natgillin/translations-raw huggingface dataset:
8 mg+500 mg +30 mg capsule, tablet, effervescent tablet 
8 mg+500 mg +30 mg capsulă, comprimat, comprimat efervescent
8mg + 520mg + 6.25mg 
8mg + 520mg + 6.25mg drajeu
1000mg+30mg suppository rectal use 
1000mg+30mg supozitor administrare rectală
GlaxoSmithKline Consumer Healthcare or SmithKline Beecham 
Marea Britanie Activând sub denumirile Sterling Health sau GlaxoSmithKline Consumer Healthcare sau SmithKline Beecham
300 mg and 14,05 mg capsule, hard oral use 
300 mg and 14,05 mg capsulă
Luxembourg Mylan bvba/sprl Rozendal Businesspark Terhulpsesteenweg 6A B-1560 Hoeilaart Belgium 
Luxemburg Mylan bvba/sprl Rozendal Businesspark
A.C. 
z o.o.
30,6 mg + 500 mg film-coated tablet oral use 
30,6 mg + 500 mg comprimat filmat administrare orală
500 mg, 10 mg and 30 mg film-coated tablet oral use 
500 mg, 10 mg and 30 mg comprimat filmat administrare orală
Paracetamol/Codeine KLIPAL CODEINE 600 mg/50 mg, comprimé 
Paracetamol/Codeină KLIPAL CODEINE 600 mg/50 mg, comprimé
PANADOL ULTRA RAPIDE 8 mg + 500 mg + 30 mg effervescent tablet 
PANADOL ULTRA RAPIDE 8 mg + 500 mg + 30 mg comprimat efervescent
Hafnarfjörður Iceland codeine phosphate+paracetamo l 
Hafnarfjörður Islanda fosfat de codeină +paracetamol
Codeine + paracetamol 
Codeină + paracetamol
325 mg and 15 mg tablet 
325 mg and 15 mg comprimat
Paracetamol/Codeine COMPRALGYL 400 mg/20 mg, comprimé sécable 
Paracetamol/Codeină COMPRALGYL 400 mg/20 mg, comprimé sécable
Bristol-Myers Squibb Polska Sp. z o.o. 
Bristol-Myers Squibb Polska Sp.
Paracetamol/Codeine KLIPAL CODEINE 300 mg/25 mg, comprimé 
Paracetamol/Codeină KLIPAL CODEINE 300 mg/25 mg, comprimé
400mg + 20mg suppository rectal use 
400mg + 20mg supozitor administrare rectală
Acetylsalicylic acid, codeine phosphate hemihydrate and ascorbic acid 
Acid acetilsalicilic, fosfat de codeină hemihidrat şi ascorbic acid
Slovenia codeine, paracetamol, propyphenazone, caffeine 
Slovenia codeină, paracetamol, propifenazonă, cafeină
paracetamol + codeine Codis 500 Tablets tablet for oral solution 
paracetamol + codeină Codis 500 Tablets
Kodein/Paracetamol 
Codeină/Paracetamol
1000mg/60 mg suppository rectal use 
1000mg/60 mg supozitor administrare rectală
Winthrop Pharms Cocodamol 8/500 effervescent tablets effervescent tablet 
Winthrop Pharms Cocodamol 8/500 effervescent tablets
The Boots Company Plc, 1 Thane Road West, NG2 3AA, Nottingham, United Kingdom ibuprofen + codeine Boots Ibuprofen and Codeine Tablets 
The Boots Company Plc, 1 Thane Road West, NG2 3AA, Nottingham, Marea Britanie ibuprofen + codeină Boots Ibuprofen and Codeine Tablets
450mg 10mg 5mg 30mg 
450mg 10mg 5mg
Germany codeinphosphathemihydrat paracetamol talvosilen 1000 mg/20 mg Zäpfchen suppository rectal use 
81479 München Germania fosfat de codeină hemihidrat paracetamol talvosilen 1000 mg/20 mg Zäpfchen supozitor administrare rectală
Germany codeinphosphathemihydrat paracetamol talvosilen 500 mg/30 mg 30 mg 500 mg suppository rectal use 
81479 München Germania fosfat de codeină hemihidrat paracetamol talvosilen 500 mg/30 mg 30 mg 500 mg supozitor administrare rectală
Paracetamol Codeine 
Paracetamol Codeină
Actavis UK Limited Whiddon Valley, Barnstaple, Devon, EX32 8NS United Kingdom 
Actavis UK Limited Whiddon Valley, Barnstaple, Devon, EX32 8NS Marea Britanie
500/30 mg suppository rectal use 
500 mg/30 mg supozitor administrare rectală
Ibuprofenum + Codeini phosphas 
Ibuprofen + Fosfat de codeină
Sandoz Limted, Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR, United Kingdom codeine phosphate 
Sandoz Limted, Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR, Marea Britanie fosfat de codeină
500 mg and 30 mg effervescent granules 
500 mg and 30 mg granule efervescente
Co-codamol tablets BP 8mg + 500mg 
Co-codamol tablets BP 8mg + 500mg comprimat
Paracetamol/Codeine CODOLIPRANE ENFANTS 400 mg/20 mg, comprimé sécable 
Paracetamol/Codeină CODOLIPRANE ENFANTS 400 mg/20 mg, comprimé sécable
400 mg and 30 mg film-coated tablet oral use 
400 mg and 30 mg comprimat filmat administrare orală
Sandoz Limted, Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR, United Kingdom paracetamol + codeine Sandoz Co-Codamol Tablets 30/500mg 
Sandoz Limted, Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR, Marea Britanie paracetamol + codeină Sandoz Co-Codamol Tablets 30/500mg
8mg + 30mg + 500 mg capsule 
8mg + 30mg + 500 mg capsulă
Acetylsalicylic acid + Codeine phosphate hemihydrate + Caffeine 
Acid acetilsalicilic + Fosfat de codeină hemihidrat + Cafeină
Paracetamol, codeine phosphate and caffeine 
Paracetamol, fosfat de codeină şi cafeină
500 mg and 10 mg tablet 
500 mg and 10 mg comprimat
500mg + 30mg capsule 
500mg + 30mg capsulă
Acetylsalicylic acid, codeine phosphate hemihydrate and caffeine 
Acid acetilsalicilic, fosfat de codeină hemihidrat şi cafeină
500mg +8mg + 30mg tablet for oral solution 
500mg +8mg + 30mg comprimat pentru soluţie orală
Germany codeinphosphathemihydrat paracetamol talvosilen 
Germania fosfat de codeină hemihdirat paracetamol
Codeini phosphas hemihydricus + paracetamolum + pitofenoni hydrochloridum + fenpiverinii bromidum 
Fosfat de codeină hemihidrat + paracetamol + clorhidrat de pitofenonă + bromură de fenpiverină
Actavis UK Limited Whiddon Valley, Barnstaple, Devon, EX32 8NS United Kingdom codeine phosphate 
Actavis UK Limited Whiddon Valley, Barnstaple, Devon, EX32 8NS Marea Britanie fosfat de codeină
500mg + 8mg + 30mg capsule 
500mg + 8mg + 30mg capsulă
Paracetamol, Codeine Phosphate Hemihydrate, Caffeine 
Paracetamol, Fosfat de codeină hemihidrat, Cafeină
500mg + 8mg + 6.25mg coated tablet 
500mg + 8mg + 6.25mg drajeu
Codeine phosphate Paracetamol 
Fosfat de codeină Paracetamol
Sweden BioPhausia AB Blasieholmsgatan 2 
BioPhausia AB Blasieholmsgatan 2 111 48 Stockholm Suedia
Czech Republic paracetamolum+ codeinum 
Republica Cehă paracetamol+ codeină
300 mg and 30 mg tablet 
300 mg and 30 mg comprimat
30mg + 500 mg capsule 
30mg + 500 mg capsulă
Paracetamol/Codeine CODOLIPRANE ADULTES 400 mg/20 mg, comprimé sécable 
Paracetamol/Codeină CODOLIPRANE ADULTES 400 mg/20 mg, comprimé sécable
500mg + 8mg + 30mg film-coated tablet oral use 
500mg + 8mg + 30mg comprimat filmat administrare orală
Germany codeinphosphathemihydrat paracetamol talvosilen 250 mg/5 mg Zäpfchen suppository rectal use 
81479 München Germania fosfat de codeină hemihidrat paracetamol talvosilen 250 mg/5 mg Zäpfchen supozitor administrare rectală
Ibuprofen/Codeine Phosphate Hemihydrate 
Ibuprofen/Fosfat de codeină hemihidrat
Bayer plc, Bayer House, Strawberry Hill, Newbury, Berkshire RG14 1JA, United Kingdom paracetamol + codeine Bayer Co-Codamol 8/500mg capsules capsule, hard Oral use 
Bayer plc, Bayer House, Strawberry Hill, Newbury, Berkshire RG14 1JA, Marea Britanie paracetamol + codeină Bayer Co-Codamol 8/500mg capsules
500 mg and 15 mg tablet 
500 mg and 15 mg comprimat
The Boots Company Plc, 1 Thane Road West, NG2 3AA, Nottingham, United Kingdom paracetamol + codeine Boots Pain Relief Plus Capsules capsule 
The Boots Company Plc, 1 Thane Road West, NG2 3AA, Nottingham, Marea Britanie paracetamol + codeină Boots Pain Relief Plus Capsules
Codeine 
Codeină
Codeine phosphate/ Paracetamol 
Fosfat de codeină/ Paracetamol
Paracetamol/ Codeine Phosphate Hemihydrate/ Caffeine 
Paracetamol/Fosfat de codeină hemihidrat/Cafeină
Codeine phosphate + paracetamol + buclizine hydrochloride 
Fosfat de codeină + paracetamol + clorhidrat de buclizină
The Boots Company Plc, 1 Thane Road West, NG2 3AA, Nottingham, United Kingdom paracetamol + codeine Paracetamol and Codeine Caplets 
The Boots Company Plc, 1 Thane Road West, NG2 3AA, Nottingham, Marea Britanie paracetamol + codeină Paracetamol and Codeine Caplets
Codeine phosphate hemihydrate + caffeine + paracetamol 
Fosfat de codeină hemihidrat + cafeină + paracetamol
Paracetamol + Codeine phosphate + Buclizine hydrochloride 
Paracetamol + Fosfat de codeină + Clorhidrat de buclizină
650 mg and 30 mg tablet 
650 mg and 30 mg comprimat
500mg + 30mg effervescent granules 
500mg + 30mg granule efervescente
Actavis UK Limited Whiddon Valley, Barnstaple, Devon, EX32 8NS United Kingdom aspirin + codeine phosphate 
Actavis UK Limited Whiddon Valley, Barnstaple, Devon, EX32 8NS Marea Britanie acid acetilsalicilic + fosfat de codeină
Dafalgan codéine effervescent tablet 
Dafalgan codéine comprimat efervescent
The Boots Company Plc, 1 Thane Road West, NG2 3AA, Nottingham, United Kingdom paracetamol + codeine + caffeine 
The Boots Company Plc, 1 Thane Road West, NG2 3AA, Nottingham, Marea Britanie paracetamol + codeină + cafeină
Paracetamol Codeine Phosphate Buclizine Hydrochloride 
Paracetamol Fosfat de codeină Clorhidrat de buclizină
500 mg/8 mg/30 mg hard capsule 
500 mg/8 mg/30 mg capsulă
Paracetamol and codeine phospate 
Paracetamol şi fosfat de codeină
500mg + 30mg film-coated tablet oral use 
500mg + 30mg comprimat filmat administrare orală
Bayer plc, Bayer House, Strawberry Hill, Newbury, Berkshire RG14 1JA, United Kingdom paracetamol + codeine Paracodol Capsules capsule 
Bayer plc, Bayer House, Strawberry Hill, Newbury, Berkshire RG14 1JA, Marea Britanie paracetamol + codeină Paracodol Capsules
Germany codeinphosphathemihydrat paracetamol talvosilen 500 mg/10 mg Zäpfchen suppository rectal use 
81479 München Germania fosfat de codeină hemihidrat paracetamol talvosilen 500 mg/10 mg Zäpfchen supozitor administrare rectală
SOLPADEINE TABLET 500mg/8mg/30mg tablet 
SOLPADEINE TABLET 500mg/8mg/30mg comprimat
SOLPADEINE SOLUBLE 500 mg/8 mg/30 mg effervescent tablet 
SOLPADEINE SOLUBLE 500 mg/8 mg/30 mg comprimat efervescent
Veganin Plus Tablets 500mg 8mg 
Veganin Plus Tablets 500mg 8mg comprimat filmat administrare orală
12.8mg + 200mg tablet 
200mg +12.8mg drajeu
Germany codeinphosphathemihydrat acetylsalicylsäure 
Germania fosfat de codeină hemihidrat acid acetilsalicilic
Ibuprofen and codeine phosphate hemihydrate 
Ibuprofen şi fosfat de codeină hemihidrat
500 mg + 10 mg effervescent tablet 
500 mg + 10 mg comprimat efervescent
500mg + 12.8mg + 30mg effervescent tablet 
500mg + 12.8mg + 30mg comprimat efervescent
Paracetamol/Codeine PARACETAMOL CODEINE SANDOZ 500 mg/30 mg, comprimé effervescent sécable 
Paracetamol/Codeină PARACETAMOL CODEINE SANDOZ 500 mg/30 mg, comprimé effervescent sécable
Paracetamol/Codeine COPRALGIR 400 mg/20 mg, comprimé sécable coated tablet 
Paracetamol/Codeină COPRALGIR 400 mg/20 mg, comprimé sécable
Codeini phosphas sesquihydricus + paracetamolum 
Fosfat de codeină sesquihidrat + paracetamol
15mg + 500mg tablet 
15mg + 500mg drajeu
500 mg and 30 mg film-coated tablet oral use 
500 mg and 30 mg comprimat filmat administrare orală
500 mg and 30 mg tablet 
500 mg and 30 mg comprimat
Sandoz Limted, Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR, United Kingdom paracetamol + diphenhydramine hydrochloride + caffeine + codeine 
Sandoz Limted, Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR, Marea Britanie paracetamol + clorhidrat de difenhidramină + cafeină + codeină
Germany codeinphosphathemihydrat coffein paracetamol 
Germania fosfat de codeină hemihidrat cafeină paracetamol
Paracetamolum INN/Codeini Phosphas Hemihydricus 
Paracetamol INN/Fosfat de codeină hemihidrat
Paracetamol Codeine Phosphate Caffeine 
Paracetamol Fosfat de codeină Cafeină
200 mg/ 12.8 mg film-coated tablet oral use 
200 mg/ 12.8 mg comprimat filmat administrare orală
Paracetamol, codeine phosphate hemihydrate 
Paracetamol, fosfat de codeină hemihidrat
Acidum acetylsalicylicum + Codeini phosphas 
Acid acetilsalicilic + Fosfat de codeină
The Boots Company Plc, 1 Thane Road West, NG2 3AA, Nottingham, United Kingdom aspirin + codeine phosphate 
The Boots Company Plc, 1 Thane Road West, NG2 3AA, Nottingham, Marea Britanie acid acetilsalicilic + fosfat de codeină
Paracetamol/Codeine PARACETAMOL CODEINE BIOGARAN 500 mg/30 mg, comprimé effervescent sécable 
Paracetamol/Codeină PARACETAMOL CODEINE BIOGARAN 500 mg/30 mg, comprimé effervescent sécable
500mg/50mg/30mg effervescent tablet 
500mg/50mg/30mg comprimat efervescent
Salicylamide + Codeine + Caffeine + Propyphenazone 
Salicilamidă + Codeină + Cafeină + Propifenazonă
Paracetamol + codeine phosphate hemihydrate+ caffeine 
Paracetamol + Fosfat de codeină hemihidrat+ cafeină
Paracetamol+ Codeine phosphate hemihydrate 
Paracetamol+ Fosfat de codeină hemihidrat
Paracetamol/Codeine PARACETAMOL CODEINE CRISTERS 500 mg/30 mg, comprimé effervescent sécable 
Paracetamol/Codeină PARACETAMOL CODEINE CRISTERS 500 mg/30 mg, comprimé effervescent sécable
500 mg+8 mg+30 mg effervescent tablet 
500 mg+8 mg+30 mg comprimat efervescent
Sandoz Limted, Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR, United Kingdom paracetamol + doxylamine succinate + caffeine + codeine 
Sandoz Limted, Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR, Marea Britanie paracetamol + succinat de doxilamină + cafeină + codeină
Paracetamol/Codeine PARACETAMOL CODEINE TEVA 500 mg/30 mg, comprimé effervescent sécable 
Paracetamol/Codeină PARACETAMOL CODEINE TEVA 500 mg/30 mg, comprimé effervescent sécable
Paracetamol Codeine Phosphate Hemihydrate Caffeine 
Paracetamol Fosfat de codeină hemihidrat Cafeină
Paracetamol/Codeine PARACETAMOL CODEINE ARROW 500 mg/30 mg, comprimé effervescent sécable 
Paracetamol/Codeină PARACETAMOL CODEINE ARROW 500 mg/30 mg, comprimé effervescent sécable
Paracetamol/Codeine PARACETAMOL CODEINE MYLAN 500 mg/30 mg, comprimé effervescent sécable 
Paracetamol/Codeină PARACETAMOL CODEINE MYLAN 500 mg/30 mg, comprimé effervescent sécable
Codeine phosphate codeine phosphate tablets BP 60mg 
Fosfat de codeină codeine phosphate tablets BP 60mg
Codeine phosphate + paracetamol 
Fosfat de codeină + paracetamol
Ibuprofen Codeine phosphate 
Ibuprofen Fosfat de codeină
Bayer plc, Bayer House, Strawberry Hill, Newbury, Berkshire RG14 1JA, United Kingdom paracetamol + codeine Co-Codamol Disp tablet for oral solution 
Bayer plc, Bayer House, Strawberry Hill, Newbury, Berkshire RG14 1JA, Marea Britanie paracetamol + codeină Co-Codamol Disp
Codeine phosphate + paracetamol + caffeine 
Fosfat de codeină +paracetamol+ cafeină
Paracetamol/Codeine PARACETAMOL CODEINE EG 500 mg/30 mg, comprimé effervescent sécable 
Paracetamol/Codeină PARACETAMOL CODEINE EG 500 mg/30 mg, comprimé effervescent sécable
Paracetamol/Codeine PARACETAMOL CODEINE ALMUS 500 mg/30 mg, comprimé effervescent sécable 
Paracetamol/Codeină PARACETAMOL CODEINE ALMUS 500 mg/30 mg, comprimé effervescent sécable
Bayer plc, Bayer House, Strawberry Hill, Newbury, Berkshire RG14 1JA, United Kingdom paracetamol + codeine Paracodol Tablets tablet for oral solution 
Bayer plc, Bayer House, Strawberry Hill, Newbury, Berkshire RG14 1JA, Marea Britanie paracetamol + codeină Paracodol Tablets
Sweden codeine phosphate hemihydrate/ paracetamol 
167 14 Bromma Suedia fosfat de codeină hemihidrat/ paracetamol
500mg 8mg 30mg capsule, hard oral use 
500mg 8mg 30mg capsulă
500mg + 30mg + 8mg effervescent tablet 
500mg + 30mg + 8mg comprimat efervescent
Codeine phosphate hemihydrate 
Fosfat de codeină hemihidrat
15mg + 500mg effervescent tablet 
15mg + 500mg comprimat efervescent
500 mg and 30 mg effervescent tablet 
500 mg and 30 mg comprimat efervescent
500mg 8mg 30mg effervescent tablet 
500mg 8mg 30mg comprimat efervescent
Ibuprofen Codeine Phosphate Hemihydrate 
Ibuprofen Fosfat de codeină hemihidrat
Azur compositum 40 mg 50 mg 
Azur compositum 40 mg 50 mg supozitor administrare rectală
Codeine phosphate codeine phosphate tablets BP 30mg 
Fosfat de codeină codeine phosphate tablets BP 30mg
Venus, 72 
Loira, 46
Paracetamol and codeine phosphate hemihydrate 
Paracetamol şi fosfat de codeină hemihidrat
Codeine phosphate codeine phosphate tablets BP 15mg 
Fosfat de codeină codeine phosphate tablets BP 15mg
8mg + 500mg + 30mg effervescent tablet 
8mg + 500mg + 30mg comprimat efervescent
Codeine phosphate hemihydrate + paracetamol 
Fosfat de codeină hemihidrat + paracetamol
Codeine phosphate + caffeine + paracetamol + doxylamine succinated 
Fosfat de codeină + cafeină + paracetamol + succinat de doxilamină
30mg + 500 mg effervescent tablet 
30mg + 500 mg comprimat efervescent
Paracetamol/ Codein phosphate hemihydrate 
Paracetamol/Fosfat de codeină hemihidrat
Paracetamol/Codeine phosphate hemihydrate 
Paracetamol/ Fosfat de codeină hemihidrat
500mg + 8mg + 30mg effervescent tablet 
500mg + 8mg + 30mg comprimat efervescent
Ireland codeine phosphate+paracetamo l 
Irlanda fosfat de codeină +paracetamol
TALVOSILEN FORTE 30 mg + 500 mg capsule, hard oral use 
TALVOSILEN FORTE 30 mg + 500 mg capsulă
Paracetamol+ Caffeine+ Codeine phosphate hemihydrate 
Paracetamol + Cafeină + Fosfat de codeină
Migraleve Pink Tablets: Paracetamol, codeine phosphate, buclizine hydrochloride 
Paracetamol, fosfat de codeină, clorhidrat de buclizină Migraleve Yellow Tablets:
Paracetamol Codeine Phosphate 
Paracetamol Fosfat de codeină
200mg +12,8 mg film-coated tablet oral use 
200mg +12,8 mg comprimat filmat administrare orală
8mg + 500mg + 30mg soluble tablet 
8mg + 500mg + 30mg comprimat pentru soluţie orală
30mg + 500mg effervescent tablet 
30mg + 500mg comprimat efervescent
500 mg/8 mg/30 mg effervescent tablet 
500 mg/8 mg/30 mg comprimat efervescent
Paracetamol/Codeine CODOLIPRANE 500 mg/30 mg, comprimé effervescent sécable effervescent tablet 
Paracetamol/Codeină CODOLIPRANE 500 mg/30 mg, comprimé effervescent sécable
Paracetamol Codeine Phosphate hemihydrate 
Paracetamol Fosfat de codeină hemihidrat
Paracetamolum + Codeini phosphas 
Paracetamol + Fosfat de codeină
500mg/8mg/30mg effervescent tablet 
500mg/8mg/30mg comprimat efervescent
Cupanol Co-codamol effervescent tablet 
Algocod comprimat efervescent
500 mg, 8 mg, 30 mg effervescent tablet 
500mg, 8mg 30mg comprimat efervescent
200mg + 12,8mg film-coated tablet oral use 
200mg + 12,8mg comprimat filmat administrare orală
200mg +12.8mg film-coated tablet oral use 
200mg +12.8mg comprimat filmat administrare orală
Paracetamol Codeine Phosphate Hyoscine Hydrobromide Anhydrous caffeine 
Paracetamol Fosfat de codeină Bromhidrat de hioscină
SW1V 2SA United Kingdom ibuprofen +codeine 
32 Vauxhall Bridge Road London SW1V 2SA Marea Britanie ibuprofen + codeină Solpaflex Tablets
Codeini phosphas hemihydricus + paracetamolum 
Fosfat de codeină hemihidrat +paracetamol
Paracetamol/ Codeine phosphate 
Paracetamol/ Fosfat de codeină
Paracetamol/codeine phosphate 
Paracetamol/Fosfat de codeină
Estrada Consiglieri Pedroso, 69 A - Queluz de Baixo 2730-055 Barcarena Portugal 
2730-055 Barcarena Portugalia
10mg + 30 mg + 450mg + 5mg 
10mg + 30 mg + 450mg + 5mg comprimat filmat
Content (concentration) 
Conţinutul (concentraţia)
1 cartridge and 1 pen 
1 cartuș și un stilou (pen)
MA (EU) number (Invented) name 
Numărul (UE) APP
Strength Pharmaceutical Form 
Numele (inventat) Concentraţia Forma farmaceutică
3 cartridges 
3 cartușe
1 cartridge 
1 cartuș
EU (MA) Number 
Numărul (UE) APP Numele (inventat)
Annex A 
Anexa A
EU (MA) Number 
Număr(AC) UE Denumire atribuită
- Summary of Product Characteristics (in full) 
- rezumatul caracteristicilor produsului (în întregime)
• Detailed information about the risk of haematological disorders (notably anaemia) associated with Victrelis, consisting of factual description of the haematological disorders in terms of frequency and time to onset and related clinical symptoms. 
• Informaţii detaliate cu privire la riscul de tulburări hematologice (în special anemia) asociat cu Victrelis, constând din descrierea efectivă a tulburărilor hematologice în ceea ce priveşte frecvenţa şi timpul până la debut şi simptomele clinice asociate.
Prior to the launch in each Member State, the Marketing Authorisation Holder shall agree with the National Competent Authority the format and content of the Physician Educational Materials and must implement such programme nationally to ensure that, prior to prescribing, all physicians are provided with a healthcare information pack containing: 
Anterior punerii pe piaţă în statele membre, deţinătorul autorizaţiei de punere pe piaţă va agrea cu autoritatea naţională competentă asupra formatului şi conţinutului materialului educaţional pentru medici şi va implementa acest program naţional pentru a se asigura că anterior prescrierii, toţi medicii au primit pachetul care conţine informaţii pentru profesioniştii din domeniul sănătăţii.
Key elements to be included in the educational material: 
Materialul educaţional trebuie să conţină următoarele elemente esenţiale:
The member States must ensure that all conditions with regard to the safe and effective use of the medicinal product described below are implemented. 
Statele Membre trebuie să asigure că sunt implementate toate condiţiile cu privire la siguranţa şi eficacitatea administrării medicamentului, descrise în cele ce urmează.
The final study report shall be submitted by 31 December 2021. 
Raportul final al studiului se transmite până la 31 decembrie 2021.
Your doctor will tell you: 
Medicul vă va spune:
Do not take a double dose to make up for a forgotten dose. 
Nu luaţi o doză dublă pentru a compensa o doză uitată.
Treatment and monitoring recommendations* 
Recomandări pentru tratament şi monitorizare*
• what dose to take and for how long. 
• ce doză să luaţi şi cât timp.
Just take your normal dose at the usual time the next day. 
Luaţi doar doza dumneavoastră normală la ora obişnuită în ziua următoare.
Not known (frequency cannot be estimated from the available data) 
Cu frecvență necunoscută (frecvența nu poate fi estimată din datele disponibile)
The objectives of the study are: 
Obiectivele studiului sunt:
• At least one marker from each of the following categories: 
• Cel puţin un marker din fiecare dintre următoarele categorii:
The usual dose that you will need to take is listed below. 
Doza obişnuită pe care va trebui să o luaţi este prezentată mai jos.
• Do not drink any type of grapefruit juice. 
• Nu beţi niciun fel de suc de grepfrut.
There is no specific treatment in the event of overdose. 
Nu există nici un tratament specific în caz de supradozaj.
Do not change the dose yourself. 
Nu vă modificaţi singur doza.
Genetic confirmation of HoFH should be obtained whenever possible. 
Trebuie obţinută confirmarea genetică a HoFH când este posibil.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 31 July 2013 
DATA PRIMEI AUTORIZĂRI SAU A REÎNNOIRII AUTORIZAŢIEI Data primei autorizări: 31 iulie 2013
48155 Münster Germany 
48155 Münster Germania
Therefore, particular caution should be exercised in these patients. 
Prin urmare, trebuie acordată o atenţie specială la aceşti pacienţi.
*Recommendations based on an ULN of approximately 30-40 international units/L. 
*Recomandări bazate pe o LSVN de aproximativ 30-40 unităţi internaţionale/l.
There are no reliable data on its use in pregnant women. 
Nu există date fiabile privind utilizarea medicamentului la femeile gravide.
Date of latest renewal: 23 April 2018 
Data ultimei reînnoiri a autorizației: 23 aprilie 2018
Any impact on efficacy is likely to be variable. 
Impactul asupra eficacităţii este posibil să fie variabil.
o Ginkgo (to improve memory) 
o Ginkgo (pentru îmbunătăţirea memoriei)
The MAH must agree the content and format of the educational materials together with a communication plan with the national competent authority in each Member State prior to distribution in their territory. 
DAPP trebuie să convină asupra conţinutului şi formatului materialelor educaţionale, concomitent cu un plan de comunicare, împreună cu autorităţile naţionale competente din fiecare stat membru înainte de a începe distribuţia pe teritoriul acestuia.
If you feel dizzy during treatment then do not drive or use machines until you feel better. 
Dacă vă simţiţi ameţit în timpul tratamentului nu conduceţi vehicule şi nu folosiţi utilaje până când nu vă simţiţi mai bine.
This means that due to the rarity of the disease it has not been possible to obtain complete information on this medicinal product. 
Aceasta înseamnă că din cauza rarității bolii nu a fost posibilă obținerea informațiilor complete privind acest medicament.
It is typically passed down by both father and mother, who also have high cholesterol passed down from their parents. 
Aceasta este transmisă de obicei atât de tată cât şi de mamă, care au de asemenea niveluri mari ale colesterolului transmise de la părinţii acestora.