gel der 1x30 g (tuba Al))	3.5.2019	O
5.6.2019	Mylan Pharmaceuticals Limited (MLB-IE-1)	7762B	Duloxetin Mylan 60 mg tvrdé gastrorezistentné kapsuly (cps end 28x60 mg (blis.OPA/Al/PVC-Al))	5.6.2019	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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