Details
Product Name in the RMS: Vortemyel 3,5 mg
MR Number: NL/H/3175/002
Date of outcome: 27.05.2015
Type of application | |
---|---|
Level 1: Level 2: Level 3: Level 4: Level 5: |
Abridged Additional Strength/Form Generic Chemical Substance Prescription Only |
Active Substances |
BORTEZOMIB 3,5 mg |
Form | Powder for solution for injection |
MA Holder in the RMS |
Alvogen IPCo S.a.r.l, 5, Rue Heienhaff, L-1736, Senningerberg, Luxembourg |
RMS | Netherlands |
Date of last change | 14.01.2021 |
ATC-Code |
L01XX32 Bortezomib |
CMS Country | Domestic Product Name |
---|---|
Bulgaria | Vortemyel |
Croatia | Vortemyel 3,5 mg prašak za otopinu za injekciju |
Hungary | VORTEMYEL 3,5 mg por oldatos injekcióhoz |
Iceland | VORTEMYEL 3,5 mg Stungulyfsstofn, lausn |
Poland | Vortemyel |
Romania | VORTEMYEL 3,5 mg pulbere pentru soluție injectabilă |
Documents | |
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PAR: | NL_H_3175_002_PAR.pdf (24.03.2016) |
PARSummary: | NL_H_3175_002_PARSummary.pdf (24.03.2016) |
FinalSPC: | NL_H_3175_002_FinalSPC.pdf (10.08.2016) |
FinalPL: | NL_H_3175_002_FinalPL.pdf (10.08.2016) |
FinalLabelling: | NL_H_3175_002_FinalLabelling.pdf (10.08.2016) |